AMC & GM to Part 21 — Issue 2, Amendment 9

Annex to ED Decision 2019/018/R

‘AMC/GM to Part 21 — Issue 2, Amendment 9’

The text of the amendment is arranged to show deleted, new or amended, or unchanged text as shown below: — deleted text is struck through; — new or amended text is highlighted in grey; — an ellipsis ‘[…]’ indicates that the rest of the text is unchanged.

The Annex to ED Decision 2012/020/R of the Executive Director of the Agency of 30 October 2012 is amended as follows:

1. AMC 21.A.14(b) is amended as follows:

AMC 21.A.14(b) Alternative Pprocedures to demonstrate design capability

The availability of Alternative procedures that state the specific design practices, resources and sequence of activities are is an acceptable means to demonstrate design capability in the cases described in points 21.A.14(b), 21.A.112B(b) or 21.A.432B(b). This concept is that the implementation, in the context of specific projects, of the procedures required in for a Subpart J DOA, will to ensure that the applicant will performs the relevant activities as expected by the Agency, but without the requirements on the organisation itself that can be found in Subpart J. The setting up of those establishment of these alternative procedures may be seen as a starting phase for a design organisation to develop into a Subpart J DOA, allowing at a later stage at the discretion of the applicant to move towards a full Subpart J DOA by the addition of the missing elements. 1. Scope 1.1 As alternative to DOA, a A manual of procedures must should be provided that sets out the specific design practices, resources and the sequence of activities that are relevant for the specific projects, taking the Part 21 account of Part 21 requirements into account. 1.2 These procedures mustshould be concise and limited to the information that is needed for the quality and proper control of activities by the applicant/holder, and by the AgencyEASA.

2. Management of the (supplemental) type-certification process 2.1 Certification programme: Ssee AMC 21.A.2015(b) for type- certification and AMC 21.A.11493(b) for supplemental type- certification. 2.2 Compliance demonstration: see GM 21.A.20. 2.3 Reporting: see GM 21.A.20(b). 2.24 Compliance documentation: see AMC 21.A.20(c).

2.5 Declaration of compliance: see GM 21.A.20(d).

3. Management of design changes to type certificates, repair designs and production deviations 3.1 ApprovalManagement of changes to a type designcertificate or supplemental type certificate (hereinafter referred to as ‘changes’), repairs designs and production deviations from the approved design data The TC or STC applicant mustshould provide procedures that are acceptable to the AgencyEASA for the classification and approval of changes to type design (see paragraphs 3.2 and 3.3), and repairs designs and production deviations from the approved design data (see paragraph 3.4). 3.2 Classification

3.2.1 Content

The procedure mustshould address the following points: — the identification of the product configuration(s) to which the change is to be made, — the identification of the changes to type design areas of the product that are changed or affected by the change, — the identification of any reinvestigations that are necessary (see point 21.A.93(b)(2)), including the identification of the applicable certification specifications or environmental protection requirements and means of compliance, — airworthiness classification, — changes to type design initiated by sub-contractors, — documents to justify the classification, — authorised signatories, — the Ccriteria used for classification must be in compliance with 21.A.91 and the corresponding interpretations.

3.2.2 Identification of changes to type design

The procedure must should indicate how the following are identified: — major changes to type design, — those minor changes to type design where additional work is necessary to demonstrate compliance with the certification specifications, — other minor changes to type design that requireing no further demonstrationng of compliance. 3.2.3 Airworthiness classification Considerations of effects of the change The procedure mustshould show how the effects on airworthiness, operational suitability or environmental protection are analysed, from the very beginning, by reference to the applicable certification specifications. If no specific certification specifications are applicable to the change, the above review mustshould be carried out at the level of the part or system where the change is integrated and where specific certification specifications are applicable.

3.2.4 Control of changes to type design initiated by sub-contractors The procedure mustshould indicate, directly or by cross reference to written procedures, how changes to type design initiated by sub-contractors are controlled.

3.2.5 Documents to justify the classification

All decisions of classification of changes to type design mustshould be documented and approved by the AgencyEASA. ItThe documentation may be in the format of meeting notes or a register.

3.2.6 Authorised signatories

The procedure should identify the persons authorised to sign the proposed classification before release to the Agency EASA for approval. 3.3 Approval of changes to type design

3.3.1 Content

The procedure must should address the following points: — compliance documentation, — the internal approval process, — authorised signatories.

3.3.2 Compliance documentation

For major changes and those minor changes to type design where additional work to demonstrate compliance with the applicable certification specifications typecertification basis, operational suitability data certification basis, and environmental protection requirements (hereinafter referred to as the ‘certification basis’) is necessary, compliance documentation mustshould be established in accordance with AMC 21.A.20(c).

3.3.3 Approval process

A) For the approval of major changes to type design, a certification programme as defined in AMC 21.A.973(b) must be established. B) For major changes and those minor changes to type design where additional work to showdemonstrate compliance with the applicable certification basisspecifications is necessary, the procedure should define a document to support the approval process. This document mustshould include at least: - identification and a brief description of the change and its classification, - references to the applicable certification basisspecifications, - reference to the compliance documents, - effects, if any, on limitations and on the approved design datadocumentation, - the name of the authorised signatory.

C) For the other minor changes, the procedure mustshould define a means: - to identify the change, - to present the change to the AgencyEASA for approval.

3.3.4 Authorised signatories

The procedure mustshould identify the persons authorised to sign the change before release to the AgencyEASA for approval. 3.4 Repairs designs and production deviations from the approved design data A procedure following the principles of paragraphs 3.2 and 3.3 mustshould be established for the classification and approval of repairs designs and unintentional deviations from the approved design data occurring in production (concessions or non-conformances). For repairs designs, the procedure mustshould be established in accordance with Part 21, Section A, Subpart M and the associated acceptable means of compliance (AMC) or guidance material (GM).

4. Issue of data and information and(including instructions) to owners, operators or others required to use the data and information 4.1 General Data and Iinformation and instructions include the operational suitability data. 4.2 Data related to changes The data and information or(including instructions) issued by the holder of a design approval (a TC, STC, approval of a changes to type design, approval of a repair design) holder are intended to provide the owners of a product with all the necessary data and information to implementembody a change or a repair on the product, or a repair, or to inspect it. The data and information or(including instructions) may be issued in a format of a Sservice Bbulletin as defined in ATA 100 system, or in Sstructural Rrepair Mmanuals, Mmaintenance Mmanuals, Eengine and Ppropeller Mmanuals, etc. The preparation of this data involves design, production and inspection. The three aspects should be properly addressed and a procedure should exist. 4.3 Procedure The procedure should address the following points: - preparation; - verification of technical consistency with corresponding approved change(s), repair(s) design(s) or approved data, including effectivity, description, effects on airworthiness or operational suitability, especially when limitations are changed; - verification of the feasibility in practical applications.; - approval for the release of data and information.

The persons authorised to sign before release of information and instructions to the Agency for approval should be identified in the procedure. The procedure should include the information or(including instructions) prepared by subcontractors or vendors, and declared applicable to its products by the holder of the TC, STC, approval of changes to type design or approval of repair designs holders. 4.4 Statement The data and information and(including instructions) should contain a statement showing AgencyEASA’s approval.

5. Obligations addressed in 21.A.44 (TC holder), 21.A.118A (STC holder) or 21.A.451 (major repair design approval holder) The applicant for alternative procedures to demonstrate their design capabilities should establish the necessary procedures to show to the AgencyEASA how it will fulfil the obligations that are required under 21.A.44, 21.A.118A or 21.A.451, as appropriate.

6. Control of design sub-contractors The applicant for alternative procedures to demonstrate their design capabilities should establish the necessary procedures to show to the AgencyEASA how it will control design subcontractors subcontractors and ensure the acceptability of the parts or appliances that are designed, or the design tasks that are performed.

2. The following AMC 21.A.15(a) is inserted:

AMC 21.A.15(a) Form and manner

The applicant should file an application using the web-based ‘EASA Applicant Portal’ or the application form for a type certificate or restricted type certificate (FO.CERT.00030) , which may be downloaded from the EASA website. The form should be completed in accordance with the instructions embedded at the bottom of the application form, and sent to EASA by fax, email or regular mail following the information provided on the EASA website .

3. The following AMC 21.A.15(b) is inserted:

AMC 21.A.15(b) Content of the certification programme

The certification programme is a document that allows the applicant and EASA to manage and control the evolving product type design or OSD, as well as the process of compliance demonstration by the applicant and its verification by EASA when required. The certification programme may be based on modules that may be updated independently.

The level of detail in the certification programme depends on the complexity of the product and its intended use. In particular, the following information should typically be expected: General — Identification of the relevant personnel who make decisions affecting airworthiness, operational suitability and environmental protection, and who will interface with EASA, unless otherwise identified to EASA (e.g. within the DOA procedures). — A project schedule including major milestones. — Subcontracting arrangements for design, operational suitability, environmental protection and/or production as well as design organisation approval (DOA) responsibility sharing. 21.A.15(b)(1) ‘a detailed description of the type design, including all the configurations to be certified’ An overview of the: — architecture, functions, systems; — dimensions, design weights, payloads, design speeds; — engines and power/thrust rating; — materials and technologies; — maximum passenger seating capacity, minimum flight and cabin crew; — cabin configuration aspects; — options (e.g. weight variants, power/thrust rating variants, optional avionics equipment items, auxiliary power unit (APU) choices, brake options, tire options, floats, skids); — noise/emissions level; and — other items, if considered to be more appropriate, that address the specific aeronautical product. 21.A.15(b)(2) ‘proposed operating characteristics and limitations’ — Operating speed limitations. — Service ceiling, maximum airfield elevation. — Cabin pressure. — Limit load factors. — Number of passengers, minimum crew, payload, range. — Weight and centre-of-gravity (CG) envelope and fuel loading. — Performance. — Environmental envelope. — Runway surface conditions. — Other items, if considered to be more appropriate, that address the specific aeronautical product.

21.A.15(b)(3) ‘the intended use of the product and the kind of operations for which certification is requested’ — Category A or B (relevant for CS-27 and CS-29), ditching, take-off and landing on water, emergency floatation equipment. — Extended overwater operation, high-altitude operation (above 41 000 ft). — High-airfield operation, steep approach, short take-off and landing, extended-range twin-engine operations (ETOPS), all-weather operations (AWO), visual flight rules (VFR)/instrument flight rules (IFR), reduced vertical separation minimum (RVSM), required navigation performance (RNP) type, increased bank angles, single-pilot operation, flight into known icing conditions. — Flight in ice crystal icing. — Engine operations in ice-forming conditions, helicopter hoist operations, operation on unpaved runway, operation on narrow runway. — Take-off and landing in tailwind. — Volcanic-ash operation (limitation or operation as per CS 25.1593 and CS-E 1050). — Design service goal (DSG)/limit of validity targets. — Fatigue missions (general description of assumptions for flight durations, main phases, and parameters, as appropriate). — Other items, if considered to be more appropriate, that address the specific aeronautical product. 21.A.15(b)(4) ‘a proposal for the initial type-certification basis, operational suitability data certification basis, where applicable, and environmental protection requirements, considering the requirements and options specified in 21.B.80, 21.B.82 and 21.B.85’ The proposed certification basis should include applicable certification specifications, proposed special conditions, proposed equivalent safety findings, as well as a proposed ‘elect to comply’ and proposed deviations, as applicable. 21.A.15(b)(5) ‘a proposal for a breakdown of the certification programme into meaningful groups of compliance demonstration activities and data, hereinafter referred as “compliance demonstration items” (CDIs), including references to their proposed means of compliance and related compliance documents’ See AMC 21.A.15(b)(5) for the determination of the compliance demonstration items (CDIs). 21.A.15(b)(6) on information relevant for the determination of the level of involvement (LoI) The applicant should provide sufficient detailed information about the novelty, complexity, and criticality aspects of each proposed CDI. It is recommended to provide this information at the level of each EASA panel or discipline affected by a proposed CDI. Further interpretative material on the necessary level of details is provided in AMC 21.B.100(a) and 21.A.15(b)(6). The applicant should provide detailed information about the proposed means of compliance with the applicable requirements identified under 21.A.15(b)(4). The information provided should be sufficient

for EASA to determine its (initial) LoI. This should include the following, as far as this information is available at the time of submission to EASA: — a compliance checklist addressing each requirement, the proposed means of compliance (see Appendix A to AMC 21.A.15(b) below for the relevant codes), and the related compliance document(s); — identification of industry standards (Society of Automotive Engineers (SAE), American Society for Testing and Materials (ASTM), European Organisation for Civil Aviation Equipment (EUROCAE), AeroSpace and Defence Industries Association of Europe (ASD), etc.), methodology documents, handbooks, technical procedures, technical documents and specifications specified in the type certificate data sheet, certification memoranda, policy statements, guidance material, etc., that should be followed in the demonstration of compliance; — when the compliance demonstration involves testing, a description of the ground and flight test article(s), test method(s), test location(s), test schedule, test house(s), test conditions (e.g. limit load, ultimate load), as well as of the intent/objective(s) of the testing; and — when the compliance demonstration involves analyses/calculations, a description/identification of the tools (e.g. name and version/release of the software programs) and methods used, the associated assumptions, limitations and/or conditions, as well as of the intended use and purpose; furthermore, the validation and verification of such tools and methods should be addressed. For every aspect mentioned above, the applicant should clearly identify whether the demonstration of compliance involves any method (analysis or test) which is novel or unusual for the applicant. This should include any deviations from the published AMC to the relevant CS.

4. The following Appendix A to AMC 21.A.15(b) is inserted:

Appendix A to AMC 21.A.15(b) Means of compliance codes

5. The following AMC 21.A.15(b)(5) is inserted:

AMC 21.A.15(b)(5) Breakdown of the certification programme into compliance demonstration items (CDIs)

1. What is a CDI? A CDI is a meaningful group of compliance demonstration activities and data identified in the certification programme which can be considered in isolation for the purpose of performing the risk assessment that allows EASA to determine its level of involvement (LoI) using a risk-based approach. The possibility to create this grouping of compliance demonstration activities and data is intended to facilitate the risk assessment. However, there may be cases in which the risk assessment may also be performed at the level of the compliance demonstration activity or data, or at the level of the whole certification project. The chosen breakdown into CDIs may affect the resulting risk classes (please refer to AMC 21.B.100(a) and 21.A.15(b)(6)), but should not have any effect on the compliance demonstration itself or on EASA’s LoI. 2. The grouping of compliance demonstration activities and data The compliance demonstration activities and data grouped in a CDI may demonstrate compliance with a requirement, a group of requirements, or even a part of a requirement. In this context, ‘requirement’ means any element of the type-certification basis or operational suitability data (OSD) certification basis as specified in 21.B.80 and 21.B.82, or the environmental protection requirements as specified in 21.B.85. A CDI may comprise any of the means of compliance listed in Appendix A to AMC 21.A.15(b). CDIs may be tailored to the scope and size of the project. On simple projects, a CDI may address all the compliance demonstration activities within a given technical area (e.g. avionics, flight, structures, hydromechanical systems, OSD-cabin crew data (CCD), etc.) or of the whole project. A CDI should not be too large, by combining completely unrelated compliance demonstration activities or data, so that it becomes meaningless, but neither should it be so small that it might not be considered in isolation from some other related compliance demonstration activities or data. A way of meaningfully grouping compliance demonstration activities and data, for example, is to select some activities and data and group them into a single CDI, as the certification programme must already contain the applicable requirements, the proposed means of compliance for each requirement, as well as the associated compliance documents for each means of compliance. Another way to meaningfully group the data is to do it at the level of the technically related compliance demonstration activities and data. This may facilitate the assessment of those

activities and data against the novelty, complexity, and criticality criteria (see AMC 21.B.100(a) and 21.A.15(b)(6)). The resultant CDI may encompass various means of compliance. 3. Description of CDIs Each CDI should be sufficiently described in the certification programme, and should detail the following: — the scope of the CDI; and — the information on the novelty, complexity, and criticality of the item being certified. However, in cases where the rationale of the assessment is obvious, it is considered to be sufficient to indicate whether or not a CDI is novel or complex, and whether or not the impact is critical. Note: Obvious cases are cases for which the classification is straightforward and does not require additional clarifications. In general, applicant explanations/notes regarding the proposed classification should be provided, since this will also facilitate the acceptance of the LOI proposal. Nevertheless, to avoid unnecessary additional effort, these explanations can be omitted if they are obvious. Additionally, it is recommended to identify the EASA panel(s)/discipline(s) affected by each CDI, as this will support the determination of the novelty, complexity, and criticality, and finally identify the performance of the design organisation approval (DOA) holder.

6. The following GM 21.A.15(c) is inserted:

GM 21.A.15(c) Updates to the certification programme

Point 21.A.15(b) recognises that the initial submission of the certification programme may not be fully complete, e.g. due to schedule constraints of the design, analysis and testing activities. Furthermore, even if the initial submission of the certification programme is complete, it may be necessary to amend it throughout the duration of the project. The certification programme should be updated and resubmitted to EASA. In particular, updates to the following elements should be provided: — any complementary information that was not included in the initial submission of the certification programme; — any change in the intended use or kind of operations of the product itself, or of the aircraft on which the product is installed; — a change in the key characteristics of the product such as but not limited to any declared limits that are intended to be recorded in the type certificate data sheet (TCDS); — any change in the product design or its characteristics that may affect the criteria used to assess the likelihood of an unidentified non-compliance with the type-certification basis, operational suitability data (OSD) certification basis or the environmental protection requirements, including the potential impact of that non-compliance on product safety or environmental protection, as defined in 21.A.15(b)(6) and 21.B.100(a)(1) to (4); Note: An update of the DOA dashboard after the first issuance of the certification programme only needs to be considered if there is a significant change in the performance.

— any change to the initial type-certification basis, OSD certification basis or environmental protection requirements, as applicable to the product, regardless whether the change is initiated by EASA or by the applicant;

— any change in the breakdown of the certification programme into compliance demonstration items (CDIs) or in the content of those CDIs;

— any change in the proposed means of compliance, including its/their methodology;

— any change in the structure of compliance documents that may affect the determination of EASA’s level of involvement (LoI), as defined in 21.B.100;

— any relevant change to the design organisation approval (DOA) holder’s personnel (and design organisation (DO) suppliers) who are involved in the project; and

— any changes to the schedule that impact on the EASA LoI.

Following each update to the certification programme as submitted by the applicant, EASA may update the determination of its LoI in accordance with 21.B.100(c).

7. GM No 1 to 21.A.15(d) is amended as follows:

GM No 1 to 21.A.15(d) Clarification of the term ‘as applicable’Application for the approval of operational suitability data — MMEL for ELA1 and ELA2

For ELA1 and ELA2, the applicant may develop a list of the required equipment to be included in the TCDS and/or AFM/POH. This list, in combination with the equipment required for the flight by the applicable implementing rules for a given type of operations, establishes the list of equipment that must be operative for all flights. The list of the other installed equipment that may be inoperative constitutes the MMEL. The term ‘as applicable’ indicates that not all OSD constituents as listed in 21.A.15(d)(1) through (5) are always part of the OSD. For example, when the operational rules do not require cabin crew for an aircraft with a certain number of passenger seats, the element of (d)(4) is not required for the OSD of this aircraft. Another example is that a minimum syllabus for pilot type rating training is not required if the aircraft is in a class rating. If a new aircraft type is considered a variant for licensing purposes a full syllabus for type rating training is not required, but the applicant can suffice with the syllabus for differences training. Most of the OSD elements are not applicable to aircraft in the category ‘other than complex motorpowered’. In more detail: — The requirement to produce minimum syllabi for type training of pilots is only applicable when the aircraft has a type rating. By default. small aircraft will be in a class rating. However, the Agency can decide on an ad-hoc basis that a type rating is necessary due to performance, design or other features that require specific training. For most small aircraft this is not the case and they will be in a class rating. Whether a new aircraft type should have a type rating or can be in a class rating will be part of the OSD approval process and finally will be decided by the Agency. The assessment is based on objective criteria which are included in the Certification Specifications for the related OSD element. When no individual type rating is required for the aircraft, it means that the relevant OSD elements are not required. Nevertheless, on a voluntary basis, the applicant can always provide a minimum syllabus for type rating training to be approved under OSD.

— The requirement to produce minimum syllabi for type training of maintenance certifying staff is only applicable for the aircraft required to have a type rating training, which are the aircraft in Group

1 as per Annex III of (EC) Regulation 1321/2014 (point 66.A.5). When no individual type rating training is required for the aircraft, it means that the relevant OSD elements are not required. Nevertheless, on a voluntary basis, the applicant can always provide a minimum syllabus for type training to be approved under OSD.

— The OSD constituent ‘simulator data’ is only required when the syllabus for pilot type rating includes the use of full flight simulators or flight training devices (FTDs) Level 3for helicopters. This is typically not the case for most small aircraft.

— The type specific data for cabin crew training is only required when the operational rules require cabin crew for the maximum approved passenger seating capacity. Currently, cabin crew is required for aircraft with a maximum approved passenger seating configuration of more than 19. Small aircraft do not have this number of passenger seats.

— The requirement to establish an MEL is applicable to all complex-motor-powered aircraft and to all aircraft that are used for commercial. This means that also for other-than-complex aircraft type certificate or restricted type-certificate an MMEL will be required. However, in order to minimise the burden for the TC and STC applicants, the following applies: For other-than-complex aeroplanes excluding very light aeroplanes (VLA), light sport aeroplanes (LSA) and powered sailplanes, generic MMELs by means of a dedicated CS are established by the Agency. The TC or STC applicant for an aircraft or change to an aircraft within that category can suffice with identifying the items of the generic MMEL that are appropriate for its design. This does not preclude that the applicant may elect to develop a type-specific MMEL, using CS-MMEL

For ELA1 and ELA2 aircraft, the Agency considers that the list of required equipment as included in the TCDS and/or AFM/POH, in combination with equipment required for the flight by the associated implement rules, such as operational requirements, airspace requirements and any other applicable requirements to the intended operation, establishes the list of equipment that must be operative for all flights. Other equipment may be inoperative and this constitutes the MMEL. Design approval applicants for these aircraft are, therefore, not required to establish an MMEL. The applicability of the different OSD constituents is further clarified below in the tables of Appendix 1 to this GM.

Appendix 1 to GM No 1 to 21.A.15(d)

OSD applicability tables

Note 1: These tables illustrate the applicability of OSD to new applications for TC.

Note 2: Unmanned aircraft have not been considered in these applicability tables.

Flight crew data (FCD)

Aircraft categories FCD required?

— Aeroplanes with:  above 5 700 kg maximum take-off YES mass (MTOM); or

 more than 19 passengers; or  a minimum crew of two pilots; or  one turbojet engine; or  two or more turboprop engines; — helicopters except very light rotorcraft (VLR); — tilt rotors; and — gas airships. — Aeroplanes with:  5 700 kg MTOM or less but above Generally: NO 2 000 kg; and In some cases: YES. If based on operational  a minimum crew of one pilot; and experience, data, its handling characteristics,  no turbojet engine; and performance or level of flight deck technology, type  no more than one turboprop engine; 1 rating training is required for its safe operation. and — VLR. — Aeroplanes with:  2 000 kg MTOM or less; and  a minimum crew of one pilot; and  no turbojet engine; and NO  no more than one turboprop engine; — sailplanes, powered sailplanes; — balloons; and — hot-air airships. 1 This is generally the case when the requirements for pilot licensing and air operations do not adequately address training, checking, or currency for safely operating the aircraft, or when the aircraft is not part of a class rating.

Simulator data (SIMD)

Aircraft categories SIMD required? Aircraft for which FCD is required and the minimum syllabus refers to the use of: — a full flight simulator (FFS) for aeroplanes; YES or — an FFS or FTD Level 3 for helicopters.

— Aircraft for which FCD is required but the minimum syllabus does not refer to the use of an FFS or FTD Level 3 for NO helicopters; and — aircraft for which FCD is not required.

Cabin crew data (CCD)

Aircraft categories CCD required? Aircraft with maximum passenger seating YES configuration of more than 19. Aircraft with maximum passenger seating 1 NO configuration of 19 or less. 1 In exceptional cases, YES: cabin crew and, therefore, CCD may be required when it is needed to mitigate non-compliance with airworthiness requirements.

Maintenance certifying staff data (MCSD)

Aircraft categories MCSD required? — Aeroplanes with:  above 5 700 kg MTOM; or  more than 19 passengers; or  a minimum crew of two pilots; or  turbojet; or  two or more turboprops; or  an operating altitude > FL290; or  fly-by-wire (FBW); YES — helicopters with:  above 3 175 kg MTOM; or  more than nine passengers; or  minimum crew of two pilots; or  FBW; or  more than one engine; and — tilt rotors.

— Aeroplanes with:  MTOM of 5 700 kg or less; and  19 passengers or less; and  minimum crew of one 1 pilot; and  one piston engine or one turboprop; and  an operating altitude < FL290; and  no FBW; — helicopters with: NO  MTOM of 3 175 kg or less; and  nine passengers or less; and  minimum crew of one pilot; and  no FBW; and  one engine; — sailplanes, powered sailplanes; — balloons; and — airships 1 In exceptional cases, YES: to be determined by the Agency. This should be understood as the legal basis enabling the Agency to decide on OSD-MCSD applicability to any aircraft that due to some of its novel/unusual/special technical elements, would benefit from an evaluation of MCSD. Whilst the regulation leaves the decision to the Agency, an internal formal process is needed in order to make such a decision following a TC application. It should be expected that this process would be based on the OSD-MCSD expert proposal with the support of cross-expert panels and after Product Certification Manager consultation.

Master minimum equipment list (MMEL)

Aircraft categories MMEL required? — Aeroplanes with:  5 700 kg MTOM or more; or  more than 19 passengers; or  a minimum crew of two pilots; or  turbojet; or  two or more turboprops; YES: CS-MMEL — helicopters with:  3 175 kg MTOM; or  more than 9 passengers; or  a minimum crew of two pilots; or — tilt rotors. — Helicopters with: YES: special condition based on CS-MMEL

 less than 3 175 kg MTOM; and  9 passengers or less; and  a minimum crew of one pilot; and  not being VLR; and — non-ELA2 airships. CS-23 aeroplanes with: — less than 5 700 kg MTOM; and — 19 passengers or less; and YES: CS-GEN-MMEL — a minimum crew of one pilot; and — one piston engine or one turboprop; and — not being ELA1 or ELA2 ELA1 or ELA2 aircraft. NO: concept of ‘required equipment’

8. The following GM to 21.A.15(e) and (f) is inserted:

GM 21.A.15(e) and (f) Period of validity for the application for a type certificate (TC) or restricted type certificate (RTC)

Point 21.A.15(e) establishes a maximum period of validity for an application for a TC or an RTC. During this period, the type-certification basis, operational suitability data (OSD) certification basis, and the environmental protection requirements (hereinafter referred to as the ‘certification basis’), established and notified by EASA in accordance with points 21.B.80, 21.B.82 and 21.B.85, remain effective. However, the period of validity of the certification basis is limited so that the standards notified as part of the certification basis at the time of application do not become outdated. For various reasons (e.g. development, business, commercial, etc.), the applicant may not be able to complete the certification within the established time limit. In this case, the applicant has the following two options (see 21.A.15(f)(1) and (2)): 1. Submit a new application In this case, EASA establishes and notifies a new certification basis in accordance with points 21.B.80, 21.B.82 and 21.B.85, considering the standards that are available at the date of the new application. In accordance with point 21.A.15(e), the new application has a maximum period of validity that is equal to the first one, corresponding to the product category. Beyond this period of validity, the applicant may need to choose again between the two options of either submitting a new application or applying for an extension of the initial application. 2. Apply for an extension of the initial application In this case, the applicant proposes a ‘new target date’ to EASA for the issuance of the certificate, and selects a date that becomes the reference date for the establishment of the certification basis by EASA. For the purposes of this GM, the selected reference date is referred to as the ‘new effectivity date’ of the initial application.

The ‘new effectivity date’ of the initial application may be any date in the past between the following time limits: — the ‘new target date’ for a TC proposed by the applicant minus the time limit used under 21.A.15(e) (e.g. 5 years for large aeroplanes and large rotorcraft, 3 years for the other products); and — the date on which the applicant applies for the extension of the initial application. This calculation is visualised in Figure 1 below:

21.A.15(e) 21.A.15(e) Figure 1 This ensures that the standards used to establish the certification basis are never older than the ones available at the start of the period of validity required by point 21.A.15(e). If the applicant is not able to complete the product certification by the new target date, the applicant may choose again between the two options of either submitting a new application or applying for a new extension of the initial application.

9. GM 21.A.16B is deleted.

10. GM 21.A.17B(a)(1) is deleted.

11. AMC 21.A.20(b) is deleted.

12. Appendix to AMC 21.A.20(b) is deleted.

13. GM 21.A.20(b) is deleted.

14. The following GM 21.A.20 is inserted:

GM 21.A.20 Compliance demonstration process

Point 21.A.20 applies to the compliance demonstration process for a type certificate (TC) (or a restricted type certificate (RTC)) and, by cross references to Part 21 Subpart D and E, to compliance demonstration processes for major changes to a TC (see point 21.A.97(b)(3)) and an STC (see point 21.A.115(b)(4)). Applicants for a TC (or an RTC) should apply point 21.A.20 in full. Applicants for a major change to a TC (or an STC) are required (see points 21.A.97(b)(3) and 21.A.115(b)(4)) to apply point 21.A.20 as applicable to the change. ‘As applicable to the change’ means that: — the certification programme to be followed is the one prepared for the major change or STC in accordance with point 21.A.93, as accepted by EASA; and — the certification basis (consisting of the type-certification basis, operational suitability data (OSD) certification basis, and the environmental protection requirements) is the one established by EASA in accordance with point 21.A.101 and notified to the applicant in accordance with point 21.B.105 (for a major change to a TC) or point 21.B.109 (for an STC). Point 21.A.20 also applies to major changes to a TC or an STC approved by design organisation approval (DOA) holders under their privilege as per point 21.A.263(c)(8) or (9) (see also points 21.A.97(b)(3) and 21.A.115(b)(4)). As in this case there is no application and no EASA involvement, point 21.A.20 should be applied with the following adaptions: — the certification programme to be followed, including the certification basis and the detailed means of compliance, should be almost identical to the one accepted by EASA for a major change or an STC when approved for the scope of the privilege as per point 21.A.263(c)(8) or (9); it may differ in some aspects (e.g. the detailed description of the changes), but it should be shown to remain in the frame of the corresponding justification document; and — the means by which such compliance has been demonstrated (see point 21.A.20(a)) and the final declaration of compliance (see point 21.A.20(e)) should be kept on record and submitted to EASA only if EASA requests them during its DOA continued surveillance process.

15. The following GM 21.A.20(b) is inserted:

GM 21.A.20(b) Reporting on the compliance demonstration process

The applicant should report to EASA any unexpected difficulty or event encountered during the compliance demonstration that invalidates or appreciably affects the assumptions previously made, for example: — an increase in the severity of the consequences of a certain condition (e.g. failure mode) of the product; — significantly reduced margin(s) for the ‘pass–fail’ criteria of the compliance demonstration;

— changes to the test sequences and conditions that are not in line with the certification specifications or guidance; — an unusual interpretation of the results of the compliance demonstration; and — any significant failure or finding resulting from the tests performed as per points 21.A.33 or 21.A.35. The applicant should also evaluate whether the unexpected difficulty or event encountered will impact on the certification programme and, if necessary, amend it as per point 21.A.15(c).

16. AMC 21.A.20(c) is amended as follows:

AMC 21.A.20(c) Compliance documentation

1. Compliance documentation comprises of one or more test or inspection programmes/plans, reports, drawings, design data, specifications, calculations, analyses analysis, etc., and provides a record of the means by which compliance with the applicable type-certification basis, the operational suitability certification basis and environmental protection requirements is demonstrated. 2. Each compliance document should normally contain: - an adequate link with the corresponding certification programme - the reference of the certification specifications, special conditions or environmental protection requirements addressed by the document; - substantiation data demonstrating compliance (except test or inspection programmes/plans); - a statement by the applicant declaring that the document provides the proof of compliance for which it has been created; and - the appropriate authorised signature. 3. Each compliance document should have a be unequivocally identified by its number reference and issue date. The various issues of a document should be controlled and comply with point 21.A.55.

17. GM 21.A.20(d) is amended as follows:

GM 21.A.20(d) Final statement

All compliance demonstrations in accordance with the certification programme, including all the inspections and tests in accordance with point 21.A.33 and all flight tests in accordance with point 21.A.35, should be completed before the issuance of the final statement of compliance required by point 21.A.20(d). If so agreed by the AgencyEASA, some compliance documentation may be produced after the issuance of the final statement of compliance required by 21.A.20(d). ‘No feature or characteristics’ in point 21.A.20(d)2 means the following: while every effort is made to address in the applicable certification basis all the risks to product safety or to the environment that may be caused by the product, experience shows that safety-related events may occur with products in

service, even though compliance with the certification basis is fully demonstrated. One of the reasons may be that some existing risks are not properly addressed in the certification basis. Therefore, the applicant has to declare that they have not identified any such features or characteristics. Point 21.A.20 also applies by reference to minor changes, in which case the risk to product safety or to environmental protection is quite low. Nevertheless, minor changes should not be approved if either the applicant/design organisation approval (DOA) holder approving minor changes under their privileges, or EASA, is aware of a feature or characteristic that may make the product unsafe for the uses for which certification is requested.

18. The following GM 21.A.21(a)(3)(A) is inserted:

GM 21.A.21(a)(3)(A) Clarification of the term ‘determined’

A type certificate ‘determined’ in accordance with Part 21 means a type certificate, or a document that allows the issuance of a certificate of airworthiness, issued before 28 September 2003 by a Member State complying with Article 3(1)(a) of Regulation (EU) No 748/2012.

19. GM No 1 to 21.A.21(f), 21.A.23(b) and 21.A.103(a)(4) is amended as follows:

GM No 1 to 21.A.21(f)(b), 21.A.23(b) and 21.A.103(a)(4) 21.A.95(c), 21.A.97(c), 21.A.115(c), 21.B.103(b), 21.B.107(b) and 21.B.111(b) Approval of operational suitability data (OSD)

It is acknowledged that it may not always be possible to have the operational suitability data OSD available on the date of the issue of the (restricted) type certificate ((R)TC), change approval or supplemental type certificate (STC). The derogation provided by points 21.A.21(fb), 21.A.23(b) and 21.A.103(a)(4)21.A.95(c), 21.A.97(c), 21.A.115(c), 21.B.103(b), 21.B.107(b) and 21.B.111(b) areis intended for that case. The (R)TC, change approval or STC can be issued before compliance with the operational suitability dataOSD certification basis has been demonstrated. However, the OSD have toneeds to be approved before the data must beis used by a training organisation for the purpose of obtaining a European Union (EU) licence, rating or attestation, or by an EU operator. This is normally done uponbefore the entry into service of the first aircraft by an EU operator but it could also be done later for some of the OSD constituents, such as the definition of the scope of validation source data to support the objective qualification of a simulator, which should only be available when a simulator has to be qualified. The derogation provided in points 21.A.103(a)(4)(21.A.97(c), 21.A.115(c), 21.B.103(b), 21.B.107(b), and 21.B.111(b) is applicable to all major changes to a TC, so it is also applicable to minor design changes when triggering a major master minimum equipment list (MMEL) change, and alsoas well as to changes in which where onlyat least one of the OSD constituent changes is major. However, there may be a need to make one or several OSD constituents available before the entry into service. For example, there may be a need to start training activities before all OSD constituents contained in the OSD application can be approved. Making use of the derogation of point 21.A.21(f), 21.A.23(b), or 21.A.103(a)(4), the relevant OSD constituent can be approved under the TC, a change approval or the STC, the use of which can then be limited to specific purposes.

There may, in some specific cases, even be a need to make provisional OSD available before the TC (or STC) is issued. In such cases, before the availability of a complete and fully compliant OSD, the Agency can confirm partial compliance of only one or several provisional OSD constituents.

20. GM 21.A.33 is amended as follows:

GM 21.A.33(d) Inspections and Ttests

The requirements of 21.A.33(a) should not preclude the applicant should inform EASA sufficiently in advance about the execution of inspections and tests that are used for compliance demonstration purposes unless EASA has explicitly excluded these inspections and tests from its involvement according to 21.B.100. Additionally, the applicant requestingmay propose to the AgencyEASA to makeperform or witness flight or other tests of particular aspects of the product during its development and before the type design is fully defined. and a Declaration of Compliance can be issued for all the applicable certification specifications (CS). However in case of flight test, before EASA performs or witnesses any flight test, the applicant should have performed subjectthese tests already before the AgencyEASA tests and should ensure that no features of the product preclude the safe conduct of the evaluation requested. The AgencyEASA may require to repeat any such tests to be repeated once the type design is fully defined to ensure that subsequent changes have not adversely affected the conclusions from any earlier evaluation. A statement of complianceconformity withas per point 21.A.33(b)(c) is also required for the above tests.

21. The following AMC 21.A.33 is inserted:

AMC 21.A.33 Inspections and tests

Use of the term ‘applicant’: point 21.A.33 is applicable to type certification, major changes, major repairs and supplemental type certificates (STCs), and through reference in point 21.A.604 to ETSO for auxiliary power units (APUs). Despite using the word ‘applicant’, it is also applicable to major changes, major repairs and STCs approved under DOA privileges (see point 21.A.263(c)(5), (8) or (9)). Proposed type design: this term defines the type design (or the portion of the type design) as it is determined at the time when the inspection or test is undertaken. Statement of conformity: for each certification inspection or test, the statement of conformity issued in accordance with point 21.A.33(c) must address the conformity of the test specimen (see point 21.A.33(b)(1)) as well as of the test equipment and measuring equipment (see point 21.A.33(b)(2)). Conformity of the test specimen: the statement of conformity required by point 21.A.33(c) is intended to ensure that the manufactured test specimen adequately represents the proposed type design. Possible types of non-conformity may be the following: — Non-conformity between the design of the test specimen and the proposed type design at the time of the test. These are typically identified in the early stage of the test planning, and should be addressed as early as possible (e.g. in the test plan). There may be several reasons for such a non-conformity: to account for interfaces with the test equipment, to conservatively cover several or future design configurations, etc.

— Non-conformity between the manufactured test specimen and the design of the test specimen. Such a non-conformity may be the result of the manufacturing of the test specimen. While it is convenient to define any possible non-conformity in (a) as early as possible, the applicant does not need to make the distinction between the two types of non-conformity above as long as they are explicitly addressed and justified in the statement of conformity or by cross reference to the test plan or other documents. Type certification is typically an iterative process in which the design is under continuous evolution. If the type design evolves after the time of the inspection or test, then the final type design should be checked against the proposed type design (as it was at the time of the inspection or test), and the differences (if any) should be analysed to ensure that the inspection or test results are representative of the final configuration. However, such changes made to the type design may lead to the invalidation of the inspection or test results and a need to repeat the inspection or test. It is recommended that the design organisation should have a thorough configuration management process to track the evolving type design. Conformity of test and measuring equipment: the configuration of the test and measuring equipment should be defined in the test plan and include the following: — definition/design of the test equipment (relevant tools, mechanical parts, electronic components used to execute the test); and — definition of the measuring equipment: — type/model of sensors, together with their technical characteristics; — position and orientation of exciters and sensors; and — electronic measuring equipment (in some cases, this may also include the acquisition and post-processing of data). The configuration of the test and measuring equipment should be defined and controlled through certification test plans and supporting documentation, according to the design assurance system, if applicable. The test plan should also include the following elements: — the test cases, methods, and procedures for test execution; — the pass–fail criteria; and — pre-, during- and post-test inspections. The statement of conformity of point 21.A.33(c) should confirm that the test and measuring equipment conform to its purpose, and that the sensors and measuring system are appropriately calibrated. Any non-conformity should be assessed, and it should be justified that it will not compromise the test purpose and results. This can be done either in the statement of conformity or by cross reference to other documents (test minutes of meetings, test notes, etc.). Use of the term ‘adequate’: the test specimen, as well as the test and measuring equipment, are considered to be ‘adequate’ as long as the test execution on the manufactured test specimen (including any non-conformity) and the use of the installed test set-up does not compromise the test purpose and results (for example, by providing better performance than the proposed type design, or masking any potential failure mode or behaviour).

Changes that affect the validity of the statement of conformity (see point 21.A.33(e)(2)): if changes need to be introduced to the test specimen or to the test and measurement equipment after the statement of conformity is issued (and before the test is undertaken), the statement of conformity must be updated. The updated statement of conformity must be made available to EASA before the test if EASA has informed the applicant that it will witness or carry out the tests. Development versus certification tests: sometimes, tests of specimens that conform to a preliminary design, but are not intended for certification (known as development tests), are performed as part of a risk control strategy and to develop knowledge of a subject. Problems and failures found during development are part of the process of increasing the understanding of the design, including its failure modes and the potential for optimisation. Such development tests do not need to meet the requirements of point 21.A.33. Any planned test event should be classified in advance as either a development test or a certification test. Tests that support the compliance demonstration should be classified as certification tests. Nevertheless, if agreed by EASA, it is acceptable for a development test to finally form part of the compliance demonstration, and it may be declared afterwards to be a certification test as long as it meets the requirements of point 21.A.33. For this reason, it is important to keep the configuration of such tests under the control of the design organisation. In addition to this, the level of involvement (LoI) notified by EASA as per 21.B.100(c) should be taken into account: if EASA has determined that it will witness or conduct a certain test, this test may need to be repeated so that EASA can witness or conduct the test. If the test specimen used for a certification test has already undergone a series of previous tests that may affect or ultimately invalidate its acceptance as required by point 21.A.33(b), this aspect should be considered when issuing the statement of conformity required by point 21.A.33(c), and specific analyses or inspections may be required to support such a statement. Because of the above aspects, EASA advises applicants to inform EASA if they intend to conduct a campaign of development tests that may eventually be used as certification tests. Availability of compliance data (see point 21.A.33(d)(1)): data and information requested from the applicant for review should be made available in a reliable and efficient way that is agreed between the applicant and EASA. Point 21.A.33(d)(1) refers to any data or information related to compliance data; the scope of that requirement is therefore not limited to inspections and tests. In particular, point 21.A.33(d)(1) is not limited to data and information related to compliance demonstration items (CDIs) in which EASA is involved.

22. GM to 21.A.90A is amended as follows:

GM to 21.A.90A Scope

The term ‘changes to the type certificate’ is consistently used in Part 21, Subpart D and E, as well as in the related AMC and GM. This term does not refer to changing the document that reflects the type certificate (TC) but to the elements concept of the TC as defined in 21.A.41. It means that the processes for the approval of changes, as described in the said two Subparts, do not only apply to changes to the type design, but may also apply to changes to:

— the operating limitations; — the type certificate data sheet (TCDS) for airworthiness and emissions; — the applicable type-certification basis and environmental protection requirements with which the Agencyapplicant has to demonstrates compliance; — any other conditions or limitations prescribed for the product in the applicable certification specifications (CSs) and environmental protection requirementsby EASA; — the applicable operational suitability data (OSD) certification basis; — the OSD; and — the TCDS for noise. NOTE: OSD is only applicable to aircraft TCs and not to engine or propeller TCs. Therefore, changes to OSD are only relevant for changes to aircraft TCs.

23. GM 21.A.91 is amended as follows:

GM 21.A.91 Classification of changes to a type certificate (TC)

the change independently. This will facilitate the approval of a major change with no verification by the Agency of the OSD component if the change to OSD is considered minor, or with no verification by the Agency of the design change if the design change is considered minor (see also GM to 21.A.103). 3.3 Classification Pprocess (see also the flow chart ‘Classification process’ in Appendix A to

GM 21.A.91attached diagram)

21.A.91 requires all changes to be classified as either major or minor, using the criteria of 21.A.91. Wherever there is doubt as to the classification of a change, the AgencyEASA should be consulted for clarification. When the strict application of the paragraph 3.4 criteria results in a major classification, the applicant may request reclassificationre-classification, if justified, and the AgencyEASA could take the responsibility infor reclassifyingre-classifying the change. A simple design change planned to be mandated by an airworthiness directive may be reclassifiedre-classified as minor due to the involvement of the AgencyEASA in the continued airworthiness process when this is agreed between the AgencyEASA and the DOA holder. The Rreasons for a classification decision should be recorded. 3.4 Complementary guidance for classification of changes A change to the TC is judged to have an ‘appreciable effect on the mass, balance, structural strength, reliability, operational characteristics, noise, fuel venting, exhaust emission, operational suitability or other characteristics affecting the airworthiness, environmental protection or operational suitability of the product’ and, therefore, should be classified as major, in particular but not only, when one or more of the following conditions are met: […] (e) where the change alters the airworthiness limitations or the operating limitations; (ef) where the change is made mandatory by an airworthiness directive or the change is the terminating action of an airworthiness directive (ref. 21.A.3B), see Note 1; and; (fg) where the change introduces or affects functions where the failure effect is classified as catastrophic or hazardous. Note 1: The A change previously classified as minor and approved prior to the airworthiness directive issuance decision needs no reclassificationre-classification. However, the AgencyEASA retains the right to review the change and reclassifyre-classify/reapprovere-approve it if found necessary. Note 2: The above conditions listed in (a) through (g) above are an explanation of the criteria noted in 21.A.91. For an understanding of how to apply the above conditions, it is useful to take note of the examples given in Appendix A to GM 21.A.91. 3.5 Complementary guidance on the classification of changes to OSD […]

3.6 Complementary guidance for the classification of changes to aircraft flight manuals (AFMs) The following changes to the AFM are deemed to be minor: (a) revisions to the AFM associated with changes to the type design that are classified as minor in accordance with point 21.A.91; (b) revisions to the AFM that are not associated with changes to the type design (also identified as stand-alone revisions) which fall into one of the following categories: (1) changes to limitations or procedures that remain within already certified limits (e.g. weight, structural data, noise, etc.); (2) consolidation of two or more previously approved and compatible AFMs into one, or the compilation of different parts taken from previously approved and compatible AFMs that are directly applicable to the individual aircraft (customisation); and (3) the introduction into a given AFM of compatible and previously approved AFM amendments, revisions, appendices or supplements; and (c) administrative revisions to the AFM, defined as follows: (1) for the AFMs issued by the TC holder: (i) editorial revisions or corrections to the AFM; (ii) changes to parts of the AFM that do not require approval by EASA; (iii) conversions of previously Federal Aviation Administration (FAA)- or EASA-approved combinations of units of measurement added to the AFM in a previously approved manner; (iv) the addition of aircraft serial numbers to an existing AFM where the aircraft configuration, as related to the AFM, is identical to the configuration of aircraft already covered by that AFM; (v) the removal of references to aircraft serial numbers no longer applicable to that AFM; and (vi) the translation of an EASA-approved AFM into the language of the State of design or State of registration; (2) for AFM supplements issued by STC holders: (i) editorial revisions or corrections to the AFM supplement; (ii) changes to parts of the AFM supplement that are not required to be approved by EASA; (iii) conversions of previously FAA- or EASA-approved combinations of units of measurement added to the AFM supplement in a previously approved manner; (iv) the addition of aircraft serial numbers to an existing AFM supplement where the aircraft configuration, as related to the AFM supplement, is identical to that of the aircraft already in that AFM supplement; ‘identical’ means here that all the aircraft have to belong to the same type and model/variant;

(v) the addition of a new STC to an existing AFM supplement, when this supplement is fully applicable to the new STC; (vi) the removal of references to aircraft serial numbers that are no longer applicable to that AFM supplement; (vii) the translation of an EASA-approved AFM supplement into the language of the State of design or the State of registration. 3.7 Complementary guidance for classification of changes to environmental protection characteristics See Section 8 of Appendix A to GM 21.A.91.

24. Appendix A to GM 21.A.91 is amended as follows:

Appendix A to GM 21.A.91: Examples of Mmajor Cchanges per discipline

[…] 8. Environment The introductory text to Appendix A to GM 21.A.91 describes how in Part 21 a negative definition is given of minor changes only. This philosophy is similar to the manner in which the ICAO Standards and Recommended Practices for environmental protection (ICAO Annex 16) and the associated Guidance Material (ICAO Environmental Technical Manual) define changes affecting a product’s environmental characteristics in terms of ‘no-acoustical changes’, and ‘no-emissions changes’ and ‘no-CO2 changes’ (i.e. changes which do not appreciably affect the product’s environmental characteristics). Following the general philosophy of this Appendix, however, it is preferred to give examples of changes which might have an appreciable effect on a product’s environmental characteristics (i.e. the effect might be greater than the no-acoustic change, and no-emissions change and no-CO2 change criteria) and might therefore lead to a ‘major change’ classification. Where a change is made to an aircraft or aircraft engine, the effect of the change on the product’s environmental characteristics should be taken into account. Examples of changes that might have an appreciable effect on the product’s environmental characteristics, and might therefore be classified as a major changes, are listed below. The examples are not exhaustive and will not, in every case, result in an appreciable change to the product’s environmental characteristics, and therefore, will not per se per-se and in every case result in a ‘major change’ classification. An appreciable effect is considered to be one which exceeds the ICAO criteria for a no-acoustical change, or a no-emissions change or a no-CO2 change. For the definition of a no-acoustical change, refer to the section of the ICAO Environmental Technical Manual, Volume I (ICAO Doc 9501, Volume I — Procedures for the Noise Certification of Aircraft) concerning changes to aircraft type designs involving no-acoustical changes (see also the definition of a ‘derived version’ in ICAO Annex 16, Volume I). For the definition of a no-emissions change, refer to the section of the ICAO Environmental Technical Manual, Volume II (ICAO Doc 9501, Volume II — Procedures for the Emissions Certification of Aircraft Engines) concerning no-emissions changes. For the definition of a no-CO2 change, refer to ICAO Doc 9501 ‘Environmental Technical Manual’, Volume III ‘Procedures for the CO2 Emissions Certification of Aeroplanes’, 1st Edition 2018, concerning no-CO2 changes. (i) Noise: A change that introduces either: […] (iii) CO2: a change that introduces either: — an increase in the CO2 emissions certification level; or — a decrease in the CO2 emissions certification level for which an applicant wishes to take credit. Examples of CO2 emission-related changes that may lead to a ‘major change’ classification are:

— a change to the maximum take-off mass; — a change that may affect the aeroplane’s specific air range performance, including one or several of the following: — a change that increases the aircraft’s drag; — a change of engine or, if fitted, propeller type; — a change in the engine design that affects the engine specific fuel consumption in cruise. — a change to the aeroplane’s reference geometric factor (RGF). […]

Classification process

Change to a type certificate (TC)

Goal: classification of changes to a TC as per point 21.A.91

Is there any appreciable effect on: Wherever there is doubt — mass, as to the classification of — balance, a change, EASA should be — structural strength, consulted for — reliability, clarification. — operational characteristics, — environmental characteristics, Yes — operational suitability, or — any other characteristics that affect the airworthiness of the product?

No No Yes Is there any appreciable effect on any of the following?

For design changes (please refer to Section 3.4): For changes to OSD — adjustment of the type-certification basis; constituents, please refer — a new interpretation of the requirements used for to Section 3.4, as the type-certification basis; applicable, and Section — aspects of compliance demonstration that were not 3.5. previously accepted; — there is a considerable extent of new substantiation data as well as a considerable degree of reassessment and re-evaluation; — the airworthiness limitations or the operating limitations are altered; — the change is mandated by an airworthiness directive (AD) or a terminating action of an AD; or — the change introduces or affects a function where the failure condition is catastrophic or hazardous. — See also Appendix A: examples: 1. Structure, 2. Cabin safety, 3. Flight, 4. Systems, See also examples in 5. Propellers, 6. Engines, 7. Rotors and drive systems, Section 3.5. 8. Environment, and 9. Power plant installation.

Yes Any good reason to No EASA decides on Request for classification reclassification reclassify it as ‘minor’?

Minor Major

25. The following AMC 21.A.93(a) is inserted:

AMC 21.A.93(a) Form and manner

The applicant should file an application using the web-based ‘EASA Applicant Portal’ or the application forms for the approval of major changes/major repair designs (FO.CERT.00031) or for the approval of minor changes/minor repair designs (FO.CERT.00032 ), which may be downloaded from the EASA website. The forms should be completed in accordance with the instructions embedded at the bottom of the application forms, and sent to EASA by fax, email or regular mail following the information provided on the EASA website .

26. GM 21.A.93(b) is amended as follows:

GMAMC 21.A.93(b) Major Changes: ApplicationCertification programme for a change to a TC or an STC

The description of the change should include an explanation of the purpose of the change, the pre-modification and post-modification configuration(s) of the product, schematics/pictures, and any other detailed features and boundaries of the physical change (this may be supplemented by drawings or outlines of the design, if this helps to understand the design change), as well as the identification of the changes in areas of the product that are functionally affected by the change, and the identification of any changes to the approved manuals. Guidance on areas that are changed and affected by the change is found in GM 21.A.101, Section 3.9.1. Identification of re-investigations reinvestigations referred to in point 21.A.93(b)(2), necessary to demonstrate compliance, does not mean the demonstrationg of compliance itself, but the list of affected items of the applicable certification basiscertification specifications for which a new demonstration is necessary, together with the means (e.g. calculation, test or analysis) by which it is proposed to demonstrate compliance. Before submitting the application for a change, the analysis and classification activities of points 21.A.91 and 21.A.101 should be performed using the corresponding GM. For repair designs, the analysis of point 21.A.91 should be performed using GM 21.A.435(a). For a major change, AMC 21.A.15(b) should be used as applicable to the change.

27. GM No 1 to 21.A.93(c) is amended as follows:

GM No 1 to 21.A.93(cb)(1)(iii) Interaction of changes to the type design and changes to operational suitability data (OSD)

In general, it has to be assumed that changes to the type design can have an effect on the OSD. Due to the alleviating nature of the OSD constituent master minimum equipment list (MMEL), the impact of design changes on the MMEL can be treated differently from the impact on other OSD constituents. Therefore, a separate GM No 2 to 21.A.93(c) 21.A.93(b)(1)(iii) is available to explain the interaction between design changes and the MMEL. The following guidance is, therefore, only applicable to the other OSD constituents: flight crew data (FCD), cabin crew data (CCD), simulator data (SIMD), and maintenance certifying staff data (MCSD). […] (e) When the design change makes an OSD constituent applicable (see GM No 1 to 21.A.15(d) — Clarification of the term ‘as applicable’the applicability of operational suitability data (OSD) constituents) where it was not applicable before, that OSD constituent should be added to the application for the approval of the change to the TC. In accordance with paragraph (e), this does not apply to the OSD constituents SIMD and MCSD.

28. GM No 2 to 21.A.93(c) is amended as follows:

GM No 2 to 21.A.93(cb)(1)(iii) Interaction of changes to the type design and changes to the master minimum equipment list (MMEL)

In general, it has to be assumed that changes to the type certificate (TC) that affect the type design can have an effect on the MMEL. Due to its alleviating nature, the MMEL is developed to improve aircraft use, thereby providing a more convenient and economical air transportation for the public. Therefore, not introducing an MMEL relief for new equipment, system or function has no effect on the safety of the operation. The introduction of an MMEL relief for new equipment can, therefore, be treated as a stand-alone MMEL change, separately from the design change, and can be processed at a later date than the date of entry into service of the aircraft including the design change. Not modifying an MMEL item whose validity is altered by a type design modification may, however, have an effect on the safety of the operation. The applicant for a change to the TC that changes the type design should, therefore, identify whether if this change needs to be supplemented by a change to the MMEL. However, the update of MMEL relief for an already addressed equipment, system or function can be treated at a later date than the date of entry into service of the aircraft including the design change, provided that the change to the MMEL is of an alleviating nature. When t he change to the MMEL is not of an alleviating nature, it has to be made availableapproved according to point 21.A.103(a)(4)21.A.97(b)(2) and (c). […]

29. The following GM 21.A.93(c) is inserted:

GM 21.A.93(c) Period of validity for the application

For guidance on the determination of the period of validity for the application, refer to GM 21.A.15(e) and (f).

30. The following AMC 21.A.95 is inserted:

AMC 21.A.95 Requirements for the approval of a minor change

(a) Applicability of point 21.A.95 Point 21.A.95 has to be complied with by applicants for the approval of a minor change to a type certificate (TC), and by design organisation approval (DOA) holders that approve minor changes under their own privileges. Point 21.A.95(e), however, only applies to projects for which an application is submitted to EASA. For DOA holders that approve minor changes under their privileges, the substantiating data and the statement of compliance required by point 21.A.95(e) should be produced but do not need to be submitted to EASA. They should be, however, kept on record and submitted to EASA on request during its DOA continued surveillance process. (b) The approval process The approval process comprises the following steps: Note: Steps 1, 2 and 5 should be followed only by applicants for minor changes approved by EASA. DOA holders that approve minor changes under their privileges should refer to AMC No 1 to 21.A.263(c)(2) or AMC No 2 to 21.A.263(c)(2), as applicable to their approval process. (1) Application When the minor change is approved by EASA, an application should be submitted to EASA as described in point 21.A.93(a) and (b) and in AMC 21.A.93(a). (2) Certification programme The certification programme should consist of the information defined in points 21.A.93(b)(1) and 21.A.93 (b)(2). Please refer to AMC 21.A.93(b) for further information. (3) Certification basis (4) Demonstration of compliance (5) Statement of compliance (c) Certification basis The certification basis for a minor change consists of a subset of the elements of the product’s certification basis ‘incorporated by reference in the type certificate’ (see also the additional guidance below on the meaning of certification specifications that became applicable after those ‘incorporated by reference in the type certificate’), which have been identified in accordance with point 21.A.93(b)(2) due to a reinvestigation of compliance being necessary because compliance

was affected by the minor change (see also additional guidance below on the meaning of ‘specific configurations’). The certification basis ‘incorporated by reference in the type certificate’ is the certification basis for the product as recorded in the type certificate data sheet (TCDS) for the product type/model in the configuration(s) identified in accordance with point 21.A.93(b)(1)(i). The certification basis contains the applicable airworthiness and (for aircraft only) operational suitability data certification specifications (CS-OSD), environmental protection requirements specified by reference to their amendment level, as complemented by special conditions, equivalent safety findings, deviations, an ‘elect to comply’, etc., as applicable. See also the additional guidance below on the meaning of ‘Minor changes affecting OSD constituents’. By derogation from the above, CSs that became applicable after those incorporated by reference in the TC may be used for the approval of a minor change (see the guidance below on certification specifications that became applicable after those ‘incorporated by reference in the type certificate’). If other changes are required for the embodiment of the minor change, the certification basis corresponding to the product modified by these other changes should also be considered when determining the certification basis for the minor change. (d) Demonstration of compliance required by point 21.A.95(b)(1) and (2) The applicant needs to demonstrate compliance with the certification basis established for the minor change for all areas that are either physically changed or functionally affected by the minor change. (1) Means of compliance: the applicant should define and record the means (calculation, test or analysis, etc.) by which compliance is demonstrated. Appendix A to AMC 21.A.15(b) may be used to describe how compliance is demonstrated. (2) Compliance documents: the compliance demonstration should be recorded in compliance documents. For minor changes, one comprehensive compliance document may be sufficient, provided that it contains evidence of all aspects of the compliance demonstration. AMC 21.A.20(c) can also be used, where applicable. See also the additional guidance in item (e). (3) Aircraft manuals: where applicable, supplements to manuals (e.g. aircraft flight manual (AFM), aircraft maintenance manual (AMM), etc.) may be issued. See also additional guidance below on embodiment/installation instructions (item (f)). (e) Definition of the change to the type certificate The change to the type certificate should be defined in accordance with GM 21.A.90A. (f) Embodiment/installation instructions The instructions for the embodiment/installation of the change (e.g. service bulletin, modification bulletin, production work order, etc.) should be defined. This may include the installation procedure, the required material, etc. (g) Minor changes affecting OSD constituents (i.e. master minimum equipment list (MMEL))

Some minor changes to the type design may only have an effect on the MMEL (see GM No 1 to 21.A.93(b)(1)(iii)). In such cases, GM No 2 to 21.A.93(b)(1)(iii) is also applicable. This also means that a dedicated assessment of the effects of the minor type design change on the other OSD constituents is not needed. (h) Meaning of ‘specific configurations’ in point 21.A.95(f) These ‘specific configurations’ are defined as the combination of the product type/model (on which the minor change will be installed) with (if applicable) the list of those already approved changes (minor, major, supplemental type certificate (STC)) that are required for the installation of the minor change. (i) Certification specifications that became applicable after those incorporated by reference in the type certificate (1) Minor changes are those changes that do not affect the airworthiness of the product and thus are, by definition, non-significant as per point 21.A.101. This means that the certification basis for the minor change may consist of the items of the certification basis incorporated by reference in the TCDS of the product type/model, and normally it should not be necessary for a minor change to use certification specifications that became applicable after those that are incorporated by reference in the type certificate. (2) On the other hand, the applicant may elect to use later amendments of the affected certification specifications for the compliance demonstration. This does not affect the classification of the change; however, the applicant should also comply with any other certification specifications that EASA considers to be directly related. (3) If other changes are required for the installation of the minor change (as explained in ‘specific configurations’), the certification basis for the minor change should also take into account the corresponding certification basis. (j) Meaning of ‘no feature or characteristics’ in point 21.A.95(b)(4) See GM 21.A.20(d).

31. The following GM 21.A.95(b) is inserted:

GM 21.A.95(b) Requirements for the approval of a minor change

The level of detail of the documents that are referred to in 21.A.93(b) should be the same regardless of whether the change is approved by EASA or under a design organisation approval (DOA) privilege, to allow the change to be assessed in the frame of the DOA surveillance.

32. AMC 21.A.97 is amended as follows:

AMC 21.A.97 Compliance demonstration process for major changes Requirements for the approval of a major change

1. AMC/GM to 21.A.20 should be used for a major change. 2. For major changes not requiring long and complex compliance demonstration activities, a certification programme, as described in AMC 21.A.20(b), can be submitted with the application

in a simplified format. The certification programme should contain at least the following elements: - Purpose of change - Description of change - Applicability - Applicable certification specifications, special conditions, equivalent safety findings and environmental protection requirements - The description on how compliance will be demonstrated, with selected means of compliance (see Appendix to AMC 21.A.20(b) for the codes to be used) and reference to compliance documents - If relevant, the delivery schedule of compliance documents. 1. For major changes approved by EASA, the applicant should use all the AMC 21.A.20(c), as well as the GM to 21.A.20. 2. For the application of point 21.A.97(c), see GM 21.A.21(b), 21.A.95(c), 21.A.97(c), 21.A.115(c), 21.B.103(b), 21.B.107(b) and 21.B.111(b). 3. In accordance with point 21.A.97(c), the compliance demonstration process always takes into account the specific configuration(s) in the type certificate (TC) to which the major change under approval is applied. These configurations may be defined by type models/variants or by design changes to the type design. The demonstration of compliance covers these applicable specific configurations. Consequently, the approval of the major change excludes any other configurations, in particular those that already exist but are not considered in the compliance demonstration process, as well as those that may be certified in future. 4. For major changes approved by the design organisation approval (DOA) holder on the basis of their privilege as per point 21.A.263(c)(8), the process described under AMC No 2 to 21.A.263(c)(5), (8) and (9) applies.

33. The following GM 21.A.97(b) is inserted:

GM 21.A.97(b) Requirements for the approval of a major change

The level of detail of the documents that are referred to in 21.A.93(b) should be the same regardless of whether the change is approved by EASA or under a design organisation approval (DOA) privilege, to allow the change to be assessed in the frame of the DOA surveillance.

34. GM 21.A.101 is amended as follows:

GM 21.A.101 Establishing the certification basis of changed aeronautical products

Foreword

This guidance material (GM) provides guidance for the application of the ‘Changed Product Rule (CPR)’, pursuant to point 21.A.101, Designation of the applicable certification specifications and environmental

protection requirements, and 21.A.19, Changes requiring a new type certificate, for changes made to type-certified aeronautical products.

1. INTRODUCTION

1.1 Purpose.

This GM provides guidance for establishing the certification basis for changed aeronautical products pursuant to point 21.A.101, Designation of the applicable certification specifications and environmental protection requirements. The guidance is also intended to help an applicants and approved design organisations to determine whether it will be necessary to apply for a new type certificate (TC) under point 21.A.19, Changes requiring a new type certificate. The guidance describes the process for establishing the certification basis for a change to a TC, for a supplemental type certificate (STC), or for a change to an STC, detailing the requirements (evaluations, classifications, and decisions) throughout

the process.

1.2 Applicability.

1.2.1 This GM is for an applicant applying that applies for changes to TCs under Subpart D, for STCs, or changes to STCs under Subpart E, or for changes to European Technical Standard Order Authorisations (ETSOAs) for auxiliary power units (APUs) under Subpart O. This GM is also for approved design organisations that classifying changes and approve approving minor changes under their 21.A.263(c)(1) and (2) privileges. 1.2.2 This GM applies to major changes under point 21.A.101 for aeronautical products certified under Part 21, and the certification specifications (CSs) applicable to the changed product (CS-23, CS-25, CS-27, CS-29, CS-MMEL, CS-FCD, CS-CCD, etc.). References to ‘change’ include the change and areas affected by the change pursuant to point 21.A.101. 1.2.3 Minor changes are within the scope of 21.A.101 and this GM but are automatically considered to not be significant under the ‘does not contribute materially to the level of safety’ provision of point 21.A.101(b). 1.2.4 This GM also applies to changes to restricted type certificates. 1.2.5 The term ‘aeronautical product’, or ‘product’, means a type-certified aircraft, aircraft engine, or propeller and, for the purpose of this GM, an ETSOA’d APU. 1.2.6 This GM primarily provides guidance for the designation of applicable airworthiness certification specifications and other airworthiness standards for the type-certification basis for the changed product. However, portions of this GM, as specified in GM No 1 to 21.A.101(g), can be applied by analogy to establish the operational suitability data (OSD) certification basis for the changed product. This GM is not intended to be used to determine the applicable environmental protection requirements (aircraft noise, fuel venting, and engine exhaust emissions and aeroplane CO2 emissions requirements) for changed products, as they are designated through point 21.B.85. 1.2.7 This GM is not mandatory and is not an EU regulation. This GM describes an acceptable means, but not the only means, to comply with point 21.A.101. However, an applicant who uses the means described in this GM must follow it entirely.

1.3 Reserved.

1.4 GM Content

This GM contains 5 chapters and 10 appendices. 1.4.1 This chapter clarifies the purpose of this GM, describes its content, specifies the intended audience affected by this GM, clarifies which changes are within the scope of this GM, and references the definitions and terminology used in this GM. 1.4.2 Chapter 2 provides a general overview of points 21.A.101 and 21.A.19, clarifies the main principles and safety objectives, and directs an applicant to the applicable guidance contained in subsequent chapters of this GM. 1.4.3 Chapter 3 contains guidance for the implementation of point 21.A.101(b) to establish the certification basis for changed aeronautical products. It describes in detail the various steps for developing the certification basis, which is a process that applies to all changes to aeronautical products. Chapter 3 also addresses the point 21.A.19 considerations for identifying the conditions under which an applicant for a change is required to submit an application for a new TC, and it provides guidance regarding the stage of the process at which this assessment is performed.

1.4.4 Chapter 4 provides guidance about products excepted from the requirement of point 21.A.101(a). 1.4.5 Chapter 5 contains considerations for: — Ddesign-related operating requirements, — Ddefining a baseline product, — Ppredecessor standards, — Uusing special conditions under point 21.A.101(d), — The effective period of application for a change to a TC under point 21.A.101(e), — Ddocumenting revisions to the TC basis, — Iincorporating STCs into the type design, — Rremoving changes, — Ddetermining a certification basis after removing an approved change, and — Ssequential changes. 1.4.6 Appendix A contains examples of typical type design changes for small aeroplanes, large aeroplanes, rotorcraft, engines, and propellers. The European Union Aviation Safety Agency (EASA) has categorised these examples into individual tables according to the classifications of design changes: ‘substantial’, ‘significant’, and ‘not significant’.’ 1.4.7 Appendix B contains application charts for applying the point 21.A.101 process, including the excepted process. 1.4.8 Appendix C contains one method for determining the changed and affected areas of a product. 1.4.9 Appendix D contains additional guidance on affected areas that is not discussed in other parts of this GM. 1.4.10 Appendix E provides detailed guidance with examples for evaluating the ‘impracticality’ exception in the rule. 1.4.11 Appendix F provides guidance with examples on the use of relevant service experience in the certification process as one way to demonstrate that a later amendment may not contribute materially to the level of safety, allowing the use of earlier certification specifications. 1.4.12 Appendix G provides an example CPR decision record. 1.4.13 Appendix H provides examples of documenting a proposed certification basis list. 1.4.14 Appendix I lists the Part 21 points related to this GM. 1.4.15 Appendix J lists the definitions and terminology applicable for the application of the rule.

1.5 Terms Used in this GM.

1.5.1 The following terms are used interchangeably and have the same meaning: ‘specifications’, ‘standards’, ‘certification specifications’ and ‘certification standards’. They refer to the elements of the type-certification basis for airworthiness or OSD certification basis. 1.5.2 The term ‘certification basis’ refers to the type-certification basis for airworthiness provided for in point 21.A.17A 21.B.80 and the operational suitability data (OSD) certification basis provided for in point 21.A.17B 21.B.82. For more terms, consult Appendix J.

2. OVERVIEW OF POINTS 21.A.19 AND 21.A.101 2.1. Point 21.A.19.

2.1.1 Point 21.A.19 requires an applicant to apply for a new TC for a changed product if EASA finds that the change to the design, power, thrust, or weight is so extensive that a substantially complete investigation of compliance with the applicable type-certification basis is required. 2.1.2 Changes that require a substantial re-evaluation of the product’s compliance findings of the product are referred to as ‘substantial changes’.’ For guidance, see paragraph 3.3 in Chapter 3 of this GM. Appendix A of this GM provides examples of changes that will require a new TC. 2.1.3 If EASA determines through point 21.A.19 that a proposed change does not require a new TC, see point 21.A.101 for the applicable requirements to develop the certification basis for the proposed change. For guidance, see Chapter 3 and the examples in Appendix A of this GM.

2.2. Point 21.A.101.

2.2.1 Point 21.A.101(a). Point 21.A.101(a) requires a change to a TC, and the areas affected by the change to comply with the certification specifications that are applicable to the changed product and that are in effect aton the date of application for the change (i.e. the latest certification standards in effect at the time of application), unless the change meets the criteria for the exceptions identified in point 21.A.101(b) or (c), or unless an applicant chooses to comply with the certification specifications of later effective amendments* in accordance with point 21.A.101(f). The intent of point 21.A.101 is to enhance safety by incorporating the latest requirements into the certification basis for the changed product to the greatest extent practicable.

* NOTE: Certification specifications that were amended after the date of application and during the time

period of the certification of the change.

2.2.2 Point 21.A.101(b). Point 21.A.101(b) pertains to when an applicant may show that a changed product complies with an earlier amendment of a certification specification, provided that the earlier amendment is considered to be adequate and meets the criteria in point 21.A.101(b)(1), (2), or (3). When changes involve features or characteristics that are novel and unusual in comparison with as compared to the airworthiness standard at the proposed amendment, more recent airworthiness standards and/or special conditions will be applied for these features. An applicant is considered to comply with the earlier amendment of the certification specifications consistent with point 21.A.101(b), when: (a) a change is not significant (see point 21.A.101(b)(1)); (b) an area, system, part or appliance is not affected by the change (see point 21.A.101(b)(2)); (c) compliance with a later amendment for a significant change does not contribute materially to the level of safety (see point 21.A.101(b)(3)); or (d) compliance with the latest amendment would be impractical (see point 21.A.101(b)(3)). Earlier amendments may not precede the amendment level of the certification basis of the identified baseline product’s certification basis. Points 21.A.101(b)(1)(i) and (ii) pertain to changes that meet the automatic criteria where the change is significant.

2.2.3 Point 21.A.101(c). Point 21.A.101(c) provides an exception from the requirements of point 21.A.101(a) for a change to certain aircraft with less than the specified maximum weight. An applicant who applies for a change to an aircraft (other than rotorcraft) of 2 722 kg (6 000 lb) or less maximum weight, or to a non-turbine-powered rotorcraft of 1 361 kg (3 000 lb) or less maximum weight, can show that the changed product complies with the standards incorporated by reference in the type certificate. An applicant can also elect to comply or may be required to comply with the later standards. See paragraph 4.1 of this GM for specific guidance on this provision.

2.2.4 Point 21.A.101(d). Point 21.A.101(d) provides for the use of special conditions, under 21.A.16B21.B.75, when the proposed certification basis and any later certification specifications do not provide adequate standards to for the proposed change because of a novel or unusual design feature.

2.2.5 Point 21.A.101(e). Point 21.A.101(e) prescribes the effective period that an application will remain valid for a change. provides the legal basis under which an applicant may propose to certify a change and the areas affected by the change against alternative requirements to the certification specifications established by EASA.

2.2.6 Point 21.A.101(f). Point 21.A.101(f) requires that if an applicant chooses (elects) to comply with a certification specification of or an amendment to the certification specifications that is effective after the filing of the application for a change to a TC, the applicant shall also comply with any other certification specifications that EASA finds is are directly related. The certification specifications which are directly related must be, for the purpose of compliance demonstration, considered together at the same amendment level to be consistent.

2.2.7 Point 21.A.101(g). Point 21.A.101(g) pertains to the designation of the applicable OSD certification basis when the application for a change to a type certificate for an aircraft includes, or is supplemented after the initial application to include, changes to the OSD. It implies that the same requirements of paragraphs (a), (b), (c), (d) and (f) that are applicable to the establishment of the airworthiness type-certification basis also apply to the establishment of the OSD certification basis. For specific guidance, see GM No 1 to 21.A.101(g).

[…]

3.3.3 If it is not initially clear that a new TC is required, Appendix A of this GM provides some examples of substantial changes to aid in this classification. A substantial change requires an application for a new TC. See points 21.B.80, 21.B.82, 21.B.85 21.A.17 and 21.A.19. If the change is not substantial, proceed to step 3. […]

3.7.2.2 In a case where the change has not been approved, or it is clear that it will not be approved under the time limit established, the applicant will be required to comply with an upgraded certification basis established according to points 21.A.101(e)(1) or (2) 21.B.80, 21.B.82 and 21.B.85 from the certification specifications that have become effective after since the date of the original initial application. […]

3.11.1 For a change that contains new design features that are novel and unusual for which there are no later applicable certification specifications at a later amendment level, EASA will designate special conditions pursuant to point 21.B.7521.A.16B. EASA will impose later certification specifications that contain adequate or appropriate safety standards for this feature, if they exist, in lieu of special conditions. An example is adding a flight-critical system, such as an electronic air data display on a CS-25 large aeroplane whose existing certification basis does not cover protection against lightning and high-intensity radiated fields (HIRF). In this case, EASA will require compliance with the certification specifications for lightning and HIRF protection, even though EASA determined that the change is not significant. 3.11.2 For new design features or characteristics that may pose a potential unsafe condition for which there are no later applicable certification specifications, new special conditions may be required to address points 21.A.21(c)(3). 21.B.107(a)(3) or 21.B.111(a)(3). […]

5.6. Effective Period for an Application to Change a Type Certificate, point 21.A.101(e). Reserved.

According to point 21.A.101(e), an application for a change to a TC for large aeroplanes and large rotorcraft is effective for 5 years from the date of application, and an application for a change to any other TC is effective for 3 years. EASA intended this to ensure that the certification basis for the changed product is as current as practicable. 5.6.1 If EASA has not approved a change, or if it is clear that EASA will not approve the change, within the time limit, the applicant may do either of the following: (1) file for a new application, or (2) file for an extension to the original application.

5.6.2 When filing for an extension, the applicant must choose a completion date, then apply the applicable effectivity from point 21.A.101(e) to determine an effective application date. The effective application date must not precede the new completion date for the proposed change by more than the time limit provided for in point 21.A.101(e) for the original application. 5.6.3 If an applicant requests an extension to the application date, and the product change is significant, a new certification basis is required. The new certification basis requires the additional latest certification specifications that became effective through the new effective date of application. However, the applicant may use earlier certification specifications by documenting their justification that the latest certification specifications for the change would not contribute materially to the level of safety or would be impractical. 5.6.4 If the product change is not significant, the applicant may continue to use the existing certification basis for product certification. However, if the applicant makes additional changes to the product, and EASA finds the existing certification basis for the change inadequate, the new certification basis will require the later appropriate standards. […]

E.3.1 Example 1: FAR § 25.963, Fuel Tank Access Covers. NOTE: This example is taken from the FAA’s certification experience, so references to FAR sections and amendments are kept. This example is part of a significant change to a transport aeroplane that increases the passenger payload and gross weight by extending the fuselage by 20 feet (6.1 metres). To accommodate the higher design weights and increased braking requirements and to reduce the runway loading, the applicant will change the landing gear from a two-wheel to four-wheel configuration; this changes the debris scatter on the wing from the landing gear. EASA will require the new model of the aeroplane to comply with the latest applicable certification specifications based on the date of application. The wing will be strengthened locally at the side of the body and at the attachment points of the engines and the landing gear, but the applicant would not like to alter the wing access panels and the fuel tank access covers. Although the applicant recognises that the scatter pattern and impact loading on the wing from debris thrown from the landing gear will change, the applicant proposes that it would be impractical to redesign the fuel tank access covers.

Note: Points 21.A.21(c)(3) 21.B.107(a)(3) or 21.B.111(a)(3) may be an additional reason why EASA would

require compliance with CS 25.963(e), regardless of the ‘significant’ determination. […]

E.3.1.7 Step 7: Document the conclusion.

It is concluded that compliance with the latest certification specification increases the level of safety at a minimal cost to the applicant. Based on the arguments and information presented by the applicant through the certification review item (CRI) process, EASA determined that meeting the latest amendment would be practical. EASA has also found that fuel tank access covers that are not impact resistant and fire resistant, and which are located where a strike is likely, are is an unsafe features or characteristics which precludes the issue of a type certificate under 21.21(c)(3)21.B.107(a)(3). […]

E.3.2.1 Step 1: Identify the regulatory change being evaluated.

The existing certification basis of the aeroplane that is being changed includes § 25.365 at Amendment 25-00. The initial release of § 25.365 required that the interior structure of passenger compartments to be designed to withstand the effects of a sudden release of pressure through an opening resulting from the failure or penetration of an external door, window, or windshield panel, or from structural fatigue or penetration of the fuselage, unless shown to be extremely remote. Amendment 25-54 revised § 25.365 to require that the interior structure to be designed for an opening resulting from penetration by a portion of an engine, an opening in any compartment of a size defined

by § 25.365(e)(2), or the maximum opening caused by a failure that was not shown to be extremely improbable. The most significant change is the ‘formula hole size’ requirement introduced into § 25.365(e)(2) at Amendment 25-54. Amendment 25-71/72 (Amendments 25-71 and 25-72 are identical) extended the regulation to all pressurised compartments, not just passenger compartments, and to the pressurisation of unpressurised areas. Pressurisation of unpressurised areas had previously been identified as an unsafe feature under § 21.21(b)(2) 21.B.111(a)(3). […]

APPENDIX I. RELATED DOCUMENTS I.1 Related Part 21 requirements.

— 21.A.15, Application — 21.A.16A,21.B.70, Certification specifications — 21.A.16B,21.B.75, Special conditions — 21.A.17A,21.B.80, Type-certification basis for a type-certificate or restricted type-certificate — 21.A.17B,21.B.82, Operational suitability data certification basis for an aircraft type certificate or restricted type-certificate — 21.A.19, Changes requiring a new type certificate — 21.A.21,21.B.103, Issue Issuance of a type-certificate or restricted type-certificate — 21.A.23, Issue of restricted type certificate — 21.A.31, Type design — 21.A.41, Type certificate — 21.A.91, Classification of changes to a type certificate — 21.A.93, Application — 21.A.97, Requirements for approval of a major change — 21.A.101, Designation of applicable certification specifications and environmental protection requirements Type-certification basis, operational suitability data certification basis and environmental protection requirements for a major change to a type-certificate — 21.A.103, 21.B.107, Issue Issuance of an approval of a change to a type-certificate — 21.A.113, Application for a supplemental type-certificate — 21.A.115, Requirements for approval of major changes in the form of a supplemental type-

certificate

— 21.A.115, 21.B.111, Issue Issuance of a supplemental type-certificate […]

J.4 Certification basis. The applicable airworthiness and OSD certification specifications as provided for in points 21.A.17A and 21.A.17B and established for the change according to point 21.A.101, as appropriate, special conditions, equivalent level of safety findings, elects to comply, and deviations applicable to the product to be certified. The combination of the: — airworthiness certification specifications as provided for in point 21.B.80; — OSD certification specifications as provided for in point 21.B.82; and — environmental protection requirements, as provided for in point 21.B.85, and as established for the change according to point 21.A.101, as well as the: — special conditions; — equivalent safety findings; — elects to comply; and

— deviations, applicable to the product to be certified. J.5 Change. The term ‘change’ refers to a change to a product type certificate (as defined in point 21.A.41) approved or to be approved under Subpart D or Subpart E (as a supplemental type certificate) of Part 21, including a change to an STC or a change to the ETSOA for auxiliary power units (APUs) under Subpart O. A change may consist of a single stand-alone change to one TC component or several interrelated changes to different TC components (e.g. the type design, operating characteristics, OSD, environmental protection characteristics, etc. (see point 21.A.41 and GM to 21.A.90A)). […]

35. GM No 1 to 21.A.101(g) is amended as follows:

GM No 1 to 21.A.101(g) Establishment of the operational suitability data (OSD) certification basis of changedfor changes to type certificates (TCs)

This GM provides guidance on the application of point 21.A.101(g) in order to determine the applicable OSD certification basis in accordance with points 21.A.101(a), (b), (c), (d), (e) and (f) for major changes to the OSD of type-certified aircraft. 1. Minor changes Minor changes to the OSD are automatically considered not significant under 21.A.101(b)outside the scope of point 21.A.101. See GM 21.A.95 for their certification basis. 2. Major changes a. If the design change that triggered the change to the OSD constituent is classified as nonsignificant, the change to the OSD constituent is also non-significant. b. If the design change that triggered the change to the OSD constituent is classified as significant, the change to the OSD constituent should comply with the latest amendment of the applicable CSs, unless the exceptions of point 21.A.101(b)(3) apply or unless the OSD change can be classified as minor as per point 21.A.91. The guidance of GM 21.A.101 chapter 3, paragraph 10 Section 3.10, regarding the exceptions ‘impractical’ and ‘not contributing materially to the level of safety’ can be applied by analogy and as far as applicable to OSD changes. c. Stand-alone changes to an OSD constituent are considered to be non-significant. d. When a new OSD constituent is added or required to be added, it should comply with the latest amendment of the applicable certification specification (CSs). e. In accordance with Article 7a(3) of Regulation (EU) No 69/2014, the Operational Evaluation Board (OEB) reports and Master Minimum Equipment Lists (MMEL) issued in accordance with the JAA procedures or by the Agency before the entry into force of Regulation (EU) No 748/2012, are deemed to constitute the OSD approved in accordance with 21.A.21(e). The original procedures, guidance material (GM), advisory circular joint (ACJ) and/or acceptable means of compliance (AMC), advisory material joint (AMJ) material, that were

used to establish the original documents (JAA/Agency MMEL or OEB report), are deemed to be the original certification basis for these documents. Reserved. f. Reserved. g. Point 21.A.101(c) provides an exception from the requirements of point 21.A.101(a) for a change to the OSD of certain aircraft under below a specified maximum weight. If an applicant applies for a change to the OSD for an aircraft (other than rotorcraft) of 2 722 kg (6 000 lb) or less maximum weight, or for a non-turbine-powered rotorcraft of 1 361 kg (3 000 lb) or less maximum weight, the applicant can demonstrate that the changed OSD complies with the OSD certification basis incorporated by reference in the TC. The applicant can also elect to comply, or may be required to comply, with a later amendment. See also Chapter 4, Section 24.1 (GM No. 1 to 21.A.101) for specific guidance on this provision. Note: Refer to GM No 1 to 21.A.15(d) for the applicability of the OSD to aircraft other-than-complex motor-powered aeroplanesaircraft.

36. GM No 1 to 21.A.103, 21.A.115 and 21.B.70 is amended as follows:

GM No 1 to 21.A.103, 21.A.115 and 21.B.70 21.B.107 and 21.B.111 Operational suitability data (OSD) considerations for the Aapproval of changes to type certificates (TCs) or supplemental type certificates (STCs)

The Rrequirement for the AgencyEASA in 21.B.70points 21.B.107(c) or 21.B.111(c) are applicable to necessary changes to the OSD as foreseen by 21.A.95(b) Section 2 for minor changes, 21.A.97(b) Section 2 for major changes, and 21.A.115(b) Section 3 for STCs. By analogy, these requirements should also be considered by design organisation approval (DOA) holders that approve changes or issue supplemental type certificates (STCs) under their privileges (without EASA’s involvement), as stated in the GM to A.21.A.90A. mainly addresse stand-alone changes to OSD. For such stand-alone changes, there is a separate classification process (see GM 21.A.91), and the way to administer the changes depends on the extent of the change, but normally, an update of the TCDS is not required. However, the requirement can also be applied to combinations of design changes and OSD changes. Changes to TCs can comprise several interrelated changes to different components of the TC. For example, a change to the cockpit design may trigger a necessary change to the flight crew data, being which is part of the OSD, and is, therefore, included in the TC. All interrelatedInterrelated changes (e.g. type design changes and necessary changes to the MMEL and/or flight crew data) should ultimately be approved together under a single approval. However, before issuing such a comprehensive approval, it is possible that different processes are used for the different parts of the change. The complete change can be split up in a change to the type design and changes to the OSD constituents. Each part of the change can be classified as minor or major separately (see GM 21.A.91). — In case all parts of the change are classified as minor, the design organisation approval (DOA) holder can approve the whole change.

— In case one or more parts of the change is/are classified as major, while the associated part(s) of the change is/are classified as minor, the approved design organisation can propose to the Agency not to verify the classification and the part(s) of the change classified as minor in accordance with its privilege under 21.A.263(b)2 or (3). The Agency should then accept the part(s) of the change classified as minor without further verification. Once it is satisfied that compliance has been demonstrated for the part(s) of the change classified as major, EASA can then issue the complete change approval or supplemental type certificate (STC). — In case all parts of the change are classified as major, the Agency will issue the approval for the whole change once it is satisfied that compliance has been demonstrated.

37. The following AMC 21.A.113(a) is inserted:

AMC 21.A.113(a) Form and manner

The applicant should file an application using the web-based ‘EASA Applicant Portal’ or the application form for a supplemental type certificate (STC) (FO.CERT.00033) , which may be downloaded from the EASA website. If the form is filled in offline, it should be completed in accordance with the instructions embedded at the bottom of the application form, and sent to EASA by fax, email or regular mail following the information provided on the EASA website .

38. AMC 21.A.114 is deleted.

39. The following AMC 21.A.115 is inserted:

AMC 21.A.115 Requirements for the approval of major changes in the form of a supplemental type certificate (STC)

(a) For STCs approved by EASA, the AMC and GM to point 21.A.20 should be followed by the applicant. (b) For an application under point 21.A.115(c), see GM 21.A.21(b), 21.A.95(c), 21.A.97(c), 21.A.115(c), 21.B.103(b), 21.B.107(b) and 21.B.111(b). (c) In accordance with point 21.A.115(d), the compliance demonstration process must always cover the specific configuration(s) in the type certificate (TC) to which the STC under approval is applied. These configurations should be defined by the change to the type certificate considering the type certificate data sheet (TCDS) and the relevant optional installations. The demonstration of compliance should cover these specific applicable configurations. Consequently, the approval of the STC excludes any other configurations, in particular those that already existed, but were not considered in the compliance demonstration process, and those that may be certified in future. (d) For STCs approved by the design organisation approval (DOA) holder under their privilege as per point 21.A.263(c)(9), the process described under AMC No 2 to 21.A.263(c)(5), (8) and (9) applies.

40. GM No. 2 to 21.A.121 is amended as follows:

GM No. 2 to 21.A.121 Applicability — Applicable design data

Applicable design data is defined as all the necessary drawings, specifications and other technical information provided by the applicant for, or holder of a design organisation approval, TC, STC, approval of repair or minor change design, or ETSO authorisation (or equivalent when Part 21 Section A Subpart F is used for production of products, parts or appliances, the design of which has been approved other than according to Part 21), and released in a controlled manner to the manufacturer that producesing under Part 21 Subpart F. This should be sufficient for the development of production data to enable manufacture in conformity with the design data. Prior to the issue of the TC, STC, approval of repair or minor change design or ETSO authorisation, or equivalent, design data is defined as ‘not approved’, but parts and appliances may be released with an EASA Form 1 as a certificate of conformity. After the issue of the TC, STC, approval of repair or minor change or ETSO authorisation, or equivalent, this design data is defined as ‘approved’ and items manufactured in conformity are eligible for release on an EASA Form 1 for airworthiness purposes. For the purpose of Subpart F of Part 21, the term ‘applicable design data’ includes, in the case of engines and when applicable, the information related to the applicable engine exhaust emissions and aeroplane CO2 emissions production cut-off requirements. […]

41. AMC No. 1 to 21.A.130(b) is amended as follows:

AMC No. 1 to 21.A.130(b) Statement of conformity for complete aircraft

[…] 3 COMPLETION OF THE AIRCRAFT STATEMENT OF CONFORMITY BY THE ORIGINATOR […] Block 1 […] Block 14 Remarks: Any statement, information, particular data or limitation which may affect the airworthiness of the aircraft. If there is no such information or data, state;: ‘NONE’. If the competent authority has endorsed a CO2 emissions production cut-off exemption, make the following record: ‘Aeroplane exempted from the applicability of paragraph 2.1.1 [x] as referenced in the 1st Edition of Annex 16, Volume III, Part II, Chapter 2 (July 2017).’ […]

42. AMC to 21.A.130(b)(4) is amended as follows:

AMC 21.A.130(b)(4) Applicable engine exhaust emissions requirements

[…]

43. AMC to 21.A.130(b)(5) is inserted as follows:

AMC 21.A.130(b)(5) Applicable aeroplane CO2 emissions requirements

1. General This determination is made according to the data provided by the aeroplane type certificate holder. This data should allow the determination of whether the aeroplane complies with the CO2 emissions applicability requirements of Annex 16 to the Chicago Convention, Volume III, Part II, Chapter 2, paragraph 2.1.1. It should be noted that the competent authority has the possibility to grant exemptions as noted in Volume III, Part II, Chapter 1, paragraph 1.11 and Chapter 2, paragraph 2.1.3.

44. GM to 21.A.131 is amended as follows:

GM 21.A.131 Scope — Applicable design data

[…] For the purpose of Subpart G of Part 21, the term ‘applicable design data’ includes, in case of engines and when applicable, the information related to the applicable engine exhaust emissions and aeroplane CO2 emissions production cut-off requirements. […]

45. GM to 21.A.145(b)(2) is amended as follows:

GM 21.A.145(b)(2) Approval Rrequirements — Airworthiness and environmental protection, noise, fuel venting and exhaust emissions /production/quality data procedures

1 When a POA holder/applicant is developing its own manufacturing data, such as computer-based data, from the design data package delivered by a design organisation, procedures are required to demonstrate the right transcription of the original design data. 2 Procedures are required to define the manner in which airworthiness and environmental, noise, fuel venting and exhaust emissions data is used to issue and update the production/quality data, which determines the conformity of products, parts and appliances. The procedure must also define the traceability of such data to each individual product, part or appliance for the purpose of certifying a condition for safe operation and issuing a Statement of Conformity or EASA Form 1. […]

46. AMC No 2 to 21.A.163(c) is amended as follows:

AMC No 2 to 21.A.163(c) Completion of EASA Form 1

[…]

EASA Form 1 Block 12 ‘Remarks’

Examples of conditions which would necessitate statements in bBlock 12 are:

[…] Examples of data to be entered in this block as appropriate: • For complete engines, a statement of compliance with the applicable emissions requirements current on the date of manufacture of the engine. • For ETSO articles, state the applicable ETSO number. • Modification standard. • Compliance or non-compliance with airworthiness directives or Sservice Bbulletins. • Details of repair work carried out, or reference to a document where this is stated. • Shelf-life data, manufacture date, cure date, etc. • Information needed to support shipment with shortages or reassemblyre-assembly after delivery. • References to aid traceability, such as batch numbers. • In the case of an engine, if the Ccompetent Aauthority has granted an engine exhaust emissions production cut-off exemption, the record: ‘[“NEW OR SPARENew or Spare”] ENGINE EXEMPTED FROM NOx EMISSIONS PRODUCTION CUT-OFF REQUIREMENTengine exempted from NOx emissions production cut-off requirements’. […]

47. AMC to 21.A.165(c)(3) is amended as follows:

AMC 21.A.165(c)(3) Applicable engine exhaust emissions requirements

[…]

48. AMC to 21.A.165(c)(4) is inserted as follows:

AMC 21.A.165(c)(4) Applicable aeroplane CO2 emissions requirements

1. General This determination is made according to the data provided by the aeroplane type certificate holder. This data should allow the determination of whether the aeroplane complies with the CO2 emissions applicability requirements of Annex 16 to the Chicago Convention, Volume III, Part II, Chapter 2, paragraph 2.1.1. It should be noted that the competent authority has the possibility to grant exemptions as noted in Volume III, Part II, Chapter 1, paragraph 1.11 and Chapter 2, paragraph 2.1.3.

49. AMC-ELA No 2 to 21.A.239(a) is amended as follows:

AMC-ELA No 2 to 21.A.239(a) Design assurance system — Ensuring compliance

[…] Note: For more information, see GM No 1 to 21.A.15(d), clarification of the term ‘as applicable’. […]

50. AMC-ELA No 3 to 21.A.239(a) is amended as follows:

AMC-ELA No 3 to 21.A.239(a) Design assurance system — Discharge of responsibilities

As part of the design assurance system (DAS), at least the following responsibilities have to be allocated: — Head of the design organisation (HDO):  control of budget and staffing to ensure the completion of the development and certification tasks of the design organisation approval (DOA) within reasonable time frames and workload. The HDO is ultimately responsible for providing the necessary resources for the proper functioning of the design organisation;  issuing the declaration of compliance (see points 21.A.15(b), 21.A.15(c), 21.A.20(c) and 21.A.20(d) and 21.A.97(a)(3)) with the applicable type-certification basis, the applicable operational suitability data certification basis and the environmental protection requirements after verifying the satisfactory completion of the type investigation;

[…]

51. GM No. 1 to 21.A.239(a) is amended as follows:

GM No. 1 to 21.A.239(a) Design assurance system

[…] 3.1.5 Maintenance and Operating Instructions (a.) Ensuring the preparation and updating of all maintenance and operating instructions (including instructions for continued airworthiness and Sservices Bbulletins) needed to maintain airworthiness (continuing airworthiness) in accordance with the relevant CSs. For that purpose, the applicant should: — establish the list of all documents it is producing to comply with the CS 2X.1581 and with the Appendix referred to in CS 2X.1529, CS 25.1529, CS 27.1529, CS 29.1529, CS-E 20/25 or CS-P 40 (NPA P-3); — establish a system to collect in-service experience to be used for the improvement of the instructions; — define procedures and organisation to produce and issue these documents, using where applicable and so elected 21.A.263(c)(3) privilege under the obligation of point 21.A.265(h); the procedures should cover:

— preparation, including the format and language (available industrial standards can be referred to and used); — proofreading (checking for clarity, readability, typos, etc.); — checking of technical consistency with the corresponding approved change(s), repair(s) or approved data, including the effectivity, description, effects on airworthiness and environmental protection, especially when limitations are changed; — checking of feasibility in practical applications; and — responsibilities and authorised signatories. (b.) In accordance with points 21.A.57, 21.A.61, 21.A.107, 21.A.119, 21.A.120A and 21.A.449, ensuring that these documents are provided to all affectedknown operators and involved authorities. 3.1.6 Operational Suitability Data (OSD) (a.) Ensuring the preparation and updating of all operational suitability dataOSD in accordance with the relevant CSs. For that purpose, the applicant should: — establish the list of all the documents it is producing to comply with CS- MMEL or CS-GEN-MMEL, CS-FCD, CS-CCD, CS-SIMD and CS-MCSD, as applicable; — define its procedures and the organisation to produce and issue these documents, using where applicable and so elected 21.A.263(c)(3) privilege under the obligation of point 21.A.265(h); these procedures should cover the aspects described in 3.1.5(a) above. […]

52. GM No 2 to 21.A.243(d) is amended as follows:

GM No 2 to 21.A.243(d) Data requirements — Statement of the qualification and experience — Organisations that designing minor changes to type designs or minor repairs to products

For organisations that design designing minor changes to type design or minor repairs to products, the statement of the qualifications and experience required by 21.A.243(d) should be addressed as follows: 1. The nominated managers should be identified and their credentials submitted to the Agency EASA on EASA Form 4 - DOA (see EASA website: http://easa.europa.eu/certification/applicationforms.php) in order that they may be seen to be appropriate in terms of relevant knowledge and satisfactory experience related to the nature of the design activities as performed by the organisation. 2. The persons responsible for to: — classifying changes to type designs or repairs; — verifying compliance [(21.A.239(b))]; — approvinge minor changes to type design and minor repairs [(21.A.263(c)(2))];

— issuinge information or instructions [21.A.263(c)(3)(21.A.265(h))], should be selected by the organisation in accordance with a procedure and criteria agreed with the AgencyEASA.

53. GM 21.A.247 is amended as follows:

GM 21.A.247 Significant changes in the design assurance system

In addition to a change in ownership (see 21.A.249), the following changes to the design assurance system should be considered as to be ‘significant’ to the demonstration of compliance or to the airworthiness, operational suitability or environmental protection of the products: 1. Organisation — Relocation to new premises (see also GM 21.A.249); — Change in the industrial organisation (partnership, suppliers, design work sharing), unless it can be shown that the independent checking function of the demonstration of compliance is not affected; — Change in the parts of the organisation that contribute directly to the airworthiness, operational suitability or environmental protection (independent checking function, office of airworthiness [(or equivalent)]); — Change to the independent monitoring principles (see 21.A.239(a)(3)). 2. Responsibilities — Change of the management staff;  the Head of the design organisation [(GM No 1 to 21.A.239(a), para.3.1.2;, GM No 1 to 21.A.245, para.4.1;, GM 21.A.265(b))];  the Chief of the Office of Airworthiness [(GM No 1 to 21.A.245, para. 4.2)];  the Chief of the independent monitoring function of the design assurance system [(21.A.239(a)(3) and AMC No 1 to 21.A.243(a), para.2]). — New distribution of responsibilities affecting airworthiness, operational suitability or environmental protection; — For organisations that design designing minor changes to type designs or minor repairs to products, a change of the persons identified in GM No 2 to 21.A.243(d).

3. Procedures Change to the principles of procedures related to: — the type certification; — the classification of changes and repairs as ‘major’ or ‘minor’ [(21.A.263(c)(1)]); — the treatment of major changes and major repairs; — the approval of the design of minor changes and minor repairs [(21.A.263(c)(2)]); — the issue of information and instructions under the privilege of 21.A.263(c)(3) — the approval of minor revisions to the Aircraft Flight Manual [21.A.263(c)(4)]

— the approval of the design of certain major repairs [21.A.437(21.A.435(b) or 21.A.263(c)(5)]); — the approval of the conditions under which a permit to fly can be issued (21.A.263(c)(6)); — the issue of a permit to fly (21.A.263(c)(7)); — the approval of certain major changes to a type certificate (21.A.263(c)(8)); — the approval of certain supplemental type certificates (21.A.263(c)(9)); — the approval of certain major changes to certain supplemental type certificates; (21.A.263(c)(9)); — continued airworthiness or continued operational suitability (see 21.A.3); — the configuration control, when airworthiness, operational suitability or environmental protection is affected; — the acceptability of design tasks undertaken by partners or subcontractors sub-contractors [(21.A.239(c));]. — the issue of data and information under the obligation of 21.A.265(h). 4. Resources — A Ssubstantial reduction in the number and/or experience of staff (see 21.A.245(a)).

54. GM No 2 to 21.A.251 is amended as follows:

GM No 2 to 21.A.251 Terms of approval — Organisations that designing minor changes to type design or minor repairs to products

[…] 3. Privileges The holder of this approval is entitled to: Llist of the privileges granted with the approval, pursuant to 21.A.263(c)(1), and (2) and (3).

55. GM 21.A.263(b) is deleted.

56. AMC 21.A.263(b)(1) is deleted.

57. AMC No 1 to 21.A.263(c)(1) is amended as follows:

AMC No 1 to 21.A.263(c)(1) Procedure for the classification of changes to a type certificate (TC) or to a supplemental type certificate (STC) and of repairs designs as ‘minor’ or ‘major’

1. INTENT This AMC provides the means to develop a procedure for the classification of changes to a TC, APU ETSO or to that part of the product covered by an STC, and repairs designs. Each design organisation approval (DOA) applicant should develop its own internal classification procedure following this AMC, in order to obtain the associated privilege under 21.A.263(c)(1). 2. PROCEDURE FOR THE CLASSIFICATION OF CHANGES TO A TCTYPE CERTIFICATE, APU ETSO, OR TO THAT PART OF THE PRODUCT COVERED BY AN STC, AND REPAIRS DESIGNS 2.1 Content The procedure should address the following points: — the identification of changes to a TC, APU ETSO type certificate or to that part of the product covered by an STC, and repairs designs, — classification, — justification of the classification, — authorised signatories, and — supervision of changes to a TCtype certificate, APU ETSO or to that part of the product covered by an STC, and repairs designs initiated by subcontractorssub-contractors. For changes to a TCtype certificate, APU ETSO or to that part of the product covered by an STC, the criteria used for the classification should be in compliance with point 21.A.91 andas further explained in GM 21.A.91. For repairs, the criteria used for the classification should be in compliance with point 21.A.435 andas further explained in GM 21.A.435(a). 2.2 Identification of changes to a TCtype certificate, APU ETSO or to that part of the product covered by an STC, and repairs designs The procedure should indicate how the following are identified: — major changes to a TCtype certificate, APU ETSO or to that part of the product covered by an STC or major repairs; — those minor changes to a TCtype certificate, APU ETSO or to that part of the product covered by an STC or minor repairs where additional work is necessary to demonstrate compliance with the applicable CSs and environmental protection requirements; and — other minor changes to a TCtype certificate, APU ETSO or to that part of the product covered by an STC or minor repairs requiringthat require no further demonstration of compliance. 2.3 Classification

The procedure should show how the effects on airworthiness, as well as on operational suitability and environmental protection are analysed, from the very beginning, by reference to the applicable requirements. If no specific CS or environmental protection requirements are applicable to the change or repairs, the above review should be carried out at the level of the part or system where the change or repair is integrated and where specific CS or environmental protection requirements are applicable. 2.4 Justification of the classification All decisions onof the classification of changes to a TC, APU ETSO type certificate or to that part of the product covered by an STC, and repairs designs as ‘major’ or ‘minor’ should be recorded and, for those which are not straightforward, also documented. These records should be easily accessible to the AgencyEASA for sample checking. 2.5 Authorised signatories All classifications of changes to a TCtype certificate, APU ETSO or to that part of the product covered by an STC, and repairs designs should be accepted by an appropriately authorised signatory, belonging to or tasked by the Office of Airworthiness, as explained in GM No 1 to 21.A.239(a)(3.1.4)(r). The procedure should indicate the authorised signatories for the various products listed in the terms of approval. For those changes or repairs that are handled by subcontractorssub-contractors, as described under paragraph 2.6, it should be described how the DOA holder manages its classification responsibility. 2.6 Supervision of changes to a TCtype certificate, APU ETSO or to that part of the product covered by an STC, and repairs designs initiated by subcontractorssub-contractors The procedure should indicate, directly or by cross referencecross-reference to written procedures, how changes to a TCtype certificate or to that part of the product covered by an STC, and repairs designs may be initiated and classified by subcontractorssub-contractors and are controlled and supervised by the DOA holder.

58. AMC No 2 to 21.A.263(c)(1) is amended as follows:

AMC No 2 to 21.A.263(c)(1) Privileges — Organisations that designing minor changes to a type certificate (CTC) or a supplemental type certificate (STC) and minor repairs to products: classification procedure

1. Content The procedure should address the following points: — configuration control rules, especially the identification of changes to a TC, APU ETSO type certificate or to that part of the product covered by an STC, and repairs designs; — classification in compliance with point 21.A.91 and considering GM 21.A.91 for changes and GM 21.A.435(a) for repairs;

— justification of the classification; — authorised signatories. 2. Identification of changes to a TCtype certificate, APU ETSO or to that part of the product covered by an STC, and repairs designs The procedure should indicate how the following minor changes to a TCtype certificate or minor repairs are identified: — those minor design changes to a TCtype certificate or minor repairs where additional substantiation data is necessary to demonstrate compliance with the CS or environmental protection requirements; — other minor design changes to a TCtype certificate or minor repairs that requireing no further demonstration of compliance. 3. Classification The procedure should show how the effects on airworthiness, as well as on operational suitability and environmental protection are analysed, from the very beginning, by reference to the applicable requirements. If no specific requirements are applicable to the change or the repair, the above review should be done at the level of the part or system where the change or repair is integrated and where specific CS or environmental protection requirements are applicable. For repair, see also GM 21.A.435(a). 4. Justification of the classification All decisions on the classification of changes to a TCtype certificate, APU ETSO or to that part of the product covered by an STC, and repairs designs as ‘minor‘ should be recorded and, for those which are not straightforward, also documented. These records should be easily accessible to the AgencyEASA for sample checking. It may be in the format of meeting notes or a register. 5. Authorised signatories All classifications of changes to a TCtype certificate, APU ETSO or to that part of the product covered by an STC, and repairs designs should be accepted by an appropriately authorised signatory. The procedure should indicate the authorised signatories for the various products listed in the terms of approval.

59. AMC No 1 to 21.A.263(c)(2) is amended as follows:

AMC No 1 to 21.A.263(c)(2) Procedure for the approval of minor changes to a type certificate (CTC), APU ETSO or a supplemental type certificate (STC), and or minor repairs

1. INTENT

This AMC provides the means to develop a procedure for the approval of minor changes to a type certificateTC, APU ETSO or to that part of the product covered by an STC, and or minor repairs. Each design organisation approval (DOA) applicant should develop its own internal procedures following this AMC in order to obtain the associated privilege under 21.A.263(c)(2). 2. PROCEDURE FOR THE APPROVAL OF MINOR CHANGES TO A TYPE CERTIFICATETC, APU ETSO OR TO THAT PART OF THE PRODUCT COVERED BY AN STC, AND OR MINOR REPAIRS 2.1 Content The procedure should address the following points: — compliance documentation; — approval under the DOA privilege; — authorised signatories; — supervision of minor changes to a type certificateTC, APU ETSO or to that part of the product covered by an STC or and minor repairs handled by subcontractorssub-contractors. 2.2 Compliance documentation For those minor changes to a type certificateTC, APU ETSO or to that part of the product covered by an STC, andor minor repairs where additional work to demonstrate compliance with the applicable CSs and environmental protection requirements is necessary, compliance documentation should be established and independently checked as required by point 21.A.239(b). The procedure should describe how the compliance documentation is produced and checked. 2.3 Approval under the DOA privilege 2.3.1 For those minor changes to a type certificateTC, APU ETSO or to that part of the product covered by an STC, andor minor repairs where additional work to demonstrate compliance with the applicable CSs and environmental protection requirements is necessary, the procedure should define a document to formalise the approval under the DOA privilege. This document should include at least: — the identification and brief description of the change or repair and the reasons for the change or repair; — the applicable CSs or environmental protection requirements and methods of compliance; — references to the compliance documents; — effects, if any, on limitations and on the approved documentation; — evidence of the independent checking function of the demonstration of compliance; — evidence of the approval under the privilege of point 21.A.263(c)(2) by an authorised signatory; and — the date of the approval. For repairs, see AMC 21.A.433(a)(b) and 21.A.447.

2.3.2 For the other minor changes to a type certificateTC, APU ETSO or to that part of the product covered by an STC, andor minor repairs, the procedure should define a means to identify the change or repair and the reasons for the change or repair, and to formalise its approval by the appropriate engineering authority under an authorised signatory. This function may be delegated by the Office of Airworthiness but should be controlled by the Office of Airworthiness, either directly or through appropriate procedures of the DOA holder’s design assurance system. 2.4 Authorised signatories The persons authorised to sign for the approval under the privilege of point 21.A.263(c)(2) should be identified (name, signature and scope of authority) in appropriate documents that may be linked to the handbook. 2.5 Supervision of minor changes to a type certificateTC, APU ETSO or to that part of the product covered by an STC, andor minor repairs handled by subcontractorssub-contractors For the minor changes to a type certificateTC, APU ETSO or to that part of the product covered by an STC, andor minor repairs described in 2.3.2, thatwhich are handled by subcontractorssubcontractors, the procedure should indicate, directly or by cross referencecross-reference to written procedures, how these minor changes to a type certificateTC, APU ETSO or to that part of the product covered by an STC, andor minor repairs are approved at the subcontractorsubcontractor level and the arrangements made for the control and supervision by the DOA holder.

60. AMC No 2 to 21.A.263(c)(2) is amended as follows:

AMC No 2 to 21.A.263(c)(2) Privileges — Organisations that designing minor changes to a type certificate (TC), APU ETSO or a supplemental type certificate (STC) and minor repairs to products: procedure for the approval of minor changes to a TC, APU ETSO or minor repairs

1. Content The procedure should address the following points: — compliance documentation; — approval under the DOA privilege; — authorised signatories. 2. Compliance documentation For those minor changes to a type certificateTC, APU ETSO or to that part of the product covered by an STC, and minor repairs where additional work to demonstrate compliance with the applicable CSs and environmental protection requirements is necessary, compliance documentation should be established and independently checked as required by point 21.A.239(b). The procedure should describe how the compliance documentation is produced and checked. 3. Approval under the DOA privilege 3.1. For those minor changes to a type certificateTC, APU ETSO or to that part of the product covered by an STC, and minor repairs where additional work to demonstrate compliance with the

applicable CSs or environmental protection requirements is necessary, the procedure should define a document to formalise the approval under the DOA privilege. This document should include at least: (a) the identification and brief description of the change or the repair and the reason for change or repair; (b) the applicable CSs or environmental protection requirements and methods of compliance; (c) references to the compliance documents; (d) effects, if any, on limitations and on the approved documentation; (e) evidence of the independent checking function of the demonstration of compliance; (f) evidence of the approval under the privilege of point 21.A.263(c)(2) by an authorised signatory; and (g) the date of the approval. For repairs, see also AMC 21.A.433(a)(b) and 21.A.447. 3.2. For the other minor changes to a type certificateTC, APU ETSO or to that part of the product covered by an STC, and minor repairs, the procedure should define a means to identify the change or repair and the reasons for the change or repair, and to formalise its approval by the appropriate engineering authority under an authorised signatory. This function should be controlled through appropriate procedures of the DOA holder’s design assurance system. 4. Authorised signatories The persons authorised to sign for the approval under the privilege of point 21.A.263(c)(2) should be identified (name, signature and scope of authority) in appropriate documents that may be linked to the handbook.

61. The following AMC No 3 to 21.A.263(c)(2) is inserted:

AMC No 3 to 21.A.263(c)(2) Procedure for the approval of minor changes to a type certificate (TC) which affect the aircraft flight manual (AFM)

1. Intent This AMC provides additional guidance for developing a procedure for the approval of minor changes to a TC which affect the aircraft flight manual (AFM). Each design organisation approval (DOA) applicant/holder should develop its own internal procedure, based on these guidelines. For guidance on the classification of changes to a TC which affect the AFM, see GM 21.A.91. 2. Procedure for the approval of minor changes to a TC which affect the AFM 2.1 Content The procedure should address the following points: — assessment of any change to a TC for the impact of the change on the AFM; — preparation of revisions or supplements to the AFM; — classification of the change to a TC, taking into account the impact on the AFM; — classification of stand-alone revisions or supplements to the AFM; — control of the configuration of the AFM; — approval of the revisions or supplements to the AFM; and — the approval statement. 2.2 Assessment of a change for its impact on the AFM The procedure should include an assessment of whether or not the AFM is impacted by the change. 2.3 Preparation The procedure should indicate how revisions or supplements to the AFM are prepared and how the coordination among the persons in charge of design changes is performed. 2.4 Classification The procedure should indicate how changes to a TC which affect the AFM are classified, in accordance with the criteria of GM 21.A.91 Section 3.4. The procedure should indicate how classification decisions are recorded, documented and signed. Easy accessibility of these records to EASA for sample checking should be ensured. All classifications should be accepted by an appropriately authorised signatory. The procedure should indicate the authorised signatories for the various products listed in the terms of approval. 2.5 Configuration control of the AFM The procedure should explain the traceability of changes in order to understand who has approved what. Especially if a given page or data module has been revised several times, it should be

traceable which part(s) of the page or data module has (have) been approved directly by EASA under which approval, and which part(s) has (have) been approved under the privilege of a DOA holder. 2.6 Approval The procedure should indicate how the approval under the privilege of point 21.A.263(c)(2) is formalised. The authorised signatories should be identified (name, signature), together with the scope of the authorisation, in a document that is linked to the DOA handbook. 2.7 Approval statement The amended AFM, or the supplement to the AFM, approved under the privilege of point 21.A.263(c)(2) should be issued under the obligation of point 21.A.265(h) (see point 21.A.265(h) and the related GM) with a respective statement in the log of revisions.

62. GM 21.A.263(c)(3) is deleted.

63. GM 21.A.263(c)(4) is deleted.

64. AMC 21.A.263(c)(6) is amended as follows:

AMC 21.A.263(c)(6) Procedure for the approval of the conditions for issueissuing of a permit to fly

1. INTENT This AMC provides means to develop a procedure to determine that an aircraft can fly, under the appropriate restrictions compensating for non-compliance with the certification basis applicable

to the aircraft category.

Each DOA applicant or holder mustshould develop its own internal procedure following this AMC, in order to obtain the privilege to make this determination and approve associated conditions without AgencyEASA’s involvement, under 21.A.263(c)(6). When the privilege does not apply, the DOA holder will prepare all the necessary data required for the determination in accordance with the same procedure required for the privilege, and will apply for AgencyEASA’s approval. The establishment of flight conditions may include conditions related to engines/propellers without a type certificate or with unapproved changes that are fitted on the aircraft, for which a permit to fly is requested. These conditions (i.e. installation, operating, maintenance conditions or limitations) should be defined by the organisation responsible for the design of the engine/propeller and provided to the organisation responsible for the design of the aircraft. In this context, the organisation responsible for the design of the engine/propeller acts as a supplier of the organisation responsible for the design of the aircraft. These conditions should be established and substantiated under an arrangement between the organisation responsible for the design of the aircraft and the organisation responsible for the design of the engine/propeller. However, the establishment and substantiation of the flight conditions for the aircraft, including its engine(s), is the ultimate responsibility of the organisation responsible for the design of the aircraft.

[…]

65. AMC-ELA No 1 to 21.A.263 is amended as follows:

AMC-ELA No 1 to 21.A.263 Privileges and AMC-ELA No 1 to 21.A.265(h) Obligations of the holder

[…] (c) Instructions required by the certification specifications, such as the maintenance manual, the MMEL, etc., are usually prepared within the type investigation process to comply with the certification requirements. These documents are covered by the type investigation process. The generation and publication of information or instructions related to continued airworthiness, including updates to the above-mentioned ICA and MMEL and to any related design activity, are handled according to the same principles as any type design, change design or repair design activity/documentation if no separate method/process as per GM 21.A.263(c)(3) 21.A.265(h) is defined. The DOH should state how documents under this privilege obligation are issued and distributed to the aircraft owner and to other interested parties. Using the change/repair process would be the simplest way for small companies to do this. […]

66. The following AMC No 1 to 21.A.263(c)(5), (8) and (9) is inserted:

AMC No 1 to 21.A.263(c)(5), (8) and (9) Scope and criteria

1. Definition of ‘certain major repairs’ ‘Certain major repairs’ for which privileges may be granted as per point 21.A.263(c)(5) are: (a) major repairs to products or auxiliary power units (APUs) for which the design organisation approval (DOA) holder holds the type certificate (TC) or the supplemental type certificate (STC) or the European technical standard order authorisation (ETSOA); or (b) major repairs to products or APUs for which the DOA holder does not hold the TC or the STC or ETSOA and that meet the criteria of 3(a), (b) and (c) below. 1.1 Criteria for limitations on eligibility An EASA approval may be required in cases of major repairs proposed by DOA holders who are the TC, STC or APU ETSOA holders if the major repair is: (a) related to a new interpretation of any item of the certification basis as used for the type certification (such as the certification specifications (CSs), certification review items (CRIs) for special conditions, equivalent safety findings, deviations or ‘elect to comply’); and (b) related to the application of a CS that is different from the one used for type certification. Note: This should be established at the time of granting the privilege to the DOA holder, or later through an EASA-agreed procedure. 2. Definition of ‘certain major changes’ and ‘certain supplemental type certificates’

‘Certain major changes’ and ‘certain supplemental type certificates’ for which privileges may be granted as per point 21.A.263(c)(8) and (9) are changes similar to those that have been previously approved by EASA for the same DOA holder. The similarity of the changes is to be seen in terms of the design, the installation, and the operational characteristics, whereas their repetitiveness is seen in terms of the applicable requirements and the compliance demonstration. In this context, a ‘requirement’ means any element of the type-certification basis as specified in point 21.B.80, or the operational suitability data (OSD) certification basis as specified in point 21.B.82, or the environmental protection requirements as specified in point 21.B.85. 2.1 Criteria for limitations on eligibility The following types of changes are not eligible: (a) changes that require a revision to a type certificate data sheet (TCDS) (e.g. the introduction of a derivative model or variant) or a type certificate data sheet for noise (TCDSN); (b) changes that require an amendment to the existing certification basis by a special condition, equivalent safety finding, deviation or ‘elect to comply’; (c) changes that revise airworthiness limitations or operating limitations, unless otherwise agreed with EASA; (d) changes that are intended to be used as alternative method of compliance (AMOC) to an airworthiness directive (AD); (e) changes that are made mandatory by an AD or that are the terminating action of an AD; (f) changes that are classified as ‘significant’ in accordance with point 21.A.101; (g) changes for which, in the affected area and for the operations for which the design is to be certified, more conservative certification requirements are applicable which were not used in the description of the EASA-approved procedure of the DOA holder, e.g. in the case of a type, model or modification with a later, more stringent certification basis; (h) changes that affect the noise and/or emissions characteristics of the changed product, unless otherwise agreed with EASA; (i) changes that affect a part or system, a single failure of which may have a catastrophic effect upon the product, and for which critical characteristics have been identified, which should be controlled to ensure the required level of integrity; (j) changes to engines or propellers, a single failure of which may have a hazardous effect upon the product, and for which critical characteristics have been identified, which should be controlled to ensure the required level of integrity; and (k) changes for which a non-compliance has been found in the referenced change during the continued-airworthiness process. 3 Criteria for major repairs, major changes and STCs for which the privileges of point 21.A.263(c)(5), (8) and (9) may be granted The following criteria need to be met:

(a) Similarity The installation on the product, the design, the operation, and the equipment qualification are basically the same as in projects for which EASA has already been involved and issued an approval for the same DOA holder. (b) Repetitiveness of the certification process The whole certification process is repetitive, i.e. identical to, or part of, an already approved referenced process. For a change or repair that is a part of the referenced ‘certain major repairs’, ‘certain major changes’ or ‘certain supplemental type certificates’, the certification process is still identical to the one for the affected change. This is the case when each compliance demonstration is performed to the same extent in accordance with the same requirements, GM, and content of the interpretative material, as well as with the same means and method of compliance (not only the same means-of-compliance (MoC) code). Note: In this AMC, a ‘requirement’ means any element of the type-certification basis as specified in point 21.B.80, or OSD certification basis as specified in point 21.B.82, or an environmental protection requirement as specified in point 21.B.85. (c) Performance and experience in previous projects EASA should have classified as ‘medium’ or ‘high’ the level of performance of the organisation during at least the latest project referenced, to demonstrate ‘similarity’ and ‘repetitiveness’. In addition, EASA should have classified as ‘low’ or ‘very low’ the likelihood of an unidentified non-compliance for all the included compliance demonstration items (CDIs) identified in at least the latest project referenced, to demonstrate ‘similarity’ and ‘repetitiveness’ (applying the criteria for the determination of EASA’s level of involvement (LoI) in product certification, see AMC 21.B.100(a) and 21.A.15(b)(6)). The process to obtain and to use the privileges of point 21.A.263(c)(5), (8) and (9) is described in AMC No 2 to 21.A.263(c)(5), (8) and (9).

67. The following AMC No 2 to 21.A.263(c)(5), (8) and (9) is inserted:

AMC No 2 to 21.A.263(c)(5), (8) and (9) Procedure for the approval of a major repair, a major change to a type certificate (TC), or a supplemental type certificate (STC) by a design organisation approval (DOA) holder under their privileges

This AMC describes the process to be followed in order to obtain and use the privilege to approve ‘certain major repairs’ and ‘certain major changes’ to a TC, and ‘certain supplemental type certificates’ as defined in points 1(b) and 2 of AMC No 1 to 21.A.263(c)(5), (8) and (9). 1. PROCESS FOR OBTAINING A PRIVILEGE A DOA holder that applies for the privileges referred to in point 21.A.263(c)(5), (8) or (9) should do the following: (a) Submit to EASA an application for a significant change in the design assurance system (see points 21.A.247 and 21.A.253).

(b) Establish internal procedures for the application of the privilege covering the following elements, and add them to the application: (1) The definition of the ‘list associated with the privilege’ of certain major repairs/changes/STCs. The ‘list associated with the privilege’ is a list of all ‘certain major changes’, ‘certain STCs’ and ‘certain major repairs’ (or families thereof) plus the associated ‘justification document’ references for which the privileges as per point 21.A.263(c)(5), (8) and (9) have been granted. (2) A ‘justification document’ for a ‘certain major repair’, ‘certain major change’ or a ‘certain STC’, as applicable. The ‘justification document’ should contain: (i) The reference(s) to the EASA-approved major change(s), STC(s) and major repair(s), which is (are) used to demonstrate the DOA holder’s experience and performance. Note: The number of already EASA-approved major change(s), STC(s) or major repair(s) used to demonstrate the DOA holder’s experience and performance is based on an assessment of the scope of the ‘certain major repairs’, ‘certain major changes’ or ‘certain supplemental type certificates’ which is requested to be added to the ‘list associated with the privilege’, as well as on the performance of the DOA holder during previous projects. (ii) The certification programme(s) of the major change(s), STC(s), or major repair(s), accepted by EASA, used to demonstrate the applicant’s experience and performance. (iii) The applicable product configuration(s). The applicant should list the type(s) and model(s) to which the major change(s)/STC(s)/repair(s) applies (apply) or may apply. Exceptionally, this may be done for a dedicated product, system or equipment if the type or model has no technical influence on the major change(s)/STC(s)/repair(s), i.e. when the installation issues are negligible (e.g. the TCAS 7.1 software change for a certain equipment), such a listing is not mandatory, but it needs to be justified. (iv) The list of ‘requirements’ for the demonstration of compliance, if not identical to the ones referenced in the certification programme. (v) The certification process, if not identical to the one referenced in the certification programme. (vi) A detailed description with all the technical data relevant to the installation of the product, the design, the operation and the qualification which ensures the proper use of the privilege for future major changes, major repairs or STCs. This description should include the criteria defining the conditions that should be met in order to apply the privileges. (vii) Any other limits on the use of the privilege.

(3) The assessment of the acceptability of using the privilege for major repairs, major changes or STCs against the ‘list associated with the privilege’ and the ‘justification document’ of ‘certain major repairs’, ‘certain major changes’ or ‘certain STCs’. (4) The approval process, including the templates to be used, the authorised signatories, records management and the provision of a ‘summary list’ of major changes, major repairs and STCs approved under the privilege of point 21.A.263(c)(5), (8) and (9). This process should clarify that the approval is issued under the DOA holder’s privilege. The persons authorised under the privilege of point 21.A.263(c)(5), (8) and (9) should be identified by their names, signatures and scopes of authority in the appropriate documents and referenced in the procedure. A ‘summary list’ of all the major changes, STCs and major repairs approved under a privilege should be provided to EASA on a regular basis, as agreed with EASA. (5) Extension of the ‘list associated with the privilege’ after the privilege is granted. After the granting of the privilege, the initial list of ‘certain major repairs’, ‘certain major changes’ and ‘certain STCs’ under the privilege may be further extended by an EASA agreement, as shown in Section 2 as well as in Figures 2 and 3 below. (c) Identify in the ‘list associated with the privilege’ the eligible major changes, major repairs or STCs proposed for inclusion in the scope of the privilege (see also AMC No 1 to 21.A.263(c)(5), (8) and (9)). (d) Provide a ‘justification document’ for each proposed certain major change, certain major repair or certain STC identified under (c) above. Note: The ‘list associated to the privilege’ identifying all certain major repairs, certain major changes and certain STCs and the associated ‘justification document(s)’ are to be referenced in the DOA holder procedure mentioned under (b) above. The process for obtaining the privilege, referred to in 21.A.263(c)(5), (8) and (9), is summarised in Figure 1 below:

Approval of process for the 21.A.263(c)(5), (8) or (9) privilege

DOA holder submits an application to EASA in accordance with 21.A.247

DOA holder proposes internal procedure covering the following:  Definition of the List associated with the privilege ;  Creation of the Justification document ;  Assessment of major repairs/changes or STCs against the List associated with the privilege ;  Approval process of major repairs/changes or STCs using the privilege as per 21.A.263(c)(5), (8) or (9); and  Extension of the List associated with the privilege .

The DOA holder identifies major repairs, major changes or STCs eligible for inclusion in the List associated with the privilege using the criteria provided in AMC No. 1 to 21.A.263(c)(5),(8) and (9)

The DOA holder provides a Justification document for each proposed major repair, major change or STC included in the List associated with the privilege

Does EASA agree with the NO proposed procedure(s)?

EASA reviews the Justification document(s) proposed The DOA holder to resubmit the Justification document or remove it from the list Does EASA agree with the NO Justification document(s) ?

A new privilege under 21.A.263(c)(5), (8) or (9) List associated with the privilege granted and the initial List associated with the privilege accepted

Figure 1

The privilege referred to in point 21.A.263(c)(5), (8) and (9) may be used by a DOA holder for the approval of major repairs, major changes or STCs, as applicable, under the following conditions: (a) the privilege has already been granted by EASA; (b) the major repair/change/STC to be approved falls under the ‘List associated with the privilege’ agreed by EASA; and (c) the criteria established in the relevant ‘Justification document’ are met and the relevant assessment is recorded. If all the above conditions are met, the privilege may be used and the approval of major repairs, major changes or STCs, as applicable, can be obtained by the DOA holder without EASA’s involvement. Note: If a DOA holder applies for a third-country validation after having approved a modification under its DOA holder privilege, EASA may review some of the compliance demonstration data in order to support the validation activity. 2. EXTENSION OF THE ‘PRIVILEGE LIST’ OF ‘CERTAIN MAJOR REPAIRS’, ‘CERTAIN MAJOR CHANGES’ OR ‘CERTAIN STCs’ AFTER THE PRIVILEGE IS GRANTED When the DOA holder intends to update the ‘List associated with the privilege’, a ‘Justification document’ needs to be provided to EASA, as described in Section 1(b)(2) above. After EASA agrees with the updated ‘privilege list’ as part of the DOA holder’s procedure, the DOA holder may proceed as per Section 4 below.

Figure 2

Figure 3

3. TC, STC OR APU ETSOA HOLDER APPROVAL OF A MAJOR REPAIR UNDER A MAJOR REPAIR PRIVILEGE — SPECIFIC CONSIDERATIONS TC, STC or APU ETSOA DOA holders that intend to approve a major repair design under the privilege of point 21.A.263(c)(5) should ensure that: (a) the type-certification basis for the product, part or appliance to be repaired is identified, together with all the other relevant requirements; (b) all the records and substantiation data, including the documents that demonstrate compliance with all the relevant requirements, are provided to EASA for review; and (c) for repair designs created for a specific product serial number, an assessment is made as to whether or not the repair design is affected by the presence of any embodied STC, change or repair. 4. DOA HOLDER’S APPROVAL BASED ON THE PRIVILEGE FOR A MAJOR REPAIR, MAJOR CHANGE OR STC — SPECIFIC CONSIDERATIONS For the approval of: — major repairs by DOA holders that are not the TC, STC or APU ETSO authorisation holders; — major changes; and — STCs by a DOA holder under the privilege of point 21.A.263(c)(5), (8) and (9), the following should be considered. 4.1 Eligibility of the proposed major repair, major change or STC The DOA holder should assess the proposed major repair, major change or STC against the ‘list associated with the privilege’ and the ‘justification document’ of ‘certain major repairs’, ‘certain major changes’ or ‘certain supplemental type certificates’ in order to determine whether the criteria of AMC No 1 to 21.A.263(c)(5), (8) and (9), Section 2.2, are met. 4.2 Forms for approval certificates The DOA holder should use the following forms for the issuance of an approval under their privilege: — EASA Form 991 for an STC; — EASA Form 993 for a major change; and — EASA Form 994 for a major repair. If the DOA holder chooses to use their own forms, it must be ensured that at least the same information as requested on the EASA forms is presented. For the numbering of major changes to TCs, STCs, as well as of major repairs approved under the privilege of point 21.A.263(c)(5), (8) or (9), please refer to GM 21.A.263(c)(5), (8) and (9).

4.3 Approval under the DOA holder’s privilege When the DOA holder makes use of the privilege of point 21.A.263(c)(5), (8) or (9), they should include the following in the certification data package: — a record of the assessment as described in 4.1 above; — the reference to the ‘justification document’; — the applicable product configuration; — the applicable CSs or environmental protection requirements and methods of compliance; — the compliance documents; — the effects, if any, on limitations and on the approved documentation; — the evidence of the independent checking of the compliance demonstration; — the approval document containing the statement of the approval under the privilege of point 21.A.263(c)(5), (8) and (9) by an authorised signatory; and — the date of approval. In any case, before the major change, STC or major repair is approved under the DOA privilege, the DOA holder should ensure that the Part 21 requirements, in particular points 21.A.97, 21.A.115 and 21.A.433, are met. 4.4 Authorised signatories An authorised person that is identified and authorised as described in Section 1(b)(4) above should sign the approval under the privilege of point 21.A.263(c)(5), (8) and (9). 4.5 Summary list The DOA holder should add to the ‘summary list’ as described in Section 1(b)(4) above the major change, STC or major repair approved under the privilege of point 21.A.263(c)(5), (8) and (9).

68. The following GM 21.A.263(c)(5), (8) and (9) is inserted:

GM 21.A.263(c)(5), (8) and (9) Numbering system for supplemental type certificates (STCs), major changes and major repairs issued by design organisation approval (DOA) holders, and information to EASA

STCs, major changes and major repairs issued by a DOA holder under their privilege of point 21.A.263(c)(5), (8) and (9) should each be given a unique and consecutive reference number.

The following numbering system may be considered: DOA holder Type of Year of Sequential Issue Dash reference certificate approval number reference STC or MCH 21Jxxx 17 — 001 A or MRE Example: 21J999STC17—001A Note: ‘MCH’ refers to ‘major changes’, ‘MRE’ to ‘major repairs’. With reference to STCs only, after the STC approval, the DOA holder should send a copy of the STC to EASA in a timely manner (as agreed with EASA).

69. The following GM 21.A.265(h) is inserted:

GM 21.A.265(h) Designation of data and information issued under the authority of a design organisation approval (DOA) holder

1. INTENT This GM provides guidance for complying with the obligation of 21.A.265(h), and addresses the various aspects that the DOA holder should cover in order to have a comprehensive procedure for the designation of data and information. 2. SCOPE The term ‘data and information’ as used in point 21.A.265(h) also includes instructions. Data and information referred to in point 21.A.265(h) are issued by a DOA holder and cover the following: — embodiment instructions for design changes or repairs (usually in the form of a service bulletin, a modification bulletin, repair instructions or engineering order, etc.); — manuals required by Part 21 or the applicable CSs (such as the aircraft flight manual (AFM), rotorcraft flight manual, instructions for continuing airworthiness (ICAs), etc.); — operation suitability data (OSD); — continued-airworthiness instructions (usually in the form of service bulletins) which may be covered by airworthiness directives (ADs); — additional data to be defined by the DOA holder (e.g. alternative maintenance instructions that are not, per se, ICAs). Note: This data and information may be issued in a digital or paper format. The obligation does not apply to, and the statement provided with the data and information should not be used on, the following documents: — certification documents (e.g. the certification programme, compliance checklist, etc.); — compliance documents; — design data transferred to production organisations; and

— production deviations (also referred to as ‘unintended deviations’ or ‘concessions’). 3. RATIONALE The purpose of this obligation is to give certainty to the end users about the approval status of the data and information issued by the DOA holder. 4. STATEMENT The statement provided with the data and information should also cover those items prepared by subcontractors or vendors that the DOA holder has declared as applicable to their products. The technical content of the statement is related to the type certificate data and information. The approval included in the statement means that: — the type certificate data has been appropriately approved; and — the information contains practical and well-defined installation or inspection methods, and, when those methods are implemented, the product is in conformity with the approved type certificate data. Note: Data and information related to the measures required by point 21.A.3B(b) (airworthiness directives (ADs)) are submitted to EASA to ensure their compatibility with the content of an AD (see point 21.A.265(e)), and contain a statement that they are, or will be, subject to an AD issued by EASA.

70. GM 21.A.431(a) is amended as follows:

GM 21.A.431A(a) Scope

[…] NB: Flow Chart 1 addresses the procedures that should be followed for products where the State of design is a Member State Flow Chart 2 addresses procedures that should be followed for products where the State of design is not a Member State. […]

GM 21.A.445 is amended as follows:

GM 21.A.445 Unrepaired damage

[…]

71. GM 21.A.431(d) is amended as follows

GM 21.A.431A(e)(d) Repairs to European technical standard order (ETSO) articles other than auxiliary power units (APUs)

[…]

72. The following GM 21.A.432B(b) is inserted:

GM 21.A.432B(b) Alternative procedures

See AMC 21.A.14(b) for the details of the alternative procedures.

73. The following AMC 21.A.432C(a) is inserted:

AMC 21.A.432C(a) Form and manner

The applicant should file an application using the web-based ‘EASA Applicant Portal’ or the application forms for the approval of major changes/major repair designs (FO.CERT.00031) or for the approval of minor changes/minor repair designs (FO.CERT.00032) , which may be downloaded from the EASA website. The forms should be completed in accordance with the instructions embedded at the bottom of the application forms, and sent to EASA by fax, email or regular mail following the information provided on the EASA website .

74. The following AMC 21.A.432C(b) is inserted:

AMC 21.A.432C(b) Certification programme for a repair design approval

Clarification of 21.A.432C(b)(1): the description of the repair should consist of: — the pre- and post-repair configuration; — a drawing or outline of the repair; — a list of the detailed features; — a description of the type and extent of the inspection; and — an outline of the damage. Clarification of 21.A.432C(b)(3): the identification of reinvestigations does not refer to the demonstration of compliance itself, but to the list of the affected certification specifications (CSs), together with the means of compliance.

75. AMC 21.A.433(a) and 21.A.447 is amended as follows:

AMC 21.A.433(ab) and 21.A.447 Repair design and record keeping

1. Relevant substantiation data associated with a new major repair design and record keeping should include: a. the identification of the damage identification and the reporting source,; b. the major repair design approval sheet identifying the applicable specifications and references of justifications,; c. the repair drawing and/or instructions and scheme identifier,; d. the correspondence with the holder of the type certificate (TC), supplemental type certificate (STC), or auxiliary power unit European technical standard order (APU ETSO) authorisation holder, if its advice on the design has been sought,; e. the structural justification (static strength, fatigue, damage tolerance, flutter, etc.) or references to this data,; f. the effect on the aircraft, engines and/or systems, (performance, flight handling, etc., as appropriate),; g. the effect on the maintenance programme,; h. the effect on Aairworthiness Llimitations, the Fflight Mmanual and the Ooperating Mmanual,; i. any weight and moment changes,; and j. special test requirements. 2. Relevant minor repair documentation includes paragraphs 1(a) and (c). Other points of paragraph 1 may be included where necessary. If the repair is outside the approved data, a justification for the classification is required. 3. Special consideration should be given to repairs that impose subsequent limitations on the part, product or appliance, (e.g., engine turbine segments that may only be repaired a finite number of times, the number of repaired turbine blades per set, oversizing of fastener holes, etc.). 4. Special consideration should also be given to Llife -Llimited parts and Ccritical Pparts, notably with the involvement of the type certificateTC or STC holder, when deemed necessary under point 21.A.433(b)(a)(4). 5. Repairs to engine or APU critical parts would normally only be accepted with the involvement of the TC holder.

76. The following GM 21.A.435(b) is inserted:

GM 21.A.435(b) Repair design approval

(a) REPAIR DESIGN APPROVAL BY EASA (1) Products first type-certified by EASA or first type-certified by a Member State (covering those type-certified through Joint Aviation Authorities (JAA) procedures or under national regulations and those nationally certified without a type certificate (TC)) EASA approval is required in cases of major repair designs proposed by design organisation approval (DOA) holders that do not hold the necessary privilege as per point 21.A.263(c)(5) to approve certain major repair designs, as well as in cases of minor repair designs proposed by persons or organisations that do not hold a DOA. (2) Products first type-certified by the competent authority (CA) of a third country EASA approval is always required for major repairs on products first type-certified by the CA of a third country. Approval privileges granted to DOA holders (see point 21.A.435(b)) are not available to TC holders of products first type-certified by the CA of a third country unless this third country has since become an EASA Member State. TC holders of products first type-certified by the CA of a third country may need to be involved in a repair design when an arrangement with the TC holder has been determined to be necessary under point 21.A.433(a)(4). For repairs approved by the CA of a third country, the conditions for acceptance may be defined in the bilateral arrangement between EASA and the third country. In the absence of such an arrangement, the repair data should follow the approval route of Part 21. (b) REPAIR DESIGN APPROVAL BY THE DOA HOLDER (1) Approval by the DOA holder Approval of repairs through the use of procedures agreed with EASA implies that the DOA holder issues the approval without EASA’s involvement. EASA will monitor the application of this procedure within the surveillance plan for the relevant organisation. When the organisation exercises this privilege, the repair release documentation should clearly show that the approval is issued on the basis of its privilege. (2) Previously approved data for other applications When it is intended to use previously approved data for other applications, it is expected that an appropriately approved design organisation has checked the applicability and effectiveness of this data. After damage identification, if a repair solution exists in the available approved data, and if the application of this solution to the identified damage remains justified by the previously approved repair design (structural justifications still valid, possible airworthiness limitations unchanged), the solution may be considered to be approved and may be used again. (3) Temporary repairs These are life-limited repairs to be removed and replaced by permanent repairs after a limited service period. These repairs should be classified under point 21.A.435, and the service period should be defined when the temporary repair is approved.

(4) Fatigue and damage tolerance An approved design issued before the fatigue- and damage-tolerance evaluation has been completed should specify the limited service period.

77. GM 21.A.437 is deleted.

78. GM 21.A.437(a) is deleted.

79. AMC 21.A.437(b) is deleted.

80. The following AMC 21.A.605(a)(1) is inserted:

AMC 21.A.605(a)(1) Certification programme

(a) For the purpose of the compliance demonstration in accordance with point 21.A.606(b), the applicant should: (1) establish a certification programme; (2) submit the certification programme to EASA; and (3) keep the certification programme updated during the authorisation process. (b) The certification programme should contain the following information: (1) a detailed description of the relevant European technical standard order (ETSO) article, including all of its configurations to be certified, and the identification of ETSO and non- ETSO functions, if any; (2) the applicable CS-ETSO, in case of different minimum performance standard (MPS) available, the selected MPS, the other requirements and any optional aspects (applicable standards, applicable requirements, choice of classes (if applicable)) as well as the expected deviations; (3) the operating characteristics and the expected limitations; (4) the intended use of the article and the kind of operations for which the approval is requested; (5) the proposed means of compliance, including the list of documents and deliverables for EASA; (6) an overview of the safety assessment for the functions supported by the article, including the main failure conditions, their classification, the associated assumptions, and architectural features supporting the safety aspects; (7) the way in which the applicant will record the justifications of compliance; and (8) a project schedule, including major milestones.

81. The following GM 21.A.605(b) is inserted:

GM 21.A.605(b) Reporting from the compliance demonstration process and updates to the certification programme

The applicant should report to EASA any unexpected difficulty or event encountered during the compliance demonstration which invalidates or appreciably affects the assumptions previously made, e.g.: — an increase in the severity of the consequences of a certain condition (e.g. a failure mode) of the article; — one or more significantly reduced margins on the ‘pass–fail’ criteria of the compliance demonstration; — an unusual interpretation of the results of the compliance demonstration; — a deviation from the agreed means as defined in the certification programme; — a change to the conditions set out in the AMC No 2 to 21.B.100(b); and — any potential deviations discovered by the applicant. The applicant should also evaluate whether the unexpected difficulty or event encountered will impact on the certification programme and, if necessary, they should amend the certification programme as per point 21.A.603.

82. The following AMC 21.A.606(d) is inserted:

AMC 21.A.606(d) Declaration

The related declaration should confirm that compliance with the applicable ETSO is successfully demonstrated and that all the assumptions, constraints, deviations, limitations, and open problem reports that are relevant for the approval of the installation are defined for both the ETSO and the non-ETSO functions. Additionally, the applicant should demonstrate and declare that the non-ETSO functions do not interfere with the ETSO functions.

83. GM 21.A.701(a) is amended as follows:

GM 21.A.701(a) Permit to fly when a certificate of airworthiness or a restricted certificate of airworthiness is not appropriate

[…] (16) Flying an aircraft for troubleshooting purposes or to check the functioning of one or more systems, parts or appliances after maintenance. — After maintenance, when the diagnosis of the functioning of an aircraft system needs to be made in flight and the design approval holder has not issued instructions to perform this diagnosis within the approved aircraft limitations, the flight should be conducted under a permit to fly. Further guidance is available in subparagraph (b) of GM M.A.301(i) of the AMC and GM to Part-M.

Note: The above listing is of cases when a permit to fly MAY be issued; it does not mean that in the described cases a permit to fly MUST be issued. If other legal means are available to allow the intended flight(s), they can also be used.

84. GM 21.A.703 is amended as follows:

GM 21.A.703 Applicant for a permit to fly

1. The applicant for a permit to fly may be a person other than the registered owner of the aircraft. As the holder of this permit will be responsible for ensuring that all the conditions and limitations associated with the permit to fly are continuously satisfied, the applicant for the permit should be a person or organisation suitable for assuming these responsibilities. In particular, the organisations designing, modifying or maintaining the aircraft should normally be the holder of the associated permits to fly. 2. An appropriately approved design organisation can apply for the approval of the flight conditions when using its privilege in accordance with 21.A.263(b)(1).

85. The following GM 21.B.75 is inserted:

GM 21.B.75 Special conditions

The term ‘novel or unusual design features’ should be judged in view of the applicable certification basis for the product. A design feature, in particular, should be judged to be a ‘novel or unusual design feature’ when the certification basis does not sufficiently cover this design. The term ‘unsafe condition’ is used with the same meaning as described in GM 21.A.3B(b). The term ‘newly identified hazards’ is intended to address new risks that may be recognised in the design (e.g. questionable features) or its operational characteristics (e.g. volcanic ash) for which there is not yet enough in-service experience.

86. The following GM 21.B.80 is inserted:

GM 21.B.80 Type-certification basis for a type certificate (TC) or restricted type certificate (RTC)

1. INTRODUCTION This GM addresses the type-certification basis for a TC or an RTC. 2. APPLICABLE CERTIFICATION SPECIFICATIONS (CSs) (see point 21.B.80(a)) The type-certification basis for a TC or an RTC consists of the airworthiness CSs that were effective on the date of application and were applicable for that certificate. The effectivity date of the initial application may be changed, as per point 21.A.15(f)(2), when the period of validity of an application for a type certificate is exceeded, or it is evident that it will be exceeded, and the applicant requests an extension; see GM 21.A.15(e) and (f). The certification basis is then revised accordingly. 3. ELECT TO COMPLY (see point 21.B.80(a)(1)) It is also possible for an applicant to elect to comply with a CS that entered into force after the date on which the applicant has submitted the application.

EASA should assess whether the proposed certification basis is appropriate to ensure that the ‘elect to comply’ proposal includes any other CSs that are ‘directly related’ to one or several of the CSs in it. Directly related CSs are those that are deemed to contribute to the same safety objective by building on each other’s requirements, addressing complementary aspects of the same safety concern, etc. Typically, they are adopted simultaneously with, or prior to, the CSs with which the applicant has elected to comply. 4. EQUIVALENT LEVEL OF SAFETY (see point 21.B.80(a)(2)) In cases in which the applicable CSs cannot be literally complied with, either fully or in part, EASA may accept a suitable alternative which provides an equivalent level of safety through the use of appropriate compensating factors. In cases in which the requirements contain not only objectives but also prescriptive parts, an equivalent level of safety may be accepted if: — the objectives are met by designs or features other than those required in the CSs; or — suitable compensating factors are proposed. 5. ALTERNATIVE MEANS OF COMPLIANCE (see point 21.B.80(a)(3)) If the intent of the CSs defined in point 21.B.80(a) cannot be met, EASA may accept mitigating factors to the CSs, provided that the safety objective is met. In the case of a TC, the alternative means should provide a demonstration of compliance with the essential requirements for airworthiness laid down in Annex II to Regulation (EU) 2018/1139. In the case of an RTC, the alternative means should provide a sufficient level of safety for the intended use. Note: ‘Alternative means of compliance’ should not be confused with ‘AMC’. 6. SPECIAL CONDITIONS (see point 21.B.75) EASA may also prescribe special conditions in accordance with point 21.B.75. Guidance on special conditions is provided in GM 21.B.75.

87. The following GM 21.B.82 is inserted:

GM 21.B.82 Operational suitability data (OSD) certification basis for an aircraft type certificate (TC) or restricted type certificate (RTC)

1. INTRODUCTION This GM addresses the OSD certification basis for a TC or an RTC. 2. APPLICABLE CERTIFICATION SPECIFICATIONS (CSs) (see point 21.B.80(a)) The OSD certification basis for a TC or an RTC consists of the OSD CSs that were applicable for that certificate and that were effective on the date of application for the TC or RTC or, if applicable, on the date of the application supplement.

The effectivity date of the initial application for the TC or RTC may be changed, as per point 21.A.15(f)(2), when the period of validity for an application for a type certificate is exceeded, or it is evident that it will be exceeded, and the applicant requests an extension; see GM 21.A.15(e) and (f). As a consequence, the OSD certification basis will be revised accordingly. 3. ELECT TO COMPLY (see point 21.B.82(a)(1)) It is also possible for an applicant to elect to comply with a CS that entered into force after the date on which the applicant has submitted the application. EASA should assess whether the proposed certification basis is appropriate to ensure that the ‘elect to comply’ proposal includes any other CSs that are ‘directly related’ to one or several of the CSs in it. Directly related CSs are those that are deemed to contribute to the same safety objective by building on each other’s requirements, addressing complementary aspects of the same safety concern, etc. Typically, they are adopted simultaneously with, or prior to, the CSs with which the applicant has elected to comply. 4. EQUIVALENT LEVEL OF SAFETY (see point 21.B.82(a)(2)) In cases in which the applicable CS(s) cannot be literally complied with, either fully or in part, EASA may accept a suitable alternative which provides an equivalent level of safety through the use of appropriate compensating factors. In cases in which the requirements contain not only objectives but also prescriptive parts, an equivalent level of safety may be accepted if: — the objectives are met by designs or features other than those required in the CSs; or — appropriate compensating factors are proposed. 5. ALTERNATIVE MEANS OF COMPLIANCE (see point 21.B.82(a)(2)) If the intent of the CSs defined in point 21.B.82(a) cannot be met, EASA may accept mitigating factors to the CSs, provided that the safety objective is met. In the case of a TC, the alternative means should provide a demonstration of compliance with the essential requirements for airworthiness laid down in Annex II to Regulation (EU) 2018/1139. In the case of an RTC, the alternative means should provide a sufficient level of safety for the intended use. Note: ‘Alternative means of compliance’ should not be confused with ‘AMC’. 6. SPECIAL CONDITIONS (see point 21.B.75) EASA may also prescribe special conditions in accordance with point 21.B.75. Guidance on special conditions is provided in GM 21.B.75.

88. The following AMC 21.B.100(a) and 21.A.15(b)(6) is inserted:

AMC 21.B.100(a) and 21.A.15(b)(6) Level of involvement (LoI) in a certification project for a type certificate (TC), a major change to a TC, a supplemental type certificate (STC), a major repair design or European technical standard order (ETSO) authorisation for an auxiliary power unit (APU)

1. Definitions

Risk: the combination of the likelihood and the potential impact of a non-compliance with part of

the certification basis.

Likelihood: a prediction of how likely an occurrence of non-compliance with part of the

certification basis is, based on a combination of the novelty and complexity of the proposed design and its related compliance demonstration activities, as well as on the performance of the design organisation.

Criticality: a measure of the potential impact of a non-compliance with part of the certification

basis on product safety or on the environment.

Compliance demonstration item (CDI): a meaningful group of compliance demonstration

activities and data of the certification programme, which can be considered in isolation for the purpose of performing a risk assessment.

EASA panel: an EASA panel is composed of one or more experts who are responsible for a

particular technical area. Each technical area addressed during product certification is covered by an EASA panel.

EASA discipline: an EASA discipline is a technical subarea of an EASA panel.

EASA’s level of involvement (LoI): the compliance demonstration activities and data that EASA

retains for verification during the certification process, as well as the depth of the verification. 2. Background The applicant has to submit a certification programme for their compliance demonstrations in accordance with point 21.A.15(b). The applicant has to break down the certification programme into meaningful groups of compliance demonstration activities and data, hereinafter referred as ‘CDIs’, and provide their proposal for EASA’s LoI. The applicant should also indicate the EASA panel(s) that is (are) affected by each CDI. This AMC explains: (a) how to propose EASA’s LoI for each CDI as per points 21.A.15(b)(6), 21.A.93(b)(3)(iii), 21.A.432C(b)(6), as well as 21.A.113(b); and (b) how EASA will determine its LoI on the basis of the criteria established in point 21.B.100. EASA will review the proposal and determine its LoI. Both parties, in mutual trust, should ensure that the certification project is not delayed through the LoI proposal and determination. Additionally, in accordance with point 21.A.20, the applicant has the obligation to update the certification programme, as necessary, during the certification process, and report to EASA any difficulty or event encountered during the compliance demonstration process which may require a change to the LoI that was previously notified to the applicant.

In such a case, or when EASA has other information that affects the assumptions on which the LoI was based, EASA will revisit its LoI determination. In accordance with points 21.A.33, 21.A.447 and 21.A.615, irrespective of the LoI, EASA has the right to review any data and information related to compliance demonstration. Note: This AMC should not be considered to be interpretative material for the classification of changes or repairs. 3. Principles and generic criteria for the LoI determination EASA determines its LoI based on the applicant’s proposal in view of the risk (the combination of the likelihood of an unidentified non-compliance and its potential impact). This is performed after proper familiarisation with the certification project in three steps: — Step 1: identification of the likelihood of an unidentified non-compliance, — Step 2: identification of the risk class, and — Step 3: determination of EASA’s LoI. This AMC contains criteria, common to all EASA panels, for the determination of: — any novel or unusual features of the certification project, including operational, organisational and knowledge management aspects; — the complexity of the design and/or compliance demonstration; — the performance and experience of the design organisation of the applicant in the domain concerned; — the criticality of the design or technology and the related safety and environmental risks, including those identified on similar designs; and — the data and activities to be retained by EASA. Note: Additional panel-specific criteria are available in further informative material published by EASA . This material should not be considered to be AMC. For CS-23 commuter (or CS-23 level 4 airplanes as defined in CS-23 Amdt 5), CS-25, CS-27 and CS-29 aircraft, all the panel-specific additional criteria should be considered. For the other products, the panel-specific criteria should only be considered for CDIs that affect noise, propulsion, development assurance and safety assessment (DASA), operational suitability data (OSD) and software and airborne electronic hardware. The criteria used to determine the likelihood and the potential impact of an unidentified noncompliance generally allow a proportionate approach to be applied, in particular in order to differentiate between CS-25 and general aviation (GA) aircraft projects. 3.1. LoI determination at CDI level The determination of EASA’s LoI is performed at the level of the CDI (please refer to AMC 21.A.15(b)(5)).

The applicant should demonstrate that all the affected elements of the type-certification basis as specified in point 21.B.80, of the OSD certification basis as specified in point 21.B.82, and of the environmental protection requirements as specified in 21.B.85, the corresponding means and methods of compliance, as well as the corresponding certification activities and data, are fully covered by the proposed CDIs. If the provided data does not clearly show that this is the case, the applicant should clearly state to EASA that all the above-mentioned elements are fully covered. Note: There could be different ways to ‘clearly show’ that all the elements of the certification basis are included in at least one CDI. For instance, this could be achieved by means of a ‘CDI reference’ column added in the table that lists all the elements of the certification basis. 3.2. Method for determining the likelihood of an unidentified non-compliance 3.2.1. Principle The likelihood of an unidentified non-compliance is assessed on the basis of the following criteria: — novelty, — complexity, and — the performance of the design organisation. 3.2.2. Novelty For the purpose of risk class determination, the following simplification has been made: a CDI may be either novel or non-novel. Whether or not a CDI is novel is based on the extent to which the respective elements of the certification project, as well as the related requirement or means of compliance, are new/novel to either the industry as a whole, or to the applicant, including their subcontractors, or from an EASA panel perspective. The determination that a CDI is novel may be driven by the use of new technology, new operations, new kind of installations, the use of new requirements or the use of new means of compliance. When an applicant utilises a type of technology for the first time, or when that applicant is relatively unfamiliar with the technology, this technology is considered to be ‘novel’, even if other applicants may be already familiar with it. This also means that a type of technology may no longer be novel for one applicant, while it may still be novel for other applicants. The following list includes some examples: — new materials or combinations of materials; — a new application of materials or combinations of materials; — new manufacturing processes; — a new or unusual aircraft configuration and/or system architecture; — a novel reconfiguration of systems; — a new interface or interaction with other parts or systems;

— the unusual location of a part or a system, or an unusual construction; — a new or unusual use; — new functions; — new kinds of operations; — the potential for new failure modes; — the introduction of a new threat (e.g. new threats regarding fire, fuel, hydrogen, energy storage devices, etc.) or a new prevention/detection/mitigation method; — new maintenance techniques; — novel operating conditions or limitations; — a new human–machine interface (HMI); or — new flight or cabin crew tasks. Another consideration is the extent to which the requirements, means of compliance or guidance have changed or need to be adapted due to particular novel features of the design. The following list includes some examples: — recently issued or amended CSs with which the applicant has little or no experience; — new or adapted special conditions; — new or adapted equivalent safety findings; — new or adapted deviations; — new or adapted guidance or interpretative material; — new or adapted means of compliance (i.e. other than those previously applied by the applicant) or unusual means of compliance (different from the existing guidance material and/or different from industry standard practices), e.g. the replacing of tests by simulation, numerical models or analytical methods; — the use of new or adapted industry standards or in-house methods, as well as EASA’s familiarity with these standards and methods; — a change in methodology, tools or assumptions (compared with those previously applied by the applicant), including changes in software tools/programs; or — novelty in the interpretation of the results of the compliance demonstration, e.g. due to in-service occurrences (compliance demonstration results are interpreted differently from the past). Additional new guidance/interpretative material in the form of new certification memoranda (CM) may be considered for the determination of novelty if its incorrect application/use may lead to an unidentified non-compliance. In the context of novelty, the time between the last similar project and the current project of the applicant should also be considered.

Regardless of the extent of an organisation’s previous experience in similar projects, a CDI may be classified as novel if there are specific discontinuities in the process for transferring information and know-how within the organisation. 3.2.3. Complexity For the purpose of risk class determination, the following simplification has been made: a CDI may be either complex or non-complex. For each CDI, the determination of whether it is complex or not may vary based on factors such as the design, technology, associated manufacturing process, compliance demonstration (including test set-ups or analysis), interpretation of the results of the compliance demonstration, interfaces with other technical disciplines/CDIs, and the requirements. The compliance demonstration may be considered to be ‘complex’ for a complex (or highly integrated) system, which typically requires more effort from the applicant. The following list includes some examples: — Compliance demonstration in which challenging assessments are required, e.g.: — for requirements of a subjective nature, i.e. they require a qualitative assessment, and do not have an explicit description of the means of compliance with that requirement, or the means of compliance are not a common and accepted practice; this is typically the case where the requirement uses terms such as ‘subjective’, ‘qualitative’, ‘assessment’ or ‘suitable’/‘unsuitable’ — in contrast, engineering judgement for a very simple compliance demonstration should not be classified as ‘complex’; — a test for which extensive interpretation of the results may be anticipated; — an analysis that is sensitive to assumptions and could potentially result in a small margin of safety; — the classification of structures, depending on the conservatism of the method; — an advanced analysis of dynamic behaviour; — a multidisciplinary compliance demonstration in which several panels are involved and interface areas need to be managed (e.g. sustained engine imbalance, extendedrange twin-engine operation performance standards (ETOPS), 2X.1309 assessment, flight in known icing conditions, full authority digital engine control (FADEC)controlled engines, etc.); — when the representativeness of a test specimen is questionable, e.g. due to its complexity; — the introduction of complex work-sharing scheme with system or equipment suppliers. For major changes, the complexity of the change should be taken into account, rather than the complexity of the original system. Whether or not a CDI is complex should be determined in a conservative manner if this cannot be determined at an early stage of the certification project. When greater clarity has been achieved, the complexity may be re-evaluated and the LoI adapted accordingly.

3.2.4. Performance of the design organisation The assessment of the level of performance of the design organisation takes into account the applicant’s experience with the applicable certification processes, including their performance on previous projects and their degree of familiarity with the applicable certification requirements. For approved design organisations, EASA uses relevant data to consider the design organisation’s expected performance at an organisational, panel or discipline level, depending on the availability of data . This data stems from design organisation audits, the applicant’s measured level of performance on previous projects, and their performance during the familiarisation phase. EASA shares this data with the respective design organisations (in the form of the design organisation approval (DOA) dashboard). For each CDI proposed by the applicant, the DOA holder’s performance associated with the affected disciplines or panels is to be considered. If one CDI affects more panels or disciplines than the others, a conservative approach should be followed in selecting the lower performance level. As an alternative, that CDI may be assessed separately for each affected EASA panel or discipline. If, for a well-established organisation, there is no shared performance data available at the panel level, it may be acceptable to propose the overall DOA holder’s performance. If the organisation or its scope are fundamentally new, the ‘unknown’ level of performance should be conservatively proposed by the applicant. The determination of the performance of the design organisation may also take into consideration information that is more specific or more recent than the information on the DOA holder’s dashboard, e.g. experience gained during technical familiarisation with the current certification project, the performance of compliance verification engineers and of the affected technical areas, as well as the performance of the design organisation in overseeing subcontractors and suppliers. The performance of some applicants’ organisations is not known if: — EASA has agreed in accordance with point 21.A.14(b) that the applicants may use procedures that set out specific design practices, as an alternative means to demonstrate their capability (excluding European technical standard order (ETSO) applicants for other than APU, covered by point 21.B.100(b)); or — the applicants demonstrate their capability by providing EASA with the certification programme in accordance with point 21.A.14(c). In these cases, the assumed level of performance is ‘unknown’. Exceptionally, EASA may consider a higher level of performance for a specific CDI if that is proposed and properly justified by the applicant. The following list includes some examples: — a CDI with which EASA is fully familiar and satisfied (from previous similar projects) regarding the demonstration of compliance proposed by the applicant;

— if the applicant fully delegates the demonstration of compliance to a supplier that holds a DOA, the performance level of the supplier may be proposed. 3.2.5. Likelihood of an unidentified non-compliance Assessing the likelihood of an unidentified non-compliance is the first step that is necessary to determine the risk class. The likelihood of an unidentified non-compliance should not be confused with the likelihood of occurrence of an unsafe condition as per AMC 21.A.3B(b). In fact, that AMC provides EASA’s confidence level that the design organisation addresses all the details of the certification basis for the CDI concerned, and that a non-compliance will not occur. The likelihood of an unidentified non-compliance is established as being in one of four categories (very low, low, medium, high), depending on the level of performance of the design organisation as assessed by EASA, and on whether the CDI is novel or complex, as follows:

Step 1 — Likelihood of an unidentified non-compliance CDI No novel aspects, No novel aspects, Novel and complex but complex ones; aspects no complex aspects Performance Novel aspects, but level of the DOAH no complex ones High Very low Low Medium Medium Low Medium High Low or unknown Medium High High

3.3. Criticality The second step that is necessary to determine the risk class is the assessment of the potential impact of a non-compliance on part of the certification basis regarding the airworthiness or the environmental protection of the product. For the purpose of risk class determination, the following simplification has been made: the impact of a non-compliance can be either critical or non-critical. Some of the guidance below has been derived from GM 21.A.91, not due to a major/minor change classification, but because the same considerations may be applied to determine the effect of a non-compliance on the airworthiness or environmental protection at the CDI level. It is therefore normal that some of the CDIs of a major change that consists of several CDIs may be critical, and others may be non-critical. The potential impact of a non-compliance within a CDI should be classified as critical if, for example: — a function, component or system is introduced or affected where the failure of that function, component or system may contribute to a failure condition that is classified as hazardous or catastrophic at the aircraft level, for instance for ‘equipment, systems and installations’, e.g. where applicable as defined in 2X.1309; — a CDI has an appreciable effect on the human–machine interface (HMI) (displays, approved procedures, controls or alerts);

— airworthiness limitations or operating limitations are established or potentially affected; — a CDI is affected by an existing airworthiness directive (AD), or affected by an occurrence (or occurrences) potentially subject to an AD, a known in-service issue or by a safety information bulletin (SIB); or — a CDI affects parts that are classified as critical as per CS 27.602/29.602, CS-E 515, or that have a hazardous or catastrophic failure consequence (e.g. a principal structural element as per CS 25.571). If the classification of the potential impact of a non-compliance within a CDI as critical is based on the criterion that the CDI is affected by an AD, then the impact of a non-compliance within that CDI may be reclassified by EASA as non-critical due to the involvement of EASA in the continuedairworthiness process. During the early stages of a project, the criticality in terms of the potential safety consequence of a failure may not always be known, but should be conservatively estimated and the LoI should be subsequently re-evaluated, if appropriate. 3.4. Method for the determination of risk classes The risk is determined as a combination of the potential impact of an unidentified non-compliance with part of the certification basis (vertical axis) and of the likelihood of the unidentified noncompliance (horizontal axis) using the following matrix. As a consequence, four qualitative risk classes are established at the CDI level.

Step 2 — Risk classes Likelihood (see Section 3.2.5) Very low Low Medium High Criticality (see Section 3.3)

Non-critical Class 1 Class 1 Class 2 Class 3 Critical Class 1 Class 2 Class 3 Class 4

The various inputs and the resulting risk class determination are of a continuous nature, rather than consisting of discrete steps. The selected risk class provides the order of magnitude of EASA’s involvement and is used as a qualitative indicator for the determination of EASA’s involvement described in Section 3.5 below. Under specific circumstances, the risk class that is determined on the basis of the above criteria may be reduced or increased on the basis of justified and recorded arguments. For a reused and well-proven item of compliance demonstration for which: — the CDI is independent of the affected product type or model; and — the design, operation, qualification, and installation of the product are basically the same; and

— the certification process is identical to one that was used in a modification already approved by EASA, the CDI may be accepted as being similar, resulting in reduced LoI, as the likelihood of an unidentified non-compliance is low. Furthermore, when an identical CDI is reused for the compliance demonstration in a new project, there is no involvement in the compliance demonstration verification, as the likelihood of an unidentified non-compliance is very low. 3.5. Determination of EASA’s LoI EASA’s LoI in the verification of compliance demonstration is proposed by the applicant and determined by EASA in Step 3 on the basis of the qualitative risk class identified per CDI in Step 2, as well as by applying sound engineering judgement. EASA’s LoI is reflected in a list of activities and data, in which EASA retains the verification of compliance demonstration (e.g. review and acceptance of compliance data, witnessing of tests, etc.), as well as the depth of the verification. The depth of the verification for individual compliance reports, data, test witnessing, etc., may range from spot checks to extensive reviews. EASA always responds to those retained compliance demonstration activities and data with corresponding comments or a ‘statement of no objection’. In addition, some data that is not retained for verification may be requested for information. In this case, no ‘statement of no objection’ will be provided. It is recommended that an LoI should be proposed for each of the EASA disciplines involved. Depending on the risk classes determined in Section 3.4 above, EASA’s LoI in: (a) compliance demonstration verification data; and (b) compliance demonstration activities (witnessing of tests, audits, etc.), may be as follows: — risk Class 1: there is no EASA involvement in verifying the compliance data/activities performed by the applicant to demonstrate compliance at the CDI level; — risk Class 2: EASA’s LoI is typically limited to the review of a small portion of the compliance data; there is either no participation in the compliance activities, or EASA participates in a small number of compliance activities (witnessing of tests, audits, etc.); — risk Class 3: in addition to the LoI defined for Class 2, EASA’s LoI typically comprises the review of a large amount of compliance data, as well as the participation in some compliance activities (witnessing of tests, audits, etc.); and — risk Class 4: in addition to the LoI defined for Class 3, EASA’s LoI typically comprises the review of a large amount of compliance data, the detailed interpretation of test results, and the participation in a large number of compliance activities (witnessing of tests, audits, etc.). By default, the following activities require EASA’s involvement in all cases: — initial issues of, and changes to, a flight manual (for those parts that require EASA approval and that do not fall under the DOA holder’s privilege);

— classification of failure cases that affect the handling qualities and performance, when: — performed through test (in flight or in a simulator); and — initial issues of, and non-editorial changes to, airworthiness limitations. If the risk assessment (Steps 1 and 2 above) is made on the level of a compliance demonstration activity or on the level of a document, the risk class provides an indication for the depth of the involvement, i.e. the verification may take place only for certain compliance data within a compliance document. 4. Documentation of the LoI The LoI proposal in the certification programme should include the applicant’s proposal regarding the compliance demonstration verification activities and data that would be retained by EASA, as well as the data on which the LoI proposal has been based. For this purpose, the applicant should appropriately document the analysis per CDI, considering the above criteria. In cases where the rationale for the assessment is obvious, it is considered to be sufficient for the applicant to indicate whether or not a CDI is novel or complex, and whether or not the impact is critical. EASA documents the LoI determination by accepting the certification programme or, if it deviates from the proposal, by recording its analysis regarding the deviations from the proposal, and notifies the applicant accordingly. 5. Sampling during surveillance of the DOA holder It should be noted that all the previously defined risk classes may be complemented by the sampling of project files during surveillance of the DOA holder, independently from the ongoing certification project. This is necessary in order to maintain confidence in the DOA system and to constantly monitor its performance.

89. The following AMC No 1 to 21.B.100(b) is inserted:

AMC No 1 to 21.B.100(b) Level of involvement (LoI) in projects for minor changes and minor repairs

In contrast to 21.B.100(a), the assessment of the LoI for minor repair designs and minor changes is performed by EASA at the level of the certification project. EASA reviews the information provided by the applicant in accordance with point 21.A.93(b) for novel or unusual features, the complexity of the design and/or the compliance demonstration, as well as the criticality of the design or technology. An application for EASA’s approval of a minor change implies that the applicant either does not hold a design organisation approval (DOA) or that the change is outside the DOA holder’s terms of approval. However, EASA takes into account the performance and experience of the applicant with similar design changes, for which data may be already available at EASA. The applicant may be also requested to present its experience with similar design changes if insufficient information is available at EASA. By definition (see point 21.A.91), a minor change has no appreciable effect on the airworthiness of the product. Therefore, the potential impact of a non-compliance with part of the certification basis regarding the airworthiness or environmental protection aspects of the product should, in most cases, be non-critical.

This facilitates the assessment of the likelihood of an unidentified non-compliance. A process similar to the one described in AMC 21.B.100(a) and 21.A.15(b)(6) should be used to justify and document EASA’s LoI. Following a first assessment of the criticality of the described design or technology, EASA evaluates the existence of any novel or unusual features, as well as the complexity of the design and/or the compliance demonstration. Depending on the results of this evaluation, and based on the table below, EASA determines its LoI as follows:

Risk class

Non-novel and Class A Class A non-complex Non-critical Novel and/or Class B Class C complex

Critical All cases Class C Class C

Level of experience: Level of experience: high or medium low or unknown

— Class A: EASA’s involvement is limited to the review of the information that summarises the main results of the compliance demonstration, without any participation in compliance activities (witnessing of tests, audits, etc.). — Class B: in addition to the LoI defined for risk Class A, EASA’s involvement is limited to the review of those compliance elements that are related to the identified novel or unusual features, complexity of the design and/or compliance demonstration. EASA may exceptionally participate in the related compliance activities (by witnessing tests, audits, etc.). — Class C: EASA’s involvement is limited to the review of all the compliance documents that are related to the identified criticality of the design or technology, if applicable, or to the identified novel or unusual features. EASA may participate in the related compliance activities (by witnessing tests, audits, etc.).

90. The following AMC No 2 to 21.B.100(b) is inserted:

AMC No 2 to 21.B.100(b) Level of involvement (LoI) in European technical standard order authorisation (ETSOA) projects

The applicant for an ETSOA is required to demonstrate its capability by obtaining EASA’s agreement for the use of procedures that incorporate its specific design practices. The assessment by EASA that these procedures are properly applied is performed solely through the various ETSOA projects of the applicant. No regular audits of the organisation are performed by EASA outside the ETSOA projects. A properly completed Form 34 and the certification programme, including a technical description of the proposed design of the ETSO article, are the basis for the determination of EASA’s initial LoI.

EASA assesses the compliance of the proposed ETSO article with the ETSO requirements as defined in the applicable CS-ETSO standards, as well as compliance with Part 21 Subpart O (e.g. the declaration of design and performance (DDP), ETSO marking, rating of performance, etc.). The ETSOA applicant should deliver a complete data package per point 21.A.605. EASA’s LoI is further reassessed and adapted throughout the certification project until the ETSOA is issued, depending on the applicant’s data, as well as on the ETSO project changes regarding the applicant’s compliance demonstration (e.g. methods, design changes, deviations, limitations, problem reports, etc.). 1. Principles EASA’s LoI in ETSO projects is defined based both on the responsibility of EASA to assess the applicant’s demonstration of compliance, and on the risk evaluated, according to the following criteria: — the applicant’s level of experience in the ETSO process and scope of work; — the applicant’s level of performance in the ETSO scope of work; — the use of novelties in the technology/design or in the means of compliance; and — the complexity of the ETSO article. 1.1. Applicant’s experience in the ETSOA process and scope of work This Section addresses the experience of the applicant’s organisation in the ETSOA process, as well as in the scope of the certification basis of the ETSO article, and of the related requirements. The presence of any of the following aspects contributes to EASA’s identification of the risk related to the level of experience of the applicant in the ETSOA process, or to the scope of work of the article: — the applicant is new and has just applied for the acceptance of its procedures by EASA, or it is the first project of the applicant after EASA has accepted such procedures; — the organisation has changed significantly the agreed procedures; and — the scope of work of the ETSOA project (ETSO standards) is new to the applicant. 1.2. ETSOA applicant’s performance within its scope of work The ETSOA applicant’s level of performance within its scope of work is evaluated using criteria that enable EASA to identify risks in the applicant’s performance due to the following situations: — the applicant has deficiencies in the procedures that it uses to demonstrate compliance with the certification requirements; — the applicant has changed its methods or procedures to demonstrate compliance with the certification requirements; — the assessment of the applicant’s compliance on previous projects in the same ETSO scope of work has revealed significant issues in complying with the certification requirements, in the completion of data, or in the repetition of errors; — the scope of work is new to the applicant’s team at the facilities where the project is developed, or the team had significant issues on preceding projects;

— EASA has not conducted an ETSOA project assessment of the applicant in the same ETSO scope of work for a long period (i.e. 2 or 3 years); and — the applicant did not regularly report minor changes or occurrences in a timely manner. 1.3. Novelty in the technology or in the means of compliance A ‘novelty’ is understood to be the use of new technology, new sensors, new material, the use of new requirements or the use of new means of compliance. When an applicant is faced with a technology for the first time, or when that applicant is relatively unfamiliar with the technology, this is considered to be ‘novel’ even if other applicants may be already familiar with that technology. Also related to novelty is the extent to which requirements, means of compliance or guidance need to be adapted due to particular novel features of the design. The following list includes some examples: — recently issued CS-ETSO standards, with which the applicant has limited experience; — novel deviations; — new guidance; — new means of compliance (i.e. other than those previously applied by the applicant) or unusual means of compliance (different from the existing guidance material and/or different from industry standard practices); — the use of new industry standards or new in-house methods, as well as EASA’s familiarity with these new standards and methods; — changes in methodology, tools or assumptions (compared with those previously applied by the applicant), including changes in software tools/programs. Technology or means of compliance may be new/novel either from a global industry, applicant or EASA perspective. 1.4. Complexity Complexity may result from the design, technology, associated manufacturing process, compliance demonstration (including test set-ups or analysis), as well as from the variety of ETSOs with which the applicant intends to comply, and their possible interactions. The demonstration of compliance may be ‘complex’ for complex (or highly integrated) equipment, so it typically requires more effort from the applicant. 1.5. Criticality of the design and of the technology The criticality levels of the design and of the technology of the ETSO article are considered, but have a minor impact on the definition of EASA’s LoI. The main reasons are: — the assessment of ETSO compliance is as important for an ETSO article that hosts a critical function as it is for equipment that host less critical functions (e.g. flight data recorders); and

— the criticality of the design or technology is not always defined for an ETSO article, and it may depend on the installation of the design or technology (e.g. a multifunction display), which may only occur later. 2. Determination of EASA’s LoI

EASA’s LoI in the assessment of the applicant’s compliance demonstration is determined by EASA

on the basis of the qualitative risk class and EASA’s responsibilities in assessing the ETSO project certification data package, together with the procedures for compliance with the ETSO requirements (Part 21 Subpart O, and CS-ETSO). EASA’s LoI is defined in the following paragraph 2.1 and, as per point 21.B.100(c), the EASA’s LoI that is applicable to each project is notified to the applicant. To every LoI class corresponds a list of activities that govern EASA’s involvement. By means of these activities, EASA verifies the demonstration of compliance (e.g. by document review and acceptance, test witnessing, sampling on the applicant’s site, desktop assessments, etc.). The ETSO applicant is responsible for providing a complete ETSO certification data package. 2.1. Definition of the LoI classes EASA’s LoI for an ETSO certification project is classified as one of the following: — class high, — class high reduced, — class medium, or — class basic. Class ‘high reduced’ is, by default, EASA’s initial LoI in an ETSO project. The following is a description of each LoI class: — High EASA evaluates and samples/checks in an extensive manner all the compliance data to assess the applicant’s demonstration of compliance with the applicable ETSO standards. EASA assesses the applicant’s DDP and general compliance with Part 21 Subpart O. EASA performs desktop reviews, as well as on-site assessments of compliance demonstrations. This occurs when design and verification evidence is available. — High reduced EASA assesses all the compliance data; sampling/checking is significant and adapted to the likelihood of an unidentified non-compliance. The sampling rate may be reduced if the content of the life cycle data provides confidence in compliance and is focused in the area where confidence needs to be gained. EASA assesses the DDP and general compliance with Part 21 Subpart O. EASA performs desktop reviews, as well as an on-site assessment of the applicant’s compliance demonstration. This occurs when design and verification evidence is available. — Medium

EASA assesses all the compliance data, but for some compliance data, it performs no or limited sampling/checking. EASA adapts its sampling and focuses on the likelihood of an unidentified non-compliance, taking into account the level of complexity and novelty of the project. EASA assesses the DDP and general compliance with Part 21 Subpart O. EASA performs desktop reviews and may perform an on-site assessment of the applicant’s compliance demonstration. — Basic EASA assesses the DDP and general compliance with Part 21 Subpart O, and verifies the completeness of the data package. Generally, EASA performs a desktop assessment. 3. The process of determining EASA’s LoI The determination of EASA’s LoI is captured as a process. This process is performed mainly in three steps and is illustrated in the following figure:

1. Determination of initial LoI 2. Reassessment of LoI

Figure 1: Process of determination of EASA’s LoI in ETSO certification projects

Step 1 consists of the initial LoI determination which EASA evaluates by assessing:

— the applicant’s experience in the ETSOA process and scope of work according to Section 1.1 above, and — the ETSOA applicant’s performance within its scope of work according to Section 1.2 above. The result of this determination of EASA’s initial LoI is either high or high reduced.

Step 2 consists of reassessing EASA’s LoI. Throughout the ETSO project, EASA receives project

deliverables (e.g. plans, reports), means of compliance, requests for deviations, limitations, etc., and interacts with the applicant. If EASA’s LoI has been initially set to high reduced, EASA re-evaluates it considering: — the novelty in the technology or in the means of compliance according to Section 1.3 above, and — the complexity of the ETSO project according to Section 1.4 above. The result of this reassessment may vary from high to medium according to the following table:

Assessment results LoI adaptation

The ETSO article is novel and complex or a significant issue is detected during the LoI is increased to high. compliance demonstration. The ETSO article is novel or complex or a new 1 LoI is confirmed as high reduced. deviation is requested ( ). The ETSO article is non-novel and non-complex, no issue is detected during the compliance LoI is decreased to medium. demonstration or method, and no novel deviation or new limitation is requested. There is a major change with straightforward 2 LoI is reduced to basic. redemonstration of the ETSO compliance ( ). ( ) It refers to deviations from ETSO minimum operational performance standards (MOPSs), excluding deviations for requesting compliance with a new revision of an industry MOPS standard. ( ) When EASA agrees that a major change only requires a straightforward redemonstration of the ETSO compliance using previous methods, without any identified risk, then EASA’s LoI is reduced to basic. Please note that this may only be defined after a minimum assessment of the applicant’s compliance demonstration methods. Note: For a minor change, this process does not apply; in that case, EASA’s LoI consists of an assessment of the minor change classification, an update of the certificate, and, when needed, an assessment of the DDP.

91. GM No 2 to 21.B.220(c) is amended as follows Editorial note: the below paragraph has been added to show the highlighted change to the reference in the last sentence.

GM No 2 to 21.B.220(c) Procedures for investigation – General

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