Opinion 01/2018

European Aviation Safety Agency Draft acceptable means of compliance (AMC) and guidance material (GM) to Regulation …/… [IR] laying down rules and procedures for the operation of unmanned aircraft and to the Annex (Part-UAS — UAS operations in the ‘open’ and ‘specific’ categories) Disclaimer This document, courtesy of EASA, contains the latest draft AMC and GM to Regulation …/… [IR] laying down rules and procedures for the operation of unmanned aircraft and to its Annex (Part-UAS). It is intended to provide information to stakeholders following the publication of EASA Opinion No 01/2018. EASA does not assume any liability for its contents. Page 1 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM Table of contents Draft AMC/GM to Regulation …/… [IR] laying down rules and procedures for the operation of unmanned aircraft ..............................................................................................................................................................3 Draft AMC/GM to the Annex — Part-UAS ‘UAS operations in the “open” and “specific” categories’ ............9 SUBPART A — ‘Open’ category ........................................................................................................................9 SUBPART B — ‘Specific’ category ...................................................................................................................18 SUBPART C — LIGHT UAS OPERATOR CERTIFICATE (LUC) .............................................................................28 Page 2 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM Draft AMC/GM to Regulation …/… [IR] laying down rules and procedures for the operation of unmanned aircraft GM1 Article 1 Areas of applicability of this Regulation Regulation (EU) …/… [IR] does not apply to indoor UAS operations or to UAS operations in the ‘certified’ category. GM1 Article 2(14) Definition of ‘autonomous operation’ The definition of ‘autonomous operation’ does not include flight phases during which the remote pilot loses the ability to intervene in the course of the aircraft, either following the implementation of emergency procedures, or due to a loss of the command-and-control connection. GM1 Article 2(17) Definition of ‘dangerous goods’ Dangerous goods means articles or substances capable of posing a risk to health, safety, property or the environment, included in the list of dangerous goods of the ‘Technical Instructions’, or classified as such in accordance with that document. ‘Technical Instructions’ means the latest effective edition of International Civil Aviation Organization (ICAO) Doc 9284 ‘Technical Instructions for the Safe Transport of Dangerous Goods by Air’, including its Supplement and any Addenda/Corrigenda thereto. Dangerous goods include substances such as explosives, compressed liquids and gases, flammable liquids and solids, substances that react with water, oxidisers and organic peroxides, substances liable to spontaneous combustion, toxic or infectious substances, radioactive material, magnetised material, and corrosives. GM1 Article 3 Responsibilities of the unmanned aircraft system (UAS) operator and remote pilots The respective responsibilities of the UAS operator and its remote pilots are defined in UAS.OPEN.050, UAS.OPEN.070, UAS.SPEC.050, and UAS.SPEC.070. AMC1 Article 7 Registration number The registration number should consist of 10 digits organised as the following: — 2 digits representing the nation; — 1 digit identifying the national register (if the nation defines multiple registers); and — 7 digits uniquely identifying the operator. GM1 Article 7 Keep the registration database updated and accessible in real time Member States (MS) should define the duration of the validity of each registration and ensure that the information in the database is accurate. Considering that the typical average lifetime of a small UAS is about 2 years and the small UAS market is very dynamic, MS should consider a 3-year validity for the data contained in the registry. The database should be accessible in real time, for enforcement purposes, by persons authorised by any EU MS. Member States may allow temporary registration for third-country operators. Page 3 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM GM1 Article 8 Designation of the competent authority Member States may also designate an entity as a competent authority only for specific tasks. GM1 Article 9 Guidelines for Risk-based oversight (RBO) The guidelines below are based on the document ‘practices for risk-based oversight’ which may be found at: — https://www.easa.europa.eu/document-library/general-publications/practices-risk-based- oversight This document: — highlights the relationship between RBO and the (safety) management system, the management of change, the overall performance of the organisation and the oversight cycle; — describes the interconnection, availability and exchange of data, which will significantly change the relationship between the authority and their regulated entities, as well as their ongoing management of safety; — does not constitute regulatory material nor means of compliance nor guidance material. It reflects the RBO state of play to date, in an effort to gain a common understanding and look ahead; — can be used as guidelines for competent authorities having to implement RBO. The guidelines below will be replaced in due course by further acceptable Means of Compliance and Guidance Material 1. General Definitions: a. Oversight: the function by means of which a competent authority ensures that the applicable requirements are met by regulated entities b. Risk profile: the element of risk that are inherent to the nature and operations of the regulated entity, this includes  The specific nature of the organisation  The complexity of its activities  The risks stemming from activities carried out. c. Safety performance: the demonstration of how effectively can a regulated entity mitigate its risks substantiated through the proven ability to:  Comply with the applicable requirements  Implement and maintain effective safety management  Identify and manage safety risks  Achieve and maintain safe operations The result of past certification and /or oversight also need to be taken into account d. Risk based oversight (RBO): a way of performing oversight, where:  Planning is driven by the combination of risk profile and safety performance; and Page 4 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM  Execution focuses on the management of risk, besides ensuring compliance 2. RBO scheme: The RBO scheme is described in paragraph 2.2 of the ‘practices for risk-based oversight’. It is summed-up by the drawing below: 3. Risk profile and oversight planning: Risk profile and oversight are described in the paragraph 3 of the ‘practices for risk-based oversight’. 4. Safety information Management of safety information and information sharing with other authorities are described in paragraph 4 of ‘practices for risk-based oversight’. 5. Training an qualifications of inspectors Training and qualification of inspectors are described in paragraph 4.3 of ‘practices for risk-based oversight’. 6. Conduct of risk-based audits: Conduct of risk-based audits is described in paragraph 5 of ‘practices for risk-based oversight’. GM1 Article 11 Airspace restriction related to UAS operations 1. Article 11 of Regulation (EU) …/… [IR] should be considered as a tool for Member States to allow them flexibility to define zones over their territory where only certain categories of UAS operation may be conducted. This includes defined areas where UAS operations are limited to commercial or leisure ones or where certain equipment, such as a geo-awareness or an electronic identification system, is mandatory. Moreover, Member States may define zones where: (a) only UAS are admitted; or (b) UAS, remote pilots or operators may be exempted from certain requirements; or (c) operational limitations are extended. Page 5 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM 2. When defining those zones, their extent should be considered in 3D (horizontal and vertical). 3. Special zones for UAS operations should be established in the context of airspace reservations as specified in Regulation (EC) No 2150/2005. 4. It should be considered that a UAS operator may not be familiar with the aviation regulations and procedures. Therefore, the information on zones should be made available to all UAS operators in a manner that is simple to access and understand, maximising the use of electronic devices(e.g. websites, applications for mobile devices …); in particular, the information on the zones of a Member State should be made all available in a single source. 5. Member States should ensure that aeronautical information provided through the aeronautical information service (AIS) is consistent with the airspace areas or special zones for UAS operations. 6. Member States should also publish the airspace restrictions relevant to UAS in the National Integrated Aeronautical Information Package (AIP) Section ENR.5.1, ‘Prohibited, Restricted and Danger Areas’. The publication of airspace restrictions in the AIP should ensure the situational awareness for flight crews of the manned aviation. GM2 Article 11 Airspace restrictions GENERAL 1. Airspace restrictions are defined in Article 2.2c of Regulation (EC) No 2150/2005 of 23th December 2005, which lays down common rules for the flexible use of airspace. It is expected that the Member States will establish restricted areas, which should not affect manned aviation operations. The restricted areas that are established to protect aerodrome traffic should specify volumes of airspace within which UAS operations are not allowed. The airspace restriction, established in accordance with paragraph 2 of Article 11, should clearly specify the types of the restrictions from which UAS operations are exempted. 2. When establishing a zone of airspace where a prior authorisation is needed, Member States should specify at least: (a) the authorising entity (e.g. ATS unit, ANSP, competent authority); (b) the means of requesting the authorisation (e.g. telephone, email, web-based); (c) the minimum time for requesting the authorisation prior to the operations; (d) the minimum time for granting/rejecting the authorisation prior to operations; (e) the time duration of the restriction, if not permanent; (f) the types of UAS operations allowed; (g) the allowed UAS classes and the equipment required (e.g. geo-awareness, surveillance equipment); (h) maximum height/altitude of UAS operations. Page 6 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM GM3 Article 11 Airspace restriction consultation prior notifying an airspace restriction It is recommended that before the creation of a permanent airspace restriction, the Member State should organise a consultation of the affected stakeholders (e.g. UAS community, manned aircraft community, non-aviation authorities, etc.). It is not necessary to consult for each and every permanent airspace restrictions only for those the MS considers that they will have a significant impact. The form and manner of the consultation should be decided by the MS. GM1 Article 12(1) Exchange of safety information Cooperation between competent authorities should be organised pursuant to Article 61 of Regulation (EU) …/…. [new BR]. Cooperation between market surveillance authorities and the exchange of safety-related and non-compliance information should be organised pursuant to Regulation (EC) No 765/2008. Article 12 of Regulation …/… [IR] is intended to help organise the information flow and cooperation between the competent authorities on the one hand, and between the market surveillance authorities on the other. Cooperation should be organised primarily at the Member State level. All the competent authorities concerned should make the best use of the information systems defined in Articles 22 ‘Exchange of information — Community Rapid Information System’ and 23 ‘General information support system’ of Regulation (EC) No 765/2008, as well as of the occurrence-reporting system of Regulation (EU) No 376/2014. GM1 Article 12(2) Occurrence report According to Regulation (EU) No 376/2014, occurrences shall be reported when they refer to a condition which endangers, or which, if not corrected or addressed, would endanger an aircraft, its occupants, any other person, equipment or installation affecting aircraft operations. Article 125 of the new Basic Regulation (EU) …/… [new BR] limits the events to be reported for operations in the ‘open’ and ‘specific’ UAS categories to occurrences and other safety-related information involving such UA if the event resulted in a fatal or serious injury to a person or it involved aircraft other than UA. GM1 Article 6 Hobbyist flights Hobbyists have the following options to conduct their operations: 1. They may operate as members of a model club or association that has received from the competent authority an operational authorisation, as defined in Article 6 of Regulation (EU) …/… [IR]. In this case, they should comply with the procedures of the model club or association in accordance with the operational authorisation. The operational authorisation should define all the deviations from the aforementioned Regulation granted to the model club or association’s members, including the requirement to register individual unmanned aircraft (UA). 2. In accordance with Article 11 of Regulation (EU) …/… [IR], Member States may define zones where UAS are exempted from certain requirements, and/or where the operational limitations are extended. They may also define different height limitations for those zones. 3. Operations may be conducted in Subcategory A3 in which UAS in class C3, UAS in class C4 and homebuilt UAS that do not comply with any technical requirements, are allowed. In this case, hobbyists are required to comply with the limitations of, and demonstrate the competency defined in, UAS.OPEN.40. Page 7 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM GM1 Article 14 Recognition of remote pilot competencies demonstrated before the applicability date UAS operations are already being conducted by several remote pilots (including military pilots) in different Member States following their national rules. To facilitate the transition to comply with the requirements of Regulation (EU) …/… [IR], Member States should define a system to accept already- demonstrated remote pilot competency. Page 8 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM Draft AMC/GM to the Annex — Part-UAS ‘UAS operations in the “open” and “specific” categories’ SUBPART A — ‘Open’ category AMC1 UAS.OPEN.010(2)(a), UAS.OPEN.010(3)(e) and UAS.OPEN.070(4) Visual line of sight 1. Remote pilots should at all times keep the UA at a distance such that they, or one UA observer, are able to continuously maintain visual lines of sight to the UA without using any devices to aid them other than glasses or contact lenses. 2. Operations in first-person view (FPV) can be conducted only if the remote pilot is assisted by a UA observer positioned in his or her proximity, able to provide effective directions to the remote pilot in order to maintain the required separation between the UA and any obstacle, including other air traffic. During FPV operations, the remote pilot is still responsible for the safety of the flight. AMC UAS.OPEN.010(3) Close proximity to an obstacle When the UAS operation is conducted in proximity to an obstacle taller than 120m, the remote pilot should maintain the UA within 50 m from its perimeter. The entity responsible for the obstacle needs to request the UAS operator to conduct any operation close to it. No UAS operator should conduct any operation close to an obstacle without such an authorisation. AMC1 UAS.OPEN.020(1) Operational limitations in Subcategory A1 Operations in subcategory A1 may be conducted over people, however, the remote pilot should reduce as much as possible the time during which the UA overflies persons, and when flying close to or over people, the UA should not fly less than 3 m above ground level. Remote pilots should not fly UA over open-air assemblies of persons so as to avoid situations in which if a UA crashes, the people do not have enough space to move away from the trajectory of the UA and to avoid being hit by it. GM1 UAS.OPEN.030(1) and UAS.OPEN.040(1) Definition of ‘uninvolved person’ Due to the huge variety of possible circumstances, this GM only provides general guidelines. An involved person is someone who can reasonably be expected to follow directions and safety precautions given by the person controlling the operation, in order to avoid unplanned interactions with the UA. Spectators or any other people gathered for sport activities or other mass public events that do not occur for the purpose of the UAS operation are generally considered to be ‘uninvolved persons’. In principle, in order to be considered an ‘involved person’, one should: — be able to decide whether or not to participate in the UAS operation; — broadly understand the risks involved; — have reasonable safeguards during the UAS operations, introduced by the site manager and aircraft operator; and — not be restricted from taking part in the event or activity if they decide not to participate in the UAS operation. Page 9 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM An example: when filming with a UAS at a large music festival or public event, it is not sufficient to inform the audience or anyone present via a public address system, or via a statement on the ticket, or in advance by email or text message. Those types of communication channels do not satisfy the points above. In order to be considered an involved person, each person should be asked for their permission and be made aware of the possible risk(s). AMC1 UAS.OPEN.020(3)(b) and UAS.OPEN.040(2) Remote pilot competency to operate in Subcategory A1 and A3 The acquisition of competency by each remote pilot should be supported by an online training and testing tool that covers the following elements: 1. Regulation (EU) …/… [IR] and other relevant EU regulations on privacy and security with regard to: (a) non-reckless behaviour, important safety precautions for UAS operations, and basic requirements regarding dangerous goods. (b) VLOS, which entails: (i) keeping a safe distance from people, animals, property, vehicles, and other airspace users; (ii) the identification of open assemblies of people; (iii) a specific code of conduct in case the UA encounters other traffic; (iv) respecting the height limitation(s); and (v) using a UA observer; (c) obtaining updated information about any flight restrictions or conditions published by the Member State, such as: (i) an overview of the low-level airspace structure that affects UAS operations; and (ii) zones in which UA are banned or limited; (d) familiarising themselves with the operating environment; (e) emergency procedures (e.g. for lost-data-link connections) and what to do if an event occurs that causes a fatal or serious injury to a person, or when an aircraft other than a UA is involved (occurrence reporting); (f) human factors involved in night operations and (g) weather information sources and the effect of weather on the performance of small UA; 2. an understanding of the privacy risks; 3. an understanding of the security risks; 4. an understanding of the UAS categories and their operational limitations; 5. familiarisation with the instructions provided by the manufacturer for the operation of a UAS, and in particular with regard to: (a) an overview of the main UAS parts; Page 10 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM (b) becoming familiar with the remote control or transmitter; (c) controlling the UAS; (d) features that affect the safety of flight; (e) the preflight checklist to verify that the UA is in a safe condition; (f) controlling the take-off of the UA; (g) hovering in mid-air, when applicable, and landing the UA; (h) flying basic patterns with the UA; and (i) finding a suitable area to conduct familiarisation flights and learn how to fly the particular UAS. AMC1 UAS.OPEN.020(4)(b)&(c), UAS.OPEN.030(4) and UAS.OPEN.040(3)(b)&(c) Modification of a UAS with a CE Class mark UAS operators should not make any modifications to a UAS in class C0, C1, C2 or C3 that breach compliance with the product requirements. If the operator carries out such a modification on a UAS, that UAS is no longer considered to have a CE Class mark and it may only be operated in Subcategory A3, or in the specific category in accordance with Subpart B of Annex I to Regulation (EU) …/… [IR]. GM UAS.OPEN.020(4)(b)&(c), UAS.OPEN.030(4) and UAS.OPEN.040(3)(b)&(c) Modification of a UAS with a CE Class mark Modifications to UAS that breach compliance with the requirements for the CE marking are those that affect weight and performance outside the specifications of the manufacturer. A replacement of a part with another that has the same physical and functional characteristic is not considered to be a breach of the requirements for the CE mark (e.g. a replacement of a propeller with another of the same design). The UA user manual should define instructions for performing maintenance and apply changes that do not breach the CE mark requirements. AMC1 UAS.OPEN.30(2) Safe distance from uninvolved persons 1. The minimum horizontal distance of the UA from uninvolved persons should be defined as the distance between the point where the UA would hit the ground in the event of a vertical fall and the position of the uninvolved persons. The safe distance of the UA from uninvolved persons is variable and is heavily dependent on the type of UAS operation and the UAS involved. The remote pilot is ultimately responsible for the determination of this distance. 2. When the UA is operating in close proximity to people, the remote pilot should keep the UA at a lateral distance from any uninvolved person that is not shorter than the height (‘1:1 rule’, i.e. if the UA is flying at distance of 10 m from uninvolved person, the height of the UA should not exceed 10 m) and with a minimum value of: (a) 5 m, when operating a balloon or airship or when a low-speed mode is activated and a maximum speed of 3 m/s is set; (b) 50 m in all other cases. Page 11 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM Remote pilot a Uninvolved persons a  5 m, if operating a balloon or airship or with low speed mode  50 m without low speed mode AMC1 UAS.OPEN.030(3) Remote pilot competencies required to obtain a remote pilot certificate of competency 1. In order to be eligible to attend the test for obtaining a certificate of remote pilot competency, the remote pilot should: (a) demonstrate that they passed the online test in accordance with UAS.OPEN.040(2); (b) declare that they conducted an adequate number of familiarisation flights in suitable areas as instructed by the online training. 2. In order to obtain a certificate of remote pilot competency, the remote pilot should demonstrate that they: (a) understand the safety risks linked with a UAS operation in close proximity to uninvolved people or with a heavier UA; (b) are able to assess the ground risk related to the environment where the operation takes place, as well as to flying in proximity to uninvolved people; (c) have a basic knowledge of how to plan a flight and define contingency procedures; (d) understand how weather conditions may affect the performance of the UA; and (e) can maintain control of the UA at all times in a manner that ensures the successful outcome of a procedure or manoeuvre. 3. The approved entity should verify the identity of the applicant. 4. An applicant for a certificate of remote pilot competency may either receive competency-based training at a declared training organisation (DTO) or train themselves. GM1 UAS.OPEN.030(2) Remote pilot competencies required to obtain a certificate of remote pilot competency A remote pilot may obtain the knowledge needed to pass the exam for a certificate of remote pilot competency in one of the following two ways: 1. Competency-based training (a) Competency-based training covers aspects related to non-technical skills in an integrated manner, taking into account the particular risks associated with UAS operations. (b) Competency-based training should be developed using the analysis, design, development, implementation, evaluation (ADDIE) principles. 2. Self-study Page 12 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM (a) A remote pilot may undertake self-study in many ways in order to obtain a certificate of competency. The purpose of this self-study is to acquire some basic competency and familiarise themselves with the UA, as well as with the UA operations they want to conduct. (b) Examples of self-study: (i) reading the manual or leaflet provided by the UA manufacturer; (ii) reading related information or watching instructional films; and (iii) obtaining information from others who have already experience in flying a UA. The remote pilot may also undertake this study as classroom training, e-learning or similar training at a training organisation, including DTOs or approved training organisations (ATOs). Since this training is not mandated by the Member States, the national aviation authorities (NAAs) are not required to approve the training syllabuses, even if this training is provided by ATOs. AMC1 UAS.OPEN.040(1) Operations in Subcategory A3 1. The remote pilot should keep the UA at a safe distance from the boundaries of congested areas such that no third party is endangered in the event of a UA malfunction or a loss of control. The safe distance should be determined based on the actual performance of the UA. 2. The remote pilot should assess that reasonably, no uninvolved person will be present in the area and airspace where the UA is intended to be flown, during the entire time of the UAS operation. 3. Should a person incidentally enter the visual range of the remote pilot, the remote pilot should avoid overflying the person, and discontinue the operation if the safety of the UAS operation is not ensured. AMC1 UAS.OPEN.050(1) Operational procedures If a UAS operator employs more than one remote pilot, the UAS operator should: — develop procedures for UAS operations in order to coordinate the activities between its employees; and — compile and maintain a list of their personnel and their assigned duties. AMC1 UAS.OPEN.050(2)(e) and UAS.OPEN.070(1)(a) Physical and mental condition Remote pilots and all other personnel should not operate when under the influence of psychoactive substances or alcohol or when unfit to perform their task(s) due to injury, fatigue, medication, sickness or other similar causes. GM1 UAS.OPEN.050(3)(a) EU declaration of conformity When purchasing a UAS through online distributors, the UAS operator should verify the conformity of the UAS with the requirements of Regulation (EU) …/… [DA]. The verification should be accomplished by checking that the UAS is accompanied by the EU certificate of conformity, defined in Appendix 11 to said Regulation, which should contain the same CE Class mark as the one on the label on the UA (i.e. class C0, class C1, class C2; class C3 or class C4) AMC1 UAS.OPEN.060(1) and UAS.SPEC.060(1) Registration form 1. The UAS operator should complete the registration process online and provide at least their: Page 13 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM (a) Full name or the name of the business, if a company; (b) mailing address where the operator is established or residing; (c) email address and telephone number; (d) insurance policy number; and (e) date of birth for natural persons; 2. If it is an organisation, the UA operator should include the statement: ‘All personnel directly involved in the operations are competent to perform their tasks, and the UAS will be operated only by remote pilots with the appropriate level of competency’. AMC1 UAS.OPEN.060(3) and UAS.SPEC.060(4) Display of registration information 1. If the UAS operator owns the UAS, it should display on the UA the registration number received at the end of the registration process in a way that this information is readable at least when the UA is on the ground without the need for any devices other than eyeglasses or corrective lenses. 2. The registration number should be stated on a fire-resistant placard; a QR code (Quick Response Code) may be an acceptable means. 3. If the size of the UA does not allow the mark to be displayed in a visible way on the fuselage, a marking inside the battery compartment is acceptable if the compartment is accessible. In such a case, the placard should be acid- and fire-resistant. 4. The owner of UAS should only register if they operate the UAS. For example, if a company owns UAS with the sole purpose of renting them to customers, it is not required to register itself. The owner of the UAS should keep a record of the renter’s data at least for a period of 2 years and make it available to the competent authority, if requested. 5. If a UAS operator uses a UAS owned by a third party, the UAS operator that operates the UAS should: (a) register itself; (b) display its identification number on the UA; and (c) upload the registration number into the e-identification system, if the UA is equipped with one. GM1 UAS.OPEN.060(4) and UAS.SPEC.060(5) E-identification The operator should upload the registration number assigned to him or her into the UA. The UA e-identification system will combine the operator’s registration number with the serial number of the UA to create a unique UA identification number. This data will be broadcast by the e-identification system. AMC1 UAS.OPEN.070(1)(b) Ability to take control of the UA 1. Except in the event of a lost-link condition or a free-flight UA, the remote pilot should be able to take control of the UA at any time. Autonomous operations are not allowed in the ‘open’ category. 2. The remote pilot should: Page 14 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM (a) be focused on the operation of the UA, as appropriate; (b) not operate a UAS while operating a moving vehicle; and (c) operate only one UA at a time. 3. If the remote pilot operates a UA from a moving ground vehicle or boat, the speed of the vehicle should be slow enough for the remote pilot to maintain a visual line of sight (VLOS) to the UA and maintain control of the UA at all times. GM UAS.OPEN.070(1)(b) Free-flight UA ‘Free flight’ means performing flights with no external control, taking advantage of the ascending currents, dynamic winds and the performance of the model. Outdoor free flights are carried out with gliders or with models equipped with means of propulsion (e.g. rubber-bands, thermal engines) that raise them in altitude, before they freely glide and follow the air masses. AMC1 UAS.OPEN.070(2)(a) Obtaining updated information about any flight restrictions or conditions published by the Member State The remote pilot should check any conditions that may affect the UAS operation, such as airspace structure and limitations. This information should be retrieved from sources that are acceptable to the MS of operation. GM1 UAS.OPEN.070(2)(a) and UAS.SPEC.070(2)(a) Obtaining updated information about any flight restrictions or conditions published by the Member State Information on airspace structure and limitations will be provided by the Member States in accordance with Article 12 and may be obtained from the relevant aeronautical information publication (AIP) (usually available online), the MS’s website page or through dedicated service providers (e.g. by using an application or any other electronic means). Flight restrictions include limited zones for UA or no-UA zones, as defined in Article 11 of Regulation (EU) …/… [IR]. AMC1 UAS.OPEN.070(2)(b) Operating environment 1. The remote pilot should check any conditions that might affect the UAS operation, such as the locations of people, property, vehicles, public roads, obstacles, aerodromes, critical infrastructure, and any other elements that may pose a risk to the safety of the UAS operation. 2. Familiarisation with the environment and obstacles should be conducted by walking around the area where the operation is intended to be performed. 3. It should be verified that the weather conditions at the time when the operation starts and those that are expected for the entire period of the operation are compatible with those defined in the manufacturer’s manual. AMC1 UAS.OPEN.070(2)(c) Ensuring that the UAS is in a safe condition to complete the intended flight 1. The remote pilot should: (a) update the UAS with data for the geo-awareness function if one is available on the UA; Page 15 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM (b) ensure that the UAS is fit to fly and complies with the instructions and limitations provided by the manufacturer; (c) ensure that any payload carried is properly secured and installed and that it respects the limits for the mass and centre of gravity of the UA; (d) ensure that the UA has enough propulsion energy for the intended operation based on: (i) the planned operation; and (ii) the need for extra energy in case of unpredictable events; and (e) for UAS equipped with a loss-of-data-link recovery function, ensure that the recovery function allows a safe recovery of the UAS for the envisaged operation; for programmable loss-of-data-link recovery functions, the remote pilot may have to set up the parameters of this function to adapt it to the envisaged operation. 2. The remote pilot should be familiar with the operating environment, should consider the weather conditions (including the forecast), the light conditions, and potential sources of electromagnetic energy, which may cause undesirable effects, such as electromagnetic interference (EMI) or physical damage to the operational equipment of the UAS. AMC1 UAS.OPEN.070(3)(b) Ensuring the safe operation of the UA with respect to third parties on the ground or in the air The safe operation of the UA should be ensured by: 1. maintaining the UA at a safe distance from uninvolved people, animals, property, vehicles, aerodromes and other airspace users such that they are not endangered by the UAS operation; 2. avoiding UA operations in no-UA zones or restricted UA zones, unless the operator holds an authorisation issued by the competent authority that defined the zone. 3. avoiding manoeuvres that endanger the safe operation of the UAS; and 4. discontinuing a flight when continuing the flight may pose a hazard to other aircraft, people animals, environment or property. AMC1 UAS.OPEN.070(3)(g) and UAS.SPEC.070(3)(e) Emergency response effort When there is an emergency response effort taking place in the operational area of a UAS, the UAS operation should be immediately discontinued unless it was explicitly authorised or requested by the responsible emergency response services. Otherwise, a safe distance must be maintained between the UA and the emergency response site so that the UA does not interfere with, or endanger, the activities of the emergency response services. The UAS operator should take particular care to not hinder possible aerial support and to protect the privacy rights of persons involved in the emergency event. GM1 UAS.OPEN.070(3)(g) and UAS.SPEC.070(3)(e) Emergency response ‘Emergency response’ is an action taken in response to an unexpected and dangerous event in an attempt to mitigate its impact on people, property or the environment. Page 16 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM GM1 UAS.OPEN.070(3)(h) and UAS.SPEC.070(3)(f) Respect for other people’s privacy rights minimises any nuisance caused to other persons or animals 1. In order to respect other people's rights to privacy, UA should not be flown at altitudes of less than 20 m over private property without the owner’s consent. 2. When the UA is equipped with a camera or an audio recording equipment, the remote pilot should not continuously and/or intentionally film a person without the person’s explicit permission. 3. In order to respect wildlife, UA should not be flown close to animals. AMC1 UAS.OPEN.080(3) Renewal of remote pilot competency to operate in Subcategory A1 and A3 [To be developed.] AMC1 UAS.OPEN.080(3) Renewal of certificate of remote pilot competency [To be developed.] Page 17 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM SUBPART B — ‘Specific’ category AMC1 UAS.SPEC.020 Operational risk assessment 1. The operational safety risk assessment should be performed according to the specific operations risk assessment (SORA) methodology developed by JARUS. 2. The UAS operator should define the usage spectrum of the operational risk assessment, assess the risk, and identify appropriate mitigation measures, including but not limited to technical requirements, operational requirements, and operational limitations, as well as remote-pilot competency requirements and medical requirements. GM1 UAS.SPEC.020 Methodology for operational risk assessment The specific operations risk assessment (SORA) methodology developed by JARUS is considered by EASA to be acceptable to assess the safety risks of operations in the ’specific’ category, but other methodologies might be used as alternative means of compliance (AltMoC) and may be proposed as acceptable means of compliance (AMC). Aspects other than safety, such as security, privacy, environmental protection, the use of the radio frequency spectrum, etc. should be assessed in accordance with the applicable requirements established by the Member State in which the operation is intended to take place, or by other EU regulations. GM2 UAS.SPEC.025 Standard scenarios Standard scenarios may be proposed to EASA by competent authorities, by UAS operators, by manufacturers or by standardisation bodies. As per GM1 UAS.SPEC.020, SORA is an AMC for the assessment of the safety risk of operations, but other methodologies might be used as alternative means of compliance to develop standard scenarios. After EASA has evaluated a standard scenario, it may issue that standard scenario as an AMC to this Regulation. GM1 UAS.SPEC.030 Operational declaration An operational declaration is required for standard scenarios for which the associated operational risk assessment concludes that the overall intrinsic level of risk of the operation is low. The overall intrinsic level of risk of the operation can be considered to be low when it can be mitigated to an acceptable level by using a combination of technical means, procedures and competencies that require a low level of robustness for most of those mitigations and not more than medium level for a minority of them. The concept of the robustness of mitigations and the associated levels are described in the JARUS guidelines on Specific Operations Risk Assessment (SORA). The standard scenario includes the operational declaration form that the UAS operator is required to submit to the competent authority. The form may include the following information: 1. a reference to the standard scenario under which the declaration is submitted; 2. the registration number of the UAS operator; 3. the name of the accountable manager or the owner in the case of a private UAS operator; Page 18 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM 4. a statement that the mitigation, limitations and conditions as required by the standard scenario have been put in place by the UAS operator; 5. an acknowledgement of the UAS operator’s responsibility under Regulation (EU) …/… [IR]. AMC1 UAS.SPEC.030(2) Declaration, verification and acknowledgement of receipt 1. The competent authority should establish an online system (e.g. web based) for submission of operational declarations, which provides the submitter with an automatic acknowledgement of receipt when the submission has been successful. 2. For a submission to be considered successful, the online system should check that all the required information has been provided. Otherwise, the system should indicate to the submitter which parts of the information still need to be added to complete the submission of the declaration (e.g. fields to be filled in, compliance with requirements or statements to be accepted or acknowledged, etc.). AMC1 UAS.SPEC.030(3) Operations conducted in a Member State other that the Member State of registration 1. When a UAS operation that is subject to an operational declaration takes place in an MS other than the MS of registration of the UAS operator, the UAS operator should take into account the applicable local conditions and regulations. 2. The UAS operator should submit their declaration to both the competent authority of the MS of registration and the competent authority of the MS of the operation. 3. The competent authority of the MS of registration has the responsibility for verifying that the declaration contains all the required information and documents. AMC1 UAS.SPEC.035(1) Operational authorisation application 1. An operational authorisation application should include, at least, the following information: (a) the registration number of the UAS operator and the serial number of the UA (and if the UA is registered, the UA registration number); (b) the name of the accountable manager or the owner in the case of a private UAS operator; (c) a reference to the standard scenario under which the application is submitted, if applicable; (d) a description of the UAS, including its performance, that is relevant for the operation; (e) a description of the proposed operation of the UAS (i.e. the concept of the operation); (f) if the operation is included in a standard scenario, all the documentation required by the standard scenario; (g) if the operation is not included in a standard scenario, the operational risk assessment as per UAS.SPEC.020; (h) the list of mitigation measures put in place by the UAS operator, as required by the standard scenario or proposed by the UAS operator if no standard scenario is available with sufficient information for the Authority to assess the robustness of the mitigation means; and Page 19 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM (i) the location(s) where the operation is intended to be conducted1. 2. The standard scenario should include the operational authorisation application form that the UAS operator is required to submit to the competent authority. 3. The application should include all the information relevant to the operation, such as: (a) the name of the MS where the operation is intended to be conducted if it is different from the UAS operator’s MS of registration; (b) a statement of compliance with the limitations and conditions applicable to the relevant standard scenario, if applicable; and (c) a signed acknowledgement of the operator’s responsibility under Regulation (EU) …/… [IR]. GM1 UAS.SPEC.035(1) Application for an operational authorisation 1. An operational authorisation is required for standard scenarios for which the associated operational risk assessment concludes that the overall intrinsic level of risk of the operation is medium to high. 2. The overall intrinsic level of risk of the operation can be considered to be medium to high when it can be mitigated to an acceptable level by using a combination of technical means, procedures and competencies that require a level of robustness that is high for one or more of those mitigations. 3. The concept of robustness of mitigations and the associated levels are described in the JARUS guidelines on Specific Operations Risk Assessment (SORA). 4. The UAS operator may submit an application for an operational authorisation of a single flight, a series of flights over a specific period of time, or for an unlimited duration. AMC1 UAS.SPEC.035(3) Significant changes to the operational authorisation 1. Any non-editorial change that affects the operational authorisation, or affects any associated documentation that is submitted to demonstrate compliance with the requirements established for the authorisation, should be considered to be a significant change. 2. With regard to the information and documentation associated with the authorisation, changes should be considered significant when they involve, for example: (a) changes in the operations that affect the assumptions of the risk assessment; (b) changes that relate to the management system of the UAS operator (including changes of key personnel), its ownership or its principal place of business; (c) non-editorial changes that affect the operational risk assessment report; (d) non-editorial changes that affect the policies and procedures of the UAS operator; (e) non-editorial changes that affect the operations manual (when required). 1 The standard scenario should define whether the location may be generically described (e.g. dependent on the characteristics of the area overflown, the type of airspace, etc.) based on the concept of the operation. Page 20 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM AMC1 UAS.SPEC.040(2) Operational authorisation The operational authorisation should include the following information: 1. the registration number of the UAS operator and the serial number of the UA (and if the UA is registered, the UA registration number); 2. a reference to the operational risk assessment report developed by the UAS operator or to the applicable standard scenario; 3. the operational limitations and conditions of the operation; 4. the mitigation measures that the UAS operator has to comply with; 5. the location(s) where the operation is authorised to take place; 6. records necessary for the type of operation; and 7. the type of events that should be reported in addition to those defined in Article 125 of Regulation (EU) 376/2014, if any. GM1 UAS.SPEC.040(2) Operations manual — template MINIMUM INFORMATION The operations manual should contain at least the information listed below, if applicable, customised for the area and type of operation. OPERATIONS MANUAL TEMPLATE Operator’s name Table of contents 0. Introduction 1. Acronyms and abbreviations. 2. The system for amendment and revision of the OM (changes that require prior approval; changed to be notified to the competent authority) 3. A record of revisions 4. A list of effective pages unless the entire manual is re-issued and the manual has an effective date on it 5. A safety statement [a statement that the operations manual complies with the relevant requirements of Regulation …/… [IR] and with the authorisation or the terms of approval of the LUC and contains instructions that are to be complied with by the personnel involved in flight operations] 6. An approval Signature [the accountable manager must sign this statement] A. Concept of operation (ConOps) 1. The nature of the operation and the associated risks [description] 2. The complexity of the operation [description of the UAS, equipment, remote pilot experience, load, external systems etc., as required by the specific operation] Page 21 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM 3. The environment of operations [description of the geographical area(s) and types of operations e.g. VLOS/BVLOS in mountain area, densely populated area, on platforms, in sea or desert area, in environment sensitive area, etc.] 4. The risk analysis and methods for reduction of identified risks [description of methodology used; bow-tie presentation or other] B. The UAS, its performance and equipment [UAS used; technical log; limitations with regard to the data link, other equipment, external systems or loads, as well as performance limitations as per the manufacturer, etc.] C. The duties and responsibilities of the personnel involved in the operation – the remote pilot, supervisor, controller, operations manager etc. [initial qualifications; experience in operating UAS; experience in the particular operation; training and checking; regulations and guidance to crew members concerning health, fitness for duty and fatigue; guidance to staff on how to facilitate inspections by competent authority personnel]. D. Normal Procedures; 1. Operational procedures [applied by the remote pilot, including coordination with other personnel; the organisation and methods to exercise operational control] (a) Pre-flight preparation and checklists. This includes, but is not limited to, the following points: (i) The site of the operation (assessment of the suitability, position, surface, slope, elevation, determination of the visibility, etc.); (ii) Weather conditions (methods of obtaining weather forecasts); (iii) The class of airspace and other aircraft operations (local aerodromes or operating sites; restrictions; permissions); (iv) The individual responsibilities of crew members; (v) Communication procedures; (vi) The performance, equipment, systems, related controls and indications and operating instructions of the UA (reference to or duplication of information from the manufacturer’s manual); (vii) Cross-border operations (specific local requirements); (viii) Hazards/risks, third-party risk management, etc.; (b) Take-off and landing procedures; (c) En route procedures [Instructions on how to determine the best flight route; obstacles in the area, height; congested environments]; (d) Loss of control (loss of data link, etc.); (e) Abort procedures for use following a critical system failure. 2. Ground procedures [UA loading so that in the event of a technical fault, the load or parts of it falling from the UA do not endanger people or damage third-party property; unloading]. (a) Dangerous goods (limitations on their nature, quantity and packaging; acceptance prior to loading, inspecting packages for any evidence of leakage or damage). Page 22 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM E. Emergency procedures [include lost link; flyaway; fire (UA and ground station); preventative measures]. F. Security [instructions, guidance, procedures, and responsibilities on how to implement security requirements and protect the UAS from unauthorised modification, interference, etc.] G. Record keeping [instructions on logs and records of pilots and other data considered useful for the tracking and monitoring of the activity]. AMC1 UAS.SPEC.040(4) Operations conducted in a Member State other that the Member State of registration 1. When a UAS operation subject to an operational authorisation takes place in an MS other than the MS of registration of the UAS operator, the UAS operator should gather information about local conditions and regulations in the area of its operation and submit the application for the authorisation to the competent authority of its MS of registration. The UAS operator should satisfy the mitigation requirements related to the local conditions. 2. Liaison with the competent authority of the MS of operation may be required. AMC2 UAS.SPEC.040(4) Authorisation of a UAS operation conducted in the airspace of an MS other than the MS of registration The procedure for issuing an authorisation to a UAS operation conducted in the airspace of an MS other than the MS of registration is shown in Figure 1 and described by the following steps. 1. When a UAS operation takes place in an MS other than the UAS operator’s MS of registration, the UAS operator should also include in the application the list of local conditions published by the MS of operations, if any, and how they comply with them. 2. The competent authority of the MS of registration should verify that the local conditions published by the competent authority of the MS of registration have been taken into account by the applicant and should coordinate the authorisation with the competent authority of the MS of operation. 3. The UAS operator may then conduct the operation. Competent authority Competent authority Member State A Member State B Coordination (2) Local conditions MS B UAS operator  Zones sends an Competent  Environment application authority issues the  Security (1) authorisation  Privacy (3)  Insurance UAS Operator based  … in Member State A Specific operation in UAS operator conducts Member State B the operation (4) Page 23 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM Figure 1 - procedure for issuing an authorisation to a UAS operation conducted in the airspace of an MS other than the MS of registration AMC1 UAS.SPEC.050(1) Operator’s procedures 1. The UAS operator should develop procedures as required by the standard scenario or by the operational authorisation. 2. If a UAS operator employs more than one pilot, the UAS operator should: (a) develop procedures for UAS operations in order to coordinate the activities between its personnel; and (b) compile and maintain a list of their personnel and their assigned duties. 3. The UAS operator should allocate functions and responsibilities in accordance with the level of autonomy of the UAS during the operation. AMC1 UAS.SPEC.050(5) Logging of flight activities and record-keeping 1. An acceptable means to log and record the flight activities is to use a logbook, which may be electronic. 2. The information to be recorded should be indicated in the standard scenario or in the operational authorisation, which may include the following: (a) the identification of the UAS; NOTE: if the UAS is not subject to registration, the identification of the UAS may be done using the serial number of the UAS. (b) the date, time, and location of the take-off and landing; (c) the total number of flight hours/cycles; (d) in the case of a remotely piloted operation, the name of the remote pilot responsible for the flight; (e) any significant incident or accident that occurred during the operation; (f) a completed pre-flight inspection; (g) any defects and rectifications; (h) any repairs and changes to the UAS configuration; and (i) the information required to comply with UAS.SPEC.100. 3. Records should be stored for 2 years in a manner that ensures their protection from unauthorised access, damage, alteration, and theft. GM1 UAS.SPEC.050(8) Level of autonomy and guidelines for human-autonomy interaction The concept of autonomy, its levels and human-autonomous system interactions are currently being discussed in various domains (not only in aviation), and no common understanding has yet been reached. Guidance will therefore be provided once this concept is mature and globally accepted. Page 24 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM Nevertheless, the risk assessment of autonomous operations should ensure, as for any other operations, that the risk is mitigated to an acceptable level. Besides, it is expected that autonomous operations or operations with a high level of autonomy will be subject to authorisation and will not be covered by standard scenarios until enough experience is gained. AMC1 UAS.SPEC.055(3) Action in cases of operations/flights that exceed the conditions and limitations defined in the operational authorisation When a model club or association is informed that a member has exceeded the conditions and limitations defined in the operational authorisation, appropriate measures should be taken, proportionate to the risk posed. Considering the level of risk, the model club or association should decide whether the competent authority should be informed. In any case, occurrences that cause an injury to persons or involved aircraft other than UA, as defined in Article 125 of Regulation (EU) …/… [new BR], should be reported by the model club or association to the competent authority. GM1 UAS.SPEC.060 Registration within model aircraft associations and clubs Model clubs and associations may fulfil the UAS registration requirement on behalf of their members, and provide the related data to the entity designated for that purpose by the Member State. The procedures of model clubs and associations should define acceptable methods for their members to display the identification information on the UA. AMC1 UAS.SPEC.070(2)(a) Obtaining updated information about any flight restrictions or conditions published by the Member State The remote pilot, or the operator in the case of an autonomous operation, should check any conditions that may affect the UAS operation, such as the airspace structure and limitations. This information should be retrieved from sources that are acceptable to the MS of operation. AMC1 UAS.SPEC.070(2)(b) Operating environment 1. The remote pilot, or the operator in the case of an autonomous operation, should check any conditions that might affect the UAS operation, such as the locations of people, property, vehicles, public roads, obstacles, aerodromes, critical infrastructure, and any other elements that may pose a risk to the safety of the UAS operation. 2. Familiarisation with the environment and obstacles should be conducted through a survey of the area where the operation is intended to be performed. 3. It should be verified that the weather conditions at the time when the operation starts and those that are expected for the entire period of the operation are compatible with those defined in the manufacturer manual, as well as with the operational authorisation or standard scenario, as applicable. AMC1 UAS.SPEC.070(2)(c) Ensuring that the UAS is in a safe condition to complete the intended flight 1. The remote pilot, or the operator in the case of an autonomous operation, should: (a) update the UAS with data for the geo-awareness function if one is available on the UA; Page 25 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM (b) ensure that the UAS is fit to fly and complies with the instructions and limitations provided by the manufacturer; (c) ensure that any payload carried is properly secured and installed, respecting the limits for the mass and centre of gravity of the UA; (d) ensure that the UA has enough propulsion energy for the intended operation based on: (i) the planned operation; and (ii) the need for extra energy in case of unpredictable events; and (e) for UAS equipped with a loss-of-data-link recovery function, ensure that the recovery function allows a safe recovery of the UAS for the envisaged operation; for programmable loss-of-data-link recovery functions, the remote pilot may have to set up the parameters of this function to adapt it to the envisaged operation. 2. The remote pilot, or the UAS operator for autonomous operations, should be familiar with the operating environment, should consider weather conditions (including forecast), light conditions, and potential sources of electromagnetic energy, which may cause undesirable effects, such as electromagnetic interference (EMI) or physical damage to the operational equipment of the UAS. AMC1 UAS.SPEC.070(3)(b) Ensuring the safe operation of the UA The safe operation of the UAS should be ensured by: 1. maintaining a safe distance of the UA from uninvolved people, animals, property, vehicles, aerodromes and from other airspace users such that they are not endangered by the UAS operation. This safe distance should be derived from the operation risk assessment or defined by the standard scenario; 2. avoiding operation of the UA in no-UA zones or restricted UA zones, unless the operator holds an authorisation issued by the competent authority that defined the zone; 3. avoiding manoeuvres that endanger the safe operation of the UAS; and 4. discontinuing a flight when continuing the flight may pose a hazard to other aircraft, people, animals, environment or properties. AMC1 UAS.SPEC.070(3)(e) Emergency response effort When there is an emergency response effort taking place in the operational area of a UAS, that UAS operation should be immediately discontinued unless it was explicitly authorised or requested by the responsible emergency response services. When the emergency site is not in the UAS operational area but the UA might transit through the vicinity of that site, a safe distance must be maintained between the UA and the emergency response site such that the UA does not interfere with, or endanger, the activities of the emergency response services. The UAS operator should take particular care to not hinder possible aerial support and to protect the privacy rights of persons involved in the emergency event. GM1 UAS.SPEC.100 Use of certified equipment For the purpose of UAS.SPEC.100, 'certified equipment' is considered to be any equipment for which the relevant design organisation has demonstrated compliance with the applicable certification Page 26 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM specifications and received a form of recognition from EASA that attests such compliance (e.g. ETSO authorisation). This process is independent from the CE marking process. The use of certified equipment or certified UA in the specific category of operation does not imply a transfer of the flight activities into the certified category of operation. However the use of certified equipment or certified UA in the specific category should be considered as a risk reduction and/or mitigation measure in the specific operations risk assessment (SORA). GM1 UAS.SPEC.110 Alternative means of compliance UAS operators may propose alternative means of compliance, providing that an equivalent level of safety is guaranteed. In order to demonstrate that the proposed means of compliance meet the requirements defined in this Regulation, a risk assessment should be completed and documented. The result of this risk assessment should demonstrate that an equivalent level of safety to that established by the acceptable means of compliance (AMC) adopted by EASA is reached. Page 27 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM SUBPART C — LIGHT UAS OPERATOR CERTIFICATE (LUC) GM1 UAS.LUC.010 General requirements for an LUC LUCs are not mandatory. UAS operators may decide to apply for authorisations or issue declarations, as applicable, for their operations or apply for an LUC. An LUC holder is considered to be a UAS operator, therefore he or she should register according to UAS.SPEC.060 and can do it in parallel to the LUC application. AMC1 UAS.LUC.010(3) Application for an LUC The application for an LUC should include the following information: 1. a description of the UAS operator’s management system, including its organisational structure and safety management system; 2. the name(s) of the responsible UAS operator’s personnel, including the person responsible for authorising operations with UASs; and 3. a statement that all the documentation submitted to the competent authority has been verified by the applicant and found to comply with the applicable requirements. AMC1 UAS.LUC.020(3) Operational control The organisation and methods established by the LUC holder to exercise operational control within its organisation should be included in the operations manual. GM1 UAS.LUC.020(3) Operational control ‘Operational control’ should be understood as the responsibility for the initiation, continuation, termination or diversion of a flight in the interest of safety. ‘System’ in relation to operational control should be understood as the organisation, methods, documentation, personnel and training of those personnel for the initiation, continuation, termination or diversion of a flight in the interest of safety. AMC1 UAS.LUC.020(5) Record keeping GENERAL 1. The record-keeping system should ensure that all records are stored in a manner that ensures their protection from damage, alteration and theft. They should be accessible whenever needed within a reasonable time. These records should be organised in a way that ensures traceability, availability and retrievability throughout the required retention period, starting when the record was created or last amended. Adequate backups should be ensured. 2. Records should be kept in paper form or in an electronic format, or a combination of both. Records stored on microfilm or optical disc format are also acceptable. 3. All records shall be kept for at least 3 years. 4. Personnel records for each person shall be kept as long as the person works for the organisation, and shall be retained until 3 years after the person has left the organisation. Page 28 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM AMC1 UAS.LUC.030(1)(a) Safety management system SAFETY POLICY 1. The safety policy should: (a) be endorsed by the accountable manager; (b) reflect organisational commitments regarding safety, and its proactive and systematic management; (c) be communicated, with visible endorsement, throughout the organisation; (d) include internal reporting principles, and encourage personnel to report errors related to UAS operations, incidents and hazards; and (e) recognise the need for all personnel to cooperate with compliance monitoring and safety investigations. 2. The safety policy should include a commitment: (a) to improve towards the highest safety standards; (b) to comply with all applicable legislation, meet all applicable standards, and consider best practices; (c) to provide appropriate resources; (d) to apply the principles of human factors; (e) to enforce safety as a primary responsibility of all managers; and (f) to apply ‘just culture’ principles and, in particular, not to make available or use the information on occurrences: (i) to attribute blame or liability to someone for reporting something which would not have been otherwise detected; or (ii) for any purpose other than the improvement of safety. 3. The senior management of the operator should: (a) continually promote the operator’s safety policy to all personnel, and demonstrate their commitment to it; (b) provide the necessary human and financial resources for the implementation of the safety policy; and (c) establish safety objectives and associated performance standards. GM1 UAS.LUC.030(1)(a) Safety management system SAFETY POLICY The safety policy is the means whereby an organisation states its intention to maintain and, where practicable, improve safety levels in all its activities and to minimise its contribution to the risk of an accident or serious incident as far as is reasonably practicable. It reflects the management’s commitment to safety, and should reflect the organisation’s philosophy of safety management, as well as being the foundation on which the organisation’s safety management system is built. It serves as a Page 29 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM reminder of ‘how we do business here’. The creation of a positive safety culture begins with the issuance of a clear, unequivocal direction. The commitment to apply ‘just culture’ principles forms the basis for the organisation’s internal rules that describe how ‘just culture’ principles are guaranteed and implemented. For organisations that have their principal place of business in a Member State, Regulation (EU) No 376/2014 defines the ‘just culture’ principles to be applied (refer in particular to Article 16(11) thereof). GM2 UAS.LUC.030(1)(b) Safety management system SAFETY REPORTING AND INTERNAL INVESTIGATIONS The purpose of safety reporting and internal investigations is to use reported information to improve the level of safety performance of the UAS operator. The purpose is not to attribute blame or liability. The specific objectives of safety reporting and internal investigations are to: 1. enable assessments of the safety implications of each relevant incident and accident, including previous similar occurrences, so that any necessary action can be initiated; and 2. ensure that knowledge of relevant incidents and accidents is disseminated so that other persons and operators may learn from them. All occurrence reports that are considered to be reportable by the person who submits the report should be retained, as the significance of such reports may only become obvious at a later date. AMC1 UAS.LUC.030(1)(c) Safety management system COMMUNICATION ON SAFETY 1. The organisation should establish communication about safety matters that: (a) ensures that all personnel are aware of the safety management activities, as appropriate, for their safety responsibilities; (b) conveys safety-critical information, especially information related to assessed risks and analysed hazards; (c) explains why particular actions are taken; and (d) explains why safety procedures are introduced or changed. 2. Regular meetings with personnel, where information, actions, and procedures are discussed, may be used to communicate safety matters. GM1 UAS.LUC.030(1)(c) Safety management system TRAINING AND SAFETY PROMOTION Training, combined with safety communication and information sharing form part of safety promotion and supplement the organisation’s policies, encouraging a positive safety culture and creating an environment that is favourable to the achievement of the organisation’s safety objectives. Safety promotion can also be the instrument for the development of a just culture. Depending on the particular risk, safety promotion may constitute or complement a risk mitigation action, an effective reporting system and an organisation that learns from experience. Page 30 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM AMC1 UAS.LUC.030(1)(d) Safety management system SAFETY RISK MANAGEMENT The LUC holder should have a safety management system that is able to perform at least the following: 1. identify hazards through reactive, proactive, and predictive methodologies, using various data sources, including safety reporting and internal investigations; 2. collect, record, analyse, act on and generate feedback about hazards and the associated risks that affect the safety of the operational activities of the operator; 3. develop an operational risk assessment as required by UAS.SPEC.020; 4. carry out internal safety investigations; 5. monitor and measure safety performance through safety reports, safety reviews, in particular during the introduction and deployment of new technologies, safety audits, including periodically assessing the status of safety risk controls, and safety surveys; 6. manage safety risks related to a change, using a documented process to identify any external and internal change that may have an adverse effect on safety; the management of change should make use of the operator’s existing hazard identification, risk assessment, and mitigation processes; 7. manage the safety risks that stem from products or services delivered through subcontractors, by using its existing hazard identification, risk assessment, and mitigation processes, or by requiring that the subcontractors have an equivalent process for hazard identification and risk management; and 8. respond to emergencies using an emergency-response plan (ERP) that reflects the size, nature, and complexity of the activities performed by the organisation. The ERP should: (a) contain the action to be taken by the operator or specified individuals in an emergency; (b) provide for a safe transition from normal to emergency operations and vice versa; and (c) ensure coordination with the ERPs of other organisations, where appropriate; (d) describe emergency training/drills, as appropriate. GM1 UAS.LUC.030(1)(d) Safety management system SAFETY RISK MANAGEMENT In very broad terms, the objective of safety risk management is to eliminate risk, where practical, or reduce the risk (likelihood/severity) to acceptable levels, and to manage the remaining risk to avoid or mitigate any possible undesirable outcome. Safety risk management is, therefore, integral to the development and application of effective safety management. Safety risk management can be applied at many levels in an organisation. It can be applied at the strategic level and at operational levels. The potential for human error, its influences and sources, should be identified and managed through the safety risk management process. HF (human factors) risk management should allow the organisation to determine where it is vulnerable to human performance limitations. Page 31 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM AMC1 UAS.LUC.030(1)(e) Safety management system DOCUMENTATION 1. The safety management system documentation of the LUC holder should be included in a safety management manual (SMM) or in the LUC manual. If that documentation is contained in more than one operator’s manual and is not duplicated, cross references should be provided. 2. The SMM should include the following: (a) the scope of the activities under the UAS operator’s safety management system; (b) the safety policy and objectives; (c) the titles and names of persons referred to in UAS.LUC.30(c), as well as a chart showing the lines of responsibility between those persons; (d) procedures that specify how the LUC holder ensures compliance with the requirements of Regulation (EU) …/… [IR]; (e) the safety accountability of the accountable manager; (f) the safety responsibilities of key safety personnel; (g) documentation control procedures; (h) hazard identification and risk management methodologies; (i) safety action planning; (j) safety performance monitoring; (k) incident investigation and reporting; (l) emergency response planning; (m) management of change; and (n) procedures for record-keeping. GM1 UAS.LUC.030(1)(e) Safety management system MANAGEMENT OF CHANGE Unless properly managed, changes in organisational structure, facilities, scope of work, personnel, documentation, policies and procedures, etc. can result in the inadvertent introduction of new hazards, which expose the organisation to new, or increased risk. Effective organisations seek to improve their processes, with conscious recognition that changes can expose the organisations to potentially latent hazards and risks if the changes are not properly and effectively managed. Regardless of the magnitude of a change, large or small, proactive consideration should always be given to the safety implications. This is primarily the responsibility of the team that proposes and/or implements the change. However, change can only be successful if all the personnel affected by the change are engaged and involved, and they participate in the process. The magnitude of a change, its safety criticality, and its potential impact on human performance should be assessed in any change management process. Page 32 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM The process for the management of change typically provides principles and a structured framework for managing all aspects of the change. Disciplined application of change management can maximise the effectiveness of the change, engage staff, and minimise the risks inherent in change. Change is the catalyst for an organisation to perform the hazard identification and risk management processes. Some examples of change include, but are not limited to: (a) changes to the organisational structure; (b) a new type of UAS being employed; (c) additional UAS of the same or similar type being acquired; (d) significant changes in personnel (affecting key personnel and/or large numbers of personnel, high turn-over); (e) new or amended regulations; (f) changes in financial status; (g) new location(s), equipment, and/or operational procedures; and (h) new subcontractors. A change may have the potential to introduce new human factors issues, or exacerbate pre-existing issues. For example, changes in computer systems, equipment, technology, personnel (including the management), procedures, the work organisation, or work processes are likely to affect performance. The purpose of integrating human factors into the management of change is to minimise potential risks by specifically considering the impact of the change on the people within a system. Special consideration, including any human factors issues, should be given to the ‘transition period’. In addition, the activities utilised to manage these issues should be integrated into the change management plan. Effective management of change should be supported by the following: 1. implementation of a process for formal hazard analyses/risk assessment for major operational changes, major organisational changes, changes in key personnel, and changes that may affect the way a UAS operation is carried out; 2. identification of changes likely to occur in business which would have a noticeable impact on: (a) resources — material and human; (b) management guidance — processes, procedures, training; and (c) management control; 3. safety case/risk assessments that are focused on aviation safety. 4. involvement of key stakeholders in the change management process as appropriate. During the change management process, previous risk assessments and existing hazards are reviewed for possible effects. Page 33 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM GM2 UAS.LUC.030(1)(e) Safety management system SAFETY RISK MANAGEMENT - INTERFACES BETWEEN ORGANISATIONS Safety risk management processes should specifically address the planned implementation of, or participation in, any complex arrangements (such as when multiple organisations are contracted, or when multiple levels of contracting/subcontracting are included). Hazard identification and risk assessment start with an identification of all parties involved in the arrangement, including independent experts and non-approved organisations. This extends to the overall control structure, and assesses in particular the following elements across all subcontract levels and all parties within such arrangements: 1. coordination and interfaces between the different parties; 2. applicable procedures; 3. communication between all the parties involved, including reporting and feedback channels; 4. task allocation, responsibilities and authorities; and 5. the qualifications and competency of key personnel with reference to CAMO.A.305. Safety risk management should focus on the following aspects: 1. clear assignment of accountability and allocation of responsibilities; 2. only one party is responsible for a specific aspect of the arrangement - there should be no overlapping or conflicting responsibilities, in order to eliminate coordination errors; 3. the existence of clear reporting lines, both for occurrence reporting and progress reporting; 4. the possibility for staff to directly notify the organisation of any hazard by suggesting an obviously unacceptable safety risk as a result of the potential consequences of this hazard. Regular communication between all parties to discuss work progress, risk mitigation actions, changes to the arrangement, as well as any other significant issues, should be ensured. AMC1 UAS.LUC.030(1)(f) Safety management system COMPLIANCE MONITORING 1. The accountable manager should designate a manager to monitor the compliance of the LUC holder with: (a) the terms of approval, the privileges, the risk assessment and the resulting mitigation measures; (b) all operator’s manuals and procedures; and (c) training standards. 2. The compliance monitoring manager should: (a) have knowledge of, and experience in, compliance monitoring; (b) have direct access to the accountable manager to ensure that findings are addressed, as necessary; and (c) not be one of the other persons referred to in UAS.LUC.030(2)(c). Page 34 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM 3. The tasks of the compliance monitoring manager may be performed by the safety manager, provided that the latter has knowledge of, and experience in, compliance monitoring. 4. The compliance monitoring function should include audits and inspections of the LUC holder. The audits and inspections should be carried out by personnel who are not responsible for the function, procedure or products being audited. 5. An organisation should establish an audit plan to show when and how often the activities as required by this Regulation will be audited. 6. The independent audit should ensure that all aspects of compliance, including all the sub-contracted activities, are checked within a period defined in the scheduled plan, and agreed by the competent authority. 7. Where the organisation has more than one approved location, the compliance monitoring function should describe how these locations are integrated into the system and include a plan to audit each location on a risk-based programme as agreed by the competent authority. 8. A report should be raised each time an audit is carried out, describing what was checked and the resulting findings against applicable requirements and procedures. 9. The feedback part of the compliance monitoring function should address who is required to rectify any non-compliance in each particular case, and the procedure to be followed if rectification is not completed within appropriate timescales. The procedure should lead to the accountable manager. 10. The LUC holder should be responsible for the effectiveness of the compliance monitoring function, in particular for the effective implementation and follow-up of all corrective measures. GM1 UAS.LUC.030(1)(f) Safety management system COMPLIANCE MONITORING The primary objective of the compliance monitoring function is to enable the UAS operator to ensure a safe operation and to remain in compliance with this Regulation. An external organisation may be contracted to perform compliance monitoring functions. In such cases, that organisation should designate the compliance monitoring manager. The compliance monitoring manager may use one or more auditors to carry out compliance audits and inspections of the LUC holder under his own responsibility. AMC1 UAS.LUC.030(1)(g) Safety management system USE OF SUBCONTRACTORS 1. When an LUC holder uses products or services delivered through a subcontractor that is not itself certified in accordance with this Subpart, the subcontractor should work under the terms of the LUC. 2. Regardless of the certification status of the subcontractor, the LUC holder is responsible for ensuring that all subcontracted products or services are subject to the hazard identification, risk management, and compliance monitoring of the LUC holder. Page 35 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM AMC1 UAS.LUC.030(2) Safety management system PERSONNEL REQUIREMENTS — GENERAL 1. The accountable manager should have the authority to ensure that all activities are financed and carried out in accordance with the requirements of Regulation (EU) …/… [IR]. 2. The safety manager should: (a) facilitate hazard identification, risk analysis, and risk management; (b) monitor the implementation of risk mitigation measures, as listed in the safety action plan, unless action follow-up is addressed by the compliance monitoring function; (c) provide periodic reports on safety performance; (d) ensure maintenance of the safety management documentation; (e) ensure that there is safety management training available and that it meets acceptable standards; (f) provide all the personnel involved with advice on safety matters; and (g) ensure the initiation and follow-up of internal occurrence investigations. 3. Management and other personnel of the LUC holder should be qualified for the planned operations in order to meet the relevant requirements of Regulation (EU) …./… [IR]. 4. The LUC holder should ensure that its personnel receive appropriate training to remain in compliance with the relevant requirements of Regulation (EU) …/… [IR]. GM1 UAS.LUC.030(2)(a) Safety management system ACCOUNTABLE MANAGER The accountable manager is a single, identifiable person who has the responsibility for the effective and efficient performance of the LUC holder’s safety management system. The functions of the accountable manager cannot be delegated. GM1 UAS.LUC.030(2)(b) Safety management system PERSONNEL REQUIREMENTS The functions of the safety manager may be fulfilled by the accountable manager or another person charged by the UAS operator with the responsibility of ensuring that the operator remains in compliance with the requirements of Regulation (EU) …/… [IR]. Where the safety manager already fulfils the functions of the compliance-monitoring manager, the accountable manager cannot be the safety manager. Depending on the size of the organisation and the nature and complexity of its activities, the safety manager may be assisted by additional safety personnel for the performance of all the safety management tasks. Regardless of the organisational set-up, it is important that the safety manager remains the unique focal point as regards the development, administration, and maintenance of the organisation’s management system. Page 36 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM GM1 UAS.LUC.030(2)(c) Safety management system PERSONNEL REQUIREMENTS A UAS operator may include in the organisational structure of its safety management system a safety committee and, if needed, one or more safety action groups. 1. Safety committee (a) A safety committee should be established to support the accountable manager in their safety responsibilities. The safety committee should monitor: (i) the operator’s performance against safety objectives and performance standards; (ii) whether safety action is taken in a timely manner; and (iii) the effectiveness of the operator’s safety management processes. 2. Safety action group (a) Depending on the scope of the task and the specific expertise required, one or more safety action groups should be established to assist the safety manager in their functions. (b) The safety action group should be comprised of managers, supervisors and personnel from operational areas, depending on the scope of the task and the specific expertise required. (c) The safety action group should at least perform the following: (i) monitor operational safety and assess the impact of operational changes on safety; (ii) define actions to mitigate the identified safety risks; and (iii) ensure that safety measures are implemented within agreed timescales. GM1 UAS.LUC.030(3)(c) Safety management system KEY SAFETY PERSONNEL The operator should appoint personnel to manage key fields of activity such as operations, maintenance, training, etc. AMC1 UAS.LUC.040 Procedures for subcontractors If any activity is carried out by partner organisations or subcontractors, the LUC manual should include a relevant statement of how the LUC holder is able to ensure compliance with UAS.LUC.30(1)(f), and should contain, directly or by cross reference, descriptions of, and information on, the activities of those organisations or subcontractors, as necessary to substantiate this statement. GM1 UAS.LUC.040 LUC manual CONTENT The LUC manual should contain a statement signed by the accountable manager that confirms that the organisation will at all times work in accordance with this Regulation, as applicable, and with the approved LUC manual. When the accountable manager is not the chief executive officer of the organisation, then the chief executive officer shall countersign the statement. The LUC manual should contain at least the following information, customised according to the complexity of the operator. Page 37 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM The LUC manual may contain references to the Operations Manual (OM) where an OM is compiled in accordance with GM1 UAS.SPEC.040(2). LUC MANUAL TEMPLATE Operator’s name Table of contents 0. Introduction [the information under Chapter O, points 1-6 of the OM may be duplicated here or simply referenced to the OM] I. Safety management manual (SMM) 1. Safety policy [details of the operator’s safety policy, safety targets] 2. Organisational structure [organogram and brief description] 3. Duties and responsibilities of the accountable manager and key management personnel; [The person who authorises operations must be clearly identified] 4. Safety management system [description; lines of responsibilities] 5. Operational control system [description of the procedures and responsibilities necessary to exercise operational control with respect to flight safety] 6. Compliance monitoring system 7. Safety risk management [the information about hazard identification, safety risk assessment and mitigation under Chapter A of the OM may be duplicated here or simply referenced to the OM] 8. Management of change [description of the process to identify safety-critical changes within the organisation and its operation and to eliminate or modify safety risk controls that are no longer needed or effective due to such changes] 9. Development and approval of an operational scenario [description of the process] 10. Interface with subcontractors and partners 11. Documentation of key management system processes II. Operations manual (OM) [the information under Chapters A - G of the OM may be duplicated here or references to the OM may be provided] III. Handling, notifying and reporting accidents, incidents and occurrences IV. Handling of dangerous goods [the relevant regulations and instructions to crew members concerning the transport of dangerous goods (such as pesticides and chemicals, etc.) and the use of dangerous goods during operations (such as batteries and fuel cells, engines, magnetising materials, pyrotechnics, flares and firearms.)] AMC1 UAS.LUC.040(4) LUC Manual The LUC holder should ensure that all personnel are able to understand the language in which those parts of the LUC manual which pertain to their duties and responsibilities are written. Page 38 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM AMC1 UAS.LUC.050 Terms of approval of an LUC holder LIGHT UAS OPERATOR CERTIFICATE - LUC Terms of approval for conducting operations with unmanned aircraft in the specific category2 (1) State of the UAS operator: (3) LUC #: (2) Issuing Authority: (4) UAS operator’s Name: (7) Operational Points of Contact: (5) Trading Name: (6) UAS operator’s address: Telephone: Fax: Email: (8) UAS operator’s privileges: (9) UAS operator registration information: (10) Authorised standard scenario(s), or type(s) of operation as applicable: (11) Authorised area, zone or class of airspace for operations, if applicable: (12) Special limitations or conditions, if applicable: This certificate certifies that ……………………. (4) has the privilege to authorise operations with unmanned aircraft in the specific category as long as it complies with this certificate, the LUC manual, Annex IX to (Basic) Regulation (EC) No …/… [new BR] and its Implementing Rules. (13) Date of issue: (14) Title, name, signature and stamp: 1. Name of the State of the UAS operator. 2. Identification of the issuing competent authority. 3. Reference number, as issued by the competent authority. 4. UAS operator’s registered name. 5. UAS operator’s trading name. Insert ‘Dba’ (for ‘Doing business as’) before the trading name, if applicable. 2 The term ‘specific category’ is defined in Regulation (EU) ….. . It means a category of UAS operation that considering the risks involved, requires an authorisation by the competent authority before the operation takes place, taking into account the mitigation measures identified in an operational risk assessment, except for certain standard scenarios for which a declaration by the UAS operator is sufficient. Page 39 of 40  European Aviation Safety Agency UAS operations in the ‘open’ and ‘specific’ categories Draft AMC and GM 6. The address of the UAS operator’s principal place of business. The UAS operator’s principal place of business telephone and fax details, including the country code. The UAS operator’s email address is to be provided, if available. 7. The contact details include the telephone and fax numbers, including the country code, and the email address at which the accountable manager and the safety manager can be contacted without undue delay. 8. Description of the scope of the operator’s privileges in accordance with AMC1 UAS.LUC.060. 9. Insert the registration information in accordance with UAS.SPEC.060. 10. Specify the standard scenario(s) as authorised by the competent authority or the types of operations for which the privileges apply. 11. Specify the geographical area or zone (by geographical coordinates or national or regional boundaries) or the category of airspace, as authorised by the competent authority. 12. Specify special operational limitations. 13. Issue date of the LUC (dd-mm-yyyy). 14. Title, name and signature of the competent authority representative, and an official stamp. AMC1 UAS.LUC.060 Privileges of an LUC holder SCOPE OF PRIVILEGES Within the terms of its approval, the LUC holder should be able, without prior approval of the competent authority, to authorise one or more of the following own operations: 1. based on a standard scenario that requires a declaration; 2. based on a standard scenario that requires an authorisation; 3. based on one or more modifications of a standard scenario (variants), which do not involve changes in the concept of operation, the category of UAS used or the competencies of remote pilots; 4. that do not correspond to a standard scenario, but fall within a type of activity already performed by the UAS operator. GM1 UAS.LUC.060 Privileges of an LUC holder For the purpose of granting privileges to LUC applicants, the competent authority may apply a gradual approach. Depending on the operator’s past safety performance and safety record over a defined period of time (e.g. previous 6 months), the competent authority may expand the scope of the operator’s privileges. The gradual approach should not be understood to prevent the competent authority from granting privileges with a greater scope to a first-time LUC applicant who has an adequate structure and competent personnel, an effective safety management system and has demonstrated good compliance disposition. AMC1 UAS.LUC.070(2) Changes requiring prior approval A change of the accountable manager is a change that requires a prior approval. Page 40 of 40 European Aviation Safety Agency Opinion No 01/2018 Introduction of a regulatory framework for the operation of unmanned aircraft systems in the ‘open’ and ‘specific’ categories RELATED NPA/CRD: 2017-05 — RMT.0230 EXECUTIVE SUMMARY In accordance with the proposed new Basic Regulation, for which a political agreement between the Council, the European Commission and the European Parliament was reached on 22 December 2017, the competence of the EU has been extended to cover the regulation of all civil unmanned aircraft systems (UAS), regardless of their maximum take-off masses (MTOMs). The objective of this Opinion is to create a new regulatory framework that defines measures to mitigate the risk of operations in the: — ‘open’ category, through a combination of limitations, operational rules, requirements for the competency of the remote pilot, as well as technical requirements for UAS, such that the UAS operator may conduct the operation without prior authorisation by the competent authority, or without submitting a declaration; and — ‘specific’ category, through a system that includes a risk assessment being conducted by the UAS operator before starting an operation, or an operator complying with a standard scenario, or an operator holding a certificate with privileges. Moreover, this Opinion is intended to: — implement an operation-centric, proportionate, risk- and performance-based regulatory framework for all UAS operations conducted in the ‘open’ and ‘specific’ categories; — ensure a high and uniform level of safety for UAS operations; — foster the development of the UAS market; and — contribute to addressing citizens’ concerns regarding security, privacy, data protection, and environmental protection. The proposed regulations will provide flexibility to Member States (MSs), mainly by allowing them to create zones within their territories where the use of UAS would be prohibited, limited or, in contrast, facilitated. Pursuant to the new Basic Regulation, market product legislation (CE marking) ensures compliance with the technical requirements for mass-produced UAS operated in the ‘open’ category. Two acts are proposed that follow different adoption procedures, as defined by the new Basic Regulation: a delegated act that defines the conditions for making UAS available on the market and the conditions for UAS operations conducted by a third-country operator, and an implementing rule that defines the conditions to operate UAS and the conditions for registration. The proposed regulatory framework is expected to increase the level of safety of UAS operations, to harmonise legislation among the EU MSs, and to create an EU market that will reduce the cost of UAS and allow cross-border operations. Action area: Civil drones (unmanned aircraft systems (UAS)) Affected rules: n/a Affected stakeholders: Operators (private and commercial); competent authorities; MSs; flight crews; remote pilots; maintenance staff; UAS manufacturers; other airspace users (manned aircraft); service providers of air traffic management (ATM)/air navigation services (ANS) and other ATM network functions; air traffic services (ATS) personnel; aerodromes; general public; model aircraft associations and clubs Driver: Efficiency/proportionality; safety Rulemaking group: No, but expert group Impact assessment: Full Rulemaking Procedure: Standard 22.12.2016 4.5.2017 6.2.2018 2018/Q4 2019/Q1 TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 1 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 Table of contents Table of contents 1. About this Opinion............................................................................................................................... 3 1.1. How this Opinion was developed ........................................................................................................3 1.2. The next steps......................................................................................................................................4 2. In summary — why and what ............................................................................................................... 5 2.1. Why we need to change the rules — issue/rationale .........................................................................5 2.2. What we want to achieve — objectives ..............................................................................................6 2.3. How we want to achieve it — overview of the proposals ...................................................................6 2.4. What are the stakeholders’ views — outcome of the consultation..................................................10 2.4.1. Structure of the draft regulations .................................................................................................12 2.4.2. Delegated act on product requirements and third-country operators .........................................12 2.4.3. Implementing rule on UAS operations and registration requirements ........................................16 2.4.4. Recreational operations ................................................................................................................24 2.4.5. Date of entry into force and date of applicability .........................................................................25 2.4.6. Link with the U-Space ....................................................................................................................26 2.5. Impact assessment ............................................................................................................................27 2.5.1. Overview of the regulatory impact assessment already published ..............................................27 2.5.2. New aspects in the proposal .........................................................................................................28 2.5.3. Conclusion on the changes introduced to the proposal ...............................................................31 2.5.4. Analysis of modules .......................................................................................................................31 2.6. How do we monitor and evaluate the rules ......................................................................................39 3. References ........................................................................................................................................ 40 3.1. Affected regulations ..........................................................................................................................40 3.2. Related decisions ...............................................................................................................................40 3.3. Other reference documents ..............................................................................................................40 4. Appendix ........................................................................................................................................... 41 TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 2 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. About this Opinion 1. About this Opinion 1.1. How this Opinion was developed The European Aviation Safety Agency (EASA) developed this Opinion in line with revised Basic Regulation as described in the Executive Summary (hereinafter referred to as the ‘new Basic Regulation’) and the Rulemaking Procedure1. This rulemaking activity is included in the EASA 5-year Rulemaking Programme2 under rulemaking task RMT.0230. The scope and timescales of the task were defined in the related ToR3. The draft text of this Opinion has been developed by EASA, assisted by a UAS expert group. All interested parties were consulted through NPA 2017-054,5. More than 3 700 comments were received from around 215 stakeholders, including industry, national aviation authorities (NAAs), UAS operators, the manned aircraft community, ATM, qualified entities, security agencies, insurance companies, individual model aircraft pilots, model aircraft associations and clubs, and individuals. Figure 1 shows the distribution of the commenters. Figure 1 — Distribution of comments received according to the type of commenter 1 EASA is bound to follow a structured rulemaking process as required by Article 52(1) of Regulation (EC) No 216/2008. Such a process has been adopted by the EASA Management Board (MB) and is referred to as the ‘Rulemaking Procedure’. See MB Decision No 18-2015 of 15 December 2015 replacing Decision 01/2012 concerning the procedure to be applied by EASA for the issuing of opinions, certification specifications and guidance material (http://www.easa.europa.eu/the-agency/management- board/decisions/easa-mb-decision-18-2015-rulemaking-procedure). 2 http://easa.europa.eu/rulemaking/annual-programme-and-planning.php 3 https://www.easa.europa.eu/document-library/terms-of-reference-and-group-compositions/tor-rmt0230 4 In accordance with Article 52 of Regulation (EC) No 216/2008, and Articles 6(3) and 7 of the Rulemaking Procedure. 5 https://www.easa.europa.eu/document-library/notices-of-proposed-amendment/npa-2017-05 TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 3 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. About this Opinion EASA has addressed and analysed all the comments received on the NPA. Due to the large number of comments, individual answers will not be provided. However, all the comments have been organised according to their topics and for each of them, a summary of the comments and of the related answers is presented in Comment-Response Document (CRD) 2017-056 (planned to be published in 2018/Q1). The final text of this Opinion, including the two draft regulations, has been developed by EASA and published on the EASA website7. The major milestones of this rulemaking activity are presented on the title page. 1.2. The next steps This Opinion contains the two proposed draft regulations: an implementing rule (draft Commission Regulation (EU) …/… [IR]), and a delegated act (draft Commission Delegated Regulation (EU) …/… [DA]) and their potential impacts. The Opinion is submitted to the European Commission to be used as a technical basis in order to prepare EU regulations. The related draft acceptable means of compliance (AMCs) and guidance material (GM) will be published on the EASA website8, for information only, in week 07 of 2018. The final version will be published by EASA when the related regulations are adopted by the European Commission. 6 http://easa.europa.eu/document-library/comment-response-documents 7 http://easa.europa.eu/document-library/opinions 8 https://www.easa.europa.eu/document-library/agency-decisions TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 4 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what 2. In summary — why and what 2.1. Why we need to change the rules — issue/rationale In recent years, the development of small unmanned aircraft (UA) with MTOMs of less than 25 kg has been extremely fast and has challenged traditional aviation. In accordance with Regulation (EC) No 216/2008 (the Basic Regulation), the regulation of civil UAS with MTOMs of less than 150 kg falls within the competence of the EU MSs. On 22 December 2017, the 28 EU MSs endorsed an agreement reached with the European Parliament for the revision of the Basic Regulation9, extending the competence of the EU to all UAS, except those used for ‘state’ operations (e.g. military, customs, police, firefighting, etc.), and defining the essential requirements to ensure the safety of UAS. In addition, the said Regulation includes the possibility of ‘opting in’ for MSs wishing to place ‘state’ UAS under EU regulation. In order to harmonise the implementation of UAS regulation across the EU and to foster a European market for UAS, EASA has developed the proposed two draft regulations for the ‘open’ and ‘specific’ categories included in this Opinion. Safety issues The two main types of risks addressed are the following: — air risks (collision with a manned aircraft or another UA); and — ground risks (collision with persons or critical infrastructure). A safety risk evaluation is contained in the impact assessment (IA) (see NPA 2017-05 (B)10), including a safety risk portfolio. In this context, it should be noted that since reports on UAS occurrences are mostly made by pilots of manned aircraft, the reporting data for air risks is much more extensive compared to the data for ground risks, where only anecdotal evidence exists. In general, the number of reported occurrences has increased considerably in recent years. The risk evaluation has identified three key risk areas: — airborne conflicts; — aircraft upsets (UAS out of control); and — failures of other systems. These risk areas are reflected, where appropriate, in the requirements for the ‘open’ and ‘specific’ categories. For example, airborne conflict in the ‘open’ category is mitigated by laying down requirements for: — a maximum flying height; — operations to take place in visual line of sight (VLOS); — remote pilot competency; — for some UAS classes, a geo-awareness function and a maximum height limitation; and 9 https://ec.europa.eu/transport/modes/air/news/2017-12-22-aviation-strategy-eu-agrees-safer-skies-and-eu-wide-rules-drones_en 10 https://www.easa.europa.eu/system/files/dfu/NPA%202017-05%20%28B%29.pdf TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 5 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what — the possible introduction of zones forbidding or limiting the use of UA close to aerodromes. The EASA concept of UAS operations is largely based on the Joint Authorities for Rulemaking on Unmanned Systems (JARUS)11 concept that identifies three categories (i.e. A, B, and C) related respectively to the ‘open’, ‘specific’ and ‘certified’ categories. The draft JARUS rules for categories A and B are based on the EASA ‘Prototype’ Commission Regulation on Unmanned Aircraft Operations, published on 22 August 201612. Finally, EASA will incorporate, in a future rulemaking activity planned for 2018, additional AMCs to the proposed regulation that will introduce a methodology developed by JARUS for the risk assessment required for UAS operations in the ‘specific’ category, which is called ‘specific operations risk assessment’ (SORA). 2.2. What we want to achieve — objectives The overall objectives of the EASA system are defined in Article 1 of the new Basic Regulation. This proposal will contribute to the achievement of the overall objectives by addressing the issues outlined in NPA 2017-05 (B). The specific objectives of this Opinion related to UAS are to: — implement an operation-centric, proportionate, risk- and performance-based regulatory framework for all UAS operations conducted in the ‘open’ and ‘specific’ categories; — ensure a high and uniform level of safety for UAS; — foster the development of the UAS market; and — contribute to addressing citizens’ concerns regarding security, privacy, data protection, and environmental protection. 2.3. How we want to achieve it — overview of the proposals This paragraph provides a summary of the proposal as presented in NPA 2017-05, while the next paragraph offers an overview of the main changes, based on the feedback received during the consultation. For additional details on the initial proposal, please refer to NPA 2017-05. The proposed new regulations are a follow-up to the concept of UAS operations shown in A-NPA 2015-10 ‘Introduction of a regulatory framework for the operation of drones’13, as well as to the Opinion of a technical nature (published on 18 December 2015) and the ‘Prototype’ Commission Regulation on Unmanned Aircraft Operations published in August 2016. They take into account all comments and inputs received from the involved stakeholders, including a UAS expert group put in place by EASA and made up of representatives of the EC, EU MSs, the UAS industry (both for large and small UAS), UAS operators, the manned aviation community, and model aircraft associations and clubs. 11 See also http://jarus-rpas.org/. 12 http://www.easa.europa.eu/easa-and-you/civil-drones-rpas 13 https://www.easa.europa.eu/document-library/notices-of-proposed-amendment/npa-2015-10 TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 6 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what Moreover, the information contained in two reports (the Study and Recommendations regarding Unmanned Aircraft System Geo-Limitations14 and the ‘Drone Collision’ Task Force15) drafted by two EASA task forces was taken into consideration. According to the concept defined in A-NPA 2015-10, UAS operations are classified into three categories: — ‘“open” category’ means a category of UAS operation that, considering the risks involved, requires neither a prior authorisation by the competent authority, nor a declaration by the UAS operator before the operation takes place; — ‘“specific” category’ means a category of UAS operation that considering the risks involved, requires an authorisation by the competent authority before the operation takes place, taking into account the mitigation measures identified in an operational risk assessment, except for certain standard scenarios for which a declaration by the UAS operator is sufficient, or when the operator holds a light UAS operator certificate (LUC) with the appropriate privileges. — ‘“certified” category’ means a category of UAS operation that, considering the risks involved, requires the certification of the UA and its operator, as well as licensing of the flight crew. This Opinion addresses UAS operations in the ‘open’ and ‘specific’ categories only and it introduces: — an operation-centric approach (the consequences of an accident or incident with a UAS that does not carry people on board are highly dependent on the environment where the accident or incident takes place); — a risk-based approach (in the ‘open’ category, this is exemplified by introducing subcategories, and in the ‘specific’ category, by laying down the general principle for a risk assessment to be conducted by the operator before starting an operation); and — a performance-based approach (the main requirements in the draft regulation identify the requested performance, and related AMCs/GM and standards describe acceptable ways to comply with the rules). In addition to the above, and in order to address the strong request for flexibility made by certain MSs, several tools were introduced: — MSs can define airspace restrictions in zones where UAS operations are prohibited or limited, and other zones where certain requirements defined in the proposed regulation are alleviated. In order to ensure standardisation, the related information must be published in a manner and format established by EASA. The first type of zone may be established for safety, security, privacy or environmental reasons, while the second type is for different purposes, for example, to facilitate the flight testing of new designs or UAS operations, or to reduce the operational limitations for leisure activities. — the concept of alternative means of compliance (AltMoCs) is also used in the proposed regulation to allow UAS operators to propose to the MSs alternative means to demonstrate compliance with the requirements defined to obtain an LUC and to operate in the ‘specific’ 14 https://www.easa.europa.eu/document-library/general-publications/study-and-recommendations-regarding-unmanned-aircraft- system 15 https://www.easa.europa.eu/document-library/general-publications/%E2%80%98drone-collision%E2%80%99-task-force TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 7 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what category, and especially to propose standard scenarios as alternatives to those published by EASA. The main topic of this Opinion is the definition of requirements for conducting safe operations in the ‘open’ and ‘specific’ categories. The challenge was to reach a good balance between technical requirements, pilot competency and operational limitations, enabling safe and secure UAS operations, while respecting people’s privacy, protecting the environment and at the same time enabling the development of the market for UAS. As a general rule, the ‘open’ category has been defined as operations conducted: — with a UAS with an MTOM of less than 25 kg; — below a height of 120 m; and — in VLOS. These conditions above already provide some initial mitigation, especially for air risks, complemented by the competency of the remote pilot. It was decided to further subdivide operations in the ‘open’ category into three subcategories to allow different types of operations without the need for an authorisation. The subcategories were defined according to the risks posed to persons and objects on the ground, keeping in mind that the operations would all be below 120 m in height and far from aerodromes. These subcategories are: — A1: flights over people but not over open-air assemblies of persons; — A2: flights close to people, while keeping a safe distance from them; — A3: flights far from people. An extensive evaluation was carried out with a UAS expert group on how to set the balance between technical requirements, remote pilot competency and operational limitations. Details on the final conditions set for the ‘open’ category, resulting from the NPA consultation, are provided in paragraph 2.4. The ‘specific’ category is applicable to all operations that do not comply with the limits of the ‘open’ category. It basically requires the UAS operator to perform a risk assessment and to propose mitigation measures that the competent authority will analyse and approve through an authorisation. To limit the administrative burden for both UAS operators and the competent authorities, a system of standard scenarios has been proposed. A standard scenario involves a pre-established risk assessment and includes mitigation measures. It may be followed by a declaration submitted by the UAS operator (if the implementation of the mitigation measures is considered to be simple), or by an authorisation issued by the competent authority (when the implementation of the mitigation measures is considered to be more complex). Furthermore, an optional light UAS operator certificate (LUC) has been proposed, which allows the competent authority to issue privileges to UAS operators. This implies a significant investment from the operator’s side, which should yield benefits in the medium/long term. Indeed, the LUC privileges can ultimately allow an operator to approve their own operations. The methodology suggested for performing the risk assessment and for identifying the related mitigation measures is called a ‘specific operations risk assessment’ (SORA). This JARUS methodology is currently under consultation by JARUS, and the final version of it should be available towards the end TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 8 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what of 2018. SORA will be proposed as an AMC to UAS.SPEC.020 ‘Operational risk assessment’. The SORA mitigation measures become binding for the operator when included in its declaration or in the authorisation issued by the competent authority. The mutual recognition of authorisations by the authorities is a particular point that needs to be highlighted. The general EU principle is that an authorisation granted in accordance with an EU regulation is recognised by all competent authorities without them having to provide any additional documentation. However, it is recognised that an authorisation granted by the competent authority of the operator’s principal place of business may need to be adapted to the local conditions that may exist in another MS. The rules have been adapted to reflect this point, and an AMC will be proposed to that effect, based on the AMC for aerial work performed in cross-border operations. The requirements proposed in the Opinion also contribute to addressing security threats, protecting the environment and to enforcing privacy and data protection rights in order to ensure the social acceptability of an EU market for UAS. For example, conditions for the applicability of UAS operator registration, electronic identification and geo-awareness have been drafted not only to address safety issues, but also to consider other risks posed by UAS. The definition of zones described above can also be based on security and/or privacy reasons. Finally, the remote pilot competency requirements also include knowledge of the relevant EU and national security and privacy/data protection regulations. Model aircraft are within the scope of this Opinion since, pursuant to the definition of a UA in the new Basic Regulation, a model aircraft is a UA. It is, however, recognised that activities conducted within model aircraft clubs and associations have good safety records due to their high levels of organisation, their procedures and their safety culture. For this reason, the proposed regulation allows competent authorities to issue an operational authorisation to model aircraft clubs and associations, in which they may define deviations from it. In addition, this proposal offers two other possibilities to model aircraft pilots who do not intend to join a model aircraft club or association. They may: — operate in specific zones designated by MSs, in which MSs can alleviate the requirements of the rules proposed in this Opinion; or — operate in subcategory A3 of the ‘open’ category. Operations in subcategory A3 may be conducted with privately built UAS, or UAS in class C3 or C4. This last class was specifically developed to address model aircraft available on the market, imposing a minimum set of technical requirements and focusing mainly on providing the remote pilot with operational instructions issued by the UAS manufacturer, as well as on raising the remote pilot’s awareness of the EU regulations through consumer information. This approach will create a negligible additional burden for UAS manufacturers. All model aircraft in use before the date of entry into force of this proposed regulation will also be able to be operated afterwards, still using one of the three options explained above (i.e. to be member of a model aircraft club or association, to operate in designated areas, or to follow the operational limitations for subcategory A3), without the need for any modification to the model aircraft. The applicability of the proposed regulation has also been extended to third-country UAS operators. Since no ICAO Standards are yet available for this category of UAS operations, third-country UAS operators are required to comply with the full set of the proposed regulations. First of all, they are TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 9 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what required to register themselves in a similar manner to an EU UAS operator. In this case, the competent authority will be the one of the MS where they conduct their first operation in the EU, since this authority is best acquainted with the area of operation. The possibility to recognise certain certificates has been introduced (i.e. the certificate of the remote pilot or of the UAS operator) after EASA has analysed the regulations in place in the third country and has concluded that they provide a level of safety equivalent to that ensured by the requirements included in this Opinion. EASA will conduct this analysis at the request of the third-country authority. It was decided to propose that EASA will perform this analysis once and for all in order to avoid multiple reviews by MSs to accept certificates issued by the third country. For this purpose, EASA will involve experts from the MSs in the team performing this analysis. In accordance with the new Basic Regulation, market product legislation (CE marking) ensures compliance with the technical requirements for UAS operated in the ‘open’ category. Therefore, this Opinion also defines the new EU market harmonisation legislation that UAS operated in the ‘open’ category will have to comply with. Compliance is shown by affixing the CE marking and the UAS class to the UAS when it meets the essential technical requirements defined in this proposed regulation. The UAS harmonisation legislation has been drafted in accordance with the reference requirements of Decision No 768/2008/EC16 and calls upon the market surveillance activities defined in Regulation (EC) No 765/200817. 2.4. What are the stakeholders’ views — outcome of the consultation NPA 2017-05 was consulted from 5 May to 15 September 2017 and more than 3 700 comments from around 215 commenters were received. Figure 2 provides the distribution of comments according to their topics. 16 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82) (http://eur-lex.europa.eu/legal- content/EN/TXT/?qid=1493654386469&uri=CELEX:02008D0768-20080709). 17 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30) (http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1493654158057&uri=CELEX:02008R0765-20080813). TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 10 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what Figure 2 — Distribution of the comments received according to the topic Some of the comments conflicted with each other due to the variety of the stakeholders. There was general support regarding the approach to UAS operations that was defined in the proposed regulation and the level of flexibility granted to the MSs. The majority of the comments received were on operations in the ‘open’ category, together with a general request for simplification of the proposed regulation. The other subparts (‘specific’ category operations, LUC and market regulation) were also commented on, even if, most of the time, commenters asked EASA to provide additional clarifications, resulting in an improvement in the related AMCs and GM. The comments were classified according to their topics and were carefully analysed. For details, please refer to CRD to NPA 2017-05 (planned to be published in 2018/Q1). In addition to this formal public consultation, EASA took into account the following elements: — input from the ‘Article 29 Data Protection Working Party’; — comments received during a meeting of national security experts on unmanned aircraft, organised by DG GROW on 14 and 15 December 2017, when the ‘state of play’ of the Opinion was presented; — the political agreement on the new Basic Regulation (i.e. changes to the registration requirements and the need to present two rules: one implementing act for UAS operations and registration, and one delegated act for UA technical requirements and third-country UAS operators); — comments received during a meeting of the UAS Expert Working Group on 23 and 24 November 2017; TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 11 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what — comments received during several meetings with industry, model aircraft associations and clubs, UAS operators, etc. 2.4.1. Structure of the draft regulations The new Basic Regulation identifies which process should be carried out by the European Commission to adopt a new regulation. The process depends on the topic covered by the regulation, and for UAS it mandates the following: — regulations concerning the design, production and maintenance of UA and their engines, propellers, parts, non-installed equipment and equipment to control the aircraft remotely, and concerning third-country operators, are adopted as delegated acts; — regulations concerning the operation and registration of UA are adopted as implementing rules. Consequently, the text proposed in NPA 2017-05 has been split into two regulations. The NPA was developed with an operation-centric concept; therefore, most of the requirements included in the articles of the draft Cover Regulation and in draft Annex I (Part-UAS) may be traced back to UAS operation and registration, while the appendices to draft Annex I (technical specifications for UAS) and the requirements in draft Annex II (Part-MRK) may be traced to design and production. This led to splitting the original text of the NPA into two regulations, following the above principles: — a proposed delegated act, containing the requirement to make products available on the European Union market, including the technical requirements applicable to UAS and the article on third-country UAS operators; — an implementing rule containing the remaining provisions. The two regulations are heavily dependent on each other since, in order to enable the operation-centric approach chosen for UAS operations, a balance between limitations, pilot competency and technical requirements was established. It will, therefore, be very important for the two acts to evolve in a consistent manner. EASA will carefully monitor this point in the future. 2.4.2. Delegated act on product requirements and third-country operators As described in the previous paragraph, the proposed delegated act is made up of the articles included in Annex II of NPA 2017-05, the article on third-country operators (Article 10 in NPA) and the technical requirements for the UAS classes and e-identification (Appendices 1–6 to Annex I in the NPA). Very minor changes have been made to the articles, using essentially the same text already presented in the NPA. Some changes were made to the technical requirements, as described below. The article on third-country operators has been amended to specify that EASA will only start the assessment on the level of safety provided by the third-country regulatory framework upon the request of the national authority of the third country. 2.4.2.1. Technical requirements for UAS classes The technical requirements for the UAS classes have been slightly amended, as follows. — For all classes, the manufacturer is required to include an information notice in the UAS package. This is an essential element to promote safety, which provides UAS operators with TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 12 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what basic information on what they can and cannot do, and a link to websites where they can register, receive the online training, and obtain additional information. This requirement was already included in the NPA, and it has been only slightly reworded. Originally, the idea was to use leaflets, but the concept has now been broadened to also allow electronic means such as QR codes. The name of this item has, therefore, been modified to ‘information notice’ to reflect this change. In the NPA, the content of this document was included in the AMCs. Since product legislation does not allow the possibility to develop AMCs, a different approach had to be identified. It was, therefore, decided to require manufacturers to include in each UAS package an ‘information notice defined by EASA’. This document will be made available on the EASA website. — For UAS in class C0, a maximum speed of 19 m/s has been added for UAS that do not comply with Directive 2009/48/EC on the safety of toys18. This avoids fast UA, which are typically used for races, being classified as class C0 and operated over people. These UA will be classified as class C3 and will be operated in accordance with subcategory A3 only. Another possibility will be the use of a standard scenario, yet to be drafted. — For UAS in classes C1, C2 and C3:  a new requirement has been added to mandate a smooth transition in the event of the activation of an automatic flight mode. This will apply to those manufacturers who voluntarily decide to implement functionality that automatically limits the access of the UA to certain airspace areas or volumes. It will ensure that the safety of the flight is maintained and that the remote pilot is provided with sufficient information when such automatic functionality is about to be engaged. This will prevent UA from suddenly demonstrating unexpected behaviour during the transition to an automatic flight mode;  requirements related to the use of an electronic identification system have been introduced directly into each appendix, requiring the following information to be broadcast: o the UAS operator registration number; o the unique serial number (SN) of the UA or, if the e-identification is provided by a separate module to be added to the UA, the SN of that module; o the geographical position of the UA and its height; o the geographical position of the point from which the UA took off; and o the timestamp of the data;  it has been clarified that the information in the UA user’s manual shall at least include the mass of the UA, its MTOM, the frequency of its electronic identification emissions, the general characteristics of allowed payloads in terms of their masses and dimensions, and a description of the behaviour of the UA in the event of a loss of the data link;  a new requirement has been introduced to mandate manufacturers to assign to each UA a unique SN according to a standard to be developed. Such SN will be fed to the e- 18 Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1). TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 13 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what identification systems to be broadcast, together with the UAS operator registration number. — For UAS in class C1:  based on the large number of negative comments, the reference to the maximum resolution of a camera being 5 MP has been removed, and the requirement for e-identification and geo-awareness has been made mandatory for all UAS in this class;  it has been clarified that the requirements for lights are linked to the controllability of the UA in daylight conditions and during the night, if the UA is designed for night operations; if the manufacturer decides to install lights, their design shall be different from the design of the navigation lights of a manned aircraft so that these two types of aircraft cannot be confused. — For UAS in class C2, a new requirement has been introduced for a low-speed mode that is selectable by the operator and limits the maximum cruising speed of the UA to a maximum of 3 m/s if the UA is intended to be operated in close proximity to people. This requirement will enhance the controllability of the UA, and allow UAS operators to fly their UA as close to uninvolved persons as 3 m. — For UAS in class C4, a new requirement has been added to forbid automatic control modes. The rationale is to separate UA that are mostly used for leisure purposes or for pleasure flights (what we mostly know as model aircraft) from those that allow more automatic functions, where the payload (usually the camera) is the centre of interest. It is recognised that imposing functions such as lost link management or height limitation on model aircraft would require the UA to be equipped with sophisticated flight control systems that most of time would alter the nature of model aircraft. Therefore, forbidding automatic control modes will allow class C4 UAS to deal with model aircraft and limit the technical requirements imposed on them (Appendix 5, containing the technical requirements for UAS in class C4, only requires manufacturers to provide documentation). All other UA will be classified as class C3, on which additional technical requirements are imposed. — For UA in classes C1 and C2, the noise level requirement has been maintained at the same level; however, its expression has been corrected. The term ‘sound power level’ has been changed to ‘sound pressure level’ since it refers to the sound pressure measured at a certain distance from an object. Under certain standard conditions, a sound power level of 80 dB approximately equals a sound pressure level of 60 dB(A) measured at a distance of 3 m from the source. Moreover, A-weighting of the sound level has been introduced, as this is commonly used when describing the level of noise that is perceived by humans. While the technical basis for this (or any other) limit, as well as the details of the underlying measurement procedure for small UA, remain undefined at present, it was decided to keep a discrete noise limit. — For UA in classes C2 and C3:  lights are made mandatory for the purpose of controllability or visibility; their design shall be different from the design of the navigation lights of a manned aircraft so that these two types of aircraft cannot be confused; TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 14 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what  a new requirement has been introduced to mandate protection of the data link so as to prevent unauthorised access to the command and control functions of a UA;  following the extension of the EU competence to tethered aircraft with propulsion systems and with masses greater than 1 kg, as defined by the new Basic Regulation, all the requirements have been reviewed to extend the applicability to those aircraft. 2.4.2.2. Conformity assessment modules for CE marking Decision No 768/2008/EC, on a common framework for the marketing of products, provides a template for the establishment of new product harmonisation legislation. Among other things, it defines the conformity assessment procedures that the manufacturer has to carry out in order to demonstrate that a product, before it is placed on the market, conforms to these legislative requirements. In fact, Decision No 768/2008/EC provides a menu of conformity assessment procedures (called ‘modules’), from which the legislator can select the most appropriate one(s) in order to address the specific needs of the sector involved. The least onerous modules should be selected, taking into account the type of the product and the safety risks involved, the impact on the protection of public interests, the economic infrastructure of the given sector, the methods of production, etc., and where possible, a choice of inspection, certification, and/or quality assurance (QA) modules should be provided. These conformity assessment procedures are equivalent to each other from a legal point of view, but they are not technically identical in terms of the methods used. Their application in the sectorial legislation aims at providing a high level of confidence regarding the conformity of products to the relevant essential requirements. A number of accreditation bodies and qualified entities who have broad experience in testing consumer products have stressed that experience shows that module A (self-declaration of conformity by the manufacturer) often leads to a low conformity rate. They considered that higher risk products should require the involvement of a third party in the conformity assessment procedure, and they claimed that the approach should be more proportionate to the risk related to the different classes. In the ‘open’ category, the operational risks are mitigated by a combination of the UA technical requirements, operational restrictions and pilot competency (for instance, a higher mass is compensated by a greater distance to people). The operation-centric approach used to analyse the risks leads to the conclusion that all classes present a rather similar level of risks, which was the approach adopted in the NPA. However, when considering a possible misuse of the UA or a technical failure, this conclusion would be altered and UA of class C2 and C3 should be considered as presenting a higher risk than the other classes. After consultation with manufacturers’ representatives, it was decided to remove module A from the procedures provided to demonstrate the conformity of UA of class C2 and C3, as these classes may indeed represent a higher risk in the ‘open’ category. EASA carried out a delta impact assessment, which is summarised in paragraph 2.6, and the resulting preferred option for each of the classes is shown as follows: TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 15 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what Class Module(s) C0 A, B + C or H C1 A, B + C or H C2 B + C or H C3 B + C or H C4 A, B + C or H 2.4.3. Implementing rule on UAS operations and registration requirements The text in the draft Cover Regulation has been simplified, and the requirements related to product regulation have been removed, while keeping references that were still needed. However, the concepts expressed in the articles remained unchanged. Several definitions have been slightly updated following the comments received, and some new definitions were added, such as those for ‘dangerous goods’, ‘certificate of airworthiness (CofA)’ and ‘single European sky airspace’. 2.4.3.1. Registration The new Basic Regulation mandates the registration of UAS operators who conduct operations with a UA: — that is able to transfer ‘80 J’ of terminal kinetic energy19 in an impact with a person; — that poses a security, privacy or environmental risk; or — that is certified. It is only mandatory to register a UA that is certified, which means that the UA has been provided with a certificate of airworthiness (CofA) attesting that it conforms to a type certificate issued in accordance with Annex I (Part 21) to Regulation EU (No) 748/201220. The use of a certified UA is not required for operations in the ‘open’ category, while for operations in the ‘specific’ category, a CofA for a UA may be required in some situations in order to mitigate the risks identified by the risk assessment. The text proposed in the NPA has, therefore, been updated accordingly, removing the requirement for registration of the UA in the ‘open’ category and limiting the requirement to register UA in the ‘specific’ category to only when a CofA is required. The first condition defined in the new Basic Regulation for the registration of UAS operators is related to the operation of a UA able to transfer a terminal kinetic energy greater than 80 J in the event of an impact with a person. This value corresponds to the upper weight threshold of UAS in class C1. This condition is, therefore, met when a UAS operator uses a UAS of class C2, C3 or C4. The second condition for the registration of UAS operators, referring to security, privacy and environmental risks, requires additional consideration. During the meeting held with national security experts on unmanned aircraft, mentioned in paragraph 2.4, the DG Joint Research Centre (JRC) provided the results of a study on the potential 19 Kinetic energy transferred to the human body considering the terminal velocity of the UA when falling from an altitude of 120 m. 20 Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations (OJ L 224, 21.8.2012, p. 1). TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 16 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what lethality of explosives carried by a UA21. The study showed that a UA with a mass of up to 250 g was not able to carry a payload that posed a significant risk. However, heavier UA may potentially pose a security risk. Therefore, a UA in class C1, even if it does not pose a safety risk, may still pose a security risk. During the same meeting, the national security authorities proposed to set the registration threshold to 250 g, and this request was found to be consistent with several comments received during the NPA commenting period. The risks to privacy and data protection are essentially related to the availability on the UA of a camera or another sensor that is able to record personal information. Most of the UA available on the market, even if they are very small, are equipped with cameras. These vary from toys with very limited performance to nano-UAS that are able to carry high-resolution cameras. It was considered that a UA with a mass of less than 250 g is normally small and, therefore, in order to comply with the general requirement set in the ‘open’ category for the UA to remain in the VLOS, the UA would need to fly close to the remote pilot, and this should allow the pilot to be quickly identified. Operations conducted at a greater distance from the pilot will be classified in the ‘specific’ category, which requires the UAS operator to be registered. At this stage, it was decided not to regulate the registration of UAS operators who use UA with masses below 250 g in order to remain proportionate, even if there is a residual risk to privacy. This situation will be monitored in the future to evaluate whether there is a need to change that decision. These considerations led to the condition being set that UAS operators who use UA with MTOMs greater than 250 g need to be registered. As required by the new Basic Regulation, the registration of UAS operators will be a national responsibility and each MS may designate a competent authority or another entity for that purpose. It was considered necessary to develop in the aviation regulations a specific article to define the responsibilities of the entity that manages the UA operator database. In order to ensure interoperability between the databases developed in the EU MSs, a requirement for real-time accessibility has been included, and in addition, the format of the registration number will be defined in an AMC, together with the minimum data items to be provided, including the insurance number. As requested by several commenters, the 3-year validity of a registration proposed in the NPA has been deleted and transformed into a requirement for the MSs to keep the operator database accurate. GM will suggest a 3-year validity period, based on the considerations that the average lifetime of a small UAS is in the order of 2 years and the small UAS market is very dynamic. Moreover, a requirement has been added to equip UA with a fire-resistant placard displaying registration information. Deviations are possible for very small UA and for model aircraft. Finally, it was considered that in the future, the U-Space may require a unique identification of each UA for flight deconfliction purposes. This unique identification will be provided by mandating the standardisation of the SN of UA in the UAS technical requirements for classes C1, C2 and C3. In this 21 JRC Science for Policy Report. Scenario study: drones carrying explosives. Implications for consumer product regulation on drones. Larcher M., Karlos V., Valsamos G., Solomos G. JRC 110662, 2018. The study is not publicly available. The following is an extract of the conclusions. ‘It can be concluded that drones of class C1 has the capability of causing casualties in a limited range, while explosive attacks with drones of classes C2 - C4 can have a significant impact at soft targets/public spaces resulting in a potential high number of casualties.’ TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 17 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what way, the e-identification system of each UA will broadcast both the UAS operator registration number and the UA’s unique SN. 2.4.3.2. ‘Open’ category As mentioned above, the subpart on which the most comments were received was the ‘open’ category. The main request was for a general simplification of the table that summarised the operational limitations. Following these comments, including inputs from model aircraft clubs and associations and additional inputs from 21 MSs during the development of the NPA, a counterproposal has been developed, and as a result, the ‘open’ categorisation in Table 1 has been modified. The main changes are as follows. — The maximum height has been aligned at 120 m for all subcategories, removing the limit of 50 m for UA with an MTOM below 250 g. The change was made to simplify the table and was based on the consideration that the VLOS requirement is anyway applicable. The proposed regulation has been amended to clarify the responsibility of the remote pilot to keep the UA at a height such that it always remains in VLOS. The small size of a UA with an MTOM below 250 g will not allow the remote pilot to see the UA at a distance of more than a few tens of meters. Still, the possibility exists to exceed this limit in close proximity to an object taller than 120 m, on request from the responsible entity. In addition, it has been clarified that the remote pilot should maintain the UA at least 50 m from the perimeter of the object. — The definition of the minimum age to operate a UA has been removed from the Opinion and left to the discretion of the MSs. This decision was made based on the consideration that harmonising the minimum age would not be commensurate with the expected safety benefits. A lack of harmonisation in this field would have a very minor impact, in particular, for commercial operators that would have to comply with the legislation to provide commercial services, which may define minimum age limits, but which EASA has no power to regulate. — The minimum distance from uninvolved people to be maintained when conducting a UAS operation in subcategory A2 has been reduced to 5 m when a low-speed mode function is installed on the UA. The remote pilot needs to activate this functionality when operating close to people, so that the remote pilot will have enough time to react and alter the trajectory of the UA if it is heading towards people. In addition, the concept of the 1:1 rule (keeping the UA at a distance from uninvolved people that is no less than the height of the UA) has been introduced. — As proposed by the vast majority of the MSs, the operational limitations in subcategory A3 have been simplified by merging the previous two limitations when conducting an operation with a UA in class C3 or C4 that is privately built. For all operations in subcategory A3, the operational limitation now states: ‘Fly in an area where it is reasonably expected that no uninvolved person will be endangered and keep a safety distance from the boundaries of congested areas of cities, towns or settlements.’ It should be noticed that the previous condition ‘no uninvolved person will be present’ has been replaced with ‘no uninvolved person will be endangered’. This text is more consistent with the concept agreed during the discussion with the UAS experts and was summarised in the related AMC, already proposed in the NPA, requiring that when ‘a person incidentally enters the visual range of the remote pilot, the remote pilot should avoid overflying the person, and discontinue the operation when the safety of the UAS operation is not ensured’. TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 18 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what In order to better reflect the operation-centric approach, the structure of Part-UAS has been modified, moving the operational requirements of the subcategory to the front. Several commenters asked EASA to clarify some areas. The following changes to the text of the regulation and/or to the AMCs and GM have, therefore, been made; however, they do not alter the concept proposed in the NPA: — The point on the responsibilities of a UAS operator has been amended to:  remove the requirement for a UAS operator to develop policies, since it was considered over-demanding for the ‘open’ category; a UAS operator who employs more than one remote pilot is still required to develop procedures;  include the responsibility for a UAS operator to make their personnel aware of any information about operations promulgated by the relevant authorities. — The point on the responsibilities of a remote pilot has been amended to:  consider that, when using a free-flight UA, the remote pilot does not have the possibility to directly control the UA; in addition, free-flight UA operations will be defined in upcoming GM;  add, as an additional responsibility of the remote pilot, the requirement to ensure that the mass of the UA, including its payload, does not exceed the MTOM defined by the manufacturer and the limit of its class;  replace the requirement to give way to manned aircraft with ‘maintain a thorough visual scan of the airspace surrounding the UA in order to observe and not create a hazard to other aircraft’; the text was changed because it gave the impression that a UA may be operated in the ‘open’ category close to a manned aircraft as long as precedence is given; the new text better reflects the spirit of the requirement, which is to always be aware of the activities going on in the surrounding airspace, and to keep the UA at a safe distance from any other aircraft;  include the possibility in the ‘open’ category to carry dangerous goods, but only for operations that involve dropping them in connection with agricultural, horticultural, or forestry work when the carriage of those goods does not contravene any other applicable regulations;  add, in addition to respecting the privacy of people, the requirement to avoid harming animals or the environment;  be clarified in an upcoming AMC that a UA may be operated by a pilot on a moving ground vehicle or a boat, on the condition that the speed of the vehicle is slow enough for the remote pilot to maintain VLOS and maintain control of the UA at all times. — The references to the availability of a 5-MP camera on the UA has been removed. The e-identification and geo-awareness requirements have been made mandatory for all UA in classes C1, C2 and C3, while for C4 and privately built UA, they will be mandatory when required for the area of operation. TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 19 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what — The AMCs that describe the competency to be demonstrated by a remote pilot in order to obtain a certificate of pilot competency required to operate in subcategory A2 will be amended to specify that the remote pilot is required to firstly pass the online test (as required for operating a UA in subcategory A3) and to conduct some familiarisation flights in areas where no risk is posed. This will be added in order to address some concerns about the level of practical experience of remote pilots. It was considered that a practical test would have been expensive and disproportionate, considering that remote pilots may conduct self-training in remote areas and that the technical requirement mandate on the UA, including the slow-speed mode, will already provide some mitigation. — The point describing subcategory A3 has been amended to clarify that a class C2 UA may also be operated in this subcategory on the condition that the remote pilot has passed the online test and that the remote pilot complies with the subcategory A3 operational limitations. TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 20 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what Operation UAS Remote pilot competency Area of operation UAS operator (age according to MS MTOM/ Main technical requirements Electronic ID/ Subcategory (far from aerodromes, class registration legislation) Joule (J) (CE marking) geo awareness maximum height 120 m) A1 Privately N/a Fly over built people Read consumer info < 250 g Consumer information, No no Toy Directive or C0 <19 m/s, no sharp edges, You can fly over uninvolved people (not over selectable height limit crowds) Consumer information, <19m/s, kinetic energy,  Consumer info < 80 J or mechanical strength,  online training C1 <900 g lost-link management,  online test no sharp edges, selectable height limit.  Consumer info Consumer information, Yes +  online training mechanical strength, no A2 unique SN for You can fly at a safe distance from uninvolved  online test sharp edges, lost-link Fly close to C2 < 4 kg identification people people  theoretical test in a centre management, selectable recognised by the aviation height limit, frangibility, yes authority low-speed mode. Consumer information, lost- link management, C3 You should: selectable height limit, A3  fly in an area where it is reasonably expected  Consumer info frangibility. Fly far from that no uninvolved people will be  online training < 25 kg Consumer information, people endangered  online test C4 if required by no automatic flight  keep a safety distance from urban areas zone of Privately N/a operations built TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 21 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what 2.4.3.3. ‘Specific’ category Commenters expressed their general agreement on the concept defined for operations in the ‘specific’ category. Some concerns were raised regarding the unavailability of the full documentation explaining the ‘specific operations risk assessment’ (SORA), which is the methodology established by Joint Authorities for Rulemaking of Unmanned Systems (JARUS) Working Group 6 to assess the risks of UAS operations and determine the corresponding mitigation measures. The main document defining the process of SORA, without the annexes, has been published by JARUS22. The annexes are planned to be published by the end of 2018. Other key elements for the success of the ‘specific’ category are the standard scenarios; however, none of them has yet been made available. A pragmatic process is being put in place to allow the publication of a first set of standard scenarios as AMCs to the UAS regulation once the latter is adopted in the 3rd quarter of 2018. Similarly to the approach used for the subpart on the ‘open’ category, the points in this subpart have been rearranged in line with the operation-centric approach. Other than this, minor changes have been made as follows. — The requirements for the UAS operator have been amended to:  remove the general requirement for the UAS operator to develop policies; when needed, the standard scenario or the operational authorisation issued by the NAA will define the requirement to develop policies;  include the responsibility for the UAS operator to make available to their personnel the operations manual, when required by the standard scenario or by the operational authorisation issued by the NAA, and make their personnel aware of any information promulgated by competent authorities that is relevant to the intended operation. — The point dedicated to the development of the operations manual has been deleted since it was considered that the relevant requirements were already included in other points. — The point related to the responsibilities of model aircraft clubs and associations has been amended to specify that they should take appropriate actions only when they are informed that one of their members does not comply with the conditions and limitations defined in the operational authorisation; moreover, the responsibility of model aircraft clubs and associations is limited to assisting their members in achieving the minimum competency required by this proposed regulation. — The point regarding registrations has been amended to reflect the new requirements mandated by the new Basic Regulation, including the necessity to register the UA when, following the risk assessment, a CofA for the UA is required. — In the operational authorisation section, a new requirement has been added to ensure that the UAS operator develops a procedure for the coordination with the relevant ATC unit(s) if the entire operation or part of it is to be conducted in controlled airspace. Moreover, the competent authority is required to issue ‘without undue delay’ the operational authorisation when it is satisfied with the documentation submitted by the UAS operator. 22 http://jarus-rpas.org/publications TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 22 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what — The requirements on the operational risk assessment have been amended to also include an evaluation of privacy and security risks. — For operations covered by a standard scenario where a declaration is sufficient, the responsibilities of the competent authority have been clarified. Competent authorities are required to provide to the UAS operator an acknowledgment of the receipt of the request, and then to verify the completeness of the declaration. In order to reduce as much as possible the use of the resources of the competent authorities and reduce any ambiguity for UAS operators, an AMC will clarify that the competent authority should establish an online system (e.g. web-based or by email) for the submission of operational declarations, which provides the submitter with an automatic acknowledgement of receipt when the submission has been successful. Moreover, the template for the declaration or the application for authorisation for operations covered by standard scenarios will be included in the standard scenario itself. The time validity of a declaration will be defined in the related standard scenario, while the competent authority will define in the authorisation its validity. — The definition of the duration and validity of the operational authorisation is now left to the competent authority. — A new point has been added to define the process to be applied by a UAS operator who intends to propose an AltMoC. The concept was already introduced in draft Article 11 of NPA 2017-05. To harmonise the requirement with other aviation domains, the text has been split, leaving in Article 11 of the Cover Regulation (now Article 10) the requirement for the competent authority, and in this point, the requirements for the applicant. 2.4.3.4. Light UAS operator certificate (LUC) The concept of LUCs has also been generally supported by commenters. The majority of comments required some additional clarifications that will be reflected in new or revised AMCs and GM compared to those published in the NPA. However, the following changes were made: — The responsibility of an LUC holder has been amended to introduce a requirement for record keeping in support of oversight. — The management system has been amended to include some missing elements that are typical of a safety management system (SMS), such as the identification of the lines of responsibility and accountability; moreover, the possibility has been introduced to integrate the management system with other systems already operated by the organisation to comply with requirements in other aviation domains. For example, if a UAS operator already holds an air operator certificate (AOC) approval in accordance with Regulation (EU) No 965/201223 or a production organisation approval (POA) in accordance with Regulation (EU) No 748/2012, then when they demonstrate compliance in order to obtain an LUC, they are allowed to receive credit for requirements already included in such approvals. 23 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). TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 23 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what — The distinction between complex and non-complex organisations has been removed, making the requirements more proportionate. — The competent authority is required to specify in the terms of approval the privileges granted to an LUC holder. A new AMC will provide the form to be used for the terms of approval, and will specify that the LUC holder should be able, without prior approval of the competent authority, to authorise one or more of the following types of own operations. Operations that: 1. are based on a standard scenario; 2. are based on one or more modifications of a standard scenario (variants), which do not involve changes in the concept of operation, the category of the UAS used or the competencies of remote pilots; 3. do not correspond to a standard scenario, but fall within a type of activity already performed by the UAS operator. — In an analogy to the ‘specific’ category, a new point has been added to define the process to be applied by a UAS operator who intends to propose an AltMoC. 2.4.4. Recreational operations Several comments were provided by model aircraft clubs and associations asking for more defined exemptions for all model aircraft activities, irrespective of whether the operator was a member of a model aircraft club or association. A detailed overview of those comments may be found in the related CRD. The following is a description of the major changes developed to address those comments. The recognition of the pro-safety environment created by model aircraft clubs and associations has been kept, as this is documented in the positive safety records. Granting credit to all UA leisure pilots was not considered to be justifiable. The draft regulation provides three options for recreational activities, which will be summarised in GM1 to Article 6 of the proposed implementing regulation: — operate as members of a model aircraft club or association that has received an operational authorisation from the competent authority, as defined in Article 6 of the proposed implementing regulation; — operate in special zones defined by the MSs in accordance with Article 11 of the proposed implementing regulation, where UAS are exempted from certain requirements, and/or where the operational limitations are extended; the MSs may also define different height limitations for those zones; — operate according to subcategory A3; in this case, hobbyists are required to comply with the limitations of, and demonstrate the competency defined in, UAS.OPEN.020. The proposed regulation allows the MSs to postpone for 3 years its applicability to UAS operations conducted within model aircraft clubs and associations in order to give the MSs sufficient time to issue operational authorisations and to define special zones. Only a minor change has been made to Article 6 of the proposed implementing regulation to clarify that the operational authorisation, to be provided by the competent authority to model aircraft clubs and associations, is the same authorisation defined in UAS.SPEC.040, issued by competent authorities for other operations conducted in the ‘specific’ category. TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 24 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what The point defining the responsibility of model aircraft clubs and associations has also been slightly modified to limit the necessity to take appropriate actions and, if necessary, inform the competent authority, only if they are informed that one of their members has exceeded the conditions and limitations defined in the operational authorisation. Model aircraft clubs and associations strongly requested the 120-m height limitation to be withdrawn and to leave the definition of the height limitation to the MSs, if such a limitation is necessary. EASA is not in favour of this proposal, since the limitation to 120 m is a key requirement to separate UAS from manned aircraft, and the deletion of this separation would be badly perceived by manned aviation. Article 6 on the establishment of special zones can be used to allow model aircraft flyers to fly their model aircraft higher than 120 m. 2.4.5. Date of entry into force and date of applicability The applicability timeline has been reviewed to address a request from several stakeholders to anticipate the dates and to even allow the MSs to decide to apply the regulation earlier. Therefore, a general application date has been defined of 6 months after the publication of the regulation in the Official Journal of the European Union. This means that by that date, MSs should have: — put in place a registration and authorisation database according to the new regulation; — defined zones where UAS are not permitted to operate, where they are restricted, or where ‘open’ category limitations are alleviated; — defined the entity recognised to issue A2 remote pilot competency certificates. In addition, a derogation of a further 3 months is allowed for operators to register themselves. Authorisations and declarations for UAS operators, as well as certificates of remote pilot competency issued on the basis of national legislation prior to the applicability date of the proposed regulation, may be considered valid until 1 year after the entry into force of the proposed regulation and by that time, the MS should have converted them according the new EU framework. The proposed delegated act on product regulation mandates that UAS manufacturers, by 2 years after its entry into force, shall only place on the market UAS that are compliant with the new technical requirements. Lastly, a derogation of 3 years is proposed for the applicability of the regulation to UAS operations conducted within model aircraft clubs and associations. By that time, the MSs should have issued operational authorisations to those model aircraft clubs and associations who had applied for them. This timeline will enable UAS operations in the ‘open’ category in subcategories A1 and A3 from the first day of applicability, while operations in subcategory A2 would require the availability of UAS that are complaint with the class C2 technical requirements that may only be available after 2 years. The proposed regulation also enables, from the applicability date onwards, operations in the ‘specific’ category. EASA is planning to develop standard scenarios by 2018, and they will be published soon after the proposed UAS regulation is adopted by the European Commission. TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 25 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what 2.4.6. Link with the U-Space A high-level conference on UAS was held in Helsinki on 21 and 22 November 201724 with the intention that safe and effective use of airspace would be achieved by the delivery of cost-effective U-Space services, and that the investment in demonstrators would systematically help to open up the UAS services market. During the development of NPA 2017-05, it was considered that the fundamental pillars of U-Space should be included in it: registration, e-identification and geo-awareness. Several comments on this were received during the NPA commenting period and during the discussion in the expert group. The following two options were proposed: — wait for a better definition of the U-Space requirements and avoid including in this regulation any requirements that may potentially need to be adapted in the future; — define in this regulation a minimum set of requirements on registration, e-identification and geo-awareness. The impact of the two approaches has been extensively discussed in dedicated meetings with industry, UAS operators and security authorities. In those meetings, several MSs clearly stated that registration and e-identification requirements are already essential elements in their national regulations. Without them, enforcement authorities would not have adequate tools, which would make it necessary to impose some limitations on UAS operations, or for specific additional requirements to be added by some MSs. The development of a detailed safety regulation for U-Space at present would be challenging due to the lack of experience in this field and the lack of a commonly agreed concept of operation (CONOPS). Several effective trial projects have been carried out, and the results have been encouraging. They are all based on the creation of a network, whose features depend on the solution adopted. However, more data is necessary to be able to develop safety performance requirements. EASA will actively monitor the development of further demonstrators either by SJU or by local initiatives in order to gather the necessary information. Moreover, it has not yet been defined whether U-Space will be available throughout the territory of the EU or only in areas where the UAS operations are more concentrated. In any case, in order to define the U-Space requirements, a new NPA is required, following the EASA rulemaking process that requires a new public consultation, and this may, therefore, take several months. Security agencies provided a clear request to equip UAS with a ‘local’ e-identification system, broadcasting a minimum set of information directly from the UAS over a short range, independently from the capacity of the U-Space services to provide a network identification. Hence, a second method of e-identification, independent from the network, will anyway be required. Industry also pledged to define a legal framework as soon as possible, enabling UAS operations that will allow them to gain experience. The solution to provide ‘local’ e-identification is considered the most realistic approach today. Moreover, the proposed regulation allows for demonstrators that may also be covered by standard scenarios dedicated to specific U-Space projects. The resulting experience will support the development of an enforceable regulation. 24 Its outcome was the ‘Helsinki Declaration’ (see https://ec.europa.eu/transport/sites/transport/files/2017-drones-declaration- helsinki.pdf). TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 26 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what This approach is consistent with the recent publication by the FAA, ‘UAS Remote Tracking & ID ARC Report’25, proposing a similar plan where the local and network functionality may coexist. The proposed regulation has been reviewed to identify the presence of any requirements that may impede the future development of U-Space, or whether any additional elements could be added. The conclusions were as follows: — registration: this is an essential element for enforcement. As explained in paragraph 2.4.3.1., this proposed regulation requires the registration of any UAS operator who conducts an operation using a UA with an MTOM greater than 250 g. Since it is expected that some of the services offered by U-Space will also require the unique identification of the UA, a standardised format for the UA SN has been added in the technical requirements; — e-identification: this Opinion proposes a ‘local’ e-identification to be broadcast over a close range for enforcement purposes. The functionality is mandatory for all UAS in classes C1, C2 and C3. For the C4 class, this functionality is required when the UA is operated in an area where e-identification is mandatory. UAS in class C0 have been excluded, consistent with the registration requirements. The characteristics of this ‘local’ e-identification function corresponds to the security needs. U-Space services may however require the development of a network identification function presenting the appropriate performances; — geo-awareness: at present, this function is for awareness only, to support the remote pilot in complying with the limitations in the area defined by the MSs. The term ‘geo-fencing’ has been replaced by ‘geo-awareness’ to better reflect the nature of the requirement already proposed in the NPA. It is preferable to give to the UAS operator full responsibility for flying the UA in areas away from prohibited or restricted zones. 2.5. Impact assessment A detailed and quantified impact assessment was published in May 2017 as part of NPA 2017-05 (B)26 and this section includes a brief paragraph that summarises its main results. No major changes from the proposal or from the respective preferred options included in the NPA have been included in the final text of the Opinion. Furthermore, the comments received on the impact assessment during the public NPA consultation, reflected in the related CRD, were limited in number and did not raise any major criticisms. The only main aspect included in the proposal that was not detailed in the first impact assessment is related to modules for conformity assessment. This is further analysed in this text. In addition, this section includes a paragraph that refers to the minor changes introduced by the proposal. 2.5.1. Overview of the regulatory impact assessment already published The specific issues identified and detailed in the impact assessment (IA) are the following: — a lack of clarity and non-harmonised definitions of the categories of UAS operation boundaries, including disproportionate rules for special categories; 25 https://www.faa.gov/news/updates/?newsId=89404 26 https://www.easa.europa.eu/system/files/dfu/NPA%202017-05%20%28B%29.pdf TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 27 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what — a lack of protection for sensitive areas; — inadequate technical requirements; — a lack of classification of airspace and of rules for low-level operations; — inadequate competencies for remote pilots; and — the need for registration and e-identification. These issues have been included in a ‘problem tree’ with a view to clarifying their primary causes (drivers) as well as their consequences. The consequences identified are the following: — ground risks (accidents/incidents involving persons on the ground or sensitive areas); — air risks (collision risks, air proximity, accidents and incidents with manned aircraft); — violations of privacy, data protection, and security; and — barriers to the market, burdens for industry, a lack of potential for innovation and development. In order to address the risks and to find solutions to the issues identified, three sets of options have been proposed, together with the corresponding analysis of the impacts based on various criteria (social, economic, safety). These sets of options cover the following areas: — the ‘open’ category; — registration; — the ‘specific’ category. The analysis of the impacts was supported by qualitative and quantitative assessments, making use of the inputs received from a dedicated UAS expert group, as well as the inputs from affected stakeholders including competent authorities, UAS manufacturers, UAS operators, model aircraft clubs and associations, and training schools. The preferred options identified (for the ‘open’ and ‘specific’ categories and for registration) represent proportionate solutions for all the stakeholders who are most affected. Overall, the preferred options that are proposed would reduce the costs for UAS manufacturers, competent authorities and UAS operators, while at the same time maintaining a high safety level, not only by protecting other airspace users and uninvolved persons from the risk of being injured by a UA, but also by mitigating the privacy and security risks. 2.5.2. New aspects in the proposal The following paragraph reports the impact of the main changes, described in the previous paragraphs, included in the Opinion, compared with the proposal in the NPA. For each change, a brief analysis has been included. 2.5.2.1. Use of UAS within subcategory A3 When compared with the requirements in the NPA, UAS operations conducted in subcategory A3, using a class C3 UAS, would require operators to comply with slightly more limitations. Indeed, while in the previous proposal, class C3 UAS would need to ‘fly in an area where it is reasonably expected that no uninvolved person will be present’, in the new proposal, they would have to ‘fly in an area where it is reasonably expected that no uninvolved person will be endangered and to keep a safe distance from TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 28 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what boundaries of congested areas of cities, towns or settlements’ (which was previously only applicable to class C4 UAS). According to the research included in the earlier IA (see graph 2 at page 10 of NPA 2017-05(B)), UAS that fall into the class C3 weight range (with MTOMs between 4 and 25 kg) represent only a small part of the market. However, some professional operations are expected to be conducted around the boundaries of cities using UAS with masses greater than 4 kg. These would fall into the ‘specific’ category. Overall, no major impacts are expected, with only a minor economic impact for those professional operators who use class C3 UAS and who would need to submit to the competent authority a declaration or apply for an authorisation. Taking into account the cost of a heavier UA, the cost of obtaining an authorisation may be proportionate. This approach improves the safety of UAS operations in subcategory A3, as it would positively contribute to the reduction in occurrences in congested areas with UAS heavier than 4 kg. Criteria Impact Economic – Safety ++ Total + 2.5.2.2. Minimum age: no longer defined at EU level The minimum age required to operate a UAS will be defined at the MS level. This change does not have any effect on safety, since the regulation defines the minimum competency to be demonstrated by the remote pilot and will allow the MSs to set the requirements according to the local conditions and national needs. However, slight negative impacts in terms of harmonisation are expected. 2.5.2.3. Need to have e-identification and geo-awareness for all UAS in classes C1 and C3 UAS in classes C1 and C3 would need to be equipped with e-identification and geo-awareness equipment, irrespective of the resolution of the camera with which they are equipped or whether they have an audio sensor, or the area of operation. Therefore, for the affected UAS, additional costs to design and implement geo-awareness and e-identification equipment would be faced by the manufacturers. However, the costs are not expected to be high when compared to those already identified (see graph 27 in NPA 2017-05 (B)). Moreover, many UAS currently available on the market are already equipped with cameras with a resolution higher than 5 MP (as this was the resolution limit identified in the NPA for UAS in class C1), and it is expected that with improvements in technology, very few cameras with low resolutions will be available in the future. This change would bring positive safety benefits due to the geo-awareness function, and positive security and privacy impacts due to the additional e-identification included. Criteria Impact Economic – Safety ++ Total + TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 29 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what 2.5.2.4. Registration for UAS operators only Registration would only be mandatory for UAS operators who conduct UAS operations using UAS with MTOMs greater than 250 g (classes C1, C2, C3 and C4). Registrations of single UA will no longer be required, unless, following the risk assessment required for operations in the ‘specific’ category, a CofA of the UA is required. The change would have no impact on safety, since it may still be possible to identify the responsible UAS operator in any case of misconduct. The economic impacts would be positive for UAS operators who are planning to operate several UAS, given that they would avoid paying a registration fee for each UAS, where applicable. The very minor additional cost that operators would face would be for the fire-resistant placard that they would need to apply to the UA. This change would, therefore, overall bring positive economic impacts for operators. Criteria Impact Economic ++ Safety 0 Total + 2.5.2.5. Introduction of a low-speed mode for UAS in class C2 UAS in class C2 that are intended to be operated up to a minimum distance of 5 m from people will be required to implement a low-speed mode function to improve the controllability of the UA. According to the feedback from some manufacturers, the economic impact of this is very low, since it could take around 10–20 man-days to develop a low-speed mode. On the other hand, the minimum distance from uninvolved persons has been reduced from 20 m, as proposed in the NPA, to 5 m as proposed in the new regulation, while maintaining the safety level of UAS operations. This would allow more operations to take place closer to people for class C2 UAS. Criteria Impact Economic –/+ Safety 0 Total –/+ 2.5.2.6. Data link protection for UAS in classes C2 and C3 UAS in classes C2 and C3 need to be equipped with protection for the data command and control link against unauthorised access. Also in this case, while the safety and security benefit is evident, there would be additional minor costs for the design and production of the affected UAS. It was considered that the current technology allows for inexpensive solutions, and the majority of the UAS on the market already implement same kind of protection for the data link. The possibility of extending the requirements to UAS in class C1 was also evaluated but, considering the limited kinetic energy of this class of UA, it was decided not to mandate this. TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 30 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what Criteria Impact Economic – Safety ++ Total + 2.5.2.7. Speed limit for UAS in class C0 The speed of UAS in Class C0, if they are not already compliant with the Directive on the safety of toys, has been limited to 19 m/s. From a safety point of view, this should be very beneficial, considering that these UAS could be flown over people. However, this is expected to have a negligible impact from an economic point of view, since the manufacturers are also required to consider this in their declarations to show compliance with the technical requirements. Criteria Impact Economic – Safety ++ Total + 2.5.2.8 Unique serial number (SN) for UAS in classes C1, C2 and C3 UAS in classes C1, C2 and C3 are each required to have a unique SN. This is expected to have a negligible economic impact, while bringing a positive safety impact, especially when, in the future, U-Space will need to be able to uniquely identify a UA in order to maintain its separation from other traffic. Criteria Impact Economic – Safety ++ Total + 2.5.3. Conclusion on the changes introduced to the proposal Further to the analysis provided, overall, the impact of all the changes in the technical requirements could be considered to be neutral in terms of the economic impacts, and positive from a safety point of view. Criteria Impact Economic –/+ Safety + Total + 2.5.4. Analysis of modules 2.5.4.1. Problem definition As already highlighted in paragraph 2.4.2.2., one key aspect to be tackled in detail when drafting new product harmonisation legislation is the selection of the procedures provided to economic operators to undertake the conformity assessment of their products. Decision No 768/2008/EC defines 8 different modules and their variants, covering the definition and/or the production phase. Their TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 31 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what combinations provide 15 different possible procedures27 from which the legislator usually selects the 3 that are most appropriate for the specific area of activity concerned. These procedures range from a simple declaration of conformity submitted by the manufacturer to a more detailed verification of the design and/or of each product, or the implementation of a quality assurance system, both involving the use of notified bodies (NBs). If the set of modules to be used is not correctly selected, several consequences could result: — the system could be too burdensome (e.g. expensive checks, long checks), which could lead some companies to exit the market, especially small to medium-sized enterprise (SMEs) that could face high initial costs; — an inadequate level of product safety could lead to air risks (e.g. collisions with manned aircraft due to loss of control) or ground risks (e.g. injury to uninvolved persons). The following is an example of the compliance of a product with the requirements defined in a market regulation, to be taken into consideration for the selection of modules. In 2015, the 7th joint cross border R&TTE Market Surveillance campaign focused on the compliance of UAS with the R&TTE Directive28. This Directive allowed the use of the self-declaration procedure (module A). Market surveillance authorities found that ‘92 % of the devices did not fulfil all of the requirements’. Further reference to this has been included in the ‘Report on the 7th joint cross border R&TTE Market Surveillance campaign (2015)’29. It needs to be considered that, given their nature, UAS will anyway be subject to other already established directives such as the Radio Equipment Directive (2014/53/EU)30 and the Low Voltage Directive (2014/35/EU)31. 2.5.4.2. Objectives The specific objectives are to: — ensure an adequate level of safety when defining the modules; — establish a proportionate set of modules, considering the potential costs and benefits. 2.5.4.3. Options — A first principle guiding the choice of the legislator is to ensure that, when appropriate in terms of protection of public interest, the conformity assessment procedures used in the sector in question should be reflected in the modules selected. In the case of UAS, applicable directives, in particular the Radio Equipment Directive (2014/53/EU) and the Low Voltage Directive 27 See CERTIF 2009–04, available at http://ec.europa.eu/DocsRoom/documents/6280/. 28 Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (OJ L 91, 7.4.1999, p. 10). 29 http://ec.europa.eu/DocsRoom/documents/13343/attachments/1/translations/en/renditions/native. 30 Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62). 31 Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357). TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 32 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what (2014/35/EU), provide the three following procedures: module A, module B + C and module H32. These modules will be the basis on which the different options will be built. They are described below:  Module A: this represents the least stringent procedure, as it provides for conformity assessment to be undertaken by a self-declaration concerning the compliance of the design with the requirements, as well as of the product. It does not require the involvement of any independent third party or an accredited ‘in-house’ conformity assessment body.  Module B: in this option, NBs undertake an examination of the technical design of a product to verify that it meets the applicable requirements. On the basis of an examination of the technical documentation and a specimen supplied by the manufacturer, the NB issues an EC-type examination certificate (for those product designs/specimens that meet the relevant legislative requirements). As module B only concerns the design phase, it must be followed by a module that covers the production phase and provides a conformity assessment in relation to the type described in the EC- type examination certificate (i.e. support for the manufacturer’s declaration of conformity to type).  Module C: this is analogous to module A, but it only covers the production phase. It is used when the product design has already been subjected to an examination of the technical design of a product (i.e. module B).  Module H: in this option, a NB assesses the quality system of the manufacturer to determine whether it is suitable to ensure compliance with the requirements for both the design and production phases. After receiving a positive assessment, the manufacturer is entitled to declare that the products concerned satisfy the requirements, on their sole responsibility. In this way, it provides an alternative to product examination/testing by a third-party body, but it does require periodical surveillance. The selection of the modules should take into consideration the following aspects: — The level of the risk involved: the complexity of the modules should be proportionate to the risk and the complexity of the requirements. An operation-centric approach should be taken when analysing the risks related to the different classes. Such an analysis would lead to consider similar level of risks for all classes in the ‘open’ category as a higher UA mass is balanced by stricter UA requirements, operational restrictions and pilot competency (this was the approach taken in the NPA). However, this approach does not address enough possible misuse or failure of the UA. So, the following risks level are now considered for the selection of the modules:  Class C3 may have a high mass but should in principle be operated far from uninvolved people. However, a misuse or a product failure could happen. As a consequence, class C3 is considered to present a high risk.  Class C2 combines both a high mass (0.9 to 4 kg) and the possibility of flying close to people. This is considered to present the highest risk in the ‘open’ category. 32 Further reference can also be found in CERTIF 2009-03, available at http://ec.europa.eu/DocsRoom/documents/6278. TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 33 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what  Class C1 (due to the lower mass of the UA) and C4 (due to the fact that they are model aircraft and should be operated far from uninvolved people), are considered to present lower risks.  Class C0 (due to its very low mass) is considered to present the lowest risk. — The complexity of the requirements: the technical requirements differ according to the class. Overall, class C2 is the one that includes more requirements (e.g. lost-link management, selectable height limit, low-speed mode, frangibility, and injury reduction in the event of an impact with a person), and class C4 has almost no technical requirements. — The size of the manufacturers involved (e.g. SMEs). — The complexity of the module and the related costs. — The length of the checks that could affect the time to market. — Involvement of a third party (i.e. ‘notified bodies’ (NBs)). Option 0 — Do nothing Option 0, ‘do nothing’, would mean that there was no need to request EU conformity assessments for UA products. Even if this option is not actually contemplated by the legislator, it is included in the document purely as a theoretical exercise to provide a benchmark for comparison with the other options described below. Indeed, it is very important in an impact assessment that the options analysed are compared with a baseline (which is option 0). Option 1 — Module A is allowed for UAS in classes C0 to C4 For all classes, manufacturers could apply any of the following three sets of modules: A (internal production control), B (EC-type examination, involving NBs) + C (conformity to type based on internal production control), or H (full quality assurance, involving NBs). Module A would apply if standards were available, or for UAS in class C0, if the products complied with the Directive on the safety of toys. Class/ʽOpen’ category Module(s) C0 A, B + C or H C1 A, B + C or H C2 A, B + C or H C3 A, B + C or H C4 A, B + C or H Option 2 — Module A is not allowed for UAS in class C2 For classes C0, C1, C3 and C4, manufacturers could apply any of the following three sets of modules: A, B + C or H, provided by the other applicable directives. Module A would apply if standards were available, or for C0, if the products complied with the Directive on the safety of toys. Instead, for UAS in class C2, only modules B + C or H would be applicable. Class/ʽOpen’ category Module(s) C0 A, B + C or H C1 A, B + C or H C2 B + C or H C3 A, B + C or H C4 A, B + C or H TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 34 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what Option 3 — Module A is not allowed for UAS in classes C2 and C3 For classes C0, C1 and C4, manufacturers could apply any of the following three sets of modules: A, B + C or H, provided by the other applicable directives. Module A would apply if standards were available, or for class C0, if the products complied with the Directive on the safety of toys. In contrast, for UAS in classes C2 and C3, only modules B + C or H would be applicable. Class/ʽOpen’ category Module(s) C0 A, B + C or H C1 A, B + C or H C2 B + C or H C3 B + C or H C4 A, B + C or H Option 4 — Module A is not allowed for UAS in classes C1, C2, C3 For classes C0 and C4, manufacturers could apply any of the following three sets of modules: A, B + C or H, provided by the other applicable directives. Module A would apply if standards were available, or for class C0, if the products complied with Directive on the safety of toys. Instead, for UAS in classes C1, C2 and C3, only modules B + C or H would be applicable. Class/ʽOpen’ category Module(s) C0 A, B + C or H C1 B + C or H C2 B + C or H C3 B + C or H C4 A, B + C or H Overview of the options proposed Class/ʽOpen’ category Option 1 Option 2 Option 3 Option 4 C0 A, B + C or H A, B + C or H A, B + C or H A, B + C or H C1 A, B + C or H A, B + C or H A, B + C or H B + C or H C2 A, B + C or H B + C or H B + C or H B + C or H C3 A, B + C or H A, B + C or H B + C or H B + C or H C4 A, B + C or H A, B + C or H A, B + C or H A, B + C or H TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 35 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what 2.5.4.4. Analysis of impacts Economic The following is a list of the information gathered during consultations with stakeholders, which included targeted meetings with some UAS manufacturers. This information has been considered throughout the analysis of options. The cost estimates included represent a partial view, due to the small number of replies received: Cost definition Amount estimated Type examination if tests are supplied by the manufacturers (e.g. module B) EUR 3 000 Type examination by NBs (e.g. module B) EUR 7 000 to 50 000 Annual factory inspection (e.g. module C), cost on top of module B EUR 2 000 Audit for approval of the quality system for design, initial cost EUR 10 000 to 25 000 Surveillance of the quality system (recurrent cost for NB examinations, every 2 EUR 1 500 to 3 500 years) 33 Overall cost of conformity assessment/across modules 2 to 5 % of total costs Option 0 Manufacturers: a lack of conformity assessment at the EU level might lead to fragmentation in terms of product checks, which could lead to high costs if there is fragmentation across Europe on how producers comply. Companies would face adaptation costs, given the different assessments and procedures. This would lead to high initial costs (for setting up tests) and recurrent costs. Option 1 Manufacturers of UAS in the ‘open’ category classes would not face major costs, considering that they could apply module A (internal production control). In that case, the only costs would be for the in-house development of checks. Overall, very minor costs are expected for manufacturing companies. Considering the negative experience regarding compliance with the R&TTE Directive, as mentioned in the problem definition, the authorities would need a large amount of resources for enforcement, considering that NBs would not be involved (except if companies decide to select modules B + C or H). Therefore, negative impacts are expected. Option 2 Manufacturers: in option 2, only class C2 UAS would have to bear the additional burden of the involvement of a NB, including the cost of issuing a certificate for the design, and where module H is chosen, the approval of an in-house control system and surveillance of the quality system. Class C2 UAS represent a large part of the market according to research included in NPA 2017-05 (B)34. The burden is expected to be of limited impact, assuming that the production runs are very large and that companies producing this type of UA may already have well-developed quality assurance systems that allow them to rely on module H. Overall, minor costs are expected for manufacturing companies. Notified bodies (NBs): this option could bring some market opportunities considering the number of UAS in C2 UAS that would need to go through the checks. 33 The range depends on the UAS segment (e.g. consumer, prosumer, pro). 34 At page 10 of NPA 2017-05 (B) of RMT.0230, Graph 2 on the UAS divided by MTOM according to operators’ feedback shows that circa 92 % of the UAS would be below 4 kg, therefore, in general, fitting in categories C0, C1 and C2. TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 36 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what Authorities: a smaller amount of resources in comparison with option 1 would need to be dedicated to enforcement, considering the checks performed by NBs for UAS in class C2. Option 3 Manufacturers: in this option, NBs would also be involved in the conformity assessment of UAS in class C3. Therefore, the costs mentioned in option 2 would also apply to UAS in class C3. These do not represent a large part of the UAS market according to the research included in NPA 2017-05(B)34; however, the UAS market is expected to grow in the near future. However, SMEs who produce UAS in class C3 might face negative impacts, especially when products are produced in low numbers (e.g. < 100 units). Overall, costs are expected to be at the medium level for manufacturing companies. Notified bodies (NBs): this option could bring significant market opportunities, considering the number of UAS in classes C2 and C3 that would need to go through the checks. Authorities: a smaller amount of resources in comparison with option 2 would need to be dedicated for enforcement. Option 4 Manufacturers: in this option, as with the previous one, NBs would also be involved in the conformity assessment of class C1 UAS. The assessment required could, in addition, delay the launch of products in class C1 where the time to market is key (e.g. for small UA often used for leisure and facing high competition). Overall, very high costs are expected for manufacturing companies, especially where the costs could not be spread over a series of products. Notified bodies (NBs): this option could bring significant market opportunities (more than option 3), considering the C1, C2 and C3 products that would need to go through the checks. Authorities: a smaller amount of resources in comparison with option 3 would need to be dedicated for enforcement. Safety Option 0 No EU-wide conformity assessment process would exist, which would lead to uncertainty on the adequacy of the checks performed, and as a consequence, a significant safety risk because of the likely high level of non-conformity. Considering the likely growth of the UAS market in the future, this could lead to negative safety impacts. Option 1 Self-declaration would be authorised for all classes. This could lead to serious safety concerns, as product conformity would not be checked by NBs. This would be an issue, especially for UAS belonging to subcategory C2. Overall, high negative safety impacts are expected. Option 2 In this option, the involvement of a NB would be required for UAS in class C2, involving a high level of risk. Self-declaration would be accepted for all other classes. TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 37 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what For UAS in class C2, this provides an acceptable safety level. UAS in classes C1 and C3 may instead present a high rate of non-conformity. However, this is considered to be acceptable for UAS in class C1, given the lower level of risk involved, but this could be potentially critical for UAS in class C3, given the greater masses of the UA in this class. Overall, slight negative safety impacts are expected. Option 3 Module B + C or H would apply for UAS in classes C2 and C3. Therefore, in comparison with option 2, the risks highlighted for UAS in class C3 would be mitigated. Overall, a positive safety impact is expected. Option 4 Modules B + C and H would apply to all classes except C0 and C4. Overall, a very high positive safety impact is expected. Social No major impact is expected for any of the options. Environmental Detailed checks on the noise emissions of UAS during the conformity assessment process would positively contribute to minimise environmental impacts by ensuring that noise requirements were fulfilled. Options 3 and 4 would bring more positive impacts, considering the application of modules B + C or H to several classes, while for options 1 and 2, minor positive impacts are expected. 2.5.4.5. Comparison and conclusion Criteria Option 0 Option 1 Option 2 Option 3 Option 4 Economic 0 +/– +/– +/– – Safety – –– – + ++ Environmental 0 0/+ 0/+ + + Total 0 +/– +/– + +/– Option 3 is the preferred one, as it ensures an adequate level of safety and it includes a proportionate set of modules, considering the potential costs and benefits. Indeed, this option strikes a good balance between conformity assessment costs and safety concerns. For UAS manufacturers: a non-burdensome self-declaration procedure, module A, would apply for UAS in classes C0, C1 and C4, considering the safety risk. On the contrary, modules B + C or H for UAS in classes C2 and C3 would provide an appropriate level of safety, taking into account the potential safety risks for these two UAS classes (e.g. risks of collision on the ground and collisions with manned aircraft in the air). For authorities: the expected amount of resources to be dedicated to check product compliance would be lower in comparison with options 0, 1 and 2, taking into consideration the important role of NBs in compliance checks. For NBs: there would be positive economic impacts, taking into account the number of UAS that would need to go through a check performed by an accredited body (for UAS in classes C2 and C3). TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 38 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 2. In summary — why and what With regard to option 4, even if more detailed checks were performed on a very small part of the affected market, in comparison with option 3, this would lead to much higher costs. Therefore, overall, in comparison with the other options, option 3 would provide the best outcome. 2.6. How do we monitor and evaluate the rules Monitoring and evaluation of the rules were already proposed in Chapter 8 ‘Monitoring and evaluation’ of NPA 2017-05 (B). Done at Cologne, 6 February 2018. Patrick KY Executive Director TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 39 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 3. References 3. References 3.1. Affected regulations Not applicable. 3.2. Related decisions Not applicable. 3.3. Other reference documents Not applicable. TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 40 of 41 An agency of the European Union  European Aviation Safety Agency Opinion No 01/2018 4. Appendix 4. Appendix Appendix to Opinion No 01/2018 ‘Introduction of a regulatory framework for the operation of unmanned aircraft systems in the “open” and “specific” categories’: CRD to NPA 2017-05: To be published in 2018/Q1. TE.RPRO.00036-005 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 41 of 41 An agency of the European Union DRAFT COMMISSION DELEGATED REGULATION (EU) …/… of XXX on making available on the market of unmanned aircraft intended for use in the ‘open’ category and on third-country UAS operators THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) …/… [new BR] of the European Parliament and of the Council on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Regulation (EC) No 216/2008 (1), and in particular Articles 45, 46, 47, 48, 50 and 51 thereof, Whereas: (1) The UAS intended to be operated in the ‘open’ category covering operations presenting the lowest risks should not be subject to classic aeronautical compliance procedures. For those consumer products, the possibility to establish ‘Union harmonisation legislation’ provided for by Article 46.3 of Regulation (EU) …/… [new BR] should be used. This Regulation should, in consequence, set out the requirements that address the risk posed by operation of those UAS, taking full account of other applicable EU harmonisation legislation. (2) Unmanned aircraft and their engines, propellers, parts and non-installed equipment within the scope of Regulation (EU) …/… [new BR] and intended exclusively for airborne use are excluded from the scope of Directive 2014/53/EU (2) and Directive 2014/30/EU (3) only from the moment and in as far as the design of the unmanned aircraft and of their engines, propellers, parts and non-installed equipment are certified in accordance with Regulation (EU) …/… [new BR] and intended to be operated only on frequencies allocated by the Radio Regulations of the International Telecommunication Union for protected aeronautical use. As a consequence, Directive 2014/53/EU and, with respect to unmanned aircraft and their engines, propellers, parts and non-installed equipment which do not communicate with radio waves, Directive 2014/30/EU, apply to unmanned aircraft and their engines, propellers, parts and non- installed equipment in the ‘open’ category. ( 1) OJ reference to be added when the new ‘Basic Regulation’ repealing Regulation (EC) No 216/2008 will be adopted by the European Parliament and the Council. For referencing purposes, ‘Regulation (EU) …/… [new BR]’ is used in the proposed draft Regulation. ( 2) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62). ( 3) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast) (OJ L 96, 29.3.2014, p. 79). EN 1 EN  (3) Decision No 768/2008/EC of the European Parliament and of the Council (4) lays down common principles and reference provisions intended to apply across the legislation harmonising the conditions for the marketing of products in order to provide a coherent basis for revision or recasts of that legislation. In order to ensure consistency with other sectorial product legislation, this Regulation should therefore follow that Decision regarding the marketing of UAS intended to be operated in the ‘open’ category. (4) Regulation (EC) No 765/2008 of the European Parliament and of the Council (5) lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking. (5) This Regulation applies to a UAS which is new to the Union market when it is placed on the market; that is to say it is either a new UAS made by a manufacturer established in the Union or a UAS, whether new or second-hand, imported from a third country. (6) This Regulation should apply to all forms of supply, including distance selling. (7) Special attention should be paid to ensure compliance of products in the context of an increase of e-commerce. To that end, Member States should be encouraged to pursue cooperation with the competent authorities in third countries and to develop cooperation between market surveillance authorities and customs. Market surveillance authorities should make use, when possible, of the ‘notice and action’ procedures and establish cooperation with their national authorities competent for the implementation of the Directive on electronic commerce (6). They should establish close contacts allowing rapid response with key intermediaries that provide hosting services for products sold online. (8) Economic operators should be responsible for the compliance of UAS intended to be operated in the ‘open’ category with the requirements included in this Regulation, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of public interests, such as health and safety, and to guarantee fair competition on the Union market. (9) All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they make available on the market UAS intended to be operated in the ‘open’ category which are in conformity with this Regulation. This Regulation should provide a clear and proportionate distribution of obligations ( 4) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82). ( 5) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). ( 6) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (‘Directive on electronic commerce’) (OJ L 178, 17.7.2000, p. 1). EN 2 EN  which correspond to the role of each economic operator in the supply and distribution chain. (10) In order to facilitate communication between economic operators, national market surveillance authorities and consumers, Member States should encourage economic operators to include a website address in addition to the postal address. (11) The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure. Conformity assessment should therefore remain solely the obligation of the manufacturer. (12) It is necessary to ensure that UAS from third countries entering the Union market comply with the requirements of this Regulation when the UAS are intended to be operated in the ‘open’ category and, in particular, that appropriate conformity assessment procedures have been carried out by the manufacturers. Provision should therefore be made for importers to make sure that the UAS they place on the market comply with the requirements of this Regulation and that they do not place on the market UAS which do not comply with those requirements or which present a risk. Provision should also be made for importers to make sure that the conformity assessment procedures have been carried out and that the CE marking and technical documentation drawn up by the manufacturers is available for inspection by the competent national authorities. (13) The distributor makes a UAS intended to be operated in the ‘open’ category available on the market after it has been placed on the market by the manufacturer or the importer and the distributor must act with due care to ensure that its handling of the product does not adversely affect its compliance. Both importers and distributors are expected to act with due care in relation to the requirements applicable when placing or making products available on the market. (14) When placing on the market UAS intended to be operated in the ‘open’ category, every importer should indicate on the UAS his name, registered trade name or registered trademark and the address at which he can be contacted. Exceptions should be provided for in cases where the size or nature of the UAS does not allow this. This includes cases where the importer would have to open the packaging to put his name and address on the UAS. (15) Any economic operator that either places a UAS intended to be operated in the ‘open’ category on the market under his own name or trademark, or modifies a UAS intended to be operated in the ‘open’ category in such a way that compliance with the requirements of harmonisation legislation included in this Regulation may be affected, should be considered to be the manufacturer and should assume the obligations of the manufacturer. (16) Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by the competent national authorities, and should be prepared to participate actively, providing those authorities with all the necessary information relating to the UAS concerned. EN 3 EN  (17) Ensuring the traceability of a UAS intended to be operated in the ‘open’ category throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates the market surveillance authorities’ task of tracing economic operators who make non-compliant UAS available on the market. When keeping the information required under this Regulation for the identification of other economic operators, economic operators should not be required to update such information in respect of other economic operators who have either supplied them with a UAS or to whom they have supplied a UAS. (18) This Regulation should be limited to the expression of the essential requirements. In order to facilitate conformity assessment with those requirements, it is necessary to provide for a presumption of conformity for products which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council (7) for the purpose of expressing detailed technical specifications of those requirements. (19) The essential requirements should be worded precisely enough to create legally binding obligations. They should be formulated so as to make it possible to assess conformity with them even in the absence of harmonised standards or where the manufacturer chooses not to apply a harmonised standard. The degree of detail of the wording will depend on the characteristics of each sector. (20) Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised standards where those standards do not entirely satisfy the requirements of the harmonisation legislation included in this Regulation. (21) In order to enable economic operators to demonstrate, and the competent authorities to ensure, that UAS intended to be operated in the ‘open’ category made available on the market conform to the essential requirements, it is necessary to provide for conformity assessment procedures. Decision No 768/2008/EC establishes modules for conformity assessment procedures, which include procedures from the least to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-sectorial coherence and to avoid ad hoc variants, conformity assessment procedures should be chosen from among those modules. (22) Market surveillance authorities and UAS operators should have easy access to the EU declaration of conformity. In order to fulfil that requirement, manufacturers should ensure that each UAS intended to be operated in the ‘open’ category is accompanied either by a copy of the EU declaration of conformity or by the internet address at which the EU declaration of conformity can be accessed. ( 7) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). EN 4 EN  (23) To ensure effective access to information for market surveillance purposes, the information required to identify all applicable Union acts for UAS intended to be operated in the ‘open’ category should be available in a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, it should be possible for that single EU declaration of conformity to be a dossier made up of relevant individual declarations of conformity. (24) The CE marking, indicating the conformity of a product, is the visible consequence of a whole process comprising conformity assessment in a broad sense. The general principles governing the CE marking are set out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking on UAS intended to be operated in the ‘open’ category should be laid down in this Regulation. (25) In order to ensure compliance with the essential requirements laid down in this Regulation, it is necessary to lay down appropriate conformity assessment procedures to be followed by the manufacturer. Decision No 768/2008/EC establishes modules for conformity assessment procedures, which include procedures from the least to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-sectorial coherence and to avoid ad hoc variants, conformity assessment procedures should be chosen from among those modules. (26) Conformity assessment procedures applicable to UAS intended to be operated in the ‘open’ category covered by this Regulation require the intervention of conformity assessment bodies, which are notified by the Member States to the Commission. (27) It is necessary to ensure a uniformly high level of performance of bodies performing conformity assessment of UAS intended to be operated in the ‘open’ category throughout the Union, and all such bodies should perform their functions at the same level and under conditions of fair competition. Therefore obligatory requirements should be set for conformity assessment bodies wishing to be notified in order to provide conformity assessment services. (28) If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards, it should be presumed to comply with the corresponding requirements set out in the harmonisation legislation included in this Regulation. (29) In order to ensure a consistent level of conformity assessment quality, it is also necessary to set requirements for notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies. (30) The system set out in this Regulation should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should also be used for the purposes of notification. (31) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates of conformity, should be considered by the national public authorities throughout the Union as the means of demonstrating the technical competence of conformity assessment bodies. EN 5 EN  (32) Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for the appliances and the fittings to be placed on the Union market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies do in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified, and the monitoring of bodies already notified, also covers activities carried out by subcontractors and subsidiaries. (33) It is necessary to increase the efficiency and transparency of the notification procedure and, in particular, to adapt it to new technologies so as to enable online notification. (34) Since notified bodies may offer their services throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies. (35) In the interests of competitiveness, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved through appropriate coordination and cooperation between notified bodies. (36) Interested parties should have the right to appeal against the result of a conformity assessment carried out by a notified body. For that reason, it is important to ensure that an appeal procedure against decisions taken by notified bodies is available. (37) Member States should take all appropriate measures to ensure that UAS covered by this Regulation may be placed on the market only if, when properly stored and used for its intended purpose or under conditions of use which can be reasonably foreseen, it does not endanger the health or safety of persons. UAS covered by this Regulation should be considered as non-compliant with the essential requirements laid down in this Regulation only under conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behaviour. (38) In order to ensure legal certainty, it is necessary to clarify that the rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to products falling within the scope of this Regulation. This Regulation should not prevent Member States from choosing the competent authorities to carry out those tasks. In order to ensure a smooth transition as regards the implementation of this Regulation, appropriate transitional measures should be provided. EN 6 EN  (39) UAS operators that have their principal place of business, or are established, or are resident in a third country and that are conducting UAS operations in, out or within the single European sky airspace should be subject to this regulation. (40) The measures provided for in this Regulation are based on Opinion No 01/2018 (8) issued by the European Aviation Safety Agency (EASA) in accordance with Article 65 of Regulation (EU) …/… [new BR], HAS ADOPTED THIS REGULATION: SECTION 1 General provisions Article 1. Subject matter and scope 1. This Regulation lays down rules on the making available on the market and the free movement in the Union of those UAS intended to be operated under the rules and conditions of the ‘open’ category as defined in Regulation (EU) …/… [IR] (9). 2. This Regulation lays down requirements for the design and manufacture of five classes of unmanned aircraft systems (UAS), as well as for UAS components, except for privately built UAS. 3. This Regulation lays down also rules for UAS operators that have their principal place of business, are established, or reside in a third country, when they conduct a UAS operation in the ‘open’ or ‘specific’ category within the single European sky airspace. Article 2. Definitions For the purposes of this Regulation, the following definitions apply: 1. ‘unmanned aircraft system (UAS) operator’ means any legal or natural person who operates or intends to operate one or more UAS; 2. ‘making available on the market’ means any supply of a product for distribution, consumption or use in the EU market in the course of a commercial activity, whether in exchange of payment or free of charge; 3. ‘“open” category’ means a category of UAS operation that, considering the risks involved, requires neither a prior authorisation by the competent authority, nor a declaration by the UAS operator before the operation takes place; ( 8) EASA Opinion No 01/2018 ‘Introduction of a regulatory framework for the operation of unmanned aircraft systems in the “open” and “specific” categories’ (RMT.0230), available at https://www.easa.europa.eu/document-library/opinions. ( 9) OJ reference to be added when the draft Commission Regulation laying down rules and procedures for the operation of unmanned aircraft will be adopted. For referencing purposes, ‘Regulation (EU) …/… [IR]’ is used in the proposed draft Regulation. EN 7 EN  4. ‘unmanned aircraft system (UAS)’ means the UA and the equipment to control the unmanned aircraft remotely; 5. ‘product’ means a UAS intended to be operated under the rules and conditions of the ‘open’ category or a UAS component as defined in Appendix 6; 6. ‘Union harmonisation legislation’ means any EU legislation harmonising the conditions for placing products on the market; 7. ‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008; 8. ‘conformity assessment’ means the process demonstrating whether specified requirements relating to a product have been fulfilled; 9. ‘CE marking’ means a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixation; 10. ‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark; 11. ‘economic operators’ means the manufacturer, the authorised representative of the manufacturer, the importer, and the distributor of the UAS; 12. ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market; 13. ‘placing on the market’ means the first making available of a UAS on the Union market; 14. ‘harmonised standard’ means a harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012; 15. ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a product, process or service; 16. ‘single European sky airspace’ means airspace above the territory to which the Treaties apply, as well as any other airspace where Member States apply Regulation (EU) No 551/2004 in accordance with Article 1(3) of that Regulation; 17. ‘privately built UAS’ means a UAS assembled or manufactured for the manufacturer’s own use; this does not include UAS assembled from a set of parts placed on the market by the manufacturer as a single ready-to-assemble kit; 18. ‘equipment to control unmanned aircraft remotely’ means any instrument, equipment, mechanism, apparatus, appurtenance, software or accessory that is necessary for the safe operation of a UA other than a part and which is not carried on board that UAS; 19. ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in EN 8 EN  relation to specified tasks with regard to the latter’s obligations under the relevant Union legislation; 20. ‘market surveillance authority’ means an authority of a Member State responsible for carrying out market surveillance on its territory; 21. ‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the end user; 22. ‘unmanned aircraft (UA)’ means any aircraft operating or designed to operate autonomously or to be piloted remotely without a pilot on board; 23. ‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market; 24. ‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection; 25. ‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market; 26. ‘remote pilot’ means a natural person responsible for safely conducting the flight of a UA by operating its flight controls, either manually or, when the UA flies automatically, by monitoring its course and remaining able to intervene and change its course at any time; 27. ‘follow-me mode’ means a mode of operation of a UAS where the UA constantly follows a person or a device within a predetermined radius; 28. ‘electronic identification’ means a system that transmits the identity of the UA so that it can be identified without direct physical access to that UA 29. ‘geo-awareness’ means a function that can detect a potential breach of airspace limitations and provide the remote pilot with sufficient information and an appropriate alert to allow the remote pilot to take effective action to prevent that breach. Article 3. Making available on the market Products that fall within the scope of this Regulation shall only be made available on the Union market if they comply with the requirements set out in Appendices 1 to 6. Article 4. Free movement of products Member States shall not prohibit, restrict or impede, for the aspects covered by this Regulation, the making available on the market of products that fall within the scope of this Regulation and comply with this Regulation. EN 9 EN  SECTION 2 Obligations of economic operators Article 5. Obligations of manufacturers 1. When placing their product on the market, manufacturers shall ensure that it has been designed and manufactured in accordance with the requirements set out in Article 3. 2. Manufacturers shall draw up the technical documentation referred to in Article 16 and carry out the relevant conformity assessment procedure referred to in Article 12, or have it outsourced. Where compliance of the product with the requirements in the relevant Appendices 1 to 6 has been demonstrated by that conformity assessment procedure, manufacturers shall draw up an EU declaration of conformity referred to in Article 13 and affix the CE marking referred to in Article 14. 3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the product has been placed on the market. 4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Regulation. Changes in product design, characteristics or software, and changes in the harmonised standards or in technical specifications by reference to which conformity of a product is declared shall be adequately taken into account. When deemed appropriate with regard to the risks presented by a product, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of marketed products, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep distributors informed of any such monitoring. 5. Manufacturers shall ensure that procedures are in place to ensure that software upgrades that take place after placing the product on the market do not alter the compliance of the product. 6. Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging, or in a document accompanying it. 7. Manufacturers shall indicate their name, registered trade name or registered trademark and the postal address at which they can be contacted on the product or, where that is not possible, on its packaging, or in a document accompanying it. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be indicated in a language easily understood by end users and market surveillance authorities. EN 10 EN  8. Manufacturers shall ensure that their products bear the UA class identification label defined in the related Appendices 1 to 5. 9. Manufacturers shall ensure that the product is accompanied by the instructions and information required by Appendices 1 to 6 in a language which can be easily understood by consumers and other end users, as determined by the Member State concerned. Such instructions and information, as well as any labelling, shall be clear, understandable and legible. 10. Manufacturers shall ensure that each product is accompanied by a copy of the EU declaration of conformity or by a simplified EU declaration of conformity. Where a simplified EU declaration of conformity is provided, it shall contain the exact internet address where the full text of the EU declaration of conformity can be obtained. 11. Manufacturers who consider or have reason to believe that products which they have placed on the market are not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, manufacturers shall immediately inform the market surveillance authorities of the Member States in which they made the product available on the market to that effect, giving details, in particular, of the non-compliance, of any corrective measures taken and of the results thereof. 12. Manufacturers shall, further to a reasoned request from a competent market surveillance or authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the product with this Regulation, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the product which they have placed on the market. Article 6. Authorised representatives 1. A manufacturer may, by a written mandate, appoint an authorised representative. 2. The obligations laid down in Article 5(1) and the obligation to draw up technical documentation laid down in Article 5(2) shall not form part of the authorised representative’s mandate. 3. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following: (a) keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities for 10 years after the product has been placed on the market; (b) further to a reasoned request from a market surveillance or border control authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the product; EN 11 EN  (c) cooperate with the market surveillance or border control authorities, at their request, on any action taken to eliminate the non-conformity of the products covered by the authorised representative’s mandate or the safety risks posed by it. Article 7. Obligations of importers 1. Importers shall only place products compliant with the requirements set out in this Regulation on the Union market. 2. Before placing a product on the market, importers shall ensure that: (a) the appropriate conformity assessment procedure referred to in Article 12 has been carried out by the manufacturer; (b) the manufacturer has drawn up the technical documentation referred to in Article 16; (c) the product bears the CE marking and, when required, the UA class identification label; (d) the product is accompanied by the documents referred to in Article 5(9) and (10); (e) the manufacturer has complied with the requirements set out in Article 5(6) and (7). Where an importer considers or has reason to believe that a product is not in conformity with the requirements set out in Article 3, he shall not place the product on the market until it has been brought into conformity. Furthermore, where the product presents a risk, the importer shall inform the manufacturer and the competent market surveillance authorities to that effect. 3. Importers shall indicate on the product their name, registered trade name or registered trademark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the product. The contact details shall be in a language easily understood by end users and market surveillance authorities. 4. Importers shall ensure that the product is accompanied by the instructions and information required by Appendices 1 to 6 in a language which can be easily understood by consumers and other end users, as determined by the Member State concerned. Such instructions and information, as well as any labelling, shall be clear, understandable and legible. 5. Importers shall ensure that, while the product is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the requirements set out in Article 3. 6. When deemed appropriate with regard to the risks presented by a product, importers shall, to protect the health and safety of end users and third parties, carry out sample EN 12 EN  testing of products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming of products and product system recalls, and shall keep distributors informed of any such monitoring. 7. Importers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the applicable Union harmonisation legislation shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, importers shall immediately inform the market surveillance authorities of the Member States in which they made the product available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. 8. Importers shall, for 10 years after the product has been placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request. 9. Importers shall, further to a reasoned request from the competent market surveillance authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the product which they have placed on the market. Article 8. Obligations of distributors 1. When making a product available on the market, distributors shall act with due care in relation to the requirements of this Regulation. 2. Before making a product available on the market, distributors shall verify that the product bears the CE marking and, when relevant, the class identification label, is accompanied by the documents referred to in Article 5(9) and (10), and that the manufacturer and the importer have complied with the requirements set out in Article 5(6) and (7) and Article 7(3). Distributors shall ensure that the product is accompanied by the instructions and information required by Appendices 1 to 6 in a language which can be easily understood by consumers and other end users, as determined by the Member State concerned. Such instructions and information, as well as any labelling, shall be clear, understandable and legible. Where a distributor considers or has reason to believe that a product is not in conformity with the requirements set out in Article 3, he shall not make the product available on the market until it has been brought into conformity. Furthermore, where the product presents a risk, the distributor shall inform the manufacturer or the importer to that effect, as well as the competent market surveillance authorities. EN 13 EN  3. Distributors shall ensure that, while a product is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the requirements set out in Article 3. 4. Distributors who consider or have reason to believe that a product which they have made available on the market is not in conformity with the applicable Union harmonisation legislation shall make sure that the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore, where the product presents a risk, distributors shall immediately inform the market surveillance authorities of the Member States in which they made the product available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. 5. Distributors shall, further to a reasoned request from the competent market surveillance authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the product. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the product which they have made available on the market. Article 9. Cases in which obligations of manufacturers apply to importers and distributors An importer or distributor shall be considered a manufacturer for the purposes of this Regulation, and shall be subject to the obligations of the manufacturer under Article 5, where he places a product on the market under his name or trademark or modifies the product already placed on the market in such a way that compliance with this Regulation may be affected. Article 10. Identification of economic operators Economic operators shall, on request, identify the following to the market surveillance authorities: 1. any economic operator who has supplied them with a product; 2. any economic operator to whom they have supplied a product. Economic operators shall be able to present the information referred to in the first paragraph for 10 years after they have been supplied with the product and for 10 years after they have supplied the product. EN 14 EN  SECTION 3 Conformity of the product Article 11. Presumption of conformity A product which is in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements covered by those standards or parts thereof set out in Appendices 1 to 6. Article 12. Conformity assessment procedures 1. The manufacturer shall perform a conformity assessment of the product using one of the procedures provided in the following section with a view to establishing its compliance with the requirements set out in one of the Appendices 1 to 6. The conformity assessment shall take into account all intended and foreseeable operating conditions. 2. The procedures available to conduct the conformity assessment are the following: (a) internal production control set out in Appendix 7: (i) when assessing the compliance of a toy in the meaning of Directive 2009/48/EC (10) with the requirements set out in Appendix 1; (ii) when assessing the compliance of a product with the requirements set out in Appendix 5; (iii) where, in assessing the compliance of a product with the requirements set out in Appendices 1, 2 or 6, the manufacturer has applied harmonised standards, the references of which have been published in the Official Journal of the European Union, for all the requirements for which such standards exist; (b) EU-type examination followed by conformity to type based on internal production control set out in Appendix 8; (c) conformity based on full quality assurance set out in Appendix 9. Article 13. EU declaration of conformity 1. The EU declaration of conformity referred to in Article 5(10) shall, when relevant, identify the class of the UA and state that compliance with the corresponding requirements set out in Appendices 1 to 5 has been demonstrated. 2. The EU declaration of conformity shall have the model structure set out in Appendix 11, shall contain the elements set out in that Appendix, and shall be (10) Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1). EN 15 EN  continuously updated. It shall be translated into the language or languages required by the Member State in which market the product is placed or made available. 3. The simplified EU declaration of conformity referred to in Article 5(10) shall contain the elements set out in Appendix 12 and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the product is placed or made available on the market. The full text of the EU declaration of conformity shall be available at the internet address referred to in the simplified EU declaration of conformity, in a language or languages required by the Member State in which the product is placed or made available on the market. 4. Where a product is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned, including their publication references. 5. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the product with the requirements laid down in this Regulation. Article 14. General principles of the CE marking The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. Article 15. Rules and conditions for affixing the CE marking, the UAS class identification label and the identification number of the notified body 1. The CE marking and, when relevant, the UA class identification label, shall be affixed visibly, legibly and indelibly to the product, unless that is not possible or not warranted on account of the nature of the product. The CE marking and the UA class identification label shall also be affixed visibly and legibly to the packaging and to the user’s manual. The UA class identification label shall be affixed on the right side of the CE marking and have a similar size. 2. The CE marking and the UA class identification label shall be affixed before the product is placed on the market. 3. The CE marking and the UA class identification label shall be followed by the identification number of the notified body where the conformity assessment procedure set out in Appendix 9 is applied. The identification number of the notified body shall be affixed by the notified body itself or, under its instructions, by the manufacturer or his authorised representative. EN 16 EN  4. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking. Article 16. Technical documentation 1. The technical documentation shall contain all relevant data or details of the means used by the manufacturer to ensure that the product complies with the related requirements set out in Appendices 1 to 6. It shall, at least, contain the elements set out in Appendix 10. 2. The technical documentation shall be drawn up before the product is placed on the market and shall be continuously updated. 3. The technical documentation and correspondence relating to any EU-type examination procedure shall be drawn up in an official language of the Member State in which the notified body is established or in a language acceptable to that body. 4. Where the technical documentation does not comply with paragraphs 1, 2 or 3 of this Article, and in doing so fails to present sufficient relevant data or means used to ensure compliance of the product with the related requirements set out in Appendices 1 to 6, the market surveillance authority may ask the manufacturer or the importer to have a test performed by a body acceptable to the market surveillance authority at the expense of the manufacturer or the importer within a specified period in order to verify compliance with the related requirements set out in Appendices 1 to 6. EN 17 EN  SECTION 4 Notification of conformity assessment bodies Article 17. Notification Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Regulation. Article 18. Notifying authorities 1. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with the provisions of Article 23. 2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of, and in accordance with, Regulation (EC) No 765/2008. 3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 19. In addition, it shall have arrangements to cover liabilities arising out of its activities. 4. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3. Article 19. Requirements relating to notifying authorities 1. A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs. 2. A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities. 3. A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment. 4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform or consultancy services on a commercial or competitive basis. 5. A notifying authority shall safeguard the confidentiality of the information it obtains. 6. A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks. EN 18 EN  Article 20. Information obligation on notifying authorities Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto. The Commission shall make that information publicly available. Article 21. Requirements relating to notified bodies 1. For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11. 2. A conformity assessment body shall be established under national law of a Member State and have legal personality. 3. A conformity assessment body shall be a third-party body independent of the organisation it assesses. A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of the product which it assesses may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body. 4. A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the product which they assess, nor the representative of any of those parties. This shall not preclude the use of assessed product that is necessary for the operations of the conformity assessment body or the use of such product for personal purposes. A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of that product, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall, in particular, apply to consultancy services. Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities. 5. Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the EN 19 EN  results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities. 6. A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Appendix 8 or 9 in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility. At all times and for each conformity assessment procedure and each kind or category of product in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary: (a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks; (b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures; it shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities; (c) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product in question and the mass or serial nature of the production process. A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities. 7. The personnel responsible for carrying out conformity assessment tasks shall have the following: (a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified; (b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments; (c) appropriate knowledge and understanding of the essential requirements, of the applicable harmonised standards and of the relevant provisions of Union harmonisation legislation; (d) the ability to draw up EU-type examination certificates or quality system approvals, records and reports demonstrating that assessments have been carried out. 8. The impartiality of the conformity assessment bodies, their top-level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed. The remuneration of the top-level management and of the personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall EN 20 EN  not depend on the number of assessments carried out or on the results of those assessments. 9. Conformity assessment bodies shall take out liability insurance unless liability is assumed by the Member State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment. 10. The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Appendices 8 and 9 or any provision of national law giving effect to them, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected. 11. Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities, the regulatory activities in the area of UAS and frequency planning, and the activities of the notified body coordination group established under the relevant Union harmonisation legislation, and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group. Article 22. Presumption of conformity of notified bodies Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 21 in so far as the applicable harmonised standards cover those requirements. Article 23. Subsidiaries of and subcontracting by notified bodies 1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 21 and shall inform the notifying authority accordingly. 2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries, wherever these are established. 3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client. 4. Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Appendices 8 and 9. EN 21 EN  Article 24. Application for notification 1. A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established. 2. The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules, and the product for which that body claims to be competent, as well as by an accreditation certificate issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 21. Article 25. Notification procedure 1. Notifying authorities may only notify conformity assessment bodies which have satisfied the requirements laid down in Article 21. 2. They shall notify conformity assessment bodies to the Commission and the other Member States using the electronic notification tool developed and managed by the Commission. 3. The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules, and the product concerned and the relevant accreditation certification. 4. The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within 2 weeks of a notification. Only such a body shall be considered a notified body for the purposes of this Regulation. 5. The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification. Article 26. Identification numbers and lists of notified bodies 1. The Commission shall assign an identification number to a notified body. It shall assign a single such number even where the body is notified under several Union acts. 2. The Commission shall make publicly available the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified. The Commission shall ensure that the list is kept up to date. EN 22 EN  Article 27. Changes to notifications 1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 21, or that it fails to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw the notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly. 2. In the event of restriction, suspension or withdrawal of the notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request. Article 28. Challenge of the competence of notified bodies 1. The Commission shall investigate all cases where it has doubts, or doubt is brought to its attention, about the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject. 2. The notifying Member State shall provide the Commission, on request, with all the information relating to the basis for the notification or the maintenance of the competence of the notified body concerned. 3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially. 4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including de- notification if necessary. Article 29. Operational obligations of notified bodies 1. Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided in Appendices 8 and 9. 2. Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators. Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the UA or UAS technology in question, and the mass or serial nature of the production process. In doing so, they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the UA or UAS with this Regulation. 3. Where a notified body finds that the requirements set out in Appendices 1 to 6 or in corresponding harmonised standards or other technical specifications have not been EN 23 EN  met by a manufacturer, it shall require the manufacturer to take appropriate corrective measures and shall not issue an EU-type examination certificate or a quality system approval. 4. Where, in the course of the monitoring of conformity following the issue of an EU- type examination certificate or a quality system approval, a notified body finds that a product no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the EU-type examination certificate or the quality system approval if necessary. 5. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any EU-type examination certificates or quality system approvals, as appropriate. Article 30. Appeal against decisions of notified bodies Member States shall ensure that an appeal procedure against decisions of the notified bodies is available. Article 31. Information obligation on notified bodies 1. Notified bodies shall inform the notifying authority of the following: (a) any refusal, restriction, suspension or withdrawal of an EU-type examination certificate or a quality system approval in accordance with the requirements of Appendixes 8 and 9; (b) any circumstances affecting the scope of, or conditions for, notification; (c) any request for information which they have received from market surveillance authorities regarding conformity assessment activities; (d) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting. 2. Notified bodies shall, in accordance with the requirements of Appendices 8 and 9, provide the other bodies notified under this Regulation carrying out similar conformity assessment activities covering the same categories of UA or UAS with the relevant information on issues relating to negative and, on request, positive conformity assessment results. 3. Notified bodies shall fulfil information obligations under Appendices 8 and 9. Article 32. Exchange of experience The Commission shall provide for the organisation of exchange of experience between the Member States’ national authorities responsible for notification policy. EN 24 EN  Article 33. Coordination of notified bodies The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Regulation are put in place and properly operated in the form of a sectorial group of notified bodies. Member States shall ensure that the bodies notified by them participate in the work of that group, directly or by means of designated representatives. EN 25 EN  SECTION 5 Union market surveillance, control of products entering the Union market and Union safeguard procedure Article 34. Market surveillance and control of products entering the Union market 1. Member States shall organise and perform surveillance of the products that fall within the scope of this Regulation and are placed on the Union market in accordance with Article 15(3) and Articles 16 to 26 of Regulation (EU) No 765/2008. 2. Member States shall organise and perform control of the products that fall within the scope of this Regulation and enter the Union market in accordance with Articles 15(5) and Articles 27 to 29 of Regulation (EU) No 765/2008. 3. Member States shall ensure that their market surveillance and border control authorities cooperate with the competent authorities designated under Article 8 of Regulation (EU) …/… [IR] on safety matters and shall establish appropriate communication and coordination mechanisms between them, making the best use of the information contained in the occurrence reporting system defined under Regulation (EU) No 376/2014 (11) and the information systems defined in Articles 22 and 23 of Regulation (EC) No 765/2008. Article 35. Procedure for dealing with products presenting a risk at national level 1. Where the market surveillance authorities of one Member State have sufficient reason to believe that a product presents a risk to the health or safety of persons or to other aspects of public interest protection covered by this Regulation, they shall carry out an evaluation in relation to the product concerned, covering all applicable requirements laid down in this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose. Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the product does not comply with the requirements laid down in this Regulation, they shall, without delay, require the relevant economic operator to take all appropriate corrective actions to bring the product into compliance with those requirements, to withdraw the product from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe. The market surveillance authorities shall inform the relevant notified body accordingly. (11) Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18). EN 26 EN  Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph. 2. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take. 3. The economic operator shall ensure that all appropriate corrective action is taken in respect of all products concerned that it has made available on the market throughout the Union. 4. Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the product being made available on their national market, to withdraw the product from that market or to recall it. The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures. 5. The information referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant product, the origin of the product, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either of the following: (a) failure of the product to meet the requirements set out in Article 3; or (b) shortcomings in the harmonised standards referred to in Article 11 conferring a presumption of conformity. 6. Member States other than the Member State initiating the procedure under this Article shall, without delay, inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the product concerned, and, in the event of disagreement with the adopted national measure, of their objections. 7. Where, within 3 months of receipt of the information referred to in paragraph 5, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified. 8. Member States shall ensure that appropriate restrictive measures, such as withdrawal of the product from the market, are taken in respect of the product concerned without delay. EN 27 EN  Article 36. Union safeguard procedure 1. Where, on completion of the procedure set out in Article 35(3) and (4), objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide whether the national measure is justified or not. The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators. 2. If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant product is withdrawn or recalled from their market, and shall inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned shall withdraw that measure. 3. Where the national measure is considered justified and the non-compliance of the product is attributed to shortcomings in the harmonised standards referred to in point (b) of Article 35(5) of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012. Article 37. Compliant product which presents a risk 1. Where, having carried out an evaluation under Article 35(1), a Member State finds that although the product is in compliance with this Regulation, it presents a risk to the health or safety of persons or to other aspects of public interest protection covered by this Regulation, it shall require the relevant economic operator to take all appropriate measures to ensure that the product concerned, when placed on the market, no longer presents that risk, to withdraw the product from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe. 2. The economic operator shall ensure that corrective action is taken in respect of all the products concerned that he has made available on the market throughout the Union. 3. The Member State shall immediately inform the Commission and the other Member States. That information shall include all available details, in particular the data necessary for the identification of the product concerned, the origin and the supply chain of product, the nature of the risk involved and the nature and duration of the national measures taken. 4. The Commission shall, without delay, enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide whether the national measure is justified or not and, where necessary, propose appropriate measures. EN 28 EN  5. The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators. Article 38. Formal non-compliance 1. Without prejudice to Article 35, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non- compliance concerned: (a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 14 or Article 15 of this Regulation; (b) the CE marking has not been affixed; (c) the identification number of the notified body, where the conformity assessment procedure set out in Appendix 9 is applied, has been affixed in violation of Article 17 or has not been affixed; (d) the EU declaration of conformity has not been drawn up; (e) the EU declaration of conformity has not been drawn up correctly; (f) technical documentation is either not available or not complete; 2. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or ensure that it is withdrawn or recalled from the market. EN 29 EN  SECTION 6 Third-country UAS operators Article 39. Third-country UAS operators 1. UAS operators that have their principal place of business, are established, or reside in a third country, shall comply with Regulation (EU) .../... [IR] for the purpose of UAS operations within the single European sky airspace. 2. The competent authority for the third-country UAS operator is the competent authority of the EU Member State where the UAS operator intends to operate. 3. By way of derogation from paragraph 1 of this Article, a certificate of the remote pilot competency or the UAS operator, or an equivalent document, may be recognised by the competent authority for the purpose of operation within, to, and out of the EU provided that: (a) the third country asked for such recognition; (b) the certificate of the remote pilot competency or the UAS operator’s certificate are valid documents of the State of issue; and (c) EASA has ensured that the requirements on the basis of which such certificates have been issued provide the same level of safety as this Regulation does. EN 30 EN  SECTION 7 Final and transitional provisions Article 40. Penalties Member States shall provide for penalties applicable to infringements by economic operators of the provisions of this Regulation and shall take all measures necessary to ensure that they are enforced. The penalties provided for shall be effective, proportionate and dissuasive. They may include criminal penalties for serious infringements. Member States shall notify those rules to the Commission by DD/MM/YY, and shall notify it without delay of any subsequent amendment affecting them. Article 41. Technical guidelines In order to facilitate the implementation of this Regulation, the Commission shall draw up non-binding guidelines in consultation with the stakeholders. Article 42. Entry into force and application This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from … [2 years after the date of entry into force]. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, For the Commission The President […] EN 31 EN  APPENDICES Appendix 1 Product requirements for a class C0 UAS A class C0 UAS shall: 1. have an MTOM, including payload, of less than 250 g; 2. be safely controllable by a remote pilot following the manufacturer’s instructions; 3. if equipped with a follow-me mode, when this function is on, keep a distance not exceeding 50 m from the remote pilot, and allow the remote pilot to regain control of the UA or to activate an emergency procedure that terminates the flight; 4. be placed on the market with clear operational instructions and warnings highlighting the risks related to UAS operations, which shall be adapted to the age of the user; 5. include an information notice defined by the European Aviation Safety Agency (EASA) providing applicable limitations and obligations, in accordance with Regulation (EU) …/… [IR]; and 6. bear the following class identification label on the UA in a visible manner: 7. be designed and manufactured in such a way as to fly safely; 8. have a maximum speed in level flight of 19 m/s; 9. have a maximum attainable height above the take-off point limited to 120 m or be equipped with a system that limits the height above the surface or above the take-off point to 120 m; 10. be designed and constructed in such a way as to minimise injury to persons during operation; sharp edges shall be avoided; if equipped with propellers, the UAS shall be designed in such a way as to limit any injury that may be inflicted by the propeller blades; 11. if powered by electricity, the nominal voltage shall not exceed 24 V direct current (DC) or the equivalent alternating current (AC) voltage; its accessible parts shall not exceed 24 V DC or the equivalent AC voltage; internal voltages shall not exceed 24 V DC or the equivalent AC voltage unless it is ensured that the voltage and current EN 32 EN  combination generated does not lead to any risk or harmful electric shock even when the UAS is damaged. Requirements 7 to 11 do not apply to UAS that are already compliant with the requirements defined in Directive 2009/48/EC on the safety of toys. EN 33 EN  Appendix 2 Product requirements for a class C1 UAS A class C1 UAS shall: 1. be made of materials and have performance and physical characteristics such as to ensure that in the event of an impact at terminal velocity with a human head, the energy transmitted to the human head is less than 80 J, or, as an alternative, the UAS shall have an MTOM, including payload, of less than 900 g; 2. have a maximum speed in level flight of 19 m/s; 3. have a maximum attainable height above the take-off point limited to 120 m or be equipped with a system that limits the height above the surface or above the take-off point to a value selectable by the remote pilot; in the latter case, clear information about the height of the UA above the surface or take-off point during flight shall be provided to the remote pilot; 4. be designed and manufactured in such a way as to fly safely; 5. be safely controllable by a pilot following the manufacturer’s instructions; 6. have the requisite mechanical strength and, where appropriate, stability to withstand any stress to which it is subjected during use without any breakage or deformation that might interfere with its safe flight; 7. be designed and constructed in such a way as to minimise injury to persons or damage to property during operation; sharp edges shall be avoided; if equipped with propellers, they shall be designed in such a way as to limit any injury that may be inflicted by the propeller blades; 8. in case of a loss of data link, have a reliable and predictable method for the UA to recover or terminate the flight in a way that reduces the effect on third parties in the air or on the ground; 9. have a sound pressure level not exceeding 60 dB(A) (measured at a 3-m distance from the UA); 10. if powered by electricity, the nominal voltage shall not exceed 24 V DC or the equivalent AC voltage; its accessible parts shall not exceed 24 V DC or the equivalent AC voltage; internal voltages shall not exceed 24 V DC or the equivalent AC voltage unless it is ensured that the voltage and current combination generated does not lead to any risk or harmful electric shock even when the UAS is damaged; 11. have an electronic identification system that shall: (a) allow the user to insert the 10-digit UAS operator registration number; (b) provide in real time during the whole duration of the flight the following information through electronic data: (i) UAS operator registration number; (ii) the unique serial number of the UA or the add-on; EN 34 EN  (iii) geographical position of the UA, its height and associated time; and (iv) geographical position of the UA take-off point; (c) the information shall be protected against unauthorised modification; 12. be equipped with a geo-awareness system that provides: (a) an interface to load and update data containing information on airspace limitations, as defined by Regulation (EU) …/… [IR], which ensures that the process of loading or updating of such data does not degrade its integrity and validity; (b) a warning alert when a potential breach of airspace limitations is detected; and (c) information on its status as well as a warning alert when the positioning or navigation of the UA cannot ensure the proper functioning of the system; 13. if the UA has a function that limits its access to certain airspace areas or volumes, this function shall operate in such a manner that it interacts smoothly with the flight control system of the UA without adversely affecting flight safety; in addition, clear information shall be provided to the remote pilot when the UA flight control system is automatically engaged to keep the UA out of these areas; 14. provide the remote pilot with clear warning when the battery of the UA or its control station reaches a low level such that the remote pilot has sufficient time to safely land the UA; 15. be equipped with lights that cannot be confused with the navigation lights of a manned aircraft as required for controllability: (a) in daylight conditions; (b) during night, if designed for night operation; 16. if equipped with a follow-me mode, when this function is on, keep a distance not exceeding 50 m from the remote pilot, and allow the remote pilot to regain control of the UA or to activate an emergency procedure that terminates the flight; 17. have a unique serial number that must be affixed in a legible manner on the UA and the packaging or the user’s manual; 18. be placed on the market with a user’s manual providing the characteristics of the UA (including but not limited to the mass of the UA, its MTOM, including its payload, the frequency of the electronic identification emission, the general characteristics of allowed payloads in terms of mass and dimensions, a description of the behaviour of the UA in case of a loss of data link), clear operational instructions, troubleshooting procedures and operational limitations (including but not limited to meteorological conditions and day/night operations) as well as an appropriate description of all the risks related to UAS operations; 19. include an information notice defined by EASA providing applicable limitations and obligations in accordance with Regulation (EU) …/… [IR]; EN 35 EN  20. bear the following label on the UA in a visible manner: EN 36 EN  Appendix 3 Product requirements for a class C2 UAS A class C2 UAS shall: 1. have an MTOM, including payload, of less than 4 kg; 2. have a maximum attainable height above the take-off point limited to 120 m or be equipped with a system that limits the height above the surface or above the take-off point to a value selectable by the remote pilot; in the latter case, clear information about the height of the UA above the surface or take-off point during flight shall be provided to the remote pilot; 3. be designed and manufactured in such a way as to fly safely; 4. be safely controllable by a pilot following the manufacturer’s instructions; 5. have the requisite mechanical strength and, where appropriate, stability to withstand any stress to which it is subjected during use without any breakage or deformation that might interfere with its safe flight; 6. in the case of a tethered UA, the tensile length of the tether shall be less than 50 m and its mechanical strength shall be no less than: (a) for heavier-than-air aircraft, 10 times the weight of the aerodyne at maximum mass; (b) for lighter-than-air aircraft, 4 times the force exerted by the combination of the maximum static thrust and the aerodynamic force of the maximum allowed wind speed in flight; 7. be designed and constructed in such a way as to minimise injury to persons or damage to property during operation; sharp edges shall be avoided; if equipped with propellers, they shall be designed in such a way as to limit any injury that may be inflicted by the propeller blades; 8. unless tethered, in case of a loss of data link, have a reliable and predictable method for the UA to recover or terminate the flight in a way that reduces the effect on third parties in the air or on the ground; 9. unless tethered, be equipped with a remote pilot data link protected against unauthorised access to the command and control functions; 10. unless it is a fixed-wing UA, be equipped with a low-speed mode selectable by the remote pilot and limiting the maximum cruising speed to no more than 3 m/s. 11. have a sound pressure level not exceeding 60 dB(A) (measured at a 3-m distance from the UA); 12. if powered by electricity, the nominal voltage shall not exceed 48 V DC or the equivalent AC voltage; its accessible parts shall not exceed 48 V DC or the equivalent AC voltage; internal voltages shall not exceed 48 V DC or the equivalent AC voltage unless it is ensured that the voltage and current combination generated does not lead to any risk or harmful electric shock even when the UAS is damaged; EN 37 EN  13. unless tethered, have an electronic identification system that shall: (a) allow the user to insert the 10-digit UAS operator registration number; (b) provide in real time during the whole duration of the flight the following information through electronic data: (i) UAS operator registration number; (ii) the unique serial number of the UA or the add-on; (iii) geographical position of the UA, its height and associated time; and (iv) geographical position of the UA take-off point; (c) the information shall be protected against unauthorised modification; 14. be equipped with a geo-awareness system providing: (a) an interface to load and update data containing information on airspace limitations, as defined by Regulation (EU) .../… [IR], which ensures that the process of loading or updating of such data does not degrade its integrity and validity; (b) a warning alert when a potential breach of airspace limitations is detected; and (c) information on its status as well as a warning alert when the positioning or navigation of the UA cannot ensure the proper functioning of the system; 15. if the UA has a function that limits its access to certain airspace areas or volumes, this function shall operate in such a manner that it interacts smoothly with the flight control system of the UA without adversely affecting flight safety; in addition, clear information shall be provided to the remote pilot when the UA flight control system is automatically engaged to keep the UA out of these areas; 16. provide the remote pilot with clear warning when the battery of the UA or its control station reaches a low level such that the remote pilot has sufficient time to safely land the UA; 17. be equipped with lights for the purpose of controllability or visibility of the UA; the design of the lights shall not be confused with the navigation lights of manned aircraft; 18. have a unique serial number that must be affixed in a legible manner on the packaging, the user’s manual or the UA; 19. be placed on the market with a user’s manual providing the characteristics of the UA (including but not limited to the mass of the UA, its MTOM, including its payload, the frequency of the electronic identification emission, the general characteristics of allowed payloads in terms of mass and dimensions, a description of the behaviour of the UA in case of a loss of data link), clear operational instructions, troubleshooting procedures, and operational limitations (including but not limited to meteorological conditions and day/night operations) as well as an appropriate description of all the risks related to UAS operations; EN 38 EN  20. include an information notice defined by EASA providing applicable limitations and obligations in accordance with Regulation (EU) …/… [IR]; and 21. bear the following label on the UA in a visible manner: EN 39 EN  Appendix 4 Product requirements for a class C3 UAS A class C3 UAS shall: 1. have an MTOM, including payload, of less than 25 kg; 2. have a maximum attainable height above the take-off point limited to 120 m or be equipped with a system that limits the height above the surface or above the take-off point to a value selectable by the remote pilot; in the latter case, clear information about the height of the UA above the surface or take-off point during flight shall be provided to the remote pilot; 3. be designed and manufactured in such a way as to fly safely; 4. be safely controllable by a pilot following the manufacturer’s instructions; 5. in the case of a tethered UA, the tensile length of the tether shall be less than 50 m and its mechanical strength shall be no less than: (a) for heavier-than-air aircraft, 10 times the weight of the aerodyne at maximum mass; (b) for lighter-than-air aircraft, 4 times the force exerted by the combination of the maximum static thrust and the aerodynamic force of the maximum allowed wind speed in flight; 6. unless tethered, in case of a loss of data link, have a reliable and predictable method for the UA to recover or terminate the flight in a way that reduces the effect on third parties in the air or on the ground; 7. if powered by electricity, the nominal voltage shall not exceed 48 V DC or the equivalent AC voltage; its accessible parts shall not exceed 48 V DC or the equivalent AC voltage; internal voltages shall not exceed 48 V DC or the equivalent AC voltage unless it is ensured that the voltage and current combination generated does not lead to any risk or harmful electric shock even when the UAS is damaged; 8. unless tethered, have an electronic identification system that shall: (a) allow the user to insert the 10-digit UAS operator registration number; (b) provide in real time during the whole duration of the flight the following information through electronic data: (i) UAS operator registration number; (ii) the unique serial number of the UA or the add-on; (iii) geographical position of the UA, its height and associated time; and (iv) geographical position of the UA take-off point; (c) the information shall be protected against unauthorised modification; 9. be equipped with a geo-awareness system providing: EN 40 EN  (a) an interface to load and update data containing information on airspace limitations, as defined by Regulation (EU) …/… [IR], which ensures that the process of loading or updating of such data does not degrade its integrity and validity; (b) a warning alert when a potential breach of airspace limitations is detected; and (c) information on its status as well as a warning alert when the positioning or navigation of the UA cannot ensure the proper functioning of the system; 10. if the UA has a function that limits its access to certain airspace areas or volumes, this function shall operate in such a manner that it interacts smoothly with the flight control system of the UA without adversely affecting flight safety; in addition, clear information shall be provided to the remote pilot when the UA flight control system is automatically engaged to keep the UA out of these areas; 11. provide the remote pilot with clear warning when the battery of the UA or its control station reaches a low level such that the remote pilot has sufficient time to safely land the UA; 12. be equipped with lights for the purpose of controllability or visibility of the UA; the design of the lights shall not be confused with the navigation lights of a manned aircraft; 13. have a unique serial number that must be affixed in a legible manner on the packaging, the user’s manual or the UA; 14. be placed on the market with a user’s manual providing the characteristics of the UA (including but not limited to the mass of the UA, the MTOM, including its payload, the frequency of the electronic identification emission, the general characteristics of allowed payloads in terms of mass and dimensions, a description of the behaviour of the UA in case of a loss of data link), clear operational instructions, troubleshooting procedures, and operational limitations (including but not limited to meteorological conditions and day/night operations) as well as an appropriate description of all the risks related to UAS operations; 15. include an information notice defined by EASA providing applicable limitations and obligations in accordance with Regulation (EU) …/… [IR]; and 16. bear the following label on the UA in a visible manner: EN 41 EN  Appendix 5 Product requirements for a class C4 UAS A class C4 UAS shall: 1. have an MTOM, including payload, of less than 25 kg; 2. be designed and manufactured in such a way as to fly safely; 3. not be capable of automatic control modes; 4. be placed on the market with a user’s manual providing the characteristics of the UA (including but not limited to the mass of the UA and its MTOM, including its payload, and a description of the behaviour of the UA in case of a loss of data link), clear operational instructions and operational limitations (including but not limited to meteorological conditions and day/night operations) as well as an appropriate description of all the risks related to UAS operations; 5. include an information notice defined by EASA providing applicable limitations and obligations in accordance with Regulation (EU) …/… [IR]; and 6. bear the following label on the UA in a visible manner: EN 42 EN  Appendix 6 Electronic identification system An electronic identification add-on shall: 1. allow the user to insert the 10-digit UAS operator registration number; 2. provide in real time during the whole duration of the flight the following information through electronic data: (a) the UAS operator registration number; (b) the unique serial number of the add-on; (c) the geographical position of the UA, its height and associated time; and (d) the geographical position of the UA take-off point; 3. the information shall be protected against unauthorised modification. EN 43 EN  Appendix 7 Conformity assessment Module A — Internal production control as per Annex II to Decision No 768/2008/EC 1. Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4 of this Appendix, and ensures and declares on his sole responsibility that the products concerned satisfy the applicable requirements set out in Appendices 1 to 6. 2. Technical documentation The manufacturer shall establish the technical documentation in accordance with Article 17 of this Regulation. 3. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured product with the technical documentation referred to in point 2 of this Appendix and with the requirements set out in the relevant Appendices 1 to 6. 4. CE marking and EU declaration of conformity 4.1. The manufacturer shall affix the CE marking and, when applicable, the UA class identification label in accordance with Articles 16 and 17 of this Regulation to each product that satisfies the applicable requirements set out in Appendices 1 to 6. 4.2. The manufacturer shall draw up a written EU declaration of conformity for each product and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market. The EU declaration of conformity shall identify the product for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. 5. Authorised representative The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. EN 44 EN  Appendix 8 Conformity assessment Modules B and C — EU-type examination and conformity to type based on internal production control as per Annex II to Decision No 768/2008/EC When reference is made to this Appendix, the conformity assessment procedure shall follow Modules B (EU-type examination) and C (Conformity to type based on internal production control) of this Appendix. Module B EU-type examination 1. EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of the product and verifies and attests that the technical design of the product meets the applicable requirements set out in Appendices 1 to 6. 2. EU-type examination shall be carried out by an assessment of the adequacy of the technical design of the product through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the product (combination of production type and design type). 3. The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) a written declaration that the same application has not been lodged with any other notified body; (c) the technical documentation. The technical documentation shall make it possible to assess the product’s conformity with the applicable requirements of this Regulation and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain, wherever applicable, the elements set out in Article 18 of this Regulation; (d) the specimens representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme; (e) the supporting evidence for the adequacy of the technical design solution. That supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied or EN 45 EN  have not been fully applied. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility. 4. The notified body shall: For the product: 4.1 examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product. For the specimen(s): 4.2. verify that the specimen(s) has (have) been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards and/or technical specifications, as well as the elements which have been designed without applying the relevant provisions of those standards; 4.3. carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards and/or technical specifications, these have been applied correctly; 4.4. carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards and/or technical specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding essential requirements of the legislative instrument; 4.5. agree with the manufacturer on a location where the examinations and tests will be carried out. 5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations as provided in point 8, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer. 6. Where the type meets the requirements of this Regulation, the notified body shall issue an EU-type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the aspects of the requirements covered by the examination, the conditions (if any) for its validity, and the necessary data for identification of the approved type. The EU-type examination certificate may have one or more annexes attached to it. The EU-type examination certificate and its annexes shall contain all the relevant information to allow the conformity of the product with the examined type to be evaluated and to allow for in-service control. EN 46 EN  Where the type does not satisfy the applicable requirements of this Regulation, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. 7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicates that the approved type may no longer comply with the applicable requirements of this Regulation, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the product with the essential requirements of this Regulation or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate. 8. Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto which it has refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued. Each notified body shall inform the Member States of EU-type examination certificates it has issued and/or additions thereto in those cases where harmonised standards, the references of which have been published in the Official Journal of the European Union, have not been applied or have not been fully applied. The Member States, the Commission and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Member States and the Commission may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer for 10 years after the product has been assessed or until the expiry of the validity of that certificate. 9. The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market. 10. The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate. EN 47 EN  Module C Conformity to type based on internal production control 1. Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares that the product concerned is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Regulation that apply to it. 2. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with the approved type described in the EU-type examination certificate and with the applicable requirements set out in Appendices 1 to 6. 3. CE marking and EU declaration of conformity 3.1. The manufacturer shall affix the CE marking and, when relevant, the UA class identification label in accordance with Articles 16 and 17 of this Regulation to each product that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements set out in Appendices 1 to 6. 3.2. The manufacturer shall draw up a written EU declaration of conformity for each product type and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The EU declaration of conformity shall identify the product type for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. 4. Authorised representative The manufacturer’s obligations set out in point 3 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. EN 48 EN  Appendix 9 Conformity assessment Module H — Conformity based on full quality assurance as per Annex II to Decision No 768/2008/EC 1. Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the product concerned satisfies the applicable requirements set out in Appendices 1 to 6. 2. Manufacturing The manufacturer shall operate an approved quality system for design, manufacture, final inspection and testing of the product concerned as specified in point 3 and shall be subject to surveillance as specified in point 4. 3. Quality system 3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the product concerned. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) the technical documentation for each type of product intended to be manufactured. The technical documentation shall contain, wherever applicable, the elements set out in Appendix 10; (c) the documentation concerning the quality system; and (d) a written declaration that the same application has not been lodged with any other notified body. 3.2. The quality system shall ensure compliance of the product with the requirements of this Regulation. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. That quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality; (b) the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards will not be applied in full, the means that will be used to ensure that the requirements of this Regulation will be met; EN 49 EN  (c) the design control and design verification techniques, processes and systematic actions that will be used when designing a product pertaining to the product type covered; (d) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; (e) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out; (f) the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel, etc.; (g) the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system. 3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Regulation. The audit shall include an assessment visit on the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.1(b) to verify the manufacturer’s ability to identify the applicable requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements. The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. The notified body shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. EN 50 EN  4. Surveillance under the responsibility of the notified body 4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: (a) the quality system documentation; (b) the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.; (c) the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel, etc. 4.3 The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. 4.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits, the notified body may, if necessary, carry out UA or UAS tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. 5. CE marking and EU declaration of conformity 5.1. The manufacturer shall affix the CE marking and, when relevant, the UAS class identification label in accordance with Articles 16 and 17 of this Regulation and, under the responsibility of the notified body referred to in point 3.1 of this Appendix, the latter’s identification number to each product that satisfies the applicable requirements of this Regulation. 5.2. The manufacturer shall draw up a written EU declaration of conformity for each product type and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The EU declaration of conformity shall identify the product type for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. 6. The manufacturer shall, for a period ending 10 years after the product has been placed on the market, keep at the disposal of the national authorities: (a) the technical documentation referred to in point 3.1; (b) the documentation concerning the quality system referred to in point 3.1; (c) the change referred to in point 3.5, as approved; EN 51 EN  (d) the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4. 7. Each notified body shall inform its notifying authority of the quality system approvals it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of the quality system approvals it has refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of the quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued. 8. Authorised representative The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. EN 52 EN  Appendix 10 Contents of technical documentation The technical documentation shall, wherever applicable, contain at least the following elements: 1. a complete description of the product including: (a) photographs or illustrations showing its external features, markings and internal layout; (b) the versions of any software or firmware involved in compliance with the essential requirements; (c) user’s manual and installation instructions; 2. conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits and other relevant similar elements; 3. descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product; 4. a list of the harmonised standards applied in full or in part, the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements set out in Article 3, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied; 5. copy of the EU declaration of conformity; 6. where the conformity assessment module in Annex III has been applied, copy of the EU-type examination certificate and its annexes as delivered by the notified body involved; 7. results of design calculations made, examinations carried out, and other relevant similar elements; 8. test reports; 9. the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility. EN 53 EN  Appendix 11 EU declaration of conformity 1. The product (type, batch or serial number). 2. Name and address of the manufacturer or his authorised representative. 3. This declaration of conformity is issued under the sole responsibility of the manufacturer. 4. Object of the declaration [identification of the product allowing traceability; it may include a colour image of sufficient resolution where necessary for the identification of the products]. 5. The object of the declaration described above is of class … [include the class number of the UAS as defined by Appendices 1 to 5 to this Regulation]. 6. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation Regulation: — [include the reference to this Regulation and the Annex relevant to the class of the product]; — or other Union harmonisation legislation where applicable. 7. References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared. References must be listed with their identification number and version and, where applicable, date of issue. 8. Where applicable, the notified body … [name, number] … performed … [description of intervention] … and issued the EU-type examination certificate. 9. Where applicable, a description of accessories and components, including software, which allow the unmanned aircraft or unmanned aircraft system to operate as intended and covered by the EU declaration of conformity. 10. Additional information: Signed for and on behalf of: … [place and date of issue]: [name, function] [signature]: EN 54 EN  Appendix 12 Simplified EU declaration of conformity The simplified EU declaration of conformity referred to in Article 12(9) shall be provided as follows: [Name of manufacturer] hereby declares that the UA [system] type [designation of type of UA or UA system] is: — of class … … [include the class number of the product as defined in Appendices 1 to 5 of this Regulation]; — and in compliance with Regulations … [list all the Regulations that the product complies with]. EN 55 EN ANNEX UAS operations in the ‘open’ and ‘specific’ categories [PART-UAS] SUBPART A UAS OPERATIONS IN THE ‘OPEN’ CATEGORY UAS.OPEN.010 UAS operations in the ‘open’ category 1. The ‘open’ category of UAS operations is divided into three subcategories with defined operational limitations, remote pilot requirements and technical requirements for UAS, as follows: (a) subcategory A1; (b) subcategory A2; (c) subcategory A3. 2. Operations in the ‘open’ category shall be limited to: (a) flights conducted in visual line of sight (VLOS); (b) heights not exceeding 120 m above the surface. 3. When the operation involves flying the UA in close proximity to a fixed obstacle that is taller than 120 m, the maximum height of the UAS operation may be increased up to 50 m above the height of the obstacle, for the portion of the flight in close proximity to it and at the request of the entity responsible for the obstacle. UAS.OPEN.020 UAS operations in subcategory A1 UAS operations in subcategory A1 shall: 1. not be conducted over open-air assembly of persons; 2. by way of derogation from UAS.OPEN.070(3)(e), be conducted up to a height of 50 m above the surface when in follow-me mode; 3. be performed by a remote pilot who has: (a) been familiarised with the UAS to be operated; or (b) in the case of a UA with an MTOM, including payload, of more than 250 g, demonstrated the competencies necessary to ensure a safe flight, respecting privacy, data protection, security and environmental requirements, by having completed an online training course and passed an online test, according to a manner and format established by EASA, and provided by an entity recognised by the competent authority; 4. be performed with a UA: (a) when privately built that has an MTOM, including payload, of less than 250 g; 1  (b) marked as class C0, as defined in Appendix 1 to Regulation (EU) …/... [DA]; or (c) marked as class C1, as defined in Appendix 2 to Regulation (EU) .../... [DA] and operated with active and updated electronic identification and geo-awareness systems. UAS.OPEN.030 UAS operations in subcategory A2 UAS operations in subcategory A2 shall be performed: 1. so that the UA is not flown over uninvolved persons; 2. at a safe distance from uninvolved persons; 3. by a remote pilot who holds a certificate of remote pilot competency that is necessary to ensure a safe flight, respecting privacy, data protection, security and environmental requirements, by passing a theoretical test in a manner and format established by EASA at an entity recognised by the competent authority; and 4. with a UA marked as class C2, as defined in Appendix 3 to Regulation (EU) .../... [DA], operated with active and updated electronic identification and geo-awareness systems. UAS.OPEN.040 UAS operations in subcategory A3 UAS operations in subcategory A3 shall be performed: 1. in an area where the remote pilot reasonably expects that no uninvolved person will be endangered within the range where the UA will be flown, during the entire time of the UAS operation and keeping a safe distance from the boundaries of congested areas; 2. by a remote pilot who has demonstrated the competencies necessary to ensure a safe flight, respecting privacy, data protection, security and environmental requirements, by having completed an online training course and passed an online test, according to a manner and format established by EASA, and provided by an entity recognised by the competent authority; and 3. with a UA: (a) when privately built that has an MTOM, including payload, of less than 25 kg; (b) marked as class C2, as defined in Appendix 3 to Regulation (EU) .../... [DA] and operated with active and updated electronic identification and geo-awareness systems; (c) marked as class C3, as defined in Appendix 4 to Regulation (EU) .../... [DA] and operated with active and updated electronic identification and geo-awareness systems; or (d) marked as class C4, as defined in Appendix 5 to Regulation (EU) .../... [DA]. 2 UAS.OPEN.050 Responsibilities of the UAS operator The UAS operator shall ensure that: 1. operational procedures adapted to the type of operation and the risk involved are established, and a remote pilot for each operation is designated; 2. the remote pilots and all other personnel directly involved in the operations are: (a) competent to perform their tasks; (b) familiar with the UAS operator’s procedures; (c) aware of any information about the operation published by the relevant authorities; (d) familiar with relevant EU and national regulations, in particular those related to security, privacy, data protection, liability, insurance and environmental protection; and (e) in a physical and mental condition such that would not endanger the safe operation of the UAS; 3. when conducting an operation with a UA of one of the classes defined in this Regulation, the UA is: (a) accompanied by the corresponding EU declaration of conformity, including the reference to the appropriate class; and (b) the related class identification label is affixed on the UA. UAS.OPEN.060 Registration UAS operators that use a UA with an MTOM, including payload, of more than 250 g, shall: 1. register themselves, in a manner and format established by EASA, unless already registered in accordance with UAS.SPEC.060; 2. update their registration every time data is changed and renew the registration as required by the competent authority; 3. display the registration information on the UA; and 4. ensure that this information is inserted into the electronic identification system, if available on the UA. UAS.OPEN.070 Responsibilities of the remote pilot 1. The remote pilot shall: (a) be in a physical and mental condition such that would not endanger the safe operation of the UAS; (b) have the ability to take control of the UA, except in the case of a lost link or when operating a free-flight UA; 3  (c) have the appropriate competency in the subcategory of the intended UAS operations in accordance with UAS.OPEN.020, UAS.OPEN.030 and UAS.OPEN.040; and (d) comply with UAS.OPEN.050 and UAS.OPEN.060 if the remote pilot is also the UAS operator. 2. Before starting a UAS operation, the remote pilot shall: (a) obtain updated information, relevant to the intended UAS operation, about any flight restrictions or conditions published by the Member State of operation; (b) familiarise themselves with the operating environment; and (c) ensure that the UAS is in safe condition to complete the intended flight safely and that its mass, including payload, does not exceed the MTOM defined by the manufacturer or the MTOM limit of its class. 3. During flight, the remote pilot shall: (a) comply with the requirements applicable to the subcategory of UAS operations conducted; (b) ensure the safe operation of the UAS with respect to third parties on the ground or in the air; (c) comply with the limitations on the area and airspace restrictions; (d) operate the UAS within the limitations defined in the instructions provided by the manufacturer; (e) keep the UA in VLOS and maintain a thorough visual scan of the airspace surrounding the UA in order to observe any other aircraft and not create any hazard to them; (f) not use the UA to drop material or carry dangerous goods, except for dropping items in connection with agricultural, horticultural or forestry activities in which the carriage of the items does not contravene any other applicable regulations; (g) not fly close to or inside areas where an emergency response effort is ongoing unless they have permission to do so from the responsible emergency response services; and (h) respect privacy rights, the environment, and operate the UAS in a considerate manner that minimises any nuisance caused to other persons or animals. 4. For the purposes of paragraph 3(e), the remote pilot may be assisted by a UA observer situated in the line of sight of the remote pilot. Clear and effective communication shall be established between the remote pilot and the UA observer. UAS.OPEN.080 Duration and validity of the certificate of remote pilot competency 1. The remote pilot competencies, required by UAS.OPEN.020(3)(b) and UAS.OPEN.040(2), shall be valid for 3 years. 4 2. The certificate of remote pilot competency, required by UAS.OPEN.030(3), shall be valid for 5 years. 3. The renewal of the remote pilot competencies and of the certificate of remote pilot competency is subject to the demonstration of competencies in accordance with UAS.OPEN.040(2) or UAS.OPEN.030(3), as applicable, in a format established by EASA. SUBPART B UAS OPERATIONS IN THE ‘SPECIFIC’ CATEGORY UAS.SPEC.010 UAS operations in the ‘specific’ category Any operation that does not fall under the operational requirements of the ‘open’ category, as defined in Subpart A of this Annex, shall be subject to an operational risk assessment, and associated mitigation measures shall be put in place. UAS.SPEC.020 Operational risk assessment 1. If the intended operation is not fully addressed by a standard scenario issued by EASA, or if EASA has not issued a standard scenario for that operation, the UAS operator shall: (a) provide the competent authority with an operational risk assessment for the intended operation, except when the operator holds a light UAS operator certificate (LUC) as per Subpart C of this Annex with the appropriate privileges; and (b) identify mitigation measures to be put in place in order to limit the risk of the intended operation. 2. When conducting the operational risk assessment, the UAS operator shall consider as a minimum the following elements: (a) the characteristics of the area and the conditions under which the operation will be conducted; (b) the class of the airspace and the impact on other air traffic and air traffic management (ATM) in cooperation with the relevant air navigation service provider (ANSP); (c) the design features and performance of the UAS; (d) the type of operation; (e) the level of competency of the remote pilot; (f) organisational factors; (g) security risks; (h) privacy risks; and (i) impact on the environment. 3. The UAS operator shall regularly evaluate the adequacy of the mitigation measures taken and, if needed, update them. 5 4. If an operation is conducted partially or totally in the airspace of a Member State other than the Member State of registration, the UAS operator shall: (a) comply with the local conditions established by the Member State of operation in accordance with Article 11 of this Regulation; (b) provide the competent authority of the Member State of registration with the local conditions and the additional mitigation measures, if required by the Member State of operation. UAS.SPEC.025 Standard scenarios 1. EASA shall issue standard scenarios and the associated conditions and mitigation measures for different types of operations. 2. Each standard scenario shall: (a) define whether the UAS operator shall submit an operational declaration or apply for an operational authorisation before conducting the corresponding operation; (b) include the conditions under which an operation may be conducted. UAS.SPEC.030 Operational declaration 1. If required by the corresponding standard scenario, a UAS operator, except when the UAS operator holds an LUC as per Subpart C of this Annex with the appropriate privileges, shall submit an operational declaration to the competent authority in a manner and format established by EASA. 2. Upon receipt of the declaration, the competent authority shall: (a) provide, without undue delay, the UAS operator with a confirmation of receipt; and (b) verify that the declaration contains all the required information. 3. If the operation is conducted in the airspace of a Member State other than the Member State of registration of the UAS operator, the UAS operator shall also submit the operational declaration to the competent authority of the Member State of operation in a language accepted by this Member State. 4. After receiving the confirmation of receipt of the operational declaration by the competent authority, the UAS operator is entitled to start the operation if all the conditions identified in the corresponding standard scenario are met and the required mitigations measures are in place. 5. The UAS operator shall notify the competent authority, without delay, of any change to the statements or information contained in the operational declaration submitted. UAS.SPEC.035 Application for an operational authorisation Except when the UAS operator holds an LUC with the appropriate privileges, as per Subpart C of this Annex, the UAS operator shall: 1. submit an application for operational authorisation to the competent authority in a manner and format established by EASA, before starting an operation that: 6  (a) corresponds to a standard scenario requiring an operational authorisation; or (b) does not correspond to any standard scenario; 2. only start the operation after having received the operational authorisation issued by the competent authority in a manner and format established by EASA; 3. submit an application for an updated operational authorisation if there are any significant changes to the operation or to the mitigation measures listed in the operational authorisation. UAS.SPEC.040 Issuing of an operational authorisation 1. Upon receipt of an application from a UAS operator for the issue of an operational authorisation, the competent authority shall verify that the application contains all the information and documentation listed in paragraph 2(a) and (b) of this point. 2. The competent authority shall issue, without undue delay, an authorisation to a UAS operator to conduct an operation in the ‘specific’ category when it concludes that the operation: (a) corresponds to a standard scenario issued by EASA that requires an authorisation, and that the following conditions are met: (i) the mitigation measures required by the standard scenario have been put in place by the UAS operator; (ii) an operations manual has been compiled, when required by the standard scenario; and (iii) a procedure is in place for the coordination with the relevant ATC unit(s) if the entire operation or part of it is to be conducted in controlled airspace; or (b) does not correspond to a standard scenario, and that the following conditions are met: (i) the competent authority is satisfied with the operational risk assessment provided by the UAS operator pursuant to UAS.SPEC.020; (ii) the mitigation measures established by the UAS operator limit the risk of the operation to an acceptable level; (iii) an operations manual has been compiled; and (iv) a procedure is in place for the coordination with the relevant ATC unit(s) if the entire operation or part of it is to be conducted in controlled airspace. 3. The competent authority shall specify in the authorisation the conditions under which a UAS operator is authorised to conduct the intended operation. 4. If an operation is intended to take place partially or totally in the airspace of a Member State other than the Member State of registration of the UAS operator, the competent authority, in coordination with the competent authority of the Member State of operation, shall assess: 7  (a) the impact of local conditions on the operation; and (b) the effectiveness of the additional mitigation measures that may be required to comply with the local conditions. 5. The authorisation shall be issued in a manner and format established by EASA. UAS.SPEC.050 Responsibilities of the UAS operator The UAS operator shall: 1. ensure that operational procedures and limitations adapted to the type of the intended operation and the risk involved are established; 2. designate a remote pilot for each operation or, in the case of autonomous operations, ensure that during all phases of the operation, responsibilities and functions are properly allocated in accordance with the procedures; 3. ensure that before conducting operations, remote pilots and all other personnel directly involved in the operations are: (a) competent to perform their tasks; (b) familiar with the UAS operator’s procedures and operations manual, when required by UAS.SPEC.040(2); (c) aware of any information about the operation published by the relevant authorities; (d) familiar with relevant EU and national regulations, in particular those related to security, privacy, data protection, liability, insurance and environmental protection; and (e) in a physical and mental condition such that would not endanger the safe operation of the UAS; 4. carry out an operation within the limitations, conditions, and mitigation measures defined in the standard scenario or specified in the operational authorisation; 5. keep a record of the UAS operations information as required by the standard scenario or operational authorisation; 6. comply with the local conditions established by the Member State of operation; 7. maintain the UAS in condition for safe operations and comply with UAS.SPEC.100, if required; and 8. in cases of autonomous operations, comply with the requirements defined in UAS.SPEC.070(2) and (3). UAS.SPEC.055 Responsibilities of model clubs and associations Model clubs and associations that hold an operational authorisation defined in Article 6 of this Regulation shall: 8 1. make available to their registered members appropriate procedures to comply with the conditions and limitations defined in the operational authorisation issued by the competent authority; 2. assist UAS remote pilots, who are registered members of the club or association, in achieving the minimum competency required to operate the UAS safely in accordance with the procedures defined in paragraph 1; 3. take appropriate action when informed that a registered member does not comply with the conditions and limitations defined in the operational authorisation and, if necessary, inform the competent authority; 4. provide, upon request from the competent authority, the documentation required for oversight and monitoring purposes. UAS.SPEC.060 Registration UAS operators shall: 1. register themselves in a manner and format established by EASA unless already registered in accordance with UAS.OPEN.060; 2. register the UA when the UA concerned has been issued a certificate of airworthiness or a restricted certificate of airworthiness; 3. update the registration every time data is changed and renew the registration as required by the competent authority; 4. display the registration information on the UA; and 5. ensure that this information is inserted into the electronic identification system when required by the operational authorisation or by the standard scenario requiring a declaration, as applicable. UAS.SPEC.070 Responsibilities of the remote pilot 1. The remote pilot shall: (a) be in a physical and mental condition such that would not endanger the safe operation of the UAS; (b) have the appropriate remote pilot competency; and (c) comply with UAS.SPEC.050 and UAS.SPEC.060 if the remote pilot is also the UAS operator. 2. Before starting a UAS operation, the remote pilot shall: (a) obtain updated information, relevant to the intended operation, about any flight restrictions or conditions established by the Member State of operation; (b) ensure that the operating environment is compatible with the authorised or declared limitations and conditions or with the model clubs’ and associations’ procedures; 9  (c) ensure that the UAS is in a safe condition to complete the intended flight safely; and (d) when required by the standard scenario, by the operational authorisation or by the conditions published by the Member State for the zone of operation, ensure that the information about the operation has been made available to the relevant air traffic service (ATS) unit, other airspace users or relevant stakeholders. 3. During the flight, the remote pilot shall: (a) comply with the authorised or declared limitations and conditions or with the model clubs’ and associations’ procedures, as applicable; (b) ensure the safe operation of the UAS with respect to third parties on the ground or in the air; (c) comply with the limitations for the area and airspace restrictions; (d) operate the UAS within the limitations defined by the UAS operator; (e) not fly close to or inside areas where an emergency response effort is ongoing unless they have permission to do so from the responsible emergency response services; and (f) respect privacy rights, the environment, and operate the UAS in a considerate way that minimises any nuisance caused to other persons or animals. UAS.SPEC.075 Transferability of an operational authorisation An operational authorisation is not transferable. UAS.SPEC.080 Duration and validity of an operational authorisation 1. The competent authority shall specify in the operational authorisation its duration. 2. Notwithstanding paragraph 1, the authorisation remains valid provided that: (a) the UAS operator remains in compliance with the relevant requirements of this Regulation and with the operational authorisation issued by the competent authority; and (b) is not surrendered or revoked. 3. Upon revocation or surrender, the operational authorisation shall be returned to the competent authority without delay. UAS.SPEC.090 Access For the purpose of demonstrating compliance with this Regulation, a UAS operator shall grant any person that is duly authorised by the competent authority access to any facility, UAS, document, records, data, procedures or to any other material relevant to its activity which is subject to authorisation or declaration, regardless of whether or not its activity is contracted or subcontracted to another organisation. 10 UAS.SPEC.100 Use of certified equipment and certified UA 1. If the UAS operation is conducted with a UA which has been issued a certificate of airworthiness or a restricted certificate of airworthiness, or when using certified equipment, the UAS operator shall record the operation or service time in accordance either with the instructions and procedures applicable to the certified equipment, or with the organisational approval or authorisation. 2. The UAS operator shall follow the instructions referred to in the UA certificate or equipment certificate, and also comply with any airworthiness directives issued by EASA. UAS.SPEC.110 Alternative means of compliance (AltMoCs) 1. Means of compliance alternative to those adopted by EASA may be used by a UAS operator to establish compliance with Regulation (EU) …/… [new BR] and its implementing rules. 2. When a UAS operator wishes to use an AltMoC, it shall, prior to implementing it, provide the competent authority with a full description of the AltMoC it intends to implement. The description shall include any revisions to manuals or procedures that may be relevant, as well as an assessment demonstrating compliance with Regulation (EU) …/… [new BR] and its implementing rules. 3. The operator may implement these AltMoCs subject to prior approval by the competent authority and upon receipt of the notification as prescribed in Article 10 of this Regulation. 11  SUBPART C LIGHT UAS OPERATOR CERTIFICATE (LUC) UAS.LUC.010 General requirements for an LUC 1. Any legal person shall be eligible to apply for an LUC under this Subpart. 2. An application for an LUC or for an amendment to an existing LUC shall be submitted to the competent authority in a format and manner established by EASA. 3. An LUC holder may be granted the privilege to authorise its own operations if the requirements of this Subpart are met, in accordance with UAS.LUC.060. UAS.LUC.020 Responsibilities of the LUC holder The LUC holder shall: 1. ensure that the requirements of UAS.SPEC.050, UAS.SPEC.060 and UAS.SPEC.070 are met; 2. comply with the scope and privileges defined in its terms of approval; 3. establish and maintain a system for exercising operational control over any operation conducted under the terms of its LUC; 4. carry out an operational risk assessment of the intended operation, in accordance with UAS.SPEC.020, when it is not fully addressed by a standard scenario issued by EASA or if EASA has not issued a standard scenario for that operation; 5. for operations conducted using the privileges in accordance with UAS.LUC.060, keep records of: (a) the operational risk assessment, when required according to paragraph 4, and its supporting documentation; (b) all supporting documents as required by the standard scenario related to the operation conducted; (c) mitigation measures taken; and (d) the qualifications and experience of personnel involved in the UAS operation, compliance monitoring and safety management. UAS.LUC.030 Safety management system 1. A UAS operator, who applies for an LUC, shall establish, implement and maintain a safety management system corresponding to the nature and complexity of its activities that includes: (a) a safety policy describing the overall philosophies and principles of the organisation with regard to safety, and related safety objectives to form the basis for safety performance monitoring; 12  (b) clearly defined lines of responsibility and accountability throughout the organisation, including the direct safety accountability of the accountable manager; (c) procedures for maintaining personnel trained and competent to perform their tasks; (d) the identification of safety hazards entailed by the activities of the UAS operator, their evaluation and the management of the associated risks, including taking action to mitigate those risks and verify the effectiveness of the action; (e) documentation of all safety management system key processes, including a process for making personnel aware of their responsibilities and of the procedure for amending this documentation; (f) an independent function to monitor the compliance of the UAS operator with the relevant requirements of this Regulation, including a system to provide feedback of findings to the accountable manager to ensure effective implementation of corrective measures as necessary; and (g) a function to ensure that safety risks inherent to a service or product delivered through subcontractors are assessed and mitigated under the operator’s safety management system. 2. The following key safety personnel shall be part of the operator’s safety management system: (a) an accountable manager responsible for establishing, implementing and maintaining an effective safety management system; (b) a safety manager responsible for coordinating the safety management system; and (c) one or more persons with the responsibility of ensuring that the UAS operator remains at all times in compliance with the requirements of this Regulation. 3. Where the organisation holds one or more additional organisation certificates within the scope of Regulation (EU) …/… [new BR], the safety management system of the UAS operator may be integrated with the safety management system that is required by any of the additional certificate(s) held. UAS.LUC.040 LUC manual 1. An LUC holder shall provide an LUC manual to the competent authority, describing directly or by cross reference its organisation, the relevant procedures and the activities carried out. 2. If any activity is carried out by partner organisations or subcontractors, the LUC manual shall include a relevant statement as well as written procedures on how the LUC holder shall manage the relationship with those partner organisations or subcontractors. 3. The LUC manual shall be amended as necessary to retain an up-to-date description of the LUC holder’s organisation, and copies of amendments shall be provided to the competent authority. 13 4. The UAS operator shall distribute the relevant parts of the LUC manual to all its personnel in accordance with their functions. 5. The content of the LUC manual shall not contravene the terms of approval and the privileges granted to the LUC holder. UAS.LUC.050 Terms of approval of the LUC holder 1. The competent authority shall issue an LUC in a manner and format established by EASA after it is satisfied that the UAS operator complies with UAS.LUC.020, UAS.LUC.030 and UAS.LUC.040. 2. The terms of approval shall include the UAS operator’s privileges, authorised activities and operational limitations, as appropriate. UAS.LUC.060 Privileges of the LUC holder When satisfied with the documentation provided, the competent authority shall: 1. within its terms of approval, grant the LUC holder the privilege to authorise its own operations, in a manner and format established by EASA; 2. identify in the LUC the privileges granted to the UAS operator. UAS.LUC.070 Changes in the LUC management system After the issue of an LUC: 1. any change in the terms of approval of the UAS operator; or 2. any significant change to the elements of the LUC holder safety management system as required by UAS.LUC.030, shall require prior approval by the competent authority. UAS.LUC.075 Transferability of an LUC Except as a result of a change of ownership of the organisation, approved by the competent authority in accordance with UAS.LUC.070, an LUC is not transferable. UAS.LUC.080 Duration and validity of an LUC 1. An LUC shall be issued for an unlimited duration. It shall be valid subject to: (a) the LUC holder remaining in compliance with the relevant requirements of this Regulation and of the Member State that has issued the certificate; and (b) it not being surrendered or revoked. 2. Upon revocation or surrender, the LUC shall be returned to the competent authority without delay. UAS.LUC.090 Access For the purpose of demonstrating compliance with this Regulation, the LUC holder shall grant any person that is duly authorised by the competent authority access to any facility, UAS, 14 document, records, data, procedures or to any other material relevant to its activity which is subject to certification, authorisation or declaration, regardless of whether or not its activity is contracted or subcontracted to another organisation. UAS.LUC.110 Alternative means of compliance (AltMoCs) 1. Means of compliance Alternative to those adopted by EASA may be used by a UAS operator to establish compliance with Regulation (EU) …/… [new BR] and its implementing rules. 2. When a UAS operator wishes to use an AltMoC, it shall, prior to implementing it, provide the competent authority with a full description of the AltMoC it intends to implement. The description shall include any revisions to manuals or procedures that may be relevant, as well as an assessment demonstrating compliance with Regulation (EU) …/… [new BR] and its implementing rules. 3. The operator may implement these AltMoCs subject to prior approval by the competent authority and upon receipt of the notification as prescribed in Article 10 of this Regulation. 15 DRAFT COMMISSION REGULATION (EU) …/… of XXX laying down rules and procedures for the operation of unmanned aircraft THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) …/… [new BR] of the European Parliament and of the Council on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Regulation (EC) No 216/2008 (1), and in particular Articles 45, 46, 47, and 51 thereof, Whereas: (1) Unmanned aircraft system (UAS) operations should be regulated based on the nature and risk of the operation or activity. For these operations, which are divided into two separate categories, the ‘open’ and ‘specific’ categories of UAS operations, proportionate requirements should be applicable and adapted to the level of risk identified for each category. (2) In particular, UAS intended to be operated in the ‘open’ category, covering operations that present the lowest risks, should not be subject to classic aeronautical compliance procedures. This Regulation should, in consequence, set out requirements that address the risks posed by operations conducted with those UAS. (3) Operations in the ‘open’ category should be conducted with UAS classes that are defined in Regulation (EU) …/… [DA]. (4) Operations in the ‘specific’ category should be conducted with UAS that are compliant with the technical requirements defined in the operational authorisation or in the declaration, as appropriate. (5) In order to ensure the implementation of this Regulation, appropriate transitional measures should be provided. In particular, it is necessary to allow Member States and stakeholders sufficient time to adapt their procedures to the new regulatory framework before this Regulation applies. (6) Dedicated provisions for recreational flight activities conducted in the framework of model clubs and associations should also be laid down. ( 1) The OJ reference will be added when the new ‘Basic Regulation’ repealing Regulation (EC) No 216/2008 is adopted by the European Parliament and the Council. For referencing purposes, ‘Regulation (EU) …/… [new BR]’ is used in the proposed draft Regulation. EN 1 EN  (7) The measures provided for in this Regulation are based on Opinion No 01/2018 (2) issued by the European Aviation Safety Agency (EASA) in accordance with Article 65 of Regulation (EU) …/… [new BR]. (8) The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 116 of Regulation (EU) …/… [new BR], HAS ADOPTED THIS REGULATION: Article 1 Subject matter and scope This Regulation lays down rules and procedures for: (a) the ‘open’ and ‘specific’ categories of UAS operations within the single European sky airspace; (b) the registration of UAS operators and unmanned aircraft (UA). Article 2 Definitions For the purposes of this Regulation, the following definitions apply: 1. ‘unmanned aircraft system (UAS)’ means the unmanned aircraft (UA) and the equipment to control the UA remotely; 2. ‘“open” category’ means a category of UAS operation that, considering the low risk involved, requires neither a prior authorisation by the competent authority nor a declaration by the UAS operator before the operation takes place; 3. ‘“specific” category’ means a category of UAS operation that, considering the risks involved, requires an authorisation by the competent authority before the operation takes place, taking into account the mitigation measures identified in an operational risk assessment, except for certain standard scenarios for which a declaration by the UAS operator is sufficient; 4. ‘unmanned aircraft system (UAS) operator’ means any legal or natural person who operates or intends to operate one or more UAS; 5. ‘unmanned aircraft (UA)’ means any aircraft operating or designed to operate autonomously or to be piloted remotely without a pilot on board; 6. ‘equipment to control unmanned aircraft remotely’ means any instrument, equipment, mechanism, apparatus, appurtenance, software or accessory that is necessary for the safe operation of a UA, other than a part, and which is not carried on board that UA; ( 2) EASA Opinion No 01/2018 ‘Introduction of a regulatory framework for the operation of unmanned aircraft systems in the “open” and “specific” categories’ (RMT.0230), available at https://www.easa.europa.eu/document-library/opinions. EN 2 EN  7. ‘visual line of sight (VLOS)’ means a type of operation in which the remote pilot maintains continuous unobstructed and unaided visual contact with the UA, allowing the remote pilot to monitor the flight path of the UA in relation to other aircraft, persons, and obstacles for the purpose of maintaining separation from them and avoiding collisions; 8. ‘light UAS operator certificate (LUC)’ means a certificate issued to a UAS operator by a competent authority as per Subpart C of the Annex (Part-UAS) to this Regulation; 9. ‘competent authority’ means the authority designated by the Member State responsible for certification, authorisation, oversight, enforcement and registration in the Member State where the UAS operator has its principal place of business, or place of residence if the UAS operator is a natural person; 10. ‘remote pilot’ means a natural person responsible for safely conducting the flight of a UA by operating its flight controls, either by manual use of the remote controls or, when the UA flies automatically, by monitoring its course and remaining able to intervene and change its course at any time; 11. ‘acceptable means of compliance (AMCs)’ means non-binding standards adopted by EASA to illustrate the means to establish compliance with Regulation (EU) .../... [new BR] and its implementing rules; 12. ‘alternative means of compliance’ (AltMoCs) are those means of compliance that propose an alternative means to the existing AMCs or those that propose new means to establish compliance with Regulation (EU) No .../... [new BR] and its implementing rules for which no associated AMCs have been adopted by EASA. 13. ‘automatic operation’ means an operation in which the UAS executes preprogrammed instructions while the remote pilot is able to intervene at any time; 14. ‘autonomous operation’ means an operation during which a UA operates without the possibility for remote pilot intervention in the management of the flight; 15. ‘certificate of airworthiness (CofA)’ means a certificate attesting that an aircraft conforms to an approved design and is in a condition for safe operation in accordance with Annex I (Part 21) to Regulation (EU) No 748/2012 (3); 16. ‘congested area’ means any area in a city, town or settlement which is substantially used for residential, commercial or recreational purposes; 17. ‘dangerous goods’ means articles or substances which are capable of posing a risk to health, safety, property or the environment and which are shown in the list of dangerous goods in the ICAO Technical instructions for the safe transport of dangerous goods by air (Doc 9284-AN/905) at the latest version including any addenda or corrigenda, or those which are classified according to those instructions; ( 3) Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations (OJ L 224, 21.8.2012, p. 1). EN 3 EN  18. ‘electronic identification’ means a system that transmits the identity of the UA so that it can be identified without direct physical access to that UA; 19. ‘first-person-view (FPV) mode’ means a mode of operation of a UAS where the remote pilot navigates the UA using images from a camera installed on the UA; 20. ‘follow-me mode’ means a mode of operation of a UAS in which the UA constantly follows a person or a device within a predetermined radius; 21. ‘geo-awareness’ means a function that can detect a potential breach of airspace limitations and provides the remote pilot with sufficient information and an appropriate alert to allow the remote pilot to take effective action to prevent that breach; 22. ‘guidance material (GM)’ means non-binding material developed by EASA which helps to illustrate the meaning of a requirement or a specification and is used to support the interpretation of Regulation (EU) .../... [new BR], its implementing rules and acceptable means of compliance; 23. ‘hazard’ means a condition or an object with the potential to cause injuries, damage, loss of material or a reduction in the ability to perform a prescribed function; 24. ‘model aircraft club or association’ means an organisation legally established in a Member State for the purpose of conducting leisure flights, air displays, sport or competition activities with UAS; 25. ‘Part-UAS’ means the rules applicable to the operation of a UAS that falls into the ‘open’ or the ‘specific’ category, as laid down in the Annex (Part-UAS) to this Regulation; 26. ‘privately built UAS’ means a UAS assembled or manufactured for the manufacturer’s own use; this does not include UAS assembled from a set of parts placed on the market by the manufacturer as a single ready-to-assemble kit; 27. ‘remote pilot competency’ means a combination of skills, knowledge and conduct required for a remote pilot to perform a task to the prescribed standard; 28. ‘single European sky airspace’ means the airspace above the territory to which the Treaties apply, as well as any other airspace where Member States apply Regulation (EC) No 551/2004 (4), in accordance with Article 1(3) of that Regulation; 29. ‘specific operations risk assessment (SORA)’ means the methodology to assess the risks of a UAS operation in the ‘specific’ category, and determine the corresponding mitigation measures; 30. ‘standard scenario’ means a description of a UAS operation in the ‘specific’ category, for which mitigation measures have been determined based on a risk assessment (e.g. SORA), and adopted by EASA in its AMCs or in the AltMoCs provided to EASA by a competent authority; ( 4) Regulation (EC) No 551/2004 of the European Parliament and of the Council of 10 March 2004 on the organisation and use of the airspace in the single European sky (the airspace Regulation) (OJ L 96, 31.3.2004, p. 20). EN 4 EN  31. ‘unmanned aircraft (UA) observer’ means a natural person who, by unaided visual observation of the UA, assists the remote pilot in safely conducting the flight. Article 3 Principles applicable to all UAS operations 1. Safety rules shall be proportionate to the risk of the operation. 2. The operator of the UAS is responsible for the safety of its operations. 3. The remote pilot is responsible for the safe conduct of each individual UA flight. 4. UAS operators shall be registered in accordance with Article 7 of this Regulation. Article 4 The ‘open’ category of UAS operations The ‘open’ category of UAS operations shall comply with the requirements of Subpart A of the Annex (Part-UAS) to this Regulation. Article 5 The ‘specific’ category of UAS operations A UAS operation in the ‘specific’ category shall be subject to a prior operational risk assessment and to the application of the identified mitigation measures, in accordance with: 1. the requirements of Subpart B of the Annex (Part-UAS) to this Regulation; 2. the declaration made in accordance with a standard scenario, except when the UAS operator holds an LUC with privileges to authorise its own operations in accordance with Subpart C of the Annex (Part-UAS) to this Regulation; or 3. the authorisation issued by the competent authority, or by a UAS operator that holds an LUC with privileges to authorise its own operations in accordance with Subpart C of the Annex (Part-UAS) to this Regulation. Article 6 UAS operations conducted in the framework of model clubs and associations For UAS operations conducted in the framework of model clubs or associations, the following apply: 1. the competent authority may issue an operational authorisation, in accordance with UAS.SPEC.040, to a model club or association without further demonstration of compliance, on the basis of the model club’s or association’s established procedures, organisational structure, and management system; 2. operational authorisations granted under this Article shall include the conditions and limitations of, as well as the deviations from, the requirements of the Annex (Part-UAS) to this Regulation; 3. this authorisation shall be limited to the territory of the Member State where the authorisation was issued. EN 5 EN  Article 7 Registration of UAS operators and their UA 1. Each operator shall register itself, and where applicable, its UA, in the Member State where the operator has its principal place of business or place of residence in accordance with Subpart A and Subpart B of the Annex (Part-UAS) to this Regulation. 2. Each registered UAS operator shall obtain a registration number according to the format defined by EASA. 3. Member States shall ensure that their registries are digital and interoperable. Records shall be updated, accurate, secure and accessible in real time by authorised authorities, organisations or persons. 4. If a Member State designates one or more entities, different from the competent authority referred to in Article 8(1), then: (a) the areas of competence of each entity or competent authority shall be clearly defined; and (b) coordination shall be established between the designated entities and the competent authorities to ensure the effective implementation of this Regulation. Article 8 Designation of the competent authority 1. A Member State shall designate a competent authority with the following responsibilities: (a) issue certificates of remote pilot competency; (b) issue authorisations, acknowledge receipt of declarations, and oversee ‘specific’ category UAS operations; (c) establish airspace restrictions; (d) enforce this Regulation in respect of UAS operators and remote pilots. 2. If a Member State designates more than one entity as a competent authority: (a) the areas of competence of the competent authority shall be clearly defined; and (b) coordination shall be established between the designated competent authorities and the entities referred to in Article 7(4) to ensure the effective implementation of this Regulation. 3. The competent authority shall: (a) have a suitable organisational structure, appropriately documented procedures, and adequate resources; and (b) employ or have access to personnel with sufficient knowledge, professional integrity, experience and training to perform the allocated tasks. 4. Member States shall ensure that the personnel of the competent authority do not perform activities related to this Regulation when there is evidence that this could result, EN 6 EN  directly or indirectly, in a conflict of interest, in particular when related to their family or financial interests. Article 9 Tasks of the competent authority In the framework of the competencies allocated by the Member States in accordance with Articles 7 and 8 of this Regulation, the competent authority shall: 1. examine documents, records and reports relevant to UAS operations, remote pilots or UAS operators; 2. develop a risk-based oversight system for UAS operators who hold a declaration, an authorisation or a certificate for a UA, in which audit planning is driven by the risk profile and the safety performance of the organisation and in which execution of the audits focuses on risk management in addition to compliance; 3. provide guidance for the community of UAS operators that is intended to promote the safety of UAS operations, including the dissemination of any updated regulations that affect UAS operations; 4. inspect, as required, UAS, remote pilots, and UAS operators to assess their compliance with this Regulation; 5. have a system to detect and analyse any non-compliance of declared UAS operators, or of UAS operators that it has authorised or certified; 6. issue, maintain, amend, suspend, limit or revoke authorisations, and issue, suspend, or revoke certificates required to carry out UAS operations in the ‘open’ and ‘specific’ categories, or impose other measures or sanctions, as necessary; 7. establish, maintain and keep updated, secure and accessible in real time by authorised persons, one or more registers of operational declarations, operational authorisations, certificates of remote pilot competency and LUCs; 8. disseminate safety information, when necessary. Article 10 Means of compliance 1. The competent authority shall establish a system to consistently evaluate all AltMoCs used by itself, or by organisations and persons under its oversight, to ensure that they allow compliance with Regulation (EU) .../... [new BR] and its implementing rules to be established. 2. The competent authority shall evaluate all AltMoCs proposed by an organisation in accordance with UAS.SPEC.110 and UAS.LUC.110, by analysing the documentation provided and, if considered necessary, by inspecting the organisation. 3. When the competent authority finds that the AltMoCs are in accordance with Regulation (EU) .../... [new BR] and its implementing rules, it shall, without undue delay: EN 7 EN  (a) notify the applicant that the AltMoCs may be implemented and, as appropriate, amend the operational authorisation or certificate of the applicant accordingly; (b) notify EASA of the AltMoCs’ content and provide copies of all the relevant documentation; and (c) inform all other Member States of any AltMoCs that were accepted. 4. When the competent authority itself uses AltMoCs to achieve compliance with Regulation (EU) .../... [new BR] and its implementing rules, it shall: (a) make those AltMoCs available to all organisations and persons under its oversight; and (b) without undue delay, notify EASA. 5. The competent authority shall provide EASA with a full description of the AltMoCs, including any revisions to procedures that may be relevant, as well as an assessment that demonstrates that the implementing rules are complied with. Article 11 Airspace conditions for UAS operations 1. Member States may establish airspace restrictions on zones in which one or more of the following conditions applies: (a) certain UAS operations are not permitted without prior authorisation or are not permitted at all; (b) access is only allowed for certain UAS classes; (c) access is only allowed for UAS equipped with electronic identification and/or geo-awareness systems; (d) UAS operations comply with the specified environmental standards. 2. Member States may define airspace in which UAS operations are exempted from one or more of the ‘open’ category requirements of this Regulation, and in which operators are not required to hold an authorisation or submit a declaration. 3. Member States shall publish the information on airspace established in accordance with paragraphs 1 or 2 of this Article, as well as on how, if required, authorisation may be obtained, in a manner and format established by EASA. Article 12 Safety information 1. Competent authorities and market surveillance authorities, as designated according to Regulation (EU) …/… [DA], shall cooperate on safety matters, and establish procedures for an efficient exchange of safety information. EN 8 EN  2. Each UAS operator shall report to the competent authority any occurrence and any other safety-related information regarding its UAS, in compliance with Regulation (EU) No 376/2014 (5). 3. EASA and the competent authorities shall collect, analyse and disseminate safety information concerning UAS operations in their territory in accordance with Regulation (EU) .../... [new BR] and its implementing rules. 4. Upon receiving any of the information referred to in paragraphs 1, 2 or 3 of this Article, EASA or the authority that is competent for the corresponding domain of competence shall take appropriate measures to address any safety issues. 5. If the competent authority takes measures under paragraph 4 of this Article, it shall immediately notify all persons or organisations that need to comply with those measures under Regulation (EU) .../... [new BR] and its implementing rules. The competent authority shall also notify EASA, if EASA has not already been informed, and when combined action is required, the other Member States concerned. Article 13 Derogations and limitations UAS operators may continue to operate UAS made available on the market before the applicability of Regulation (EU) …/… [DA]: 1. in subcategory A1 of the ‘open’ category, as defined in UAS.OPEN.020, or in the ‘specific’ category in accordance with Subpart B of the Annex (Part-UAS) to this Regulation, provided that the UA has a maximum take-off mass (MTOM) of less than 250 g, including its payload; 2. in subcategory A3 of the ‘open’ category, as defined in UAS.OPEN.040, or in the ‘specific’ category in accordance with Subpart B of the Annex (Part-UAS) to this Regulation, provided that the UA has an MTOM between 250 g and 25 kg, including its payload. Article 14 Conversion of authorisations, declarations and certificates 1. Authorisations and declarations for UAS operators, as well as certificates of remote pilot competency, issued on the basis of national legislation, prior to the applicability date of this Regulation, shall remain valid until ... [1 year after the entry into force of this Regulation]. 2. Member States shall, by the end of the period specified in paragraph 1, have converted their existing certificates of remote pilot competency and their authorisations or declarations for UAS operators into those required by this Regulation, provided that the ( 5) Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18). EN 9 EN  level of safety ensured by such authorisations, declarations and certificates is equivalent to the level of safety provided for by this Regulation. Article 15 Entry into force and application 1. This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from ... [6 months after the entry into force of this Regulation]. 2. However: (a) by way of derogation from paragraph 1, Member States may decide not to apply Article 7(1) until ... [9 months after the entry into force of this Regulation]. (b) by way of derogation from paragraph 1, Member States may decide not to apply this Regulation to UAS operations conducted within model clubs and associations until ... [3 years after the entry into force of this Regulation]. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, For the Commission The President […] EN 10 EN