NPA 2024-04 Regular update of Commission Regulation (EU) No 748/2012 and the associated acceptable means of compliance and guidance material (RMT.0031 Subtask 3)

Dokumendiregister	Transpordiamet
Viit	1.8-5/24/7685-1
Registreeritud	03.05.2024
Sünkroonitud	06.05.2024
Liik	Sissetulev kiri
Funktsioon	1.8 Rahvusvahelise koostöö korraldamine
Sari	1.8-5 Rahvusvaheline kirjavahetus lennundusohutuse küsimustes: ECAC, ICAO, EASA, Eurocontrol, State Letterid
Toimik	1.8-5/2024
Juurdepääsupiirang	Avalik
Juurdepääsupiirang
Adressaat	Euroopa Lennundusohutusamet
Saabumis/saatmisviis	Euroopa Lennundusohutusamet
Vastutaja	Anastasia Levin (Users, Tugiteenuste teenistus, Õigusosakond)
Originaal	Ava uues aknas

Dokument on kokkuvõtte tegemiseks liiga mahukas (434971 tm).

Failid

npa_2024-04_a_v14 (1).pdf

npa_2024-04_b_v11.pdf

npa_2024-04_c_v11.pdf

npa_2024-04_d_v12.pdf

npa_2024-04_a_v14 (1).pdf

European Union Aviation Safety Agency

Notice of Proposed Amendment 2024-04 (A) in accordance with Article 6 of MB Decision 01-2022

TE.RPRO.00034-012 © European Union Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 1 of 38

An agency of the European Union

Regular update of Commission Regulation (EU) No 748/2012 and the associated acceptable means of compliance

and guidance material RMT.0031 — SUBTASK 3

EXECUTIVE SUMMARY

This Notice of Proposed Amendment (NPA) proposes to amend Commission Regulation (EU) No 748/2012 (the Initial Airworthiness Regulation) and the associated acceptable means of compliance (AMC) and guidance material (GM) in order to address miscellaneous issues of a non-controversial nature.

The objective is to ensure that the Initial Airworthiness Regulation and the associated AMC and GM are fit for purpose, are cost-effective, and can be implemented. To achieve this, the following main actions are proposed in this NPA:

— amend the articles of the Initial Airworthiness Regulation to match the current situation of grandfathering and transitional measures and to correct cross references to the points in Annex I (Part 21);

— clarify the competence requirements for pilots performing operational suitability data flight tests in Annex I (Part 21);

— clarify the reporting obligations for production organisation approval holders in Annex I (Part 21);

— introduce recommendations made by the International Authorities Working Group on point 21.A.101;

— correct typographical errors and cross references in Annex I (Part 21) and in the AMC and GM;

— resolve certain recurrent implementation issues by improving the text of the AMC and GM to Annex I (Part 21);

— align the AMC and GM to Annex I (Part 21) with the current industry practices and standards.

The proposed regulatory material is expected to increase the efficiency of implementing Annex I (Part 21) and ensure alignment with the current industry practices.

NPA 2024-04 is divided into four parts. This document, NPA 2024-04 (A), includes the background information pertaining to the regulatory proposal.

WORKING METHOD(S)

Development Impact assessment(s) Consultation

By EASA Light NPA — Public

Related documents/information: ToR RMT.0031 Issue 2, 22 February 2023

PLANNING MILESTONES: Refer to the latest edition of Volume II of the European Plan for Aviation Safety (EPAS).

REGULATION TO BE AMENDED

Commission Regulation (EU) No 748/2012 (IAW)

ED DECISIONS TO BE AMENDED

ED Decision 2012/020/R – AMC/GM to Part 21, Issue 2

AFFECTED STAKEHOLDERS

Design and production organisations; Member States’ competent authorities; EASA

European Union Aviation Safety Agency NPA 2024-04 (A)

Table of contents

An agency of the European Union

Table of contents

1. About this NPA ........................................................................................................................ 3

1.1. How this regulatory material was developed .......................................................................... 3

1.2. How to comment on this NPA .................................................................................................. 3

1.3. Next steps ................................................................................................................................. 4

2. In summary — why and what ................................................................................................... 5

2.1. Why we need to act — issue/rationale .................................................................................... 5

2.1.1. Description of the issues .......................................................................................................... 5

2.1.2. Who is affected by the issue .................................................................................................. 18

2.1.3. How could the issue evolve .................................................................................................... 18

2.1.4. Conclusion on rulemaking needs ........................................................................................... 19

2.2. What we want to achieve — objectives ................................................................................. 19

2.3. How we want to achieve it — overview of the proposed amendments ................................ 20

2.3.1. Proposal .................................................................................................................................. 20

2.3.2. Targeted applicability of the regulatory material .................................................................. 30

2.3.3. Legal basis ............................................................................................................................... 31

2.4. Stakeholders’ views ................................................................................................................ 31

3. Expected benefits and drawbacks of the proposed regulatory material .................................. 32

4. Proposed regulatory material ................................................................................................. 33

5. Monitoring and evaluation ..................................................................................................... 34

6. Proposed actions to support implementation ........................................................................ 35

7. References ............................................................................................................................. 36

Appendix — Quality of the NPA .................................................................................................... 37

1. The regulatory proposal is of technically good/high quality .................................................. 37

2. The text is clear, readable and understandable ..................................................................... 37

3. The regulatory proposal is well substantiated ....................................................................... 37

4. The regulatory proposal is fit for purpose (achieving the objectives set) .............................. 37

5. The regulatory proposal is proportionate to the size of the issue ......................................... 37

6. The regulatory proposal applies the ‘better regulation’ principles ....................................... 37

7. Any other comments on the quality of this document (please specify) ................................ 38

European Union Aviation Safety Agency NPA 2024-04 (A)

1. About this NPA

An agency of the European Union

1. About this NPA

1.1. How this regulatory material was developed

The European Union Aviation Safety Agency (EASA) identified a set of issues (as described in Section 2)

and, after having assessed the impacts of the possible intervention actions, identified rulemaking as

the necessary intervention action.

This rulemaking activity is included in the 2024 edition of Volume II of the European Plan for Aviation

Safety (EPAS)1 under Rulemaking Task (RMT).0031.

EASA developed the regulatory material in question in line with Regulation (EU) 2018/11392 (the Basic

Regulation) and the Rulemaking Procedure3, and in accordance with the objectives and working

methods described in the Terms of Reference (ToR) for this rulemaking task4.

1.2. How to comment on this NPA

The draft regulatory material is hereby presented for public consultation.

Please submit your comments using solely the dedicated Comment-Response Tool (CRT) available at

http://hub.easa.europa.eu/crt/5.

To facilitate the collection of comments and technically support their subsequent review by EASA in

an efficient, controlled and structured manner, stakeholders are kindly requested to submit their

comments to the relevant predefined segments of the NPA within the CRT, and to refrain from

submitting specific comments or all their comments to the ‘General Comments’ segment.

Furthermore, once all comments are placed in the relevant predefined segments, there is no need to

submit them (as a PDF attachment) to the ‘General Comments’ segment.

The deadline for the submission of comments is 30 July 2024.

1 European Plan for Aviation Safety (EPAS) 2024 - 13th edition | EASA (europa.eu) 2 Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field

of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1) (https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1535612134845&uri=CELEX:32018R1139).

3 EASA is bound to follow a structured rulemaking process as required by Article 115(1) of Regulation (EU) 2018/1139. Such a process has been adopted by the EASA Management Board (MB) and is referred to as the ‘rulemaking procedure’. See MB Decision No 01-2022 of 2 May 2022 on the procedure to be applied by EASA for the issuing of opinions, certification specifications and other detailed specifications, acceptable means of compliance and guidance material (‘rulemaking procedure’), and repealing Management Board Decision No 18-2015 (https://www.easa.europa.eu/the-agency/management-board/decisions/easa-mb-decision-01-2022-rulemaking- procedure-repealing-mb).

4 ToR RMT.0031 ‘Regular update of the Initial Airworthiness Regulation and associated AMC and GM’ Issue 2 (https://www.easa.europa.eu/en/document-library/terms-of-reference-and-rulemaking-group-compositions/tor- rmt0031).

5 In the event of technical problems, please send an email with a short description to [email protected].

European Union Aviation Safety Agency NPA 2024-04 (A)

1. About this NPA

An agency of the European Union

1.3. Next steps

Following the consultation on the draft regulatory material, EASA will review all the comments

received and will duly consider them in the subsequent phases of this rulemaking activity.

Considering the above, EASA may issue an opinion proposing amendments to Commission Regulation

(EU) No 748/20126. The opinion will be submitted to the European Commission, which shall consider

its content and decide whether to issue amendments to that Regulation.

In addition, EASA may issue a decision setting out the AMC and GM.

When issuing the opinion and the decision, EASA will also provide feedback to the commenters and

information to the public on who engaged in the process and/or provided comments during the

consultation on the draft regulatory material, which comments were received, how such engagement

and/or consultation was used in rulemaking and how the comments were considered.

6 Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations (recast) (OJ L 224, 21.8.2012, p. 1) (https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=CELEX%3A32012R0748&qid=1707392133954).

European Union Aviation Safety Agency NPA 2024-04 (A)

2. In summary — why and what

An agency of the European Union

2. In summary — why and what

2.1. Why we need to act — issue/rationale

The adoption of Regulation (EU) 2018/1139 (the Basic Regulation) and the adoption of several other

regulations amending Commission Regulation (EU) No 748/2012 have introduced certain

inconsistencies in the articles of Commission Regulation (EU) No 748/2012 regarding transition and

grandfathering measures and in cross references to its Annex I (Part 21).

The stakeholders and EASA have also identified the following gaps and errors in Annex I (Part 21), for

example:

— the reporting obligations for production organisations are incorrect (i.e. they wrongly state that

production organisations report also to the Agency);

— clear competence requirements for pilots performing operational suitability data (OSD) flight

tests are lacking.

In addition, the industry standards and practices have evolved and the design and production

organisations may benefit from the recognition of current standards/practices as acceptable means

of compliance with Annex I (Part 21).

Moreover, the experience accumulated during product certification projects and design/production

organisation approvals and oversight has highlighted recurrent issues that may impact the efficient

management of such projects.

Finally, there is a need to correct typographical errors and incorrect cross references that may affect

the clarity of the regulatory material in Annex I (Part 21) and its AMC and GM.

A detailed description of the identified issues is provided in the following section.

2.1.1. Description of the issues

Issues in the articles (enacting terms) of Commission Regulation (EU) No 748/2012

Issue 1: Article 4 — outdated cross references

After the issuance of Commission Regulation (EU) No 748/2012, Commission Delegated Regulation

(EU) 2019/897 has amended point 21.A.113(b) of Annex I (Part 21) and has added point 21.A.113(c)7.

Consequently, the cross reference in Article 4(2)(b) is now incomplete.

In addition, the cross reference in Article 4(2)(d) to point 21.A.115(a) of Annex I (Part 21) is no longer

appropriate, as the content of this point was changed with Commission Regulation (EU) No 748/2012.

7 Commission Delegated Regulation (EU) 2019/897 of 12 March 2019 amending Regulation (EU) No 748/2012 as regards the inclusion of risk-based compliance verification in Annex I and the implementation of requirements for environmental protection (OJ L 144, 3.6.2019, p. 1) (https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=CELEX%3A32019R0897&qid=1707310174775).

European Union Aviation Safety Agency NPA 2024-04 (A)

2. In summary — why and what

An agency of the European Union

Issue 2: Article 7a — outdated cross references and transitional measures

Commission Regulation (EU) No 69/20148 amended Commission Regulation (EU) No 748/2012 to

introduce new requirements on OSD. Article 7a was inserted to include grandfathering and

transitional measures for a smooth implementation of the new requirements.

Commission Delegated Regulation (EU) 2019/897 reorganised the provisions in Annex I (Part 21) to

Commission Regulation (EU) No 748/2012 in such a manner that Section A sets out the requirements

applicable only to the applicants for, and holders of, any certificate issued or to be issued in

accordance with that Annex and that Section B sets out the requirements applicable only to the

competent authorities, including EASA. Point 21.A.21(e), referenced in Article 7a and related to type-

certificate (TC) entitlement when the applicant has demonstrated compliance with the applicable OSD

certification basis, was rearranged to be partially in point 21.A.21 (demonstration of compliance) and

partially in point 21.B.103 (issuance of the TC). In addition, the OSD certification basis was moved from

point 21.A.17B to point 21.B.82. However, Article 7a was not updated accordingly.

Issue 3: Article 9 — outdated cross references

Commission Delegated Regulation (EU) 2023/10289 has fully replaced Article 9 of Commission

Regulation (EU) No 748/2012, which has been inadvertently modified by Commission Delegated

Regulation (EU) 2022/1358. However, the provisions in the current Article 9(8) have not been updated

to correctly cross-refer to the relevant paragraphs of this Article.

Issues in Annex I (Part 21) to Commission Regulation (EU) No 748/2012

Issue 4: outdated references to Regulation (EU) 2018/1139 (the Basic Regulation)

Following the adoption of the Basic Regulation, several cross references included in Annex I (Part 21)

are no longer valid.

Issue 5: point 21.A.3A(b)(3) — inconsistent reporting obligations for production organisations

The reporting obligations for production organisations wrongly included a reporting line to EASA, in

addition to the reporting line to the competent authority. Production organisations are required to

report only to the competent authority identified in accordance with point 21.1.

Issue 6: point 21.A.5(d) — typographical error in cross references

Point 21.A.5(d) contains record-keeping requirements for staff records (for approved production and

design organisations). For approved production organisations, the relevant requirements for staff

nomination are included in points 21.A.139(c), 21.A.145(c) and 21.A.145(d). Point 21.A.5(d) wrongly

refers to point 21.A.145(b).

8 Commission Regulation (EU) No 69/2014 of 27 January 2014 amending Regulation (EU) No 748/2012 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations (OJ L 23, 28.1.2014, p. 12) (https://eur- lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32014R0069&qid=1707391747451).

9 Commission Delegated Regulation (EU) 2023/1028 of 20 March 2023 amending Regulation (EU) No 748/2012 as regards the definition of complex motor-powered aircraft and correcting that Regulation (OJ L 139, 26.5.2023, p. 10) (https://eur- lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1028&qid=1707394522157).

European Union Aviation Safety Agency NPA 2024-04 (A)

2. In summary — why and what

An agency of the European Union

Issue 7: point 21.A.15(d) — deletion of provisions for a separate operational suitability data (OSD)

application

Point 21.A.15(d) was first introduced with Commission Regulation (EU) No 69/2014. The provision ‘or

be supplemented with, after the initial application’ provided the possibility of applying for the

approval of OSD separately from the type design approval. This possibility no longer exists, as the EASA

application process no longer allows a separate application for OSD approval.

With Commission Delegated Regulation (EU) 2019/897, the provision related to the application for

OSD approval as part of the TC or RTC was moved to point 21.A.15(b)(4) to refer to the OSD

certification basis. However, the provision for a separate OSD application was kept in point 21.A.15(d),

thereby contradicting the certification process.

Issue 8: obsolete requirements to return a certificate

Annex I (Part 21) includes several requirements for the certificate holders to return the relevant

certificates when these certificates have been surrendered or revoked (see points 21.A.51, 21.A.118B,

21.A.125C, 21.A.159, 21.A.181, 21.A.211, 21.A.259, 21.A.619 and 21.A.723). In current practice, in

which most of the certificates are issued electronically, the requirement to return a certificate is

obsolete.

In addition, such requirements are not harmonised with the similar requirements of EASA’s bilateral partners.

Note: The above considerations are valid for product and organisation approval certificates issued by

EASA. The situation might be different when referring to individual aircraft certificates:

airworthiness certificate, noise certificate and permit to fly. Such certificates must be carried on

board the aircraft, as required by the EU Air Operations rules. However, the rules do not

prescribe a specific format for these documents, which means that electronic/digital documents

are fully acceptable. Nevertheless, it is recognised that each Member State competent authority

may have different administrative requirements and processes for the issuance of such

certificates. Consequently, the option to request the return of the certificate should remain

available.

Please also refer to the guidance for EASA Member States on the Carriage of electronic documents on

board aircraft.

Issue 9: point 21.A.101 — improvement of regulatory provisions

Following the tragic accidents of Boeing 737 MAX aircraft, the US Federal Aviation Administration

(FAA) has been required to revise and improve the policy and standards related to the amended TC

process — the so-called changed product rule.

The changed product rule has significant importance not only for those authorities that are States of

design, but also for those authorities that have a substantial stake in the validation of the products

and those that engage in the application of their own design changes. In an effort to reduce multiple

international certification approaches, it is imperative that authorities work collectively to harmonise

their respective rules and associated guidance. Therefore, the FAA established the Changed Product

Rule International Authorities Working Group (IAWG), consisting of civil aviation authorities engaged

in the certification and validation of aviation products. Participating authorities include the FAA, EASA,

European Union Aviation Safety Agency NPA 2024-04 (A)

2. In summary — why and what

An agency of the European Union

Transport Canada Civil Aviation, the National Civil Aviation Agency of Brazil, the Civil Aviation

Administration of China and the Japan Civil Aviation Bureau.

In September 2022, the report of the IAWG was published by the FAA. The report contains several

recommendations for requirement changes that provide clarification and are consistent with current

practices:

— recommendation 1BR3: structuring rule language to be consistent with current practice;

— recommendation 1BR5: adequate certification basis;

— recommendation 1BR6: significant change criteria.

All participating authorities in the IAWG were supportive of these proposals. EASA considers these

proposals non-controversial and is using this NPA as an opportunity to put these proposals forward

for public consultation.

Issue 10: point 21.A.101 — clarification of requirements relevant to supplemental type-certificate

(STC) applicants under point (h)

Commission Delegated Regulation (EU) 2021/69910 has updated Annex I (Part 21) with the necessary

references to Annex I (Part-26) to Commission Regulation (EU) 2015/640 in order to ensure that TC

holders and STC applicants address the effects of ageing aircraft structures as part of the approval of

TC changes. According to new point 21.A.101(h), in the case of STC applications, the applicants are not

required to take into account point 26.303 of Annex I (Part-26) to Commission Regulation (EU)

2015/64011.

However, point 26.303 is not applicable to STC applicants. In addition, it was not intended to except

all STC applicants from the need to address requirements related to widespread fatigue damage and

the related establishment of a limit of validity. These requirements will become applicable to STC

applicants when the certification basis includes CS 25.571 at Amendment 19 or a later amendment.

They will need to address these requirements if an adequate certification basis cannot otherwise be

established.

Consequently, better wording is necessary to indicate why reference to Annex I (Part-26) to

Commission Regulation (EU) 2015/640 is made and to achieve the desired exception for STC

applicants.

Issue 11: point 21.A.118A(a)(2) — outdated cross references

The content of point 21.A.115 was changed and its subpoints were renumbered by Commission

Delegated Regulation (EU) 2019/897. However, the cross reference in point 21.A.118A(a)(2) has not

been updated.

10 Commission Delegated Regulation (EU) 2021/699 of 21 December 2020 amending and correcting Regulation (EU) No 748/2012 as regards the instructions for continued airworthiness, the production of parts to be used during maintenance and the consideration of ageing aircraft aspects during certification (OJ L 145, 28.4.2021, p. 1) (https://eur- lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R0699&qid=1707395815694).

11 Commission Regulation (EU) 2015/640 of 23 April 2015 on additional airworthiness specifications for a given type of operations and amending Regulation (EU) No 965/2012 (OJ L 106, 24.4.2015, p. 18) (https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=CELEX%3A32015R0640&qid=1707395951290).

European Union Aviation Safety Agency NPA 2024-04 (A)

2. In summary — why and what

An agency of the European Union

Issue 12: point 21.A.143(a)(11) — incomplete reference to the requirement for a production

management system

Commission Delegated Regulation (EU) 2022/20112 introduced in Annex I (Part 21) to Commission

Regulation (EU) No 748/2012 safety management system (SMS) requirements. The requirements for

the production management system are included in point 21.A.139, with point 21.A.139(c) covering

the safety management element and point 21.A.139(d) the quality management element.

Consequently, as part of the production organisation exposition (POE) requirements in

point 21.A.143(a)(11), the reference to point 21.A.139(c) is incomplete.

Issue 13: point 21.A.143(c) — approval of production organisation exposition (POE) amendments

related to changes as per point 21.A.147

Commission Delegated Regulation (EU) 2022/201 introduced, in point 21.A.143(b), the requirement

for the approval of the initial issue of the POE. However, a similar requirement has not been

introduced for amendments to the POE related to changes to the production management system,

which have to be approved by the competent authority under point 21.A.147.

Annex I (Part 21) to Commission Regulation (EU) No 748/2012 includes requirements for the

production organisation approval (POA) and design organisation approval (DOA) domains. The way

the applicant documentation is managed in the two domains is rather different; for example, the POA

certificate (EASA Form 55) does not include the POE reference number and the amendment level.

Consequently, it is considered appropriate that not only the initial issue of the POE but also the POE

amendments related to changes under point 21.A.147 are to be approved by the competent authority.

Issue 14: points 21.A.159(a) and 21.A.259(a) — clarification of validity conditions

Suspension is the act of temporary interruption of a certificate. During the suspension period, the

certificate holder cannot exercise the privileges granted through the certificate. The certificate is

therefore temporarily invalid.

Points 21.A.159(a) and 21.A.259(a) do not include suspension as a condition for a POA or a DOA

certificate to lose validity.

Issue 15: points 21.A.174 and 21.A.204 — ambiguity in the reference to the statement of conformity

Both application requirements for the airworthiness certificate and the noise certificate, in

points 21.A.174 and 21.A.204 respectively, refer to point 21.A.163(b) for the statement of conformity.

However, point 21.A.163(b) is not about the issuance of the statement of conformity but about the

privilege of the approved production organisations to obtain a certificate of airworthiness or a noise

certificate without further showing.

Furthermore, the text of the privilege set out in point 21.A.163(b) is not fully clear in respect of the

links with the issuance of the airworthiness certificate and noise certificate.

12 Commission Delegated Regulation (EU) 2022/201 of 10 December 2021 amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by design and production organisations, as well as procedures applied by the Agency, and correcting that Regulation (OJ L 33, 15.2.2022, p. 7) (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R0201&qid=1707396312021).

European Union Aviation Safety Agency NPA 2024-04 (A)

2. In summary — why and what

An agency of the European Union

Issue 16: point 21.A.307 — outdated cross reference to Article 9 and wrong applicability of

conditions in point (c)

Commission Delegated Regulation (EU) 2023/1028 has reorganised the paragraphs in Article 9 of

Commission Regulation (EU) No 748/2012. Consequently, the reference to Article 9(4) in

point 21.A.307(b)(7) is no longer valid.

In addition, for the derogation case contained in point 21.A.307(b)(7), the conditions in

point 21.A.307(c) do not apply.

Issue 17: point 21.B.82 — no provisions for equivalent safety findings in the case of the operational

suitability data (OSD) certification basis

Currently, there are no explicit provisions to include equivalent safety findings in the OSD certification

basis (similar to the type certification basis).

Also, point 21.B.82 contains some provisions reflecting a previous approach for product certification

where two separate applications — one for the type certification and the other for the OSD

approval — were possible. Currently, there is only one application.

Issue 18: point 21.B.103 — outdated cross reference and missing restricted type-certificate

Point 21.B.103(a) lists the provisions for the issuance of a type-certificate (TC) or a restricted TC (RTC)

by EASA. Point 21.A.21(a) contains the requirements that the applicant shall comply with to be issued

with a TC or an RTC. Points 21.A.21(b) and 21.B.103(b) provide for the conditions under which it may

be possible to derogate from points 21.A.21(a) and 21.B.103(a). Consequently, cross-referring in

point 21.B.103(a) to the whole of point 21.A.21 is incorrect.

Issue 19: point 21.B.125(d)(2)(iii) — wrong cross references

There is an incorrect cross reference to point (f)(1)(i), introduced by Commission Implementing Regulation (EU) 2022/20313.

Issue 20: points 21.B.125(d)(2)(i), 21.B.225(d)(2)(i) and 21.B.433(d)(2)(i) — extension of level 2

findings

The current text in Annex I (Part 21), Section B, for the extension of the corrective actions

implementation period, might be perceived as limiting the available approaches to extension because

it:

— suggests that the extension will be granted only at the end of the initial period;

— implies that it is a 3-month period that can be extended, when in fact the initial corrective

actions implementation period may be shorter than 3 months;

— suggests that only one extension is possible.

13 Commission Implementing Regulation (EU) 2022/203 of 14 February 2022 amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by competent authorities, and correcting Regulation (EU) No 748/2012 as regards the issuance of airworthiness review certificates (OJ L 33, 15.2.2022, p. 46) (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R0203&qid=1707397891995).

European Union Aviation Safety Agency NPA 2024-04 (A)

2. In summary — why and what

An agency of the European Union

In fact, the extension should be granted as soon as the corrective action plan is found to be acceptable.

This could be at any time between the notification date and the end of the period. Furthermore, what

is extended is not a 3-month period but the period that was initially granted for the implementation

of the corrective actions. Finally, if duly justified, the period for the implementation of the corrective

actions may be extended more than once.

In addition, specific to the DOA domain, there could be an incorrect interpretation of the rule that

level 2 findings escalated to level 1 findings cannot be de-escalated to level 2 findings again.

Issue 21: point 21.B.225(b)(4) — correction of the reference for the requirement for the

appointment of the accountable manager

When listing the cases for a level 1 finding, the current text in point 21.B.225(b)(4) wrongly cross-

refers to the requirement for the appointment of the head of the design organisation in

point 21.A.245(a) instead of the requirement for the appointment of the accountable manager in

point 21.A.145(c)(1).

Issue 22: Appendix VIII — inconsistency in the reported address

There is an inconsistency in the reported address between EASA Form 52 and EASA Form 55. EASA

Form 55 shows the registered address, but EASA Form 52 shows the location where the release has

been performed. This could lead to uncertainty or misunderstandings.

Issue 23: Appendix X — limitation of production organisation approval (POA) privileges where an

aircraft is subject to a declaration of design compliance

Commission Delegated Regulation (EU) 2022/135814 has introduced new privileges for an approved

production organisation under Annex I (Part 21), Subpart G, related to aircraft subject to a declaration

of design compliance under Annex Ib (Part 21 Light) to Commission Regulation (EU) No 748/2012.

However, Appendix X (‘Production Organisation Approval Certificate – EASA Form 55’) to Annex I

(Part 21) has not been modified, and contains the following limitation regarding the issuance of

statements of conformity: ‘A Statement of Conformity may not be issued for a non-approved aircraft’.

This limitation may prevent a POA holder from issuing a statement of conformity for an aircraft subject

to a declaration of design compliance (EASA Form 52b). Consequently, it is inconsistent with the POA

privilege set out in point 21.A.163(d).

Issue 24: Appendix XII — missing competence requirements for pilots performing operational

suitability data (OSD) flight tests

Appendix XII to Annex I (Part 21) contains requirements on the classification of flight tests in categories

and on pilot competence to perform these tests. The requirements refer to Annex I

14 Commission Delegated Regulation (EU) 2022/1358 of 2 June 2022 amending Regulation (EU) No 748/2012 as regards the implementation of more proportionate requirements for aircraft used for sport and recreational aviation (OJ L 205, 5.8.2022, p. 7) (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R1358&qid=1707398216544).

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(Part-FCL) to Commission Regulation (EU) No 1178/201115, in which privileges in terms of licences and

ratings for pilots are set out.

Appendix XII does not include a category of flight test specifically addressing OSD flight test activities

in which EASA OSD pilots participate. As a consequence, a literal application of the current

Appendix XII requires pilots to hold a flight test rating to conduct these OSD flight tests, as they are

typically performed on not yet certified aircraft types under Category 2. However, these flights are of

much lower risk than other flight tests, as they are conducted using aircraft for which the flight

envelope has already been fully tested and they are conducted within the normal operational

envelope. Furthermore, the OSD pilots act as co-pilots under the supervision of a flight test pilot

belonging to the type certification applicant acting as pilot-in-command.

EASA OSD pilots do not hold a flight test rating and EASA considers that the above-mentioned nature

of the flights does not justify requiring such a rating. In addition, for some flights, a pilot with a flight

test rating may even be deemed not appropriate (i.e. where airline pilot profiles are required).

Issues in the AMC and GM to Annex I (Part 21) to Commission Regulation (EU) No 748/2012

Issue 25: point 21.A.6 — explanation of the term ‘manuals’

The term ‘manuals’ in Annex I (Part 21) is confusing since more and more data is no longer released in the format of a ‘manual’. Data/information can instead be released in different formats (or in an app with no format).

Issue 26: GM1 21.A.7(a) — illustrated parts catalogue (IPC) status

EASA regularly receives questions from the industry and stakeholders on the status of the illustrated

parts catalogue — namely, whether or not it is part of the instructions for continued airworthiness

(ICA).

Although not specifically mentioned, part number information is a means of compliance for the

‘removing’ and ‘installing’ instructions required by the different certification specifications. The

instruction on ‘how’ a part can be installed is not enough; the instruction on ‘what’ part can be fitted

is implicitly required as essential information.

GM1 21.A.7(a) ‘Scope of ICA, their publication format and typical ICA data’ already mentions the parts

catalogue as a typical ICA, but just as an example.

Therefore, it is considered beneficial to address this topic and provide more clarification.

Issue 27: AMC1 21.A.7(c) — wrong inclusion of provisions for changes

The current AMC1 21.A.7(c) includes acceptable means of compliance for completeness and timely

availability of changes to the ICA (in section (b)). However, the correct regulatory point for the relevant

requirements for changes to the ICA is point 21.A.7(d).

15 Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 311, 25.11.2011, p. 1) (https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=CELEX%3A32011R1178&qid=1707398627823).

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Issue 28: consideration of the special conditions (SCs) published by EASA

EASA considers it necessary for a TC applicant to review the SCs already published by EASA when

proposing the type certification basis. This provision is not currently included in the AMC and GM.

The related regulatory points are 21.A.15, 21.A.91 and 21.B.80.

Issue 29: review of the GM to point 21.A.15(d)

The proposal to delete the provisions in point 21.A.15(d) — related to a separate application for OSD

approval — also requires a review of the related GM.

— GM No 1 to 21.A.15(d) does not relate to any provision in Annex I (Part 21) and incorrectly refers

to the master minimum equipment list (MMEL) for ELA1 and ELA2. CS-MMEL and CS-GEN-MMEL

do not apply to ELA1 and ELA2 and are not part of the OSD certification basis for these types of

aircraft. Any other list established by the applicant for these types of aircraft, including installed

equipment that may be temporarily inoperative, does not constitute the MMEL in accordance

with Commission Regulation (EU) No 748/2012 as required by point ORO.MLR.105 of

Commission Regulation (EU) No 965/2012.

— GM No 2 to 21.A.15(d) relates to point 21.A.15(d) as introduced with Commission Regulation

(EU) No 69/2014. However, this point has been modified by Commission Delegated Regulation

(EU) 2019/897, making the content of this GM no longer relevant. Furthermore, the criteria for

the determination of a type or variant are included in the OSD certification specifications.

— GM No 3 to 21.A.15(d) relates to the list of content of the OSD introduced in point 21.A.15(d)

with Commission Regulation (EU) No 69/2014. However, this point has been modified by

Commission Delegated Regulation (EU) 2019/897, making the contents of this GM no longer

relevant. The information on OSD elements required from or requested by the applicant, and

on which are mandatory and which are non-mandatory, is contained in the relevant OSD

certification specifications.

— GM4 21.A.15(d) needs to be amended and renumbered ‘GM1 21.A.15(b)(4)’.

The purpose of the amendment is to keep the guidance on the OSD certification for different types of

operations, which relates to the provision on OSD certification basis for the certification programme

in point 21.A.15(b)(4), and to delete the information that is already included in the certification

specifications.

Issue 30: recognition of industry standards

ASD-STAN is an international non-profit association that develops and maintains European standards

for the European aerospace and defence industry. In recent years, ASD-STAN has issued certain

standards relevant for approved design organisations under Part 21. EASA has reviewed these

standards. EASA confirmed its concurrence with them, when they were found to be suitable

acceptable means of compliance with Part 21. However, these standards have not yet been formally

recognised by cross reference in the AMC to Part 21.

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Issue 31: GM 21.A.35(b)(2) — objective and content of function and reliability testing

Flights performed for the purpose of compliance with point 21.A.35(b)(2) typically can include

operational suitability flights at EASA’s request. However, this is not reflected in the corresponding

GM 21.A.35(b)(2).

Issue 32: AMC 21.B.100(a) and 21.A.15(b)(6) — cybersecurity — new critical example

ED Decision 2020/006/R on ‘Aircraft cybersecurity’16 introduced the requirements to conduct

cybersecurity risk assessments on various products (CS-25, CS-23, CS-27, CS-29, CS-P, CS-E, CS-APU).

The cybersecurity risk assessment requires the identification of ‘threat conditions’, which are

analogous to ‘failure conditions’ defined in US 14 Code of Federal Regulations Part 25.1309 and EASA

CS 25.1309. However, whereas ‘failure conditions’ result from ‘unintentional causes’ (e.g. a part

failure), ‘threat conditions’ result from intentional unauthorised electronic interaction and the

implications for safety risk and security risk may differ (i.e. ‘low safety risk versus high security risk’ or

‘high safety risk versus low security risk’).

Therefore, using the outcome of the safety assessment process to evaluate the criticality of the

‘information security’ compliance demonstration item (CDI) may lead to an underestimation of the

level of risk and a misclassification of the CDI / level of involvement (LoI) required. The criticality of

the ‘information security’ CDI should hence be based on the impact of the change on the items that

may contribute to an unsafe condition as identified through the security risk assessment.

Issue 33: GM1 21.A.90C — additional example of stand-alone changes to the instructions for

continued airworthiness (ICA) requiring showing of compliance

Based on gained experience, EASA needs to update the guidance material for stand-alone changes to

the ICA by providing a new example of change requiring showing of compliance.

Issue 34: GM 21.A.91 — examples of major changes where fatigue and damage tolerance is

impacted

Recent discussions with the industry have highlighted some potential areas for improvement in the

guidance material associated with point 21.A.91 regarding changes impacting fatigue and damage

tolerance evaluations. A better alignment of the guidance material with associated safety risks is

required.

Issue 35: GM 21.A.91 — clarification of criteria for aircraft flight manual (AFM) changes

The complementary guidance for classification of changes to the AFM — as set out in GM 21.A.91,

Section 3.6 — inadvertently refers to noise limitations. In addition, the criteria for changes to the parts

of the AFM that do not require approval by EASA are not correctly placed in the category of

‘administrative’ revisions. Changes to non-approved sections might be more than administrative but

still considered minor if they are stand-alone (e.g. improvement of a system description).

16 ED Decision 2020/006/R of 24 June 2020 on ‘Aircraft cybersecurity’ (https://www.easa.europa.eu/en/document- library/agency-decisions/ed-decision-2020006r).

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Issue 36: GM 21.A.91 — introduction of a new item in the master minimum equipment list (MMEL)

The introduction of a new item in the MMEL in most cases directly leads to a major classification.

Indeed, GM2 MMEL.110 paragraph (c) reports that ‘Non-safety-related items need not be included in

the MMEL, unless so desired by the applicant’ and GM1 MMEL.145 cannot contain all the cases eligible

for MMEL minor change classification. The guidance material does not recognise that there might be

other cases in which a new item is introduced in the MMEL that can be classified as minor when the

conditions for major classification are not met.

Issue 37: GM 21.A.101 — inconsistencies in applicable provisions

— Point 21.A.101 was updated through Commission Delegated Regulation (EU) 2019/897, to be

applicable for major changes only. The information in the related GM still mentions ‘minor

changes’.

— In addition, Section 5.1 of GM 21.A.101 wrongly indicates that CS-26 (introduced through

Commission Regulation (EU) 2015/640 on additional airworthiness specifications for a given

type of operations (Annex I (Part 26)) is an additional airworthiness standard to be included in

the type certification basis. However, Part-26 / CS-26 is applicable only for TC holders and not

for TC applicants, and such requirements should not be introduced in the type certification

basis.

— Furthermore, due to the amendments proposed in this NPA to point 21.A.101, the revision of

the GM is necessary.

Issue 38: Approval of a major change required as a corrective action for an unsafe condition —

transposition of EASA Certification Memorandum CM-21.A-D-001

Under point 21.A.3B(c)(1), when EASA has to issue an airworthiness directive, the design approval

holder has to propose appropriate corrective action. This corrective action might necessitate a change

to the TC; therefore, it needs to be approved by EASA in accordance with point 21.A.97.

Experience has shown that there are continued airworthiness issues triggered by the fact that the

initial design is non-compliant with the applicable certification specifications. The re-establishment of

compliance may require more than one change which for practical reasons must be implemented

sequentially. In such cases, compliance with point 21.A.97(b)(1) cannot be demonstrated until the last

of the corrective changes to the TC is implemented.

However, each of these sequential changes to the TC that provides an ‘alleviating action’ (as used in

GM 21.A.3B(d)(4), points 4.1(i) and 4.2(i)) should be permitted to be approved, to mitigate a potential

unsafe condition and to maintain an adequate level of airworthiness (according to GM 21.A.3B(d)(4),

point 2.5(a)).

To address this situation and provide conditions under which incomplete compliance demonstration

for such major changes may be accepted, EASA issued CM-21.A-D-001 ‘Interpretation to 21.A.3B(c)(1)

and 21.A.103(a)(2)(i)’17 on 20 August 2018. This Certification Memorandum has not yet been

transposed into AMC to Part 21.

17 https://www.easa.europa.eu/en/document-library/product-certification-consultations/easa-cm-21a-d-001

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Issue 39: GM1 21.A.112B — demonstration of capability — examples of CS-27/CS-29 supplemental

type-certificate (STC) projects

According to point 21.A.112B(a) of Part 21, an STC applicant shall demonstrate its capability by holding

a DOA. By way of derogation from this requirement, as an alternative procedure to demonstrate its

capability, an STC applicant may seek EASA’s agreement for the use of procedures setting out the

specific design practices, resources and sequence of activities (known as alternative procedures to

DOA (ADOA)).

The decision on accepting one of the two capability demonstration options is made by EASA on a case-

by-case basis, assessing the merits of each project (e.g. complexity of the design change, complexity

of the related compliance demonstration).

To guide the potential STC applicants with regard to the expected EASA decision, GM1 to 21.A.112B

provides a list of STC examples categorised in two groups. Group 1 contains typical examples where it

is expected that EASA will require a DOA. For group 2, an ADOA will normally be acceptable.

However, EASA has noticed that more and more STC applications for rather complex rotorcraft design

changes (or involving complex compliance demonstrations) are being made by applicants that have

demonstrated their capability by an ADOA. This usually leads to challenges during the certification

projects due to applicants’ competence gaps and may even lead to the cancellation of the project.

Issue 40: GM 21.A.133(a) — production organisation approval (POA) applicants without

manufacturing facilities

There are POA applicants that outsource all the production activities and therefore could have

difficulties in justifying the need for a POA. Such applicants may also have difficulties overseeing their

subcontractors. In addition, a level playing field is required in the management of such cases by the

competent authorities. Consequently, additional guidance is considered necessary for managing such

applicants.

Issue 41: software handling in a production organisation

Production organisations are increasingly confronted with the need to handle software included in

the aircraft’s type design. Part 21 does not include any specific acceptable means of compliance or

guidance material addressing this matter. This may potentially lead to disharmonised approaches

between POA applicants/holders and their unequal treatment by the competent authorities.

Issue 42: AMC2 21.A.145(a) — qualification standards for non-destructive testing (NDT) staff

Part 21 Subpart G does not specify acceptable means of compliance for the qualifications of the staff

performing non-destructive testing (NDT) in accordance with European Standard EN 4179 which is

referenced in Annex I (Part-M) and Annex II (Part-145) to Commission Regulation (EU) No 1321/201418

(AMC M.A.606(f), AMC 145.A.30(f)). This may potentially lead to unequal treatment of POA

applicants/holders.

18 Commission Regulation (EU) No 1321/2014 of 26 November 2014 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks (OJ L 362, 17.12.2014, p. 1) (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32014R1321&qid=1707478187007).

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Issue 43: GM 21.A.151 — lack of adequate codes to describe the production organisation approval

(POA) scope of work

The codes specified in GM 21.A.151, for the description of the POA scope of work in the terms of

approval, have not been updated considering the evolution of the aviation industry and the existence

of new types of products (e.g. electrical engines).

In addition, a correction of the terminology in the terms of approval is needed for consistency with

the production organisation approval certificate (EASA Form 55).

Issue 44: AMC2 21.A.163(c) — reference to previous EASA Form 1

In practice, it has been identified that the reference to the previous EASA Form 1, when there is a

recertification of items from ‘prototype’ to ‘new’, is usually missing. Such reference is needed to

ensure proper traceability during the release process of the organisation receiving and installing the

items in question.

Issue 45: European Technical Standard Order (ETSO) authorisation versus installation approval

For some ETSO authorisation applicants, it is not clear that the installation approval is not covered in

the ETSO authorisation and consequently in the declaration required to be provided under

point 21.A.606(d).

Issue 46: forms equivalent to an EASA Form 1

In standard practice, end users often install parts covered by other airworthiness certificates that are

deemed equivalent to an EASA Form 1. This is typically the case under bilateral agreements signed

between the EU and a non-EU country, recognising a certificate issued in accordance with the non-EU

country’s regulation as equivalent to an EASA Form 1 (e.g. FAA 8130-3). Currently, there is no guidance

material in Part 21 explaining what parts are eligible for installation.

Issue 47: example of an acceptable document issued by the manufacturer

Under point 21.A.307(b)(1), certain parts are eligible for installation on a certified product without

requiring an EASA Form 1. Nevertheless, such parts need to be accompanied by a document meeting

the requirements in point 21.A.307(c). Currently, there are no acceptable means of compliance for

the accompanied documents.

Issue 48: non-ETSO functions and an incomplete ETSO article

There are different approaches by ETSO applicants to address ETSO standards that cover the

functionalities of the article. Sometimes the applicants consider all the standards covering the

functionalities of the article, and sometimes they do not. Furthermore, it is not indicated where

functions of the article are not covered by the minimum performance specification of the ETSO.

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Issue 49: AMC 21.A.608 — new declaration of design and performance (DDP) form

Based on the experience accumulated during ETSO authorisation projects, EASA has updated the

acceptable form the applicants should use for the declaration of design and performance (DDP).

This new form has been published on the EASA website19, but it is not yet included in AMC 21.A.608.

Issue 50: GM 21.A.719 — validity of flight conditions in the event of aircraft ownership change

EASA receives applications for flight conditions approval for an aircraft that already has an approved

flight conditions and whose configuration has not changed but which has been transferred to another

owner. In such cases, an additional flight conditions approval is not necessary and the related

administrative burden is therefore avoided.

Issue 51: ETSO marking — manufacturer clarification

In the EASA regulatory system, the designer and the manufacturer of an article may be different. There

are no acceptable means of compliance regarding the marking of ETSO articles in such cases. This may

potentially lead to inconsistencies in article marking or insufficient information being provided

regarding the article designer and the article manufacturer.

Issue 52: electronic marking of electronic hardware

The ETSO authorisation applicants, in the case of electronic hardware, often ask to electronically mark

the article rather than physically marking it using an article name plate or label. For similar requests,

the FAA has defined the electronic marking conditions in AC 21-46A. Currently, Part 21 does not

include acceptable means of compliance for electronic marking.

Issue 53: AMC2 21.B.100(b) — EASA’s involvement in the review of minor changes

The current AMC2 21.B.100(b) contains a note regarding EASA’s involvement in the review of minor

changes. However, this note does not cover the spectrum of minor changes actually identified in EASA

Form 34 (i.e. technical or administrative) being only applicable to the review associated with

anticipated minor changes. Therefore, the ETSO authorisation holders might have wrong expectations

regarding EASA’s involvement in the review of minor changes.

The issues identified above do not represent a direct safety risk. Nevertheless, these gaps and inconsistencies may affect the efficiency and effectiveness of the certification processes.

2.1.2. Who is affected by the issue

Design and production organisations, Member States’ competent authorities, and EASA.

2.1.3. How could the issue evolve

If no action is taken, the design and production organisations, the competent authorities of Member

States and EASA will continue to face challenges in the implementation of the Initial Airworthiness

Regulation, potentially leading to a lack of efficiency and a non-level playing field.

19 https://www.easa.europa.eu/en/downloads/120813/en

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2.1.4. Conclusion on rulemaking needs

EASA concluded, as explained further in Section 3 below, that an intervention was necessary and that

non-regulatory actions cannot effectively address the issues. Therefore, it is necessary to revise the

applicable regulations, AMC and GM.

2.2. What we want to achieve — objectives

The overall objectives of the EASA system are defined in Article 1 of the Basic Regulation. The proposed regulatory material presented here is expected to contribute to achieving these overall objectives by addressing the issues described in Section 2.1.

More specifically, through the proposed regulatory material presented here, EASA intends to address

miscellaneous issues of a non-controversial nature. The objective of this rulemaking task is to ensure

that the Initial Airworthiness Regulation and the associated AMC and GM are fit for purpose, are cost-

effective and can be implemented.

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2.3. How we want to achieve it — overview of the proposed amendments

2.3.1. Proposal

Issues in the articles (enacting terms) of Commission Regulation (EU) No 748/2012

Issue 1: Article 4 — outdated cross references

In Article 4(2)(b), it is proposed that the reference to point ‘21.A.113(a) and (b)’ is replaced with a reference to point ‘21.A.113’ such that the complete point, which relates to the application for an STC, does not apply.

It is proposed that Article 4(2)(d) is amended such that it refers to the complete point 21.A.115.

Issue 2: Article 7a — outdated cross references and transitional measures

Article 7a should be updated to match the current situation of the grandfathering and transitional

measures and to avoid any confusion between the references to points in Annex I (Part 21) to

Commission Regulation (EU) No 748/2012 that became applicable after the date of entry into force of

Article 7a.

It is proposed that paragraph 1 of Article 7a is amended to clarify that the TC holder shall demonstrate

compliance with the applicable OSD certification basis established and notified in accordance with

point 21.B.82 for the delivery of a new aircraft to an EU operator. This demonstration shall be

completed before the aircraft is operated by an EU operator, and the deadline of 18 December 2015

should be deleted because it is obsolete.

Paragraph 2 of Article 7a should be amended for applications for TCs that were filed before

17 February 2014. Since the 5-year limit of application validity has ended, applicants must either

submit a new application in accordance with point 21.A.15(f)(1) or apply for an extension in

accordance with point 21.A.15(f)(2). The applicant shall demonstrate compliance with the applicable

OSD certification basis in point 21.B.82 as established and notified by EASA, taking into account the

new date of application or the new reference date in accordance with point 21.A.15(f). In this case,

exception from the new OSD elements introduced with Commission Regulation (EU) No 69/2014 as a

transitional measure should no longer be granted. As in paragraph 1, this demonstration shall be

completed before the aircraft is operated by an EU operator, and the deadline of 18 December 2015

should be deleted because it is obsolete. The actual date of entry into force of Commission Regulation

(EU) No 69/2014 of 17 February 2014 should be added.

Paragraph 3 of Article 7a — on the grandfathering of Operational Evaluation Board reports and master

minimum equipment lists issued before 17 February 2014, the date of entry into force of Commission

Regulation (EU) No 69/2014 — should refer to point 21.B.103(a), related to the issuance of a TC.

Since the entry into force of Commission Regulation (EU) No 69/2014, all TC holders subject to

Article 7a have obtained the extension of the scope of their DOA or ADOA. Paragraph 4 of Article 7a

is obsolete and should be deleted.

Finally, in accordance with the second subparagraph of Article 11 of the Basic Regulation, Article 7a

also applies to restricted TC (RTC) holders. Reference to RTCs should be added throughout Article 7a.

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Issue 3: Article 9 — outdated cross references

It is proposed that the cross reference in Article 9(8) be corrected to read ‘The demonstration of

capability pursuant to paragraphs 1 or 7 shall …’ Article 9(7) is the correct reference for the

demonstration of production capability in accordance with Annex Ib (Part 21 Light).

Issues in Annex I (Part 21) to Commission Regulation (EU) No 748/2012

Issue 4: outdated references to the Basic Regulation

It is proposed that references to the Basic Regulation be updated in the following locations:

point 21.B.327 and Appendices III to VII.

It is also proposed that the reference to the Basic Regulation in GM 21.A.133(a) be updated.

Issue 5: point 21.A.3A(b)(3) — inconsistent reporting obligations for production organisations

It is proposed that point 21.A.3A(b)(3) retains only the reporting line to the competent authority

responsible, in accordance with point 21.1.

According to point 21.1, the competent authority is either:

— for production organisations that have their principal place of business in a territory for which

a Member State is responsible under the Convention on International Civil Aviation, signed in

Chicago on 7 December 1944 (‘the Chicago Convention’), the authority designated by that

Member State or by another Member State in accordance with Article 64 of Regulation (EU)

2018/1139, or the Agency if the responsibility has been reallocated to the Agency in accordance

with Article 64 or 65 of Regulation (EU) 2018/1139; or

— for production organisations that have their principal place of business outside a territory for

which a Member State is responsible under the Chicago Convention, the Agency.

Issue 6: point 21.A.5(d) — typographical error in a cross reference

It is proposed that the cross reference in point 21.A.5(d) be corrected to read ‘21.A.145(d)’ instead of

‘21.A.145(b)’.

Issue 7: point 21.A.15(d) — deletion of provisions for a separate operational suitability data (OSD)

application

It is proposed that the provision in point 21.A.15(d) be deleted and replaced with ‘(Reserved)’.

Issue 8: obsolete requirements to return a certificate

It is proposed that the requirement to return a certificate upon surrender or revocation be deleted

(i.e. delete points 21.A.51(b), 21.A.118B(b), 21.A.125C(b), 21.A.159(b), 21.A.259(b) and 21.A.619(b)).

For airworthiness certificates, noise certificates and permits to fly (refer to points 21.A.181(b),

21.A.211(b) and 21.A.723(c) respectively), it is proposed that the requirement to return the certificate,

but only upon the request of the competent authority, be maintained.

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Issue 9: point 21.A.101 — improvement of regulatory provisions

It is proposed that new text is added in point 21.A.101(a) to strengthen the process flow in the rule,

consistent with what is already described in the guidance material (refer to GM 21.A.101). The added

text will make clear that point 21.A.101 does not apply to major changes to a TC for which an

application for a new TC under point 21.A.19 is necessary. In addition, the applicability to the OSD

certification basis and environmental protection requirements will be clarified.

It is proposed that point 21.A.101(b) be amended to better reflect the changed product process, as

already indicated in step 2 of Figure 3-1 of GM 21.A.101.

The reference to the type certification basis and OSD certification basis clarifies that point 21.A.101(b)

applies to airworthiness (and not to environmental protection).

It is also proposed that point 21.A.101(b) be amended to clarify and enforce the requirement that the

established certification basis is adequate. This change is consistent with current guidance and

practice. In addition, it is proposed that the explicit term ‘reversion’ is used to describe the approach

of considering an earlier amendment of a certification specification for the cases presented in this

point.

Furthermore, it is proposed that it be clarified that the criteria in point 21.A.101(b)(1) are three

separate criteria. To achieve this, the three criteria will be listed in three separate bullet points instead

of the current two bullet points. The proposal clarifies the rule language and does not change current

practice.

In addition, in point 21.A.101(c) it is proposed that ‘maximum weight’ be replaced with ‘maximum

take-off mass’ since that is the term that provides certainty on the physical quantity (NB: EASA will

consistently follow up on this terminology change at the level of certification specifications, where still

necessary). It will also be clarified, through reference to the OSD certification basis, that

point 21.A.101(c) applies to airworthiness (and not to environmental protection).

Finally, the possibility of supplementing the initial application with the OSD certification basis is a

procedure that was used in the past when separate applications were expected to be submitted.

Currently, according to the procedure, only one application for the approval of the change is needed.

It is proposed that point 21.A.101(g) be deleted and replaced with ‘(Reserved)’.

Issue 10: point 21.A.101 — clarification of the requirements relevant to supplemental type-

certificate (STC) applicants under point (h)

It is proposed that point 21.A.101(h) be revised to separate the requirements placed on major change

applicants from those imposed on STC applicants. It is further proposed that, in the case of STC

applicants, it is made clear that the certification specifications equivalent to the provision on the limit

of validity in point 26.303 of Annex I (Part-26) to Regulation (EU) 2015/640 shall be considered if an

adequate certification basis is not otherwise ensured as per point 21.A.101(b).

In addition, it is proposed that GM 21.A.101 be amended to include appropriate references to point 21.A.101(h), which are currently missing.

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Issue 11: point 21.A.118A(a)(2) — outdated cross references

It is proposed that in point 21.A.118A(a)(2) the reference to point 21.A.115 be updated to read

‘21.A.115(b)(5)(ii)’ instead of ‘21.A.115(d)(2)’.

Issue 12: point 21.A.143(a)(11) — incomplete reference to the requirement for a production

management system

In point 21.A.143(a)(11), it is proposed that a reference to point 21.A.139(d) be added in order to also

cover the quality management element.

Issue 13: point 21.A.143(c) — approval of production organisation exposition (POE) amendments

related to changes as per point 21.A.147

It is proposed that point 21.A.143(c) should include the requirement for the approval of the POE

amendments, related to the changes as per point 21.A.147, by the competent authority.

Issue 14: points 21.A.159(a) and 21.A.259(a) — clarification of validity conditions

It is proposed that suspension be included as one of the conditions in points 21.A.159(a)(4) and

21.A.259(a)(4).

The national competent authorities are invited to comment on this proposal from taking into

consideration their own administrative practices for the management of the suspended certificates.

Issue 15: points 21.A.174 and 21.A.204 — ambiguity in the reference to the statement of conformity

It is proposed that the POA privileges set out in point 21.A.163(b), to obtain a certificate of

airworthiness and a noise certificate, be clarified by indicating that these certificates are issued under

point 21.A.174 or 21L.A.143(c) and point 21.A.204 or 21L.A.163 respectively.

In addition, it is proposed that the POA privilege set out in point 21.A.163(d), to obtain a restricted

certificate of airworthiness and a restricted noise certificate, be clarified by indicating that these

certificates are issued under points 21L.A.143(d) and 21L.A.163 respectively.

It is proposed that, in points 21.A.174 and 21.A.204, the acceptable statements of conformity and on

which basis these statements are issued be clarified.

In addition, it is proposed that the reference to Article 9 in points 21.A.174 and 21.A.204 be updated

in accordance with the amended Article 9 adopted with Commission Delegated Regulation (EU)

2023/1028.

Issue 16: point 21.A.307 — outdated cross reference to Article 9 and wrong applicability of

conditions in point (c)

It is proposed that the reference to Article 9 in point 21.A.307(b)(7) be updated in accordance with

the amended Article 9 adopted with Commission Delegated Regulation (EU) 2023/1028.

In addition, it is proposed that the applicability of conditions in point 21.A.307(c) be limited to cases

from point 21.A.307(b)(1) to (b)(6) (i.e. to exclude the case under (b)(7)).

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Issue 17: point 21.B.82 — no provisions for equivalent safety findings in the case of the operational

suitability data (OSD) certification basis

It is proposed that point (2), on equivalent safety findings, be included in point 21.B.82(a), similar to

the provision in point 21.B.80(a)(2). The current point ‘21.B.82(a)(2)’ will be renumbered

‘21.B.82(a)(3)’.

Due to the above-mentioned renumbering of the paragraphs in point 21.B.82(a), GM 21.A.82 is to be

updated accordingly.

In addition, it is proposed that in point 21.A.82(a) the provision for referring to the date of a separate

application supplement for OSD be deleted.

Issue 18: point 21.B.103 — outdated cross reference and missing restricted type-certificate (RTC)

It is proposed that in point 21.B.103(a) the reference to point 21.A.21 is corrected such that only point 21.A.21(a) is referred to.

In addition, it is proposed that the missing reference is added to the RTC in point 21.B.103(b).

Issue 19: point 21.B.125(d)(2)(iii) — wrong cross reference

It is proposed that the reference to ‘point (f)(1)(i)’ is replaced with a reference to ‘point (d)(1)’.

Issue 20: points 21.B.125(d)(2)(i), 21.B.225(d)(2)(i) and 21.B.433(d)(2)(i) — extension of level 2

findings

It is proposed that the requirement for the extension of level 2 findings be revised to clarify that the

extension can be granted at any point during the corrective actions implementation period, which

initially can be shorter than 3 months. In addition, the proposed revised text makes clear that more

than one extension is possible.

Also, for the DOA domain, it is proposed that a new GM 21.B.433(d) be created to explain that findings

which were originally level 2 findings and which were escalated to level 1 findings can be de-escalated

again to level 2 findings under certain prerequisites.

Note: The opportunity was taken to add in this new GM some further clarification on extensions,

escalations and de-escalations.

Issue 21: point 21.B.225(b)(4) — correction of the reference for the requirement for the

appointment of the accountable manager

It is proposed that the reference in point 21.B.225(b)(4) be corrected to read ‘21.A.145(c)(1)’ instead

of ‘21.A.245(a)’.

Issue 22: Appendix VIII — inconsistency in the reported address

It is proposed that the completion instructions for Block 4 in Appendix VIII be revised to say ‘registered

address’ instead of ‘address of the location’.

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Issue 23: Appendix X — limitation of production organisation approval (POA) privileges where an

aircraft is subject to a declaration of design compliance

It is proposed that the limitation for the issuance of a statement of conformity in Appendix X to

Part 21, EASA Form 55b, be revised to read: ‘A statement of conformity may not be issued for an

aircraft that has not been issued with a (restricted) type-certificate or a registered declaration of

design compliance.’

In addition, in Section 1 ‘Scope of work’, it is proposed that the table heading be changed from

‘PRODUCTION OF’ to ‘RATING’.

Issue 24: Appendix XII — missing competence requirements for pilots performing operational

suitability data (OSD) flight tests

It is proposed to amend:

— paragraph C of Appendix XII to Part 21 by creating a new category 5 of flight tests dedicated to

flights performed for the purpose of approving OSD;

— the table contained in paragraph D.1 of Appendix XII to Part 21 to specify a competence level 4

for the new category 5 of flight tests.

Issues in the AMC and GM to Annex I (Part 21) to Commission Regulation (EU) No 748/2012

Issue 25: point 21.A.6 — explanation of the term ‘manuals’

It is proposed that a new guidance material, GM1 21.A.6, be introduced, explaining that the meaning of the term ‘manuals’ may go beyond the traditional paper documents.

Issue 26: GM1 21.A.7(a) — illustrated parts catalogue (IPC) status

An additional paragraph is proposed in GM1 21.A.7(a) to provide an explanation of illustrated parts catalogue status when this type of document is the only source of part number information.

Issue 27: AMC1 21.A.7(c) — wrong inclusion of provisions for changes

It is proposed that Section (b) of the current AMC1 21.A.7(c) is deleted, and its content included in

new AMC1 21.A.7(d).

Issue 28: consideration of special conditions (SCs) published by EASA

It is proposed that a note be included in AMC 21.A.15(b) reminding the applicant to review the

applicability to its product of the existing EASA SCs.

In addition, it is proposed that a new note (Note 3) be included in GM 21.A.91, Section 3.4, for the

design organisations to consider published EASA SCs for the change classification process.

Furthermore, it is proposed that a new note is included in GM 21.B.80, Section 6, to indicate that EASA

will consider the already published SCs when prescribing the SCs for a specific TC application.

Issue 29: review of GM to point 21.A.15(d)

It is proposed that the following GM be deleted: GM No 1 to 21.A.15(d), GM No 2 to 21.A.15(d) and

GM No 3 to 21.A.15(d).

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GM No 4 to 21.A.15(d) is to be renumbered ‘GM1 21.A.15(b)(4)’.

Issue 30: recognition of industry standards

A new AMC2 21.A.33 is proposed for the recognition of the industry standards contained in:

— technical report TR 9250, Test Organisations — General requirements for test process and

capabilities;

— technical report TR 9251, Flammability Test Organisations Qualification Standard.

In addition, a new AMC1 21.A.239(d)(3) is proposed for the recognition of the industry standards

contained in the technical report TR 9255, Acceptance of supplier’s design capabilities and

management of design organisation authorisations.

Note: In order to facilitate the review of this NPA, the above-mentioned technical reports are made temporarily available during the period of public consultation, at the following addresses:

https://stan-shop.org/en/catalog/item/75472?search=9250%20corrigendum

https://stan-shop.org/en/catalog/item/75473?search=9251%20corrigendum

https://stan-shop.org/en/catalog/item/75474?search=9255%20corrigendum

Issue 31: GM 21.A.35(b)(2) — objective and content of function and reliability testing

It is proposed that GM 21.A.35(b)(2) be amended to mention OSD flights in the description of the

objective.

Issue 32: AMC 21.B.100(a) and 21.A.15(b)(6) — cybersecurity — new critical example

It is proposed that the list of examples in Section 3.3 of AMC 21.B.100(a) and 21.A.15(b)(6) be

complemented with the following case: ‘the installation or activation of, or a change to, a function,

component or system that, when subjected to an intentional unauthorised electronic interaction with

that function, component or system, may contribute to a condition that has an adverse effect on the

safety at the aircraft level’.

Issue 33: GM 21.A.90C — additional example of stand-alone changes to the instructions for

continued airworthiness (ICA) requiring showing of compliance

It is proposed to include in GM1 21.A.90C changes to the ‘specific inspection procedures after hard

landing’ as an example of where additional showing of compliance is needed.

In addition, a reference to point 21.A.265(h) is to be added, as that point is relevant for the process to

manage the stand-alone ICA changes.

Issue 34: GM 21.A.91 — examples of major changes where fatigue and damage tolerance is

impacted

It is proposed to amend Appendix A to GM 21.A.91, Section 1 ‘Structure’ and Section 7 ‘Rotors and

drive systems’, to indicate that design changes that are beneficial for fatigue or damage tolerance and

for which credit is sought, such as extension of an approved life limit or inspection interval, should

also be classified as major.

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Issue 35: GM 21.A.91 — clarification of criteria for aircraft flight manual (AFM) changes

It is proposed that in paragraph (b)(1), Section 3.6, the reference to ‘noise’ in the examples provided

in brackets be deleted.

In addition, it is proposed that the items related to ‘changes to parts of the AFM that do not require

approval by EASA’ and ‘changes to parts of the AFM supplement that are not required to be approved

by EASA’ be moved from paragraphs (c)(1)(ii) and (c)(2)(ii), respectively, to a new combined

paragraph ‘(b)(4)’.

Issue 36: GM 21.A.91 — introduction of a new item in the MMEL

It is proposed that Section 3.5, paragraph (a)(2), includes a new condition (subparagraph (vii)) for

minor classification in the event of the addition in the MMEL of a new item that does not meet the

conditions for major classification and does not introduce a relief in the event of the item being

required by the Basic Regulation and its delegated and implementing acts.

In addition, a typographical error is to be corrected in the same paragraph, in subparagraph (vi). The

word ‘Appendix’ is added.

Issue 37: GM 21.A.101 — inconsistencies in applicable provisions

In GM 21.A.101, Section 1.2, it is proposed that the content of paragraph 1.2.3, related to minor

changes, be deleted. Furthermore, in several locations, ‘major’ is to be added to the word ‘change’ to

more clearly indicate the scope of this GM.

In addition, in Section 5.1, it is proposed that the references to Commission Regulation (EU) 2015/640,

on additional airworthiness specifications for a given type of operations (Annex I (Part-26)) and CS-26,

be deleted.

Additional wording corrections and improvements are proposed to align with the changes in

point 21.A.101 and to clarify the guidance contents. These include the following.

— Improvement of the structure (e.g. gathering the terminology definitions in Appendix J), the

clarity of the text and consistency with point 21.A.101 and throughout the GM.

— Clarification of ‘certification basis’. For practical reasons, ‘certification basis’ is defined

throughout the AMC and GM to Part 21 as including the type certification basis, the OSD

certification basis and the applicable environmental protection requirements. In those cases in

which GM 21.A.101 provides guidance on the establishment of the certification basis for

airworthiness (the main purpose of the GM):

— text is added to clarify that both TC basis and OSD certification basis are being referred

to, when it is necessary to clarify that environmental protection is not considered; or

— ‘existing certification basis’ is to be complemented with ‘certification specification’ such

that it reads ‘certification specification in the existing certification basis’; in this case, it

applies only to airworthiness, since there are no certification specifications for

environmental protection.

— Use of ‘certification specifications’ versus ‘standards’. The GM and its appendices are to be

amended to ensure the correct use of these terms, which are not interchangeable. Certification

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specifications are the main elements of the type certification basis and the OSD certification

basis, and the GM mainly relates to certification specifications. ‘Standard’ is to be used in the

following cases:

— ‘airworthiness standards’, referring to design-related requirements from other domains

(see paragraph 5.1);

— ‘predecessor standards’, meaning ‘grandfathered’ products for which the certification

basis was established before the issuance of the certification specifications (see

paragraph 5.4);

— in some cases as an element/specification of the certification specifications (e.g.

points 21.A.101(d) and 21.B.75 referring to the certification specifications that do not

provide adequate standards).

— ‘Mass’ versus ‘weight’. ‘Maximum weight’ is to be replaced with ‘maximum take-off mass’.

‘Weight’ is to be replaced with ‘mass’ where appropriate, since mass is the term that provides

certainty on the physical quantity.

Issue 38: approval of a major change required as a corrective action regarding an unsafe condition —

transposition of EASA Certification Memorandum CM-21.A-D-001

It is proposed that a new AMC1 21.A.101(e)(1)(ii) be created for transposition of CM-21.A-D-00120.

Issue 39: GM1 21.A.112B — demonstration of capability — examples of CS-27/CS-29 supplemental

type-certificate (STC) projects

Based on the experience accumulated, EASA proposes an update of the list of CS-27/CS-29 STC cases

in GM1 21.A.112B, providing additional examples and additional conditions/information for the

existent ones to enable a better identification of the applicant’s capability demonstration

requirements. In particular, the STC cases requiring the applicant to hold a DOA are highlighted.

In addition, for CS-23 products, for one type of STC (i.e. ‘aeromedical system installation’), the

categorisation is changed from group 2 to group 1 for a consistent approach across different

categories of products.

Issue 40: GM 21.A.133(a) — production organisation approval (POA) applicants without

manufacturing facilities

It is proposed that the guidance material to point 21.A.133(a) be amended to explain that it is not the

intent to issue a POA to a company that fully subcontracts all its manufacturing activities. For a POA

applicant requesting a scope of work that includes a full product, it is proposed that the applicant

should have its own facilities at least for the final product assembly line.

In addition, it is proposed that the reference to the essential requirements of the Basic Regulation be

updated.

20 EASA CM-21.A-D-001 ‘Interpretation to 21.A.3B(c)(1) and 21.A.103(a)(2)(i)’ (https://www.easa.europa.eu/en/document- library/product-certification-consultations/easa-cm-21a-d-001).

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Issue 41: software handling in a production organisation

The Aerospace, Security and Defence Industries Association of Europe POA Working Group has

proposed to EASA a set of means of compliance for software handling. This was proposed through the

‘Position paper on software handling within POA’, Issue 1, February 2020. Based on this position

paper, it is proposed that a new AMC1 21.A.139(d)(1) be introduced to describe the acceptable means

of compliance for production organisations’ handling of aircraft-related software.

Issue 42: AMC2 21.A.145(a) — qualification standards for non-destructive testing (NDT) staff

It is proposed that AMC2 21.A.145(a) include a reference to the European Standard EN 4179 as the

relevant standard recognised by EASA for non-destructive testing (NDT) personnel qualification.

Issue 43: GM 21.A.151 — lack of adequate codes to describe the production organisation approval

(POA) scope of work

It is proposed that the list of codes in GM 21.A.151 be updated to include a new entry in the engine

section — to read ‘B5 Other’. This will be consistent with the approach used in the aircraft section,

where entry ‘A12 Other’ already exists.

It is also proposed that in GM 21.A.151, in the table heading, ‘SCOPE OF WORK’ is replaced with

‘RATING’. This will ensure consistency with the terminology used in Appendix X (EASA Form 55).

Issue 44: AMC2 21.A.163(c) — reference to the previous EASA Form 1

It is proposed that the original certificate number of the previous EASA Form 1 is added to the existing

example within AMC2 to 21.A.163(c), Block 12 ‘Remarks’, second bullet.

Issue 45: ETSO authorisation versus installation approval

It is proposed that a new AMC1 21.A.303(b) be introduced to explain that an equipment-level

approval, issued under the ETSO authorisation procedures of Subpart O, does not represent an

approval for installing the part or appliance in question on a certified product.

In addition, it is proposed that a note with a similar content is introduced in AMC1 21.A.606(d). It is

proposed that the word ‘approval’ is deleted from the first paragraph of this AMC (in the text ‘relevant

for the approval of the installation’).

Issue 46: forms equivalent to an EASA Form 1

It is proposed that GM 21.A.307 be introduced to clarify which forms are equivalent to an EASA

Form 1.

Issue 47: example of an acceptable document issued by the manufacturer

It is proposed that GM1 21.A.307(c) be introduced, indicating that the requirement in point 21.A.307

can be fulfilled using different types of documents issued by the manufacturer, as long as these

documents contain the information required in point 21.A.307(c).

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Issue 48: non-ETSO functions and an incomplete ETSO article

A new AMC to point 21.A.606(b) is proposed for addressing non-ETSO functions and an incomplete

ETSO article. In both cases, the acceptable means of compliance include the conditions to be met for

the EASA acceptance of the non-ETSO functions or the incomplete ETSO article.

Issue 49: AMC 21.A.608 — new declaration of design and performance form

It is proposed that the current EASA form for the declaration of design and performance be included

in AMC 21.A.608. This AMC is renumbered ‘AMC1 21.A.608’.

Issue 50: GM 21.A.719 — validity of flight conditions in the event of aircraft ownership change

It is proposed that GM 21.A.719 should explain that there is no need to reapprove the flight conditions

in the event of aircraft ownership change, unless there is a change to the configuration of the aircraft

that invalidates the permit to fly or the approved flight conditions. It should also be clarified that flight

conditions are linked to the specific aircraft serial number(s) and therefore do not have a holder and

are not subject to transfer. In addition, no direct obligations are linked to a flight conditions approval.

The permit-to-fly holder has the obligation to ensure that the flight conditions are met.

Issue 51: ETSO marking — manufacturer clarification

It is proposed that AMC1 21.A.807(a) be created, to present the acceptable means of compliance for

the ETSO article marking in the event that the responsible design organisation and the responsible

production organisation are different legal entities. In such a case, both organisation names and

addresses should be included in the marking.

Issue 52: electronic marking of electronic hardware

It is proposed that the conditions for electronic marking, as an alternative to physical marking, be

included in the newly created AMC1 21.A.807(a).

Issue 53: AMC2 21.B.100(b) — EASA’s involvement in the review of minor changes

It is proposed that the existent note, at the end of AMC2 21.B.100(b), should make clear that the EASA

review of minor changes may go beyond the elements that were already stated, namely classification,

updated certificate and declaration of design and performance, and include affected compliance

documents.

Note: The proposed regulatory material (see Section 4 of this NPA) may include additional typographical corrections (e.g. spelling mistakes, wrong cross references). Due to the minor nature of these corrections, they are not explicitly presented in this section.

2.3.2. Targeted applicability of the regulatory material

EASA has no targeted applicability date for this regulatory material. The applicability date will

therefore depend on the progress of this rulemaking task, and the material will become applicable as

soon as possible afterwards.

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2.3.3. Legal basis

The legal basis for amending Commission Regulation (EU) No 748/2012 and its Annex I (Part 21) lies in

Articles 17 and 19 of the Basic Regulation regarding the adoption of, respectively, implementing and

delegated acts laying down detailed provisions for the airworthiness and environmental certification

of aircraft and related products, parts and appliances, and for the certification of design and

production organisations.

The legal basis for the issuance of acceptable means of compliance and guidance material for the

application of the delegated acts lies in Article 76(3) of the Basic Regulation.

2.4. Stakeholders’ views

According to the definition of the Terms of Reference for RMT.0031, this NPA contains topics that are

considered non-controversial by EASA.

Several issues included in this NPA (e.g. Issue 5, 25, 26, 30, 36 and 41) have been proposed to EASA by

the industry.

European Union Aviation Safety Agency NPA 2024-04 (A)

3. Expected benefits and drawbacks of the proposed regulatory material

An agency of the European Union

3. Expected benefits and drawbacks of the proposed regulatory material

EASA considered that rulemaking intervention was required and that new or amended regulations,

AMC and GM are necessary to effectively address the issues described in Section 2.1, because the

objectives described in Section 2.2 cannot be achieved effectively by non-regulatory action.

It was necessary to address repetitive implementation issues and to align the AMC and GM to Part 21

with industry current practice. In addition, the rulemaking intervention was considered necessary due

to the accumulation of a number of inconsistencies (e.g. typographical errors, outdated cross

references) in Commission Regulation (EU) No 748/2012.

EASA also assessed the impacts of the proposed regulatory material to ensure that the regulatory

material delivers its full benefits with minimum drawbacks.

The main benefit of the proposals in this NPA is the expected increase in efficiency as regards the

implementation of Part 21. These proposals will maintain Part 21 and the corresponding AMC and GM

as fit for purpose.

The proposed regulatory material has been developed taking into account the better regulation

principles, and particularly the regulatory fitness principles. In particular, the proposed regulatory

material is expected to:

— alleviate existing regulatory burden by clarifying reporting obligations for production

organisations, eliminating the obligation to return surrendered or revoked certificates, and

clarifying the extension of level 2 findings;

— limit, as far as possible, the regulatory burden created by new/amended requirements by

including mainly consistency corrections and ambiguity clarifications.

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4. Proposed regulatory material

An agency of the European Union

4. Proposed regulatory material

Please refer to the following NPAs:

— NPA 2024-04 (B): Proposed amendments to Commission Regulation (EU) No 748/2012

— NPA 2024-04 (C): Proposed amendments to Annex I (Part 21) to Commission Regulation (EU)

No 748/2012

— NPA 2024-04 (D): Proposed amendments to the AMC and GM to Annex I (Part 21) to

Commission Regulation (EU) No 748/2012

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5. Monitoring and evaluation

An agency of the European Union

5. Monitoring and evaluation

No monitoring provisions are considered necessary.

European Union Aviation Safety Agency NPA 2024-04 (A)

6. Proposed actions to support implementation

An agency of the European Union

6. Proposed actions to support implementation

No specific actions to support the implementation are considered necessary.

European Union Aviation Safety Agency NPA 2024-04 (A)

7. References

An agency of the European Union

7. References

n/a

European Union Aviation Safety Agency NPA 2024-04 (A)

Appendix — Quality of the NPA

An agency of the European Union

Appendix — Quality of the NPA

To continuously improve the quality of its documents, EASA welcomes your feedback on the quality

of this document with regard to the following aspects.

Please provide your feedback on the quality of this document as part of the other comments you have

on this NPA. We invite you to also provide a brief justification, especially when you disagree or strongly

disagree, so that we consider this for improvement. Your comments will be considered for internal

quality assurance and management purposes only and will not be published (e.g. as part of the CRD).

1. The regulatory proposal is of technically good/high quality

Please choose one of the options below and place it as a comment in the CRT; if you disagree or strongly disagree, please provide a brief justification.

Fully agree / Agree / Neutral / Disagree / Strongly disagree

2. The text is clear, readable and understandable

Please choose one of the options below and place it as a comment in the CRT; if you disagree or strongly disagree, please provide a brief justification.

Fully agree / Agree / Neutral / Disagree / Strongly disagree

3. The regulatory proposal is well substantiated

Please choose one of the options below and place it as a comment in the CRT; if you disagree or strongly disagree, please provide a brief justification.

Fully agree / Agree / Neutral / Disagree / Strongly disagree

4. The regulatory proposal is fit for purpose (achieving the objectives set)

Please choose one of the options below and place it as a comment in the CRT; if you disagree or strongly disagree, please provide a brief justification.

Fully agree / Agree / Neutral / Disagree / Strongly disagree

5. The regulatory proposal is proportionate to the size of the issue

Please choose one of the options below and place it as a comment in the CRT; if you disagree or strongly disagree, please provide a brief justification.

Fully agree / Agree / Neutral / Disagree / Strongly disagree

6. The regulatory proposal applies the ‘better regulation’ principles21

Please choose one of the options below and place it as a comment in the CRT; if you disagree or strongly disagree, please provide a brief justification.

Fully agree / Agree / Neutral / Disagree / Strongly disagree

21 For information and guidance, see the following web pages:

— https://ec.europa.eu/info/law/law-making-process/planning-and-proposing-law/better-regulation-why-and- how_en

— https://ec.europa.eu/info/law/law-making-process/planning-and-proposing-law/better-regulation-why-and- how/better-regulation-guidelines-and-toolbox_en

European Union Aviation Safety Agency NPA 2024-04 (A)

Appendix — Quality of the NPA

An agency of the European Union

7. Any other comments on the quality of this document (please specify)

npa_2024-04_b_v11.pdf

European Union Aviation Safety Agency

Notice of Proposed Amendment 2024-04 (B)

in accordance with Article 6 of MB Decision 01-2022

Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 1 of 4

An agency of the European Union

Proposed amendments to Commission Regulation (EU) No 748/2012

European Union Aviation Safety Agency NPA 2024-04 (B)

Table of contents

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An agency of the European Union

Table of contents

1. Proposed amendments ................................................................................................... 3

Article 4 Continued validity of supplemental type-certificates ............................................... 3

Article 7a Operational suitability data ..................................................................................... 3

Article 9 Production organisations .......................................................................................... 4

European Union Aviation Safety Agency NPA 2024-04 (B)

1. Proposed amendments to

Commission Regulation (EU) No 748/2012

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1. Proposed amendments

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Article 4 Continued validity of supplemental type-certificates

1. […]

2. […]

(a) […]

(b) point 21.A.113 (a) and (b) of Annex I (Part 21) shall not apply;

(d) the compliance findings made under JAA or Member State procedures shall be deemed to have been made by the Agency for the purpose of complying with point 21.A.115(a) of Annex I (Part 21).

Article 7a Operational suitability data

1. The holder of an aircraft type-certificate or restricted type-certificate issued before 17 February 2014 intending to deliver a new aircraft to an EU operator on or after 17 February 2014 shall demonstrate obtain approval compliance with the applicable operational suitability data certification basis established and notified in accordance with point 21.B.82 21.A.21(e) of Annex I (Part 21) except for the minimum syllabus of maintenance certifying staff type rating training and except for aircraft validation source data to support the objective qualification of simulator(s). The approvaldemonstration of compliance shall be obtainedcompleted not later than 18 December 2015 or before the aircraft is operated by an EU operator, whichever is the latest. The operational suitability data may be limited to the model which is delivered.

2. The applicant for an aircraft type-certificate or restricted type-certificate for which the application was filed before 17 February 2014, and for which a type-certificate or a restricted type-certificate has not been issued within the time limit provided for in point 21.A.15(e) of Annex I (Part 21) and for which the applicant has submitted a new application or has applied for an extension in accordance with point 21.A.15(f) of Annex I (Part 21) is not issued before 17 February 2014 shall obtain approval demonstrate compliance with the applicable operational suitability data certification basis established and notified in accordance with point 21.B.82 21.A.21(e) of Annex I (Part 21) except for the minimum syllabus of maintenance certifying staff type rating training and for aircraft validation source data to support the objective qualification of simulator(s). The approval shall be obtaineddemonstration of compliance shall be completed not later than 18 December 2015 or before the aircraft is

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operated by an EU operator, whichever is the latest. Compliance findings made by the authorities in Operational Evaluation Board processes conducted under the responsibility of the JAA or the Agency before the entry into force of this Regulation17 February 2014 shall be accepted by the Agency without further verification.

3. Operational Evaluation Board reports and master minimum equipment lists issued in accordance with JAA procedures or by the Agency before the entry into force of this Regulation 17 February 2014 shall beare deemed to constitute the operational suitability data approved for the issuance of a type-certificate or restricted type-certificate in accordance with point 21.A.21(e)21.B.103(a) of Annex I (Part 21) and shall be included in the relevant type- certificate or restricted type-certificate. Before 18 June 2014 tThe relevant type-certificate or restricted type-certificate holders shall propose to the Agency a division of the operational suitability data ininto mandatory data and non-mandatory data.

4. Holders of a type-certificate including operational suitability data shall be required to obtain approval of an extension of the scope of their design organisation approval or procedures alternative to design organisation approval, as applicable, to include operational suitability aspects before 18 December 2015.

Article 9 Production organisations

[…]

8. The demonstration of capability pursuant to paragraphs 1 or 27 shall not be required where the production organisation or natural or legal person areis involved in the following manufacturing activities:

(a) the manufacture of parts or appliances that are eligible, in accordance with Annex I (Part 21), for installation in a type-certified product without the need to be accompanied by an authorised release certificate (that is to say EASA Form 1);

(b) the manufacture of parts that are eligible, in accordance with Annex Ib (Part 21 Light), for installation in an aircraft that has been subject to a declaration of design compliance without the need to be accompanied by an authorised release certificate (that is to say EASA Form 1);

(c) the manufacture of an aircraft that has been subject to a declaration of design compliance referred to in Article 2(3), and of parts that are eligible for installation on such aircraft. In such case, the manufacturing activities shall be conducted in accordance with Subpart R of Section A of Annex Ib (Part 21 Light) by a production organisation or a natural or legal person whose principal place of business is in a Member State.

npa_2024-04_c_v11.pdf

European Union Aviation Safety Agency

Notice of Proposed Amendment 2024-04 (C)

in accordance with Article 6 of MB Decision 01-2022

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Proposed amendments to Annex I (Part 21)

to Commission Regulation (EU) No 748/2012

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Table of contents

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Table of contents

1. Proposed amendments ........................................................................................................ 4

21.A.3A Reporting system ................................................................................................................... 4

21.A.5 Record-keeping ........................................................................................................................ 4

21.A.15 Application ............................................................................................................................. 5

21.A.51 Duration and continued validity ............................................................................................ 5

21.A.101 Type-certification basis, operational suitability data certification basis and environmental

protection requirements for a major change to a type-certificate .................................................... 5

21.A.118A Obligations and EPA marking ............................................................................................ 7

21.A.118B Duration and continued validity ........................................................................................ 7

21.A.125C Duration and continued validity ........................................................................................ 7

21.A.143 Production organisation exposition .................................................................................... 8

21.A.159 Duration and continued validity .......................................................................................... 8

21.A.163 Privileges .............................................................................................................................. 8

21.A.174 Application ........................................................................................................................... 9

21.A.181 Duration and continued validity .......................................................................................... 9

21.A.204 Application ........................................................................................................................... 9

21.A.211 Duration and continued validity ........................................................................................ 10

21.A.259 Duration and continued validity ........................................................................................ 10

21.A.307 The eligibility of parts and appliances for installation ....................................................... 10

21.A.619 Duration and continued validity ........................................................................................ 11

21.A.723 Duration and continued validity ........................................................................................ 11

21.B.82 Operational suitability data certification basis for an aircraft type-certificate or restricted

type-certificate .................................................................................................................................. 11

21.B.103 Issuance of a type-certificate or a restricted type-certificate ........................................... 12

21.B.125 Findings and corrective actions; observations .................................................................. 12

21.B.225 Findings and corrective actions; observations .................................................................. 13

21.B.433 Findings and corrective actions; observations .................................................................. 14

21.B.327 Restricted certificate of airworthiness .............................................................................. 15

Appendix III — Permit to Fly — EASA Form 20a ............................................................................... 16

Appendix IV — Permit to Fly (issued by approval organisations) — EASA Form 20b ....................... 17

Appendix V — Restricted Certificate of Airworthiness — EASA Form 24 ......................................... 18

Appendix VI — Certificate of Airworthiness — EASA Form 25 ......................................................... 19

Appendix VII — Noise Certificate — EASA Form 45 .......................................................................... 20

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Appendix VIII — Aircraft statement of conformity — EASA Form 52 ............................................... 21

Appendix X — Production Organisation Approval Certificate — EASA Form 55 .............................. 22

Appendix XII — Categories of flight tests and associated flight test crew qualifications ................. 24

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1. Proposed amendments

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Where necessary, the rationale is provided in italics.

[…]

Appendices

[…]

Appendix XII — Categories of flight tests and associated flight test crew qualification 85.

21.A.3A Reporting system

(a) […]

(b) Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, any natural or legal person that holds or has applied for a production organisation approval certificate under Subpart G of this Section, or that produces a product, part or appliance under Subpart F of this Section, shall:

1. […]

2. […]

3. report to the competent authority of the Member State responsible in accordance with point 21.1 and the Agency the deviations that have been identified in accordance with point 21.A.3A(b)2 and which could lead to an unsafe condition;

4. […]

[…]

21.A.5 Record-keeping

(a) […]

(b) […]

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(d) retain records of the competence and qualifications, referred to in points 21.A.139(c), 21.A.145(b), 21.A.145(c), 21.A.145(d), 21.A.239(c), 21.A.245(a) orand 21.A.245(e)(1), of the personnel that are involved in the following functions:

1. design or production;

2. independent monitoring of the compliance of the organisation with the relevant requirements;

3. safety management;

(e) […]

21.A.15 Application

[…]

(d) (Reserved)An application for a type-certificate or restricted type-certificate for an aircraft shall include, or be supplemented after the initial application by, an application supplement for approval of the operational suitability data.

[…]

21.A.51 Duration and continued validity

(a) […]

(b) Upon surrender or revocation, the type-certificate and restricted type-certificate shall be returned to the Agency.

21.A.101 Type-certification basis, operational suitability data certification basis and environmental protection requirements for a major change to a type-certificate

(a) A major change to a type-certificate that does not require an application for a new type- certificate under 21.A.19, and areas affected by the change, shall comply with the type- certification basis and the operational suitability data certification basis, which shall consist of either the certification specifications applicable to the changed product on the date of the application for the approval of the change or certification specifications which that became applicable after that date, in accordance with point (f) below. The validity of the application shall be determined in accordance with point 21.A.93(c).

In addition, the changed product shall comply with the environmental protection requirements designated by the Agency from the essential requirements in the first subparagraph of Article 9(2) of Regulation (EU) 2018/1139 on the date of application for the approval of the change in accordance with point 21.B.85.

The validity of the application shall be determined in accordance with point 21.A.93(c).

(b) Except as provided for in point (h), by way of derogation from point (a), if an adequate type- certification basis and operational suitability data certification basis are ensured, a reversion to an earlier amendment to of a certification specification referred to in point (a) and to any other certification specification which that is directly related may be used applied in any of the

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following situations, unless the earlier amendment became applicable before the date at which the corresponding certification specifications incorporated by reference in the type-certificate became applicable:

1. a change that the Agency finds not to be significant. In determining whether a specific change is significant, the Agency shall consider the change in the context of all previous relevant design changes and all related revisions to the applicable certification specifications incorporated by reference in the type-certificate for the product. Changes meeting one of the following criteria shall automatically be considered significant:

(i) the general configuration is not retained; or

(ii) the principles of construction are not retained; or

(ii)(iii) the assumptions used for certification of the product to be changed do not remain valid;

2. each area, system, part or appliance that the Agency finds not affected by the change;

3. each area, system, part or appliance that is affected by the change for which the Agency finds that compliance with the certification specifications referred to in point (a) does not contribute materially to the level of safety of the changed product or is impractical.

(c) By way of derogation from point (a), in the case of a change to an aircraft, other than a rotorcraft, of 2 722 kg (6 000 lb) or less maximum take-off mass weight, or to a non-turbine rotorcraft of 1 361 kg (3 000 lb) or less maximum take-off mass weight, the change and areas affected by the change shall comply with the type-certification basis and the operational suitability data certification basis incorporated by reference in the type-certificate. However, if the Agency finds that the change is significant in an area, the Agency may require that the change and areas affected by the change comply with an later amendment to a certification specification of the type-certification basis and the operational suitability data certification basis incorporated by reference in the type-certificate and with any other certification specification which that is directly related, unless the Agency also finds that compliance with that amendment does not contribute materially to the level of safety of the changed product or is impractical.

(d) If the Agency finds that the certification specifications applicable on the date of the application for the approval of the change do not provide adequate standards with respect to the proposed change, the change and areas affected by the change shall also comply with any special conditions, and amendments to those special conditions, prescribed by the Agency in accordance with point 21.B.75, to provide a level of safety equivalent to that established by the certification specifications applicable on the date of the application for the approval of the change.

(e) By way of derogation from points (a), (b) and (c), the change and areas affected by the change may comply with an alternative to a certification specification designated by the Agency if proposed by the applicant, provided that the Agency finds that the alternative provides a level of safety which is:

1. in the case of a type-certificate:

(i) equivalent to that of the certification specifications designated by the Agency under (a), (b) or (c) above; or

(ii) compliant with the essential requirements of Annex II to Regulation (EU) 2018/1139;

2. in the case of a restricted type-certificate, adequate with regard to the intended use.

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(f) If an applicant chooses to comply with a certification specification set out in an amendment that becomes applicable after submitting the application for the approval of a change to a type- certificate, the change and areas affected by the change shall also comply with any other certification specification which is directly related.

(g) (Reserved)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 operational suitability data, the operational suitability data certification basis shall be established in accordance with points (a)-(f).

(h) For large aeroplanes subject to point 26.300 of Annex I to Commission Regulation (EU) 2015/640,:

1. the applicant for a major change under this subpart shall demonstrate complyiance with certification specifications that provide at least an equivalent level of safety to points 26.300 and 26.330 of Annex I to Regulation (EU) 2015/640;

2. the applicant for a supplemental type-certificate under Subpart E or major change to a supplemental type-certificate shall demonstrate compliance with certification specifications that provide at least an equivalent level of safety to point 26.330 of Annex I to Regulation (EU) 2015/640. If an adequate certification basis is not ensured as per 21.A.101(b), the certification specifications that are equivalent to the provision on the limit of validity in point 26.303 of Annex I to Regulation (EU) 2015/640 shall be considered, except for applicants for supplemental type-certificates who are not required to take into account point 26.303.

21.A.118A Obligations and EPA marking

Each holder of a supplemental type-certificate shall:

(a) undertake the obligations: 1. […] 2. implicit in the collaboration with the type-certificate holder under point

21.A.115(d)(2)21.A.115(b)(5)(ii);

(b) […]

21.A.118B Duration and continued validity

(a) […]

(b) Upon surrender or revocation, the supplemental type-certificate shall be returned to the Agency.

21.A.125C Duration and continued validity

(a) […]

(b) Upon surrender, revocation or expiry, the letter of agreement shall be returned to the competent authority.

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21.A.143 Production organisation exposition

(a) The production organisation shall establish and maintain a production organisation exposition (POE) that provides directly or by cross reference the following information related to the production management system as described in point 21.A.139: […] 11. a description of the production management system, the policy, processes and

procedures as provided for in points 21.A.139(c) and 21.A.139(d);

[…]

organisation. Copies of any amendments shall be supplied to the competent authority.

Amendments of the POE related to changes as per 21.A.147 shall be approved by the competent

authority.

21.A.159 Duration and continued validity

(a) A production organisation approval certificate shall be issued for an unlimited period of time. It shall remain valid subject to the production organisation’s compliance with all the following conditions: 1. […] 2. […] 3. […] 4. the production organisation approval certificate has not been surrendered by the

production organisation, or suspended or revoked by the competent authority under point 21.B.65, or surrendered by the production organisation.

(b) Upon surrender or revocation, the production organisation approval certificate shall be

returned to the competent authority.

21.A.163 Privileges

Pursuant to the terms of approval issued under point 21.A.135, the holder of a production

organisation approval may:

(a) […]

(b) in the case of complete type-certified aircraft and upon presentation of a statement of conformity (EASA Form 52) issued under points 21.A.174 and 21.A.204 of this Annex or under points 21L. A.143(c) and 21L.A.163 of Annex Ib (Part 21 Light), obtain:

— an aircraft certificate of airworthiness under point 21.A.174 of this Annex or under

point 21L.A.143(c) of Annex Ib (Part 21 Light) without further showing; and

— a noise certificate under point 21.A.204 of this Annex or under point 21L.A.163 of Annex Ib (Part 21 Light) without further showing;

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(d) in the case of an aircraft that is subject to a declaration of design compliance under point 21L.A.43 of Annex Ib (Part 21 Light) and upon presentation of a statement of conformity (EASA Form 52B) issued under points 21L.A.143(d) and 21L.A.163 of Annex Ib (Part 21 Light), obtain an aircraft restricted certificate of airworthiness and a restricted noise certificate under points 21L.A.143(d) and 21L.A.163 of Annex Ib (Part 21 Light) respectively without further showing;

[…]

21.A.174 Application

(a) […]

(b) each application for a certificate of airworthiness or restricted certificate of airworthiness shall include:

1. […]

2. with regard to new aircraft:

(i) a statement of conformity:

— issued by a holder of a production organisation approval that is issued in accordance with Subpart G, and which may also be issued underfor the purpose of point 21.A.163(b); or

— issued under point 21.A.130 and validated by the competent authority; or

— for an imported aircraft, a statement of conformity issued by a holder of a production organisation approval that is issued in accordance with Subpart Gissued under point 21.A.163(b) or, in the case of an aircraft imported in accordance with Article 9(24) of this Regulation, a statement signed by the exporting authority that the aircraft conforms to a design approved by the Agency;

(ii) […]

(iii) […]

3. […]

[…]

21.A.181 Duration and continued validity

(a) […]

(b) Upon surrender or revocation, the certificate shall be returned to the competent authority of the Member State of registry, when so requested by the respective competent authority.

21.A.204 Application

(a) […]

(b) each application shall include:

1. with regard to new aircraft:

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(i) a statement of conformity:

— issued by the holder of a production organisation approval that is issued in accordance with Subpart G, and which may also be issued underfor the purpose of point 21.A.163(b); or

— issued under point 21.A.130 and validated by the competent authority; or

— for an imported aircraft, a statement of conformity issued by the holder of a production organisation approval that is issued in accordance with Subpart Gissued under point 21.A.163(b) or, in the case of an aircraft imported in accordance with Article 9(24) of this Regulation, a statement signed by the exporting authority that the aircraft conforms to a design approved by the Agency;

(ii) […]

2. […]

[…]

21.A.211 Duration and continued validity

(a) […]

(b) Upon surrender or revocation, the certificate shall be returned to the competent authority of the Member State of registry, when so requested by the respective competent authority.

21.A.259 Duration and continued validity

(a) A design organisation approval shall be issued for an unlimited period of time. It shall remain valid subject to the design organisation’s compliance with all the following conditions: 1. […] 2. […] 3. […] 4. the design organisation approval certificate has not been surrendered by the design

organisation, or suspended or revoked by the Agency under point 21.B.65, or surrendered by the design organisation.

(b) Upon surrender or revocation, the type-certificate and restricted type-certificate shall be returned to the Agency.

21.A.307 The eligibility of parts and appliances for installation

[…]

(b) By way of derogation from point (a) and provided that the conditions in point (c) are met, the following parts or appliances do not require an EASA Form 1 in order to be eligible for installation in a type-certified product:

[…]

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(6) a part or appliance that is an item of a higher assembly identified in points (b)(1) to (b)(5).;

(7) a part or appliance manufactured by a person or organisation referred to in Article 9(24) of this Regulation;.

product without being accompanied by an EASA Form 1, provided that the installer holds a document issued by the person or organisation that manufactured the part or appliance, which declares the name of the part or appliance, the part number, and the conformity of the part or appliance with its design data, and which contains the issuance date.

21.A.619 Duration and continued validity

(a) […]

(b) Upon surrender or revocation, the type-certificate and restricted type-certificate shall be returned to the Agency.

21.A.723 Duration and continued validity

(a) […]

(b) […]

(c) Upon surrender or revocation, the permit to fly shall be returned to the competent authority, when so requested by the respective authority.

21.B.82 Operational suitability data certification basis for an aircraft type-certificate or restricted type-certificate

[…]

(a) the certification specifications for operational suitability data designated by the Agency out of

those applicable to the aircraft at the date of the application or at the date of the application supplement for operational suitability data, whichever date is later, unless:

1. the applicant chooses to comply, or in accordance with point 21.A.15(f) is required to

comply, with certification specifications which became applicable after the date of the

application; If an applicant chooses to comply with a certification specification which

became applicable after the date of the application, the Agency shall include in the type-

certification basis any other certification specification that is directly related; or

2. the Agency accepts any alternative to a designated certification specification for

operational suitability data that cannot be complied with, for which compensating factors

have been found that provide an equivalent level of safety; or

32. the Agency accepts or prescribes alternative means to demonstrate compliance with the

relevant essential requirements of Annexes II, IV and V to Regulation (EU) 2018/1139.

[…]

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21.B.103 Issuance of a type-certificate or a restricted type- certificate

(a) The Agency shall issue an aircraft, engine or propeller type-certificate or an aircraft restricted type-certificate, provided that:

5. the applicant has complied with point 21.A.21(a); or

6. […]

7. […]

(b) By way of derogation from point (a), at the applicant’s request included in the declaration

referred to in point 21.A.20(d), the Agency may issue an aircraft type-certificate or restricted type-certificate before compliance with the operational suitability data certification basis has been demonstrated, provided that the applicant demonstrates such compliance before the date at which those data are to be actually used. […]

21.B.125 Findings and corrective actions; observations

[…]

(d) When a finding is detected during oversight or by any other means, the competent authority shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and its delegated and implementing acts, communicate in writing the finding to the organisation and request corrective action to address the non-compliance(s) identified. Where a level 1 finding directly relates to an aircraft, the competent authority shall inform the competent authority of the Member State in which the aircraft is registered.

1. If there are any level 1 findings, the competent authority shall take immediate and appropriate action to prohibit or limit the activities of the organisation involved and, if appropriate, it shall take action to revoke the letter of agreement or to limit or suspend it in whole or in part, depending on the extent of the level 1 finding, until successful corrective action has been taken by the organisation.

2. If there are any level 2 findings, the competent authority shall:

(i) grant the organisation a corrective action implementation period that is appropriate to the nature of the finding, and that in any case shall initially not be more than 3 months. The period shall commence from the date of the written communication of the finding to the organisation, requesting corrective action to address the non-compliance identified. At the end of that During the initial or extended corrective action implementation period, and subject to the nature of the finding, the competent authority may extend the 3-month corrective action implementation period provided that a corrective action plan or updated corrective action plan has been agreed with the competent authority;

(ii) assess the corrective action plan and implementation plan proposed by the organisation, and, if the assessment concludes that they are sufficient to address the non-compliance, accept them;

(iii) if the organisation fails to submit an acceptable corrective action plan, or fails to perform the corrective action within the time period accepted or extended by the

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competent authority, raised the finding shall be raised to level 1 and take action shall be taken as laid down in point (f)(1)(i)(d)(1).

[…]

21.B.225 Findings and corrective actions; observations

[…]

(b) A level 1 finding shall be issued by the competent authority when any significant non-

compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the certificate including the terms of approval which lowers safety or seriously endangers flight safety.

The level 1 findings shall also include:

[…]

4. failure to appoint an accountable manager pursuant to point 21.A.245(a)/ 21.A.145(c)(1).

[…]

(d) When a finding is detected during oversight or by any other means, the competent authority shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and its delegated and implementing acts, communicate the finding in writing the finding to the organisation and request corrective action to address the non-compliance(s) identified. Where a level 1 finding directly relates to an aircraft, the competent authority shall inform the competent authority of the Member State in which the aircraft is registered.

1. If there are any level 1 findings, the competent authority shall take immediate and appropriate action to prohibit or limit the activities of the organisation involved and, if appropriate, it shall take action to revoke the production organisation approval certificate or to limit or suspend it in whole or in part, depending upon the extent of the level 1 finding, until successful corrective action has been taken by the organisation.

2. If there are any level 2 findings, the competent authority shall:

(i) grant the organisation a corrective action implementation period that is appropriate to the nature of the finding, and that in any case shall initially not be more than 3 months. The period shall commence from the date of the written communication of the finding to the organisation requesting corrective action to address the non-compliance identified. At the end of that During the corrective action implementation period, and subject to the nature of the finding, the competent authority may extend the 3-month corrective action implementation period provided that a corrective action plan, or update thereto, has been agreed with the competent authority;

(ii) assess the corrective action and implementation plan proposed by the organisation, and, if the assessment concludes that they are sufficient to address the non-compliance, accept them;

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(iii) if the organisation fails to submit an acceptable corrective action plan, or fails to perform the corrective action within the time period accepted or extended by the competent authority, raise the finding shall be raised to level 1 and take action shall be taken as laid down in point (d)(1).

[…]

21.B.433 Findings and corrective actions; observations

[…]

(d) When a finding is detected during oversight or by any other means, the competent authority shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and its delegated and implementing acts, communicate in writing the finding to the organisation and request corrective action to address the non- compliance(s) identified. Where a level 1 finding directly relates to a product, the competent authority shall inform the competent authority of the Member State in which the aircraft is registered.

1. If there are any level 1 findings, the competent authority shall:

(i) grant the organisation a corrective action implementation period that is appropriate to the nature of the finding and that in any case shall not be more than 21 working days. That period shall commence from the date of the written communication of the finding to the organisation requesting corrective action to address the non-compliance(s) identified;

(ii) assess the corrective action plan and implementation plan proposed by the organisation, and, if it concludes that they are sufficient to address the non- compliance(s), accept them;

(iii) if the organisation fails to submit an acceptable corrective action plan, or fails to perform the corrective action within the time period accepted by the competent authority, take immediate and appropriate action to prohibit or limit the activities of the organisation involved and, if appropriate, take action to revoke the design organisation approval or to limit or suspend it in whole or in part, depending upon the extent of the level 1 finding, until successful corrective action has been taken by the organisation.

2. If there are any level 2 findings, the competent authority shall:

(i) grant the organisation a corrective action implementation period that is appropriate to the nature of the finding, and that in any case shall initially not be more than 3 months. That period shall commence from the date of the written communication of the finding requesting corrective action. At the end of that During the corrective action implementation period, and subject to the nature of the finding, the competent authority may extend the 3-month corrective action implementation period provided that a corrective action plan, or update thereto, has been agreed with the competent authority;

(ii) assess the corrective action and the implementation plan proposed by the organisation, and, if it concludes that they are sufficient to address the non- compliance(s), accept them;

(iii) if the organisation fails to submit an acceptable corrective action plan, or fails to perform the corrective action within the time period accepted or extended by the

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competent authority, raise the finding shall be raised to level 1 and take action shall be taken as laid down in point (d)(1).

[…]

21.B.327 Restricted certificate of airworthiness

(a) […]

(b) For an aircraft that cannot comply with the essential requirements referred to in Regulation (EU) 2018/1139 Regulation (EC) No 216/2008 and which is not eligible for a restricted type- certificate, the Agency shall, as necessary to take account of deviations from these essential requirements:

1. issue and check compliance with specific airworthiness specifications ensuring adequate safety with regard to the intended use, and

2. specify limitations for use of this aircraft.

(c) Limitations for use will be associated with restricted certificates of airworthiness, including airspace restrictions, as necessary to take account of deviations from essential requirements for airworthiness laid down in Regulation (EU) 2018/1139Regulation (EC) No 216/2008.

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Appendix III — Permit to Fly — EASA Form 20a

Competent authority logo

PERMIT TO FLY

This permit to fly is issued pursuant to Article 18(2)(b) of Regulation (EU) 2018/1139Regulation (EC) No 216/2008, Article 5(4)(a) and certifies that the aircraft is capable of safe flight for the purpose and within the conditions listed below and is valid in all Member States. This permit is also valid for flight to and within non- Member States provided separate approval is obtained from the competent authorities of such States:

1. Nationality and registration marks:

2. Aircraft manufacturer/type: 3. Serial No:

4. The permit covers: [purpose in accordance with 21.A.701(a)]

5. Holder: [in the case of a permit to fly issued for the purpose of 21.A.701(a)(15), this should state: ‘the registered owner’]

6. Conditions/remarks:

7. Validity period:

8. Place and date of issue: 9. Signature of the competent authority representative:

EASA Form 20a — Issue 2

1 For use by the State of Rregistry.

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Appendix IV — Permit to Fly (issued by approval organisations) — EASA Form 20b

Member State of the Competent Authority having issued the organisation approval under which the permit to fly is issued; or ‘EASA’ when approval issued by EASA

PERMIT TO FLY

Name and Aaddress of the organisation issuing the permit to fly

1. Nationality and registration marks:

2. Aircraft manufacturer/type: 3. Serial No:

4. The permit covers: [purpose in accordance with 21.A.701(a)]

5. Holder: [Organisation issuing the permit to fly]

6. Conditions/remarks:

7. Validity period:

8. Place and date of issue: 9. Authorised signature: Name: Approval Reference No:

EASA Form 20b — Issue 2

1 For use by the Organisation Approval holder.

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Appendix V — Restricted Certificate of Airworthiness — EASA Form 24

Competent authority LOGO

RESTRICTED CERTIFICATE OF AIRWORTHINESS

1 [Member State of registry]

[COMPETENT AUTHORITY OF THE MEMBER STATE]

1. Nationality and registration marks

2. Manufacturer and manufacturer’s designation of aircraft 3. Aircraft serial number

4. Categories

5. This Certificate of Airworthiness is issued pursuant to2 [the Convention on International Civil Aviation dated 7 December 1944] and Article 18(1)(b) of Regulation (EU) 2018/1139 Regulation (EC) No 216/2008, Article 5(4)(b) in respect of the above-mentioned aircraft which is considered to be airworthy when maintained and operated in accordance with the foregoing and the pertinent operating limitations.

In addition to above the following restrictions apply: 1 2 [The aircraft may be used in international navigation notwithstanding above restrictions].

Date of issue: Signature:

6. This Restricted Certificate of Airworthiness is valid unless revoked by the competent authority of the Member State of registry.

A current Airworthiness Review Certificate shall be attached to this certificate.

EASA Form 24 — Issue 32.

This certificate shall be carried on board during all flights.

1 For use by the State of Rregistry. 2 Delete as applicable.

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Appendix VI — Certificate of Airworthiness — EASA Form 25

Competent authority LOGO

CERTIFICATE OF AIRWORTHINESS

1 [Member State of registry] [COMPETENT AUTHORITY OF THE MEMBER STATE]

1. Nationality and registration marks

2. Manufacturer and manufacturer’s designation of aircraft

3. Aircraft serial number

4. Categories 5. This Certificate of Airworthiness is issued pursuant to the Convention on International Civil Aviation dated

7 December 1944 and Article 14(1) of Regulation (EU) 2018/1139Regulation (EC) No 216/2008, Article 5(2)(c) in respect of the above-mentioned aircraft which is considered to be airworthy when maintained and operated in accordance with the foregoing and the pertinent operating limitations.

Limitations/Remark: 1

Date of issue: Signature:

6. This Certificate of Airworthiness is valid unless revoked by the competent authority of the Member State of registry.

A current Airworthiness Review Certificate shall be attached to this certificate. EASA Form 25 — Issue 32.

This certificate shall be carried on board during all flights.

1 For use by the State of Rregistry.

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Appendix VII — Noise Certificate — EASA Form 45

For use by the State of registry 1. State of Rregistry 3. Document No:

2. NOISE CERTIFICATE

4. Registration marks:

……………………………………………...

5. Manufacturer and manufacturer’s designation of aircraft:

……………………………………………

6. Aircraft serial No:

…………………………………………..

7. Engine:

……………………………………………………………………...

8. Propeller:1

……………………………………………………………………

9. Maximum take-off mass (kg)

…………………………………………………

10. Maximum landing mass (kg)1

…………………………………………………

11. Noise certification standard:

…………………………………………………

12. Additional modifications incorporated for the purpose of compliance with the applicable noise certification standards:

……………………………………………………………………………………………………………………………………………………………………

13. Lateral/full- power noise level: 1

……………………………

14. Approach noise level1

………………………….

15. Flyover noise level1

……………………………

16. Overflight noise level1

……………………………

17. Take-off noise level1

……………………………

Remarks

18. This Noise Certificate is issued pursuant to Annex 16, Volume I to the Convention on International Civil Aviation dated 7 December 1944 and Article 14(1) of Regulation (EU) 2018/1139Regulation (EC) No 216/2008, Article 6 in respect of the abovementioned aircraft, which is considered to comply with the indicated noise standard when maintained and operated in accordance with the relevant requirements and operating limitations.

19. Date of issue ………………………………………………………… 20. Signature ………………………………………..

EASA Form 45 — Issue 2

1 These boxes may be omitted depending on noise certification standard.

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Appendix VIII — Aircraft statement of conformity — EASA Form 52

[…]

3. COMPLETION OF THE STATEMENT OF CONFORMITY BY THE ORIGINATOR

[…]

Block 4 The full name and location registration address of the organisation issuing the statement. This

block may be pre-printed. Logos, etc., are permitted if the logo can be contained within the

block.

[…]

Block 15 Enter ‘Certificate of Airworthiness’, or ‘Restricted Certificate of Airworthiness’, or for the

Certificate of Airworthiness requested Indicate the type of airworthiness certificate that

may be obtained upon presentation of EASA Form 52.

[…]

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Appendix X — Production Organisation Approval Certificate — EASA Form 55

Production organisation approval certificates referred to in Subpart G of Annex I (Part 21)

[MEMBER STATE]1

A Member of the European Union2

PRODUCTION ORGANISATION APPROVAL CERTIFICATE

Reference: [MEMBER STATE CODE3].21G.XXXX

Pursuant to Regulation (EU) 2018/1139 of the European Parliament and of the Council and to Commission Regulation (EU) No 748/2012, for the time being in force and subject to the conditions specified below, the [COMPETENT AUTHORITY OF THE MEMBER STATE] hereby certifies:

[COMPANY NAME AND ADDRESS] as a production organisation in compliance with Annex I (Part 21) Section A of Commission Regulation (EU) No 748/2012, is approved to produce products, parts and appliances listed in the attached approval schedule and issue the related certificates using the above references. CONDITIONS: 1. This approval is limited to that specified in the enclosed terms of approval.

2. This approval is subject to compliance with the procedures specified in the approved production organisation exposition.

3. This approval is valid while the approved production organisation remains in compliance with Annex I (Part 21) to Commission Regulation (EU) No 748/2012].

4. Subject to compliance with the foregoing conditions, this approval shall remain valid for an unlimited period of time unless it has previously been surrendered, superseded, suspended or revoked.

Date of original issue: ……………………………………………………………………………………………………………………………… Date of this revision: ……………………………………………………………………………………………………………………………….. Revision No: ……………………………………………………………………………………………………………………………………………. Signed: ……………………………………………………………………………………………………………………………………………………. For the competent authority: [COMPETENTAUTHORITY IDENTIFICATION4]

EASA Form 55a -— Issue 43

1 Or “‘EASA’”, if EASA is the competent authority. 2 Delete for non-EU Member States. 3 Or “‘EASA’”, if EASA is the competent authority. 4 Or “‘EASA’”, if EASA is the competent authority.

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[MEMBER STATE]1 A Member of the European Union2

Terms of Approval TA: [MEMBER STATE

CODE3].21G.XXXX

This document is part of production organisation approval number [MEMBER STATE CODE4].21G.XXXX issued to: Company name:

Section 1. SCOPE OF WORK:

PRODUCTION OF RATING PRODUCTS/CATEGORIES

For details and limitations, refer to the Production Organisation Exposition, Section xxx.

Section 2. LOCATIONS:

Section 3. PRIVILEGES:

The production organisation is entitled to exercise, within its terms of approval and in accordance with the procedures of its Production Organisation Exposition, the privileges laid down in point 21.A.163, subject to the following:

[keep only applicable text]

Prior to the approval of the design of the product, the EASA Form 1 may be issued only for conformity purposes.

A statement of conformity may not be issued for an non-approved aircraft that has not been issued with a (restricted) type-certificate or a registered declaration of design compliance.

Maintenance may be performed, until compliance with the maintenance regulations is required, in accordance with the Production Organisation Exposition Section xxx.

Permits to fly may be issued in accordance with the Production Organisation Exposition Section yyy.

Date of original issue: Signed:

Date of this revision:

Revision No.: For [COMPETENT AUTHORITY IDENTIFICATION5]

EASA Form 55b -— Issue 34

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Appendix XII — Categories of flight tests and associated flight test crew qualifications

A. […]

B. […]

C. Categories of flight test

1. General

The descriptions below address the flights performed by design and production

organisations under Annex I (Part 21).

2. Scope

If more than one aircraft is involved in a test, each individual aircraft flight shall be

assessed under this Appendix to determine if it is a flight test and when appropriate, its

category.

The flights referred to in point (6)(B)(3) are the only flights that belong to the scope of

this Appendix.

3. Categories of flight tests

Flights tests include the following four categories:

3.1. […]

3.2. […]

3.3. […]

3.4. […]

3.5. Category Five (5)

Flights performed for the purpose of approving operational suitability data.

D. Competence and experience of pilots and lead flight test engineers

1. General

Pilots and lead flight test engineers shall have the competences and experience specified in the

following table.

Categories of flight tests

Aircraft 1 2 3 4 5 CS-23 commuter or aircraft having a design diving speed (Md) above 0.6 or a maximum ceiling above 7 260 m (25 000 ft), CS-25, CS-27, CS-29 or equivalent airworthiness codes

Competence level 1

Competence level 2

Competence level 3

Competence level 4

Other CS-23 with an MTOM of or above 2 000 kg

Competence level 2

Competence level 3

Competence level 4

npa_2024-04_d_v12.pdf

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Notice of Proposed Amendment 2024-04 (D)

in accordance with Article 6 of MB Decision 01-2022

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Proposed amendments to the AMC and GM to Annex I (Part 21)

to Commission Regulation (EU) No 748/2012

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Table of contents

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Table of contents

1. Proposed amendments ........................................................................................................ 4

GM1 21.A.6 Manuals .......................................................................................................................... 4

GM1 21.A.7(a) Scope of the ICA, their publication format, and typical ICA data ............................... 4

AMC1 21.A.7(c) Completeness and timely availability of the ICA ...................................................... 5

AMC1 21.A.7(d) Instructions for continued airworthiness ................................................................. 6

AMC 21.A.15(b) Content of the certification programme .................................................................. 6

GM14 21.A.15(bd)(4) Application ....................................................................................................... 6

GM No 1 to 21.A.15(d) Application for the approval of operational suitability data – MMEL for

ELA1 and ELA2 ..................................................................................................................................... 7

GM No 2 to 21.A.15(d) Determination of type or variant .................................................................. 7

GM No 3 to 21.A.15(d) OSD content ................................................................................................... 7

AMC2 21.A.33 Inspections and tests .................................................................................................. 8

GM 21.A.35(b)(2) Flight tests Objective and Content of Function and Reliability Testing ................. 9

GM1 21.A.90C Stand-alone changes to the ICA .................................................................................. 9

GM 21.A.91 Classification of changes to a type certificate (TC) ........................................................ 9

Appendix A to GM 21.A.91 Examples of Major Changes per discipline ........................................... 12

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

certification basis, operational suitability data certification basis and environmental protection

requirements for a major change to a type-certificate .................................................................... 13

Appendix A to GM 21.A.101 Classification of design changes .......................................................... 40

Appendix B to GM 21.A.101 Application charts for changed product rule ...................................... 46

Appendix C. to GM 21.A.101 A method to determine the changed and affected areas .................. 48

Appendix D. to GM 21.A.101 Other guidance for affected areas ..................................................... 50

Appendix E. to GM 21.A.101 Procedure for evaluating material contribution to safety or

impracticality of applying latest certification specifications to a changed product ......................... 51

Appendix F. to GM 21.A.101 The use of service experience in the exception process .................... 56

Appendix G. to GM 21.A.101 Changed product rule (CPR) decision record ..................................... 58

Appendix H. to GM 21.A.101 Examples of documenting the proposed certification basis list ........ 59

Appendix I. to GM 21.A.101 Related documents ............................................................................. 66

Appendix J. to GM 21.A.101 Definitions and terminologiesy ........................................................... 66

AMC1 21.A.101(e)(1)(ii) Type-certification basis, operational suitability data certification basis and

applicable environmental protection requirements for a major change to a type-certificate ........ 68

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

for changes to type certificates (TCs) ............................................................................................... 70

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GM1 to 21.A.112B Demonstration of capability ............................................................................... 71

GM1 21.A.133(a) Eligibility – Approval appropriate for showing conformity .................................. 77

AMC1 21.A.139(d)(1) Production management system ................................................................... 78

AMC2 21.A.145(a) Resources ............................................................................................................ 80

GM 21.A.151 Terms of approval – Scope and categories ................................................................. 80

AMC2 21.A.163(c) Completion of EASA Form 1 ................................................................................ 81

AMC1 21.A.239(d)(3) Design management system .......................................................................... 82

AMC1 21.A.303(b) Compliance with applicable requirements ........................................................ 83

GM1 21.A.307 The eligibility of parts and appliances for installation .............................................. 83

GM1 21.A.307(c) The eligibility of parts and appliances for installation .......................................... 83

AMC1 21.A.606(b) Requirements for the issuance of an ETSO authorisation ................................. 84

AMC1 21.A.606(d) Declaration requirements for the issuance of an ETSO authorisation ............... 86

AMC1 21.A.608 Declaration of Design and Performance (DDP)....................................................... 87

GM 21.A.719 Transfer of a permit to fly ........................................................................................... 91

AMC1 21.A.807(a) Identification of ETSO articles ............................................................................ 93

GM 21.B.80 Type-certification basis for a type certificate (TC) or restricted type certificate (RTC)93

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

(TC) or restricted type certificate (RTC) ............................................................................................ 94

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) ................................................................................................................................................. 95

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

authorisation (ETSOA) projects ......................................................................................................... 97

GM1 21.B.433(d) Findings and corrective actions; observations .................................................... 97

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1. Proposed amendments

The amendments are arranged as follows to show deleted, new and unchanged text:

— deleted text is struck through;

— new text is highlighted in blue;

— an ellipsis, ‘[…]’, indicates that the rest of the text is unchanged.

GM1 21.A.6 Manuals

The term ‘manuals’, used in 21.A.6, could cover any kind of data/information produced by the design

approval holder to demonstrate compliance with the applicable type certification basis, the applicable

operational suitability data certification basis and the environmental protection requirements. The

data/information can be published as paper or electronic documents or in a format outside the

traditional understanding of a document, for example as a series of web pages, as IT tools or in a

publishing format linked to tasks or data modules rather than pages.

Certification specifications and their acceptable means of compliance may provide additional guidance for the publication of manuals that are not in paper format (e.g. Appendix 1 ‘Computerised aeroplane flight manual’ to AMC 25.1581).

GM1 21.A.7(a) Scope of the ICA, their publication format, and typical ICA data

(a) […]

(b) […]

(c) Instructions for continued airworthiness (ICA) should include part number (P/N) information for removable items/units to enable compliance with the removing and installing instructions required by the certification specifications (e.g. CS-25 Appendix H25.3(b)(3) for Large Aeroplanes, CS-E-25(c)(7) for Engines). It is not enough to provide instructions on ‘how’ to install a part; it is essential to know ‘what’ part(s) can be fitted. If certain parts can be replaced with non-

identical spare parts, then associated interchangeability information (i.e. which parts can be substituted and under which specific conditions), if any, should be provided as ICA in accordance with the associated approved design data.

Manuals such as illustrated parts catalogue (IPC) and relevant section(s) of the structural repair manual, or their supplements, are usually considered part of the ICA if they are the means of part identification and if this information is not already contained in another ICA (e.g. the aircraft maintenance manual (AMM) or an equivalent document).

Typically, the AMM uses index numbers to refer to the IPC for P/N and interchangeability information, if applicable, and the P/N is not directly provided in the AMM.

If the P/N information is provided in a form other than an IPC or supplement, then this document or these documents should be considered ICA.

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If different documents are provided by the design approval holder to keep P/N information in line with the type design (e.g. via service bulletins or temporary revisions in addition to regular revisions of the IPC), clear implementation instructions need to be established by the design approval holder on how this information should be consolidated to allow correct P/N identification and possible interchangeability by the end user.

The ICA status then ensures the update and publication of P/N information for stakeholders such as operators/owners in accordance with point 21.A.7(b).

(c)(d) The requirement for ICA is not intended to ensure that all products or articles may be restored to an airworthy condition. A certain level of deterioration may require a product or an article to be permanently withdrawn from service, and restoration may not be reasonably achievable. Notwithstanding the above, the existence of an MRBR task other than ‘Discard (DS or DIS)’ should be a clear indication of the necessity/obligation to produce a corresponding ICA.

Certain deteriorations or levels of deterioration may require specific instructions (e.g. inspection or restoration) that will only be developed and provided on a case-by-case basis, as needed, for a given product or article, and as such, will not be included in the ICA.

In some exceptional cases, product ICA may ultimately instruct the user to contact the DAH in order to define the specific instructions on a case-by-case basis. This typically happens when the definition of generic instructions covering all possible cases is not possible. For example, following an aircraft hard landing, a detailed analysis may have to be carried out by the DAH to determine the specific instructions to be followed, which depends on the touchdown loads, recalculated postflight, based on recorded flight data.

AMC1 21.A.7(c) Completeness and timely availability of the ICA COMPLETENESS AND TIMELY AVAILABILITY OF THE ICA FOR TYPE-CERTIFICATE (TC) AND RESTRICTED TYPE-CERTIFICATE (RTC) APPLICANTS

(a) […]

(b) Completeness and timely availability of changes to the ICA (TC/RTC)

Point 21.A.7(d) regulates the distribution of changes to the ICA required from the TC/RTC holder. Those changes to the ICA could result from the design change process (minor and major changes), in-service experience, corrections, and others.

For an EU TC/RTC holder/applicant, a programme showing how changes to the ICA are distributed is part of the respective procedures (e.g. design organisation procedures, or alternative procedures used to demonstrate capabilities). For changes to the ICA triggered by design changes, typically these procedures follow the same principles as those available for TC/RTC, Options 1 to 3, while taking into account the relevant privileges, e.g. that a DOA may approve minor changes in accordance with point 21.A.263(c)(2).

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AMC1 21.A.7(d) Instructions for continued airworthiness

CHANGES TO THE ICA

Completeness and timely availability of changes to the ICA (TC/RTC)

For an EU TC/RTC holder/applicant, the process for making changes to the ICA and distributing these changes should be documented (e.g. in design organisation procedures or alternative procedures used to demonstrate capabilities). For changes to the ICA triggered by design changes, typically these procedures follow the same principles as those available for TCs/RTCs, in AMC1 21.A.7(c), options 1– 3, while taking into account the relevant privileges (e.g. that a design organisation approval (DOA) holder may approve minor changes in accordance with point 21.A.263(c)(2)).

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

[…]

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.

Note: When proposing special conditions, the applicant should review the special conditions already published by EASA and establish their applicability to its product.

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’

[…]

GM14 21.A.15(bd)(4) Application SCOPE OF OPERATIONAL SUITABILITY DATA FOR DIFFERENT TYPES OF OPERATIONS

In the application for the approval of operational suitability data, theThe applicant for a TC or RTC

applicant may apply for the certification approval of different types of operations. If the aircraft is

certified for different certain types of operations (e.g. ETOPS, RNP, LVO), the impact on the OSD

certification basis of each operation constituents of 21.A.15(d) should be addressed.

The five defined OSD constituents are listed in paragraph (2)(k) of Article 1 of Regulation (EU) No 748/2012. As explained in GM No 1 to 21.A.15(d), they may not all be applicable to all aircraft types. The content of each OSD constituent is defined in the relevant certification specification (CS) and will be approved under a type certificate (TC), supplemental type certificate (STC) or change to those

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certificates. As explained in GM No 3 to 21.A.15(d), each OSD constituent can have a part that is mandatory for the end user (operator, training organisation, etc.) and a part that is not mandatory (recommendation) for the end user. However, both the mandatory and the non-mandatory part together are the OSD constituent. Furthermore, the OSD constituent always includes the element required from the TC/STC applicant, as specified in the CS, and may include additional elements at the request of the TC/STC applicant, but still as defined in the CS.

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

GM No 2 to 21.A.15(d) Determination of type or variant The criteria for the determination whether an aircraft with a new type certificate (TC) is considered a new type or is a variant with reference to another aircraft type from the same TC holder for the purpose of the specific OSD constituent are provided in the applicable certification specifications for maintenance certifying staff data, flight crew data and cabin crew data.

GM No 3 to 21.A.15(d) OSD content The OSD will typically consist of elements that are required to be included by the TC applicant and

elements that can be added at the request of the TC applicant. (See also GM No 4 to 21.A.15(d)).

Both the required elements and the additional elements will have a part that is mandatory to be used

by the operator or training organisation (status of rule) and a part which is not mandatory to the

operator or training organisation (status of AMC). For illustration of this concept, Figure 1 below is

included.

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Figure 1: OSD boxes concept

Box 1: required from TC holder; mandatory for end-users.

Box 2: required from TC holder; not mandatory (recommendations) for end-users.

Box 3: at request of TC holder; mandatory for end-users.

The TC applicant may wish to apply for the approval of differences training between variants or types to reduce training, checking or currency requirements for operations of more than one type or variant. This is regarded as an optional element in addition to the required elements of Box 1 and 2.

Box 4: at request of TC holder; not mandatory (recommendations) for end-users.

The exact content of the four boxes in the above figure is determined by the certification specification that is applicable to the specific OSD constituent or the special condition in case of an ‘other type- related operational suitability element’.

The status the data will have on the side of the operator or training organisation should be indicated in the OSD by segregating the data in a section called ‘Mandatory’ and a section called ‘Non- mandatory (recommendations)’.

AMC2 21.A.33 Inspections and tests

USE OF INDUSTRY STANDARDS

Compliance with the testing requirements in 21.A.33 may be demonstrated by the use and application of the industry standards contained in the ASD-STAN technical reports TR 9250, Test Organisations – General requirements for test process and capabilities, edition P1, dated 31 August 2022, and TR 9251, Flammability Test Organisations Qualification Standard, edition P1, dated 31 August 2022, as relevant.

The above-mentioned industry standards may also support the demonstration of compliance with points 21.A.5 (record-keeping), 21.A.20(c) (compliance documents) and 21.A.239(d)(3) (subcontractors) when performing testing activities.

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Note: TR 9251 complements TR 9250 for flammability test organisations.

GM 21.A.35(b)(2) Flight tests Objective and Content of Function and Reliability Testing

OBJECTIVE AND CONTENT OF FUNCTION AND RELIABILITY TESTING

1. OBJECTIVE

The objective of this testing is to expose the aircraft to the variety of uses, including training and operational suitability flights, representative of operations that are likely to occur when the aircraft is in routine service to provide an assurance that it performs its intended functions to the standard required for certification and should continue to do so in service.

2. CONTENT OF FUNCTION AND RELIABILITY TESTING

[…]

GM1 21.A.90C Stand-alone changes to the ICA

Changes to the ICA are considered to be stand-alone changes when they are not directly prepared together with a change to the type design. Stand-alone changes to the ICA are usually prepared and issued, for example, for the purpose of making corrections, or improvements, to include feedback from users, or to provide alternatives.

Also, when the ICA are completed after the product (or change to the product) was approved, this is considered to be a stand-alone change to the ICA.

When a non-ALS ICA change is triggered by a change to the type design, this does not affect the overall classification of the type certificate change as per point 21.A.91.

SStand-alone changes to the ICA are usually straightforward changes, and are not considered to require additional work in order to show compliance. However, they must be managed in accordance with a process accepted by EASA under points 21.A.239 and 21.A.265(h) or under point 21.A.14(b), for discharging the obligation to keep the ICA up to date.

Examples of changes that may require additional activities in order to show compliance are changes to the CDCCL, and EWIS ICA and specific inspection procedures after hard landing.

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

1. […]

2. […]

3. ASSESSMENT OF A CHANGE FOR CLASSIFICATION

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3.1 […]

3.2 […]

3.3 […]

3.4 Complementary guidance for classification of changes

[…]

Note 1: A change previously classified as minor and approved prior to the airworthiness directive issuance decision needs no reclassification. However, EASA retains the right to review the change and reclassify/reapprove it if found necessary.

Note 2: The conditions listed in (a) through (g) above are an explanation of the criteria noted in 21.A.91.

Note 3: Under condition (a) above, the special conditions published on the EASA website need to be considered.

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

[…]

(a) Master minimum equipment list (MMEL)

(1) […]

(2) A change to the MMEL is judged not to have an ‘appreciable effect on the operational suitability of the aircraft’ and, therefore, should be classified as minor, in particular but not only when one or more of the following conditions are met:

Modifications to an existing item when:

(i) the change only corresponds to the applicability of an item for configuration management purposes;

(ii) the change corresponds to the removal of an item;

(iii) the change corresponds to the increase in the number of items required for dispatch; and

(iv) the change corresponds to a reduction in the rectification interval of an item.

Addition of a new item when:

(v) it is considered as non-safety-related (refer to CS-MMEL, GM2 MMEL.110); or

(vi) it is indicated as eligible for minor change classification in Appendix 1 to GM1 CS-MMEL-145.; or

(vii) it does not meet any condition for major classification as per paragraph 3.5 of (a)(1) above and does not introduce a relief for an item required by Regulation (EU) 2018/1139 and its delegated and implementing acts.

(b) […]

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(d) […]

(e) […]

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) […]

(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

(4) changes to parts of the AFM or AFM supplement that do not require approval by EASA;

(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) (Reserved)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) (Reserved)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;

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[…]

Appendix A to GM 21.A.91 Examples of Major Changes per discipline

[…]

1. Structure

(i) changes such as a cargo door cut-out, fuselage plugs, change of dihedral, addition of floats;

(ii) changes to materials, processes or methods of manufacture of critical parts that impact the critical characteristics primary structural elements, such as spars, frames and critical parts. Note: This does not apply to engine critical parts; these are addressed in Section 6 ‘Engines’ below (CS-E 515);

(iii) changes to materials, processes or methods of manufacture of primary structural elements that impact mechanical properties or characteristics, such as strength, fatigue, corrosion resistance and stiffness;

(iv) changes that adversely affect fatigue or damage tolerance or life limit characteristics or that are beneficial for fatigue and damage tolerance and for which credit is sought, such as extension of an approved life limit or inspection interval. Note: This does not apply to engine critical parts; these are addressed in Section 6 ‘Engines’ below (CS-E 515);

(v) changes that adversely affect aeroelastic characteristics.

2. Cabin Safety

(i) changes which introduce a new cabin layout of sufficient change to require a re- assessment of emergency evacuation capability or which adversely affect other aspects of passenger or crew safety.

Items to consider include, but are not limited to, :

— changes to or introduction of dynamically tested seats.

— changes to the pitch between seat rows.

— changes of distance between seat and adjacent obstacle like a divider.

— changes to cabin lay outs layout that affect evacuation path or access to exits.

— installations of new galleys, toilets, wardrobes, etc.

— installations of new types of electrically powered galley insert.

(ii) changes to the pressurisation control system which adversely affect previously approved limitations.

3. […]

4. […]

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5. […]

6. […]

7. Rotors and drive systems

Changes that:

(i) adversely affect fatigue evaluation unless the service life or inspection interval are unchanged. This includes changes to materials, processes or methods of manufacture of parts, such as

rotor blades

rotor hubs including dampers and controls

gears

drive shafts

couplings

(i) changes to structural parts of the rotors (e.g. blades, hub, control mechanism, hinges, elastomeric bearings) and drive systems (e.g. gears, shafts, bearings and housings), in accordance with the guidance in Section 1 ‘Structure’ above.

(ii) affect systems the failure of which may have hazardous or catastrophic effects. The design assessment will include:

cooling system

lubrication system

rotor controls

(ii) changes that affect equipment/systems associated with the rotors and rotor drive systems (e.g. cooling and lubrication systems with their associated monitoring means, chip detection systems, rotor brake actuation and monitoring systems, VHM systems), the failure of which may have hazardous or catastrophic effects.

(iii) changes that adversely affect the results of the rotor drive system endurance test, the rotor drive system being defined in CS 27/29.917.

(iv) changes that adversely affect the results of the shafting critical speed analysis required by CS 27/29.931.

8. […]

9. […]

10. […]

[…]

GM 21.A.101 Establishing the certification basis of changed aeronautical products Type-certification basis, operational

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suitability data certification basis and environmental protection requirements for a major change to a type-certificate

ESTABLISHING THE CERTIFICATION BASIS FOR 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 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 steps requirements (evaluations, classifications, and decisions) throughout the process.

1.2. Applicability.

1.2.1 This GM is for an applicants that who applyies for major changes to TCs and restricted type-certificates under Subpart D, for supplemental type-certificates (STCs), or major 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 classify changes and approve 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 relates to 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.

1.2.35 The term ‘aeronautical product’, or ‘product’, means a type-certified aircraft, aircraft engine, or propeller and, for the purpose of this GM, an ETSO-authorised A’d APU.

1.2.4 6 This GM primarily provides guidance for the establishment designation of the applicable type-certification basis and the operational suitability data (OSD) certification basis for the changed product. However, portions of this GM, as specified in GM1 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

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protection requirements (e.g. aircraft noise, fuel venting, and engine exhaust emissions and aeroplane CO2 emissions requirements) for changed products, as they are designated from the essential requirements in the first subparagraph of Article 9(2) of Regulation (EU) 2018/1139 on the date of application for the approval of the change through point 21.B.85.

1.2.5 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.This GM is to be considered in its entirety.

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 type-certification basis and the OSD certification basis for changed aeronautical products. It describes in detail the various steps for developing the type-certification basis and the OSD certification basis, which is a process that applies to all major 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) in accordance with point 21.A.101(c).

1.4.5 Chapter 5 contains considerations for:

— design-related operating requirements, — defining a baseline product, — predecessor standards (see paragraph 5.4), — using special conditions under point 21.A.101(d), — documenting revisions to the type-certification TC basis, — incorporating STCs into the type design, — removing changes, — determining a type-certification basis and OSD certification basis after

removing an approved change, and — sequential 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 change: ‘substantial’, ‘significant’, and ‘not significant’.

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1.4.7 Appendix B contains application charts for applying the point 21.A.101 process, including the reversion excepted process.

1.4.8 Appendix C contains one method for determining the change and affected areas.

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 reversion criteria 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 of a changed product rule CPR process 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 provides the definitions and of the termsinology used in this GMapplicable 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.B.80 and the operational suitability data (OSD) certification basis provided for in point 21.B.82.

For more terms, cConsult 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 mass 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 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 ofto 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).

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Point 21.A.101(a) requires that a major 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 on the date of application for the approval of the change (i.e. the latest certification specifications standards in effect at the time of application), unless the change meets the criteria for the reversions or 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 type-certification basis and the OSD certification basis for the changed product to the greatest extent practicable.

*NOTE: Certification specifications that were amended after the date of application.

In addition, point 21.A.101(a) requires that the changed product complies with the applicable environmental protection requirements on the date of application for approval of the change (i.e. the latest level of amendment of Volumes I, II and III of ICAO Annex 16 implemented in Article 9(2) of Regulation (EU) 2018/1139).

2.2.2 Point 21.A.101(b).

Point 21.A.101(b) pertains to when an applicant may show requests to demonstrate 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 or unusual in comparison with the certification specification airworthiness standard at the proposed amendment, a more recent certification specification airworthiness standard and/or special conditions will be applied for these features.

Except as provided in point 21.A.101(h), Aan applicant is considered to may comply with request to revert to 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 specifications included by reference in the type-certification basis and the OSD certification basis of the identified baseline product.

Points 21.A.101(b)(1)(i), and (ii) and (iii) pertain to changes that meet the include automatic criteria where the change is considered 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 take-off mass weight. An applicant who applies for a major change to an

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aircraft (other than rotorcraft) of 2 722 kg (6 000 lb) or less maximum take-off mass weight, or to a non-turbine-powered rotorcraft of 1 361 kg (3 000 lb) or less maximum take-off mass weight, can show demonstrate that the changed product complies with the certification specifications standards incorporated by reference in the type-certificate. An applicant can also elect to comply or may be required to comply with the later certification specifications 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.B.75 and the conditions described there, when the proposed certification basis and any later certification specifications applicable on the date of the application for the approval of the change do not provide adequate standards 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) 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 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 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) 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 GM1 21.A.101(g).

2.2.7 Point 21.A.101(h).

Point 21.A.101(h) restricts the option described in point 21.A.101(b) for reversion to an earlier amendment of the certification specification. Refer to AMC1 21.A.101(h).

3. PROCESS FOR ESTABLISHING THE TYPE-CERTIFICATION BASIS AND THE OSD CERTIFICATION BASIS FOR CHANGED PRODUCTS

3.1. Overview.

3.1.1 The applicant and EASA both have responsibilities under point 21.A.101(a) and (b). As an The applicant for the approval certification of a change, the applicant must demonstrate that the change and areas affected by the change comply with the latest applicable certification specifications unless the applicant proposes exception(s) reversion(s) under point 21.A.101(b). An applicant proposing

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exception(s) reversions(s) should make a preliminary classification whether the change is ‘significant’ or ‘not significant’, and propose an appropriate adequate type-certification basis and OSD certification basis. EASA is responsible for determining whether the applicant’s classification of the change, and proposal for the type-certification basis and OSD certification basis, are consistent with the applicable rules and their interpretation. The EASA determination does not depend on whether the TC holder or applicant for an STC is originating the change. The type-certification basis and OSD certification basis can vary depending on the magnitude and scope of the change. The steps below present a streamlined approach for making this determination.

3.1.2 The tables in appendix A of this GM are examples of classifications of typical type design changes. See paragraph 3.6.3 of this chapter for instructions on how to use those tables.

3.1.3 If For a proposed major change is not in the examples provided in appendix A, the applicant may should use the following steps in conjunction with the flow chart in Figure 3-1 of this GM to develop the appropriate type-certification basis and OSD certification basis for the change. For clarification, the change discussed in the flow chart also includes areas affected by the change. See paragraph 3.9.1 of this GM for guidance about affected areas.

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Figure 3-1. Developing a Proposed Type-Certification Basis and OSD Certification Basis for a Changed

Product Pursuant to point 21.A.101

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Consider the exception from reversion in accordance with point 21.A.101(h).

Step 6: Prepare your Proposed Type-Certification Basis and OSD Certification Basis List. See Note 2.

Step 8: Ensure Proposed Type-Certification Basis and OSD Certification Basis are Adequate.

Submit Proposed Type-Certification Basis

and OSD Certification Basis to the Agency.

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3.2. Step 1. Identify the proposed changes to an aeronautical product.

Identify the type design being changed (the baseline product).

Identify the proposed change.

Use high-level descriptors.

3.2.1 Identify the type design being changed (the baseline product).

Prior to describing the proposed change(s), it is important to clearly identify the specific type design configuration being changed.

Note: For additional guidance on the baseline product, see paragraph 5.3 of this GM.

3.2.2 Identify the proposed change.

3.2.2.1 The purpose of this process step is to identify and describe the change to the aeronautical product. Changes to a product can include physical design changes and functional changes (e.g. operating envelope or performance changes). An applicant must identify all changes and areas affected by the change, including those where they plan to use previously approved data. EASA considers all of these changes and areas affected by the change to be part of the entire proposed type design and they are considered as a whole in the classification of whether the proposed change is substantial, significant, or not significant. The change can be a single change or a collection of changes. In addition to the proposed changes, an applicant should consider the cumulative effect of previous relevant changes incorporated since the last time the type-certification basis and OSD certification basis waswere upgraded. An applicant for a change must consider all previous relevant changes and the amendment level of the certification specifications in the type-certification basis and OSD certification basis used for these changes.

3.2.2.2 When identifying the proposed changes, an applicant should consider previous relevant changes that create a cumulative effect, as these may influence the decisions regarding the classification of the change later in the process. By ‘previous relevant changes,’ EASA means changes where effects accumulate, such as successive thrust increases, incremental weight mass increases, or sectional increases in fuselage length. An applicant must account for any previous relevant changes to the area affected by the proposed change that did not involve an upgrade of the type-certification basis and OSD certification basis in the proposed change.

3.2.2.3 Example:

An applicant proposes a 5 per cent weight mass increase, but a previous 4 per cent and another 3 per cent weight mass increase were incorporated into this aircraft without upgrading the existing type-certification basis and OSD certification basis. In the current proposal for a 5 per cent weight mass increase, the cumulative effects of the two previous weight mass increases that did not involve an upgrade of the type-certification basis and OSD certification basis will now be accounted for as an approximate 12 per cent increase in weight mass. Note that the cumulative effects the applicant accounts for are only those incremental increases since the last time the airworthiness certification specifications in the type-certification basis and

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OSD certification basis applicable to the area affected by the proposed change were upgraded.

3.2.3 Use High-Level Descriptors.

To identify and describe the proposed changes to any aeronautical product, an applicant should use a high-level description of the change that characterises the intent of, or the reason for, the change. No complex technical details are necessary at this stage. For example, a proposal to increase the maximum passenger-carrying capacity may require an addition of a fuselage plug, and as such, a ‘fuselage plug’ becomes one possible high-level description of this change. Similarly, a thrust increase, a new or complete interior, an avionics system upgrade, or a passenger- to-cargo conversion are all high-level descriptions that characterise typical changes to the aircraft, each driven by a specific goal, objective, or purpose.

3.2.4 Evolutionary changes that occur during the course of a certification program may require re-evaluation of the type-certification basis and OSD certification basis, and those changes that have influence at the product level may result in re- classification of the change.

3.3. Step 2. Verify the proposed change is not substantial.

3.3.1 Point 21.A.19 requires an applicant to apply for a new TC for a changed product if the change to design, power, thrust, or mass weight is so extensive that a substantially complete investigation of compliance with the applicable regulations is required. A new TC could be required for either a single extensive change to a previously type-certified product or for a changed design derived through the cumulative effect of a series of design changes from a previously type-certified product.

3.3.2 A ‘substantially complete investigation’ of compliance is required when most of the existing substantiation is not applicable to the changed product. In other words, an applicant may consider the change ‘substantial’ if it is so extensive (making the product sufficiently different from its predecessor) that the design models, methodologies, and approaches used to demonstrate a previous compliance finding could not be used in a similarity argument. EASA considers a change ‘substantial’ when these approaches, models, or methodologies of how compliance was shown are not valid for the changed product.

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 and 21.A.19. If the change is not substantial, proceed to step 3.

3.4. Step 3. Will the applicant use the latest certification specificationsstandards?

An applicant can use the latest certification specifications for their proposed change and the area affected by the change. If they use the latest certification specifications, they will have met the intent of point 21.A.101 and no further classification (significant or not significant) and justification is needed. Even though an applicant elects to use the latest certification specifications, the applicant will still be able to apply point 21.A.101 for future similar changes, and use the exceptions reversion possibilities under point 21.A.101(b). However, the decision to comply with the latest certification specifications sets a new basis for all future related changes to the same affected area for that amended TC.

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If using the latest certification specifications, an applicant should proceed to Step 68 (in paragraph 3.911 of this GM).

If not using the latest certification specifications, an applicant should proceed to Step 4 below.

3.5. Step 4. Arrange changes into related and unrelated groups.

3.5.1 An applicant should now determine whether any of the changes identified in Step 1 are related to each other. Related changes are those that cannot exist without another, are co-dependent, or a prerequisite of another. For example, a need to carry more passengers could require the addition of a fuselage plug, which will result in a weight mass increase, and may necessitate a thrust increase. Thus, the fuselage plug, weight mass increase, and thrust increase are all related, high-level changes needed to achieve the goal of carrying more passengers. A decision to upgrade the flight deck to more modern avionics at the same time as these other changes may be considered unrelated, as the avionics upgrade is not necessarily needed to carry more passengers (it has a separate purpose, likely just modernisation). The proposed avionics upgrade would then be considered an unrelated (or a stand-alone) change. However, the simultaneous introduction of a new cabin interior is considered related since occupant safety considerations are impacted by a cabin length change. Even if a new cabin interior is not included in the product-level change, the functional effect of the fuselage plug has implications on occupant safety (e.g. the dynamic environment in an emergency landing, emergency evacuation, etc.), and thus the cabin interior becomes an affected area. Figure 3-2 below illustrates the grouping of related and unrelated changes using the example of increasing the maximum number of passengers.

Note: An applicant who plans changes in sequence over time should refer to the discussion on ‘sequential design changes’ in paragraph 5.13 of this GM.

Figure 3-2. Related and Unrelated Changes for Example of Increasing the Maximum Number of Passengers

The Aeronautical Product

MTOM increase (Physical and

Performance change)

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3.5.2 Once the change(s) is (are) organised into groupings of those that are related and those that are unrelated (or stand-alone), an applicant should proceed to Step 5 below.

3.6. Step 5. Is each group of related changes or each unrelated (stand-alone) change a significant change?

3.6.1 The applicant is responsible for proposing the classification of groups of related changes or unrelated changes as ‘significant’ or ‘not significant’. Significant changes are product-level changes that could result from an accumulation of changes, or occur through a single significant change that makes the changed product distinct from its baseline product. The grouping of related and unrelated changes is particularly relevant to EASA’s significant Yes/No decision (point 21.A.101(b)(1)) described in Step 1 of Figure 3-1. EASA evaluates each group of related changes and each unrelated (stand-alone) change on its own merit for significance. Thus, there may be as many evaluations for significance as there are groupings of related and unrelated changes. Step 1 of Figure 3-1 explains the accumulation of changes that an applicant must consider. Additionally, point 21.A.101(b)(1) defines a change as ‘significant’ when at least one of the three automatic criteria applies:

3.6.1.1 Changes where the general configuration is not retained (significant change to general configuration).

A change to the general configuration at the product level is one that distinguishes the resulting product from other product models, for example, performance or interchangeability of major components. Typically, for these changes, an applicant will designate a new product model, although this is not required. For examples, see appendix A of this GM.

3.6.1.2 Changes where the principles of construction are not retained (significant change to principles of construction).

A change at the product level to the materials and/or construction methods that affects the overall product’s operating characteristics or inherent strength and would require extensive reinvestigation to demonstrate compliance is one where the principles of construction are not retained. For examples, see appendix A of this GM.

3.6.1.3 Product-level changes that invalidate the assumptions used for certification of the baseline product.

Examples include:

change of an aircraft from an unpressurised to pressurised fuselage,

change of operation of a fixed-wing aircraft from land-based to water-based, and

operating envelope expansions that are outside the approved design parameters and capabilities.

For additional examples, see appendix A of this GM.

3.6.2 The above criteria are used to determine whether each change grouping and each stand-alone change is significant. These three criteria are assessed at the product level. In applying the automatic criteria and the examples in appendix A of this GM,

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an applicant should focus on the change and how it impacts the existing product (including its performance, operating envelope, etc.). A change cannot be classified or reclassified as a significant change on the basis of the importance of a later amendment.

3.6.3 Appendix A of this GM includes tables of typical changes (examples) for small aeroplanes, transport large aeroplanes, rotorcraft, engines, and propellers that meet the criteria for a significant design change. The Appendix also includes tables of typical design changes that EASA classifies as not significant. The tables can be used in one of two ways:

3.6.3.1 To identify the classification of a proposed design change listed in the table, or

3.6.3.2 In conjunction with the three automatic criteria, to help classify a proposed design change not listed in the table by comparison to determinations made for changes with similar type and magnitude.

3.6.4 In many cases, a significant change may involve more than one of these criteria and will be obvious and distinct from other product improvements or production changes. There could be cases where a change to a single area, system, component, or appliance may not result in a product-level change. There could also be other cases where the change to a single system or component might result in a significant change due to its effect on the product overall. Examples may include the addition of winglets or leading-edge slats, or a change to primary flight controls of a fly-by-wire system.

3.6.5 If an unrelated (stand-alone) change or a grouping of related changes is classified as —

Significant (point 21.A.101(a)):

You must comply with the latest certification specifications airworthiness standards for the approval certification of the change and areas affected by change, unless you justify use of one of the exceptions reversion criteria provided in point 21.A.101(b)(2) or (3) to show demonstrate compliance with earlier amendment(s). The final type-certification basis and OSD certification basis may consist of a combination of the requirements recorded in the certification basis ranging from the original aircraft type-certification basis and OSD certification basis to the most current regulatory amendments.

Not Significant (point 21.A.101(b)(1)):

You may comply with the existing type-certification basis and OSD certification basis unless the standards in the proposed certification specifications basis are deemed inadequate. In cases where the existing type-certification basis or OSD certification basis is inadequate or no regulatory standards exist, later certification specifications requirements and/or special conditions are will be required. See paragraph 3.11 of this GM for a detailed discussion.

3.6.6 A new model designation to a changed product is not necessarily indicative that the change is significant under point 21.A.101. Conversely, retaining the existing model designation does not mean that the change is not significant. Significance is determined by the magnitude of the change.

3.6.7 EASA determines the final classification of whether a change is significant or not significant. To assist an applicant in its assessment, EASA has predetermined the

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classification of several typical changes that an applicant can use for reference, and these examples are listed in appendix A of this GM.

3.6.8 At this point, the determination of significant or not significant for each of the groupings of related changes and each stand-alone change is completed. For significant changes, an applicant that proposes to comply with an earlier certification specification should use the procedure outlined in paragraph 3.7 below. For changes identified as not significant, see paragraph 3.8 below.

3.7. Proposing an amendment level of a certification specification for a significant change.

3.7.1 Without prejudice to the reversion criteria and exceptions provided for in point 21.A.101(b) or (c), if the classification of a group of related changes or a stand- alone unrelated change is significant, all areas, systems, components, parts, or appliances affected by the change must comply with the certification specifications at the amendment level in effect on the date of application for the change, unless the applicant elects to comply with certification specifications that have become effective after that date (see point 21.A.101(a)).

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 certification specifications, unless the applicant proposes to use the reversion criteria of point 21.A.101(b)(3).

When a new OSD constituent is added or required to be added, it should comply with the latest amendment of the applicable certification specifications.

3.7.2 In certain cases, an applicant will be required by EASA to comply with certification specifications that have become effective after the date of application (see point 21.A.101(a)):

3.7.2.1 If an applicant elects to comply with a specific certification specification or a subset of certification specifications at an amendment which has become effective after the date of application, the applicant must comply with any other certification specification that EASA finds is directly related (see point 21.A.101(f)).

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 type-certification basis and the OSD certification basis established according to points 21.B.80 and, 21.B.82 and 21.B.85 from the certification specifications that have become effective since the date of the initial application.

Note: This also applies to environmental protection requirements.

3.7.3 Except as provided for in point 21.A.101(h), Aapplicants can may justify the use of one of the exceptions reversion possibilities in point 21.A.101(b)(2) or (3) to comply with an earlier amendment, but not with an amendment introduced earlier than the existing type-certification basis and OSD certification basis. See paragraphs 3.9 and 3.10 of this GM. Applicants who elect to comply with a specific certification specification or a subset of certification specifications at an earlier amendment will be required to comply with any other certification specification that EASA finds are directly related.

3.7.4 The final type-certification basis and OSD certification basis may combine the latest, earlier (intermediate), and existing certification specifications, but cannot

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contain certification specifications preceding the existing type-certification basis and OSD certification basis.

3.8. Proposing an amendment level of a certification specification for a not significant change.

3.8.1 When EASA classifies the change as not significant, the point 21.A.101(b) rule allows compliance with earlier amendments, but not prior to the existing type- certification basis and OSD certification basis. Within this limit, the applicant may propose an amendment level for each certification specification for the affected area. However, each applicant should be aware that EASA will review their proposals for the type-certification basis and OSD certification basis to ensure that the type-certification basis and the OSD certification basis are is adequate for the proposed change under Step 8. (See paragraph 3.11 of this GM.)

3.8.2 Even for a not significant change, an applicant may elect to comply with certification specifications which became applicable after the date of application. Applicants may propose to comply with a specific certification specification or a subset of certification specifications at a certain amendment of their choice. In such a case, any other certification specifications of that amendment that are directly related should be included in the type-certification basis and OSD certification basis for the change.

3.9. Step 6. Prepare the proposed type-certification basis and OSD certification basis list.

As part of preparing the proposed type-certification basis and OSD certification basis list, an applicant must identify any areas, systems, parts or appliances of the product that are affected by the change and the corresponding certification specifications associated with these areas. For each group, the applicant must assess the physical and/or functional effects of the change on any areas, systems, parts or appliances of the product. The characteristics affected by the change are not only physical changes, but also functional changes brought about by the physical changes. Examples of physical aspects are structures, systems, parts and appliances, including software in combination with the affected hardware. Examples of functional characteristics are performance, handling qualities, aeroelastic characteristics, and emergency egress. The intent is to encompass all aspects where there is a need for re-evaluation, that is, where the substantiation presented for the product being changed should be updated or rewritten. Appendix H of this GM contains two examples of how to document a proposed type-certification basis and OSD certification basis list.

3.9.1 An area affected by the change is any area, system, component, part, or appliance of the aeronautical product that is physically and/or functionally changed.

3.9.2 Figure 3-33 of this GM illustrates concepts of physical and functional changes of an affected area. Appendix C of this GM contains a method used to define the change and areas affected by the change. This Appendix is meant to assist applicants when they propose large, complex changes. For each change, it is important for the applicant to properly assess the effects of such change on any areas, systems, parts or appliances of the product because areas that have not been physically changed may still be considered part of the affected area. If a new compliance finding is required, regardless of its amendment level, it is an affected area.

Figure 3-3. Affected Areas versus Not Affected Areas

The Aeronautical Product

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3.9.3 An area not affected by a change can remain at the existing type-certification basis and OSD certification basis, provided that the applicant presents to EASA an acceptable justification that the area is not affected.

3.9.4 For sample questions to assist in determining affected areas, see paragraph D.1 of appendix D of this GM.

3.9.5 Consider the following aspects of a change: Physical aspects.

The physical aspects include direct changes to structures, systems, equipment, components, and appliances, and may include software/airborne electronic hardware changes and the resulting effects on systems functions.

3.9.5.1 Performance/functional characteristics.

The less obvious aspect of the word ‘areas’ covers general characteristics of the type-certified product, such as performance features, handling qualities, emergency egress, structural integrity (including load carrying), aeroelastic characteristics, or crashworthiness. A product-level change may affect these characteristics. For example, adding a fuselage plug could affect performance and handling qualities, and thus the certification specifications associated with these aspects would be considered to be part of the affected area. Another example is the addition of a fuel tank and a new fuel conditioning unit. This change affects the fuel transfer and fuel quantity indication system, resulting in the aircraft’s unchanged fuel tanks being affected. Thus, the entire fuel system (changed and unchanged areas) may become part of the affected area due to the change to functional characteristics. Another example is changing turbine engine ratings and operating limitations, affecting the engine rotors’ life limits.

3.9.6 All areas affected by the proposed change must comply with the latest certification specifications, unless the applicant shows that demonstrating compliance with the latest amendment of a certification specification would not contribute materially to the level of safety or would be impractical. Step 7 below provides further explanation.

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3.9.7 The applicant should document the change and the area affected by the change using high-level descriptors along with the applicable certification specifications and their proposed associated amendment levels. The applicant proposes this change to the type-certification basis and OSD certification basis that EASA will consider for documentation in the type certificate data sheet (TCDS) or STC, if they are different from that recorded for the baseline product in the TCDS.

3.10. Step 7. Do the latest certification specifications standards contribute materially to the level of safety and are they practical?

Pursuant to point 21.A.101(a), compliance with the latest certification specifications is required. However, except as provided in point 21.A.101(h), exceptions reversions may be allowed pursuant to point 21.A.101(b)(3). The applicant must provide justification to support the rationale for the application of earlier amendments for areas affected by a significant change in order to document that compliance with later certification specifications standards in these areas would not contribute materially to the level of safety or would be impractical. Such a justification should address all the aspects of the area, system, part or appliance affected by the significant change. See paragraphs 3.10.1 and 3.10.1.4 of this GM.

3.10.1 Do the latest certification specifications standards contribute materially to the level of safety?

Applicants could consider compliance with the latest certification specifications standards to ‘not contribute materially to the level of safety’ if the existing type design and/or relevant experience demonstrates a level of safety comparable to that provided by the latest certification specifications standards. In cases where design features provide a level of safety greater than required by the existing type- certification basis and OSD certification basis, applicants may use acceptable data, such as service experience, to establish the effectiveness of those design features in mitigating the specific hazards addressed by a later amendment. Applicants must provide sufficient justification to allow EASA to make this determination. An acceptable means of compliance is described in appendix E of this GM. Justification is sufficient when it provides a summary of the evaluation that supports the determination using an agreed evaluation method, such as that in appendix E of this GM. This reversion exception could be applicable in the situations described in the paragraphs below.

Note: Compliance with later certification specifications standards is not required where the amendment is of an administrative nature and made only to correct inconsequential errors or omissions, consolidate text, or to clarify an existing requirement.

3.10.1.1 Improved design features.

Design features that exceed the safety level of the existing type-certification basis and OSD certification basis standards, but do not meet the latest certification specifications, can be used as a basis for granting an exception reversion under point 21.A.101(b)(3) since complying with the latest amendment of the certification specifications would not contribute materially to the level of safety of the product. If EASA accepts these design features as justification for an exception reversion, the applicant must incorporate them in the amended type design configuration and record them, where necessary, in the type-certification basis and OSD certification basis. The description of the design feature would be provided in the TCDS

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or STC at a level that allows the design feature to be maintained, but does not contain proprietary information. For example1, an applicant proposes to install winglets on a Part 25 aeroplane, and part of the design involves adding a small number of new wing fuel tank fasteners. Assuming that the latest applicable amendment of § 25.981 is Amendment 25-102, which requires structural lightning protection, the applicant could propose an exception reversion from these latest structural lightning protection requirements because the design change uses new wing fuel tank fasteners with cap seals installed. The cap seal is a design feature that exceeds the requirement of § 25.981 at a previous amendment level, but does not meet the latest Amendment 25-102. If the applicant can successfully substantiate that compliance with Amendment 25-102 would not materially increase the level of safety of the changed product, then this design feature can could be accepted as an exception reversion to compliance with from the latest amendment of the certification specifications.

3.10.1.2 Consistency of design.

This provision gives the opportunity to consider the consistency of design. For example, when a small fuselage plug is added, additional seats and overhead bins are likely to be installed, and the lower cargo hold extended. These components may be identical to the existing components. The level of safety may not materially increase by applying the latest certification specifications in the area of the fuselage plug. Compliance of the new areas with the existing type-certification basis and OSD certification basis may be acceptable.

3.10.1.3 Service experience.

3.10.1.3.1 Relevant service experience, such as experience based on fleet performance or utilisation over time (relevant flight hours or cycles), is one way of showing that the level of safety will not materially increase by applying the latest amendment, so the use of earlier certification specifications could be appropriate. Appendix F of this GM provides additional guidance on the use of service experience, along with examples.

3.10.1.3.2 When establishing the highest practicable level of safety for a changed product, EASA has determined that it is appropriate to assess the service history of a product, as well as the later airworthiness standards. It makes little sense to mandate changes to well- understood designs, whose service experience has been acceptable, merely to comply with new standards. The clear exception to this premise is if the new standards were issued to address a deficiency in the design in question, or if the service experience is not applicable to the new standards.

3.10.1.3.3 There may be cases for rotorcraft and small aeroplanes where relevant data may not be sufficient or not available at all because of the low utilisation and the insufficient amount and type of data available. In such cases, other service history information may provide

1 This example is taken from the FAA experience gained prior to EASA’s start, therefore the references to the FAA sections and

amendments are kept.

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sufficient data to justify the use of earlier certification specifications, such as: warranty, repair, and parts usage data; accident, incident, and service difficulty reports; service bulletins; airworthiness directives; or other pertinent and sufficient data collected by the manufacturers, authorities, or other entities.

3.10.1.3.4 EASA will determine whether the proposed service experience levels necessary to demonstrate the appropriate level of safety as they relate to the proposed design change are acceptable.

3.10.1.4 Secondary changes.

3.10.1.4.1 The change proposed by the applicant can consist of physical and/or functional changes to the product. See Figure 3-4 below. There may be aspects of the existing type design of the product that the applicant may not be proposing to change directly, but that are affected by the overall change. For example, changing an airframe’s structure, such as adding a cargo door in one location, may affect the frame or floor loading in another area. Further, upgrading engines with new performance capabilities could require additional demonstration of compliance for minimum control speeds and aeroplane performance certification specifications. For many years, EASA has required applicants to consider these effects, and this practice is unchanged under the procedures of point 21.A.101.

Figure 3-4. Change-Affected Areas with Secondary Changes

The Aeronautical Product

3.10.1.4.2 For each change, it is important that the effects of the change on other systems, components, equipment, or appliances of the product are properly identified and assessed. The intent is to encompass all aspects where there is a need for re-evaluation, that is, where the substantiation presented for the product being changed should be reviewed, updated, or rewritten.

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3.10.1.4.3 In assessing the areas affected by the change, it may be helpful to identify secondary changes. A secondary change is a change to physical and/or functional aspects that is part of, but consequential to, a significant physical change, whose only purpose is to restore, and not add or increase, existing functionality or capacity. The term ‘consequential’ is intended to refer to:

a change that would not have been made by itself; it achieves no purpose on its own;

a change that has no effect on the existing functionality or capacity of areas, systems, structures, components, parts, or appliances affected by the change; or

a change that would not create the need for: (1) new limitations or would affect existing limitations; (2) a new aircraft flight manual (AFM) or instructions for continued airworthiness (ICA) or a change to the AFM or ICA; or (3) special conditions, equivalent safety findings, or deviations.

3.10.1.4.4 A secondary change is not required to comply with the latest certification specifications because it is considered to be ‘not contributing materially to the level of safety’ and, therefore, eligible for an exception under point 21.A.101. Determining whether a change meets the description for a secondary change, and is thus eligible for an exception, should be straightforward. Hence, the substantiation or justification need only be minimal. If this determination is not straightforward, then the proposed change is not a secondary change.

3.10.1.4.5 In some cases, a secondary area of change that restores functionality may in fact contribute materially to the level of safety by meeting a later amendment. If this is the case, it is not considered a secondary change.

3.10.2 Are the latest specifications practical?

The intent of point 21.A.101 is to enhance safety by applying the latest certification specifications to the greatest extent practicable. The concepts of contributing materially and practicality are linked. If compliance with the latest certification specifications does contribute materially to the level of safety, then the applicant may assess the incremental costs to see whether they are commensurate with the increase in safety. The additional resource requirements could include those arising from changes required for compliance and the effort required to demonstrate compliance, but excluding resource expenditures for prior product changes. The cost of changing compliance documentation and/or drawings is not an acceptable reason for an exception.

3.10.2.1 Applicants should support their position that compliance is impractical with substantiating data and analyses. While evaluating that position and the substantiating data regarding impracticality, EASA may consider other factors (e.g. the costs and safety benefits for a comparable new design).

3.10.2.2 A review of large aeroplane projects showed that, in certain cases where EASA allowed an earlier amendment of applicable certification specifications, the applicants made changes that nearly complied with the latest amendments. In these cases, the applicants successfully

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demonstrated that full compliance would require a substantial increase in the outlay or expenditure of resources with a very small increase in the level of safety. These design features can be used as a basis for granting an exceptionreversion under point 21.A.101(b)(3) on the basis of ‘impracticality.’

3.10.2.3 Appendix E of this GM provides additional guidance and examples for evaluating the impracticality of applying the latest certification specifications to a changed product for which compliance with the latest certification specifications would contribute materially to the level of safety of the product.

3.10.2.3.1 The exception of reversion on impracticality is a qualitative and quantitative cost–safety benefit assessment for which it is difficult to specify clear criteria. Experience to date with applicants has shown that a justification of impracticality is more feasible when both the applicant and EASA agree during a discussion at an early stage that the effort (in terms of cost, changes to manufacturing, etc.) required to comply would not be commensurate with a small incremental safety gain. This would be clear even without the need to perform any detailed cost–safety benefit analysis (although an applicant could always use cost analysis to support an appropriate amendment level of a certification specification). However, there should be enough detail in the applicant’s rationale to justify exceptionreversions.

— Note: An applicant should not base an exception reversion due to impracticality on the size of the applicant’s company or their financial resources. The applicant must evaluate the costs to comply with a later amendment against the safety benefit of complying with the later amendment.

3.10.2.3.2 For example, a complex redesign of an area of the baseline aircraft may be required to comply with a new requirement, and that redesign may affect the commonality of the changed product with respect to the design and manufacturing processes of the existing family of models. Relevant service experience of the existing fleet of the baseline aircraft family would be required to show that there has not been a history of problems associated with the hazard that the new amendment in question was meant to address. In this way, the incremental cost/impact to the applicant is onerous, and the incremental safety benefit realised by complying with the later amendment would be minimal. This would be justified by demonstrated acceptable service experience in relation to the hazard that the new rule addresses.

3.11. Step 8. Ensure the proposed type-certification basis and OSD certification basis is are adequate.

EASA considers a proposed type-certification basis and OSD certification basis for any change (whether it is significant or not significant) to be adequate when:

— the certification standards provide an appropriate level of safety for the intended

change, and

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— the change and the areas affected by the change do not result in unsafe design

features or characteristics for the intended use.

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.75. 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 type-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.B.107(a)(3) or 21.B.111(a)(3).

3.11.3 In cases where inadequate or no standards exist for the change to the existing type-certification basis and OSD certification basis, but adequate standards exist in a later amendment of the applicable certification specifications, the later amendment will be made part of the type-certification basis and OSD certification basis to ensure the adequacy of the type-certification basis and OSD certification basis.

3.11.4 EASA determines the final type-certification basis and OSD certification basis for a product change. This may consist of a combination of those standards ranging from the existing type-certification basis and OSD certification basis of the baseline product to the latest amendments and special conditions.

4. Excepted Products under point 21.A.101(c)

4.1. Excepted products.

For excepted products as defined in paragraph 4.1.1 below, the starting point for regulatory analysis is the existing type-certification basis and OSD certification basis for the baseline product.

4.1.1 Point 21.A.101(c) provides an exception to the compliance with the latest certification specifications required by point 21.A.101(a) for aircraft (other than rotorcraft) of 2 722 kg (6 000 lb) or less maximum take-off mass weight, or to a non-turbine rotorcraft of 1 361 kg (3 000 lb) or less maximum take-off mass weight. In these cases, the applicant may elect to comply with the existing type- certification basis and OSD certification basis. However, the applicant has the option of applying later, appropriate certification specifications.

4.1.2 If EASA finds that the change is significant in an area, EASA may require the applicant to comply with a later certification specification and with any certification specification that EASA finds is directly related. Starting with the existing type- certification basis and OSD certification basis, EASA will progress through each later certification specification to determine the amendment appropriate for the change. However, if an applicant proposes, and EASA finds, that complying with the later amendment or certification specification would not contribute materially

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to the level of safety of the changed product or would be impractical, EASA may allow the applicant to comply with an earlier amendment appropriate for the proposed change. The amendment may not be earlier than the existing type- certification basis and OSD certification basis. For excepted products, changes that meet one or more of the following criteria, in the area of change, are automatically considered significant:

4.1.2.1 The general configuration or the principles of construction are not retained.

4.1.2.2 The assumptions used for certification of the area to be changed do not remain valid.

4.1.2.3 The change contains new features (not foreseen in the existing type- certification basis and OSD certification basis and for which appropriate later certification specifications exist). In this case, EASA will designate the applicable certification specifications, starting with the existing type- certification basis and OSD certification basis and progressing to the most appropriate later amendment level of the certification specifications for the change.

4.1.2.4 The change contains a novel or unusual design feature. In this case, EASA will designate the applicable special conditions appropriate for the change, pursuant to point 21.A.101(d).

4.1.3 The exception for products under point 21.A.101(c) applies to the aircraft only. Changes to engines and propellers installed on these excepted aircraft are assessed as separate type-certified products using point 21.A.101(a) and (b).

5. Other Considerations

5.1. Design-related requirements from other aviation domains.

Some implementing rules in other aviation domains (air operations, ATM/ANS) (e.g. Commission Regulation (EU) No 965/2012 on air operations or Commission Regulation (EU) 2015/640 on additional airworthiness specifications for a given type of operations (Annex I (Part-26)) impose airworthiness standards that are not required for the issue of a TC or STC (e.g. CS-26, CS-ACNS, etc.). If not already included in the type- certification basis and OSD certification basis, any such applicable airworthiness standard may be added to the type-certification basis and OSD certification basis by mutual agreement between the applicant and EASA. The benefit of adding these airworthiness standards to the type-certification basis and OSD certification basis is to increase awareness of these standards, imposed by other implementing rules, during design certification and future modifications to the aircraft. The use of exceptionsreversions under point 21.A.101(b) is not intended to alleviate or preclude compliance with operating regulations.

5.2. Reserved.

5.3. Baseline product.

A baseline product consists of one unique type design configuration, an aeronautical product with a specific, defined, approved configuration and type-certification basis and OSD certification basis that the applicant proposes to change. As mentioned in paragraph 3.2.1 of this GM, it is important to clearly identify the type design configuration to be changed. EASA does not require an applicant to assign a new model name for a changed product. Therefore, there are vastly different changed products with the same aircraft model name, and there are changed products with minimal differences that have

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different model names. Since the assignment of a model name is based solely on an applicant’s business decision, the identification of the baseline product, for the purposes of point 21.A.101, is, as defined below.

The baseline product is an approved type design that exists on at the date of application and is representative of:

— a single certified build configuration, or

— multiple approvals over time (including STC(s) or service bulletins) and may be

representative of more than one product serial number.

Note: The type design configuration, for this purpose, could also be based on a proposed future configuration that is expected to be approved at a later date but prior to the proposed changed product.

5.4. Predecessor standards.

The certification specifications in effect on the date of application for a change are those in CS-22, CS-23, CS-25, CS-27, CS-29, CS-CCD, CS-FCD, CS-MMEL, etc., issued by EASA after 2003. However, the type-certification basis and OSD certification basis of some ‘grandfathered’ products, i.e. those with a pre-EASA TC deemed to have been issued in accordance with Commission Regulation (EU) No 748/2012 (see Article 3), may consist of other standards issued by or recognised in the EU Member States. These standards may include Joint Aviation Requirements (JARs) issued by the Joint Aviation Authorities (JAA) or national regulations of an EU Member State (e.g. BCARs) or national regulations of a non-EU State of Design with which an EU Member State had concluded a bilateral airworthiness agreement (e.g. US FARs, CARs etc.). Consequently, when using one of the exceptionreversion routes allowing electing to comply with earlier certification specifications standards, the predecessor standards may be applicable. Such predecessor standards are not recognised under point 21.A.101(a), but may be allowed under point 21.A.101(b) or (c).When choosing the amendment level of a predecessor standard, all related predecessor standards associated with that amendment level would have to be included.

5.5. Special conditions, point 21.A.101(d).

Point 21.A.101(d) allows for the application of special conditions, or for changes to existing special conditions, to address the changed designs where neither the proposed type-certification basis and OSD certification basis nor any later certification specifications provide adequate standards for an area, system, part or appliance related to the change. The objective is to achieve a level of safety consistent with that provided for other areas, systems, parts or appliances affected by the change by the other certification specifications of the proposed type-certification basis and OSD certification basis. The application of special conditions to a design change is not, in itself, a reason to classify it as either a substantial change or a significant change. Whether the change is significant, with earlier certification specifications allowed through exceptionsreversions, or not significant, the level of safety intended by the special conditions must be consistent with the agreed type-certification basis and OSD certification basis.

5.6. Reserved.

5.7. Reserved.

5.8. Reserved.

5.9. Documentation.

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5.9.1 Documenting the proposal.

In order to efficiently determine and agree upon a certification basis with EASA, the following information is useful to understand the applicant’s position:

— The current certification basis of the product being changed, including the

amendment level of the certification specifications and environmental

protection requirements.

— The amendment level of all the applicable certification specifications on at the

date of application.

— The proposed certification basis, including the amendment levels of the

applicable certification specifications and applicable environmental

protection requirements.

— Description of the affected area.

— Applicants who propose a certification basis that includes certification

specifications with amendment levels earlier than what was in effect on at the

date of application should include the exceptionreversion as outlined in

point 21.A.101(b) and their justification if needed.

Please see aAppendix H for examples of optional tools an applicant can use to document your proposed certification basis.

5.9.2 Documenting the significant/not significant decision.

5.9.2.1 EASA determines whether the changes are significant or not significant, and this decision is documented in the Certification Review Item(s). However, EASA provides an optional decision record for the applicant to make a predetermination to facilitate EASA decision. This form is provided in appendix G of this GM and follows the flow chart in Figure 3-1 of this GM. If it is used, the applicant should submit it along with the certification plan.

5.9.2.2 Changes that are determined to be significant changes under point 21.A.101, the exceptionsreversions, and the agreement of affected and unaffected areas is typically documented through the Certification Review Item (CRI) A-01 process. An example tool is provided in appendix H of this GM.

5.9.3 Documenting the certification basis.

5.9.3.1 EASA will amend the certification basis for all changes that result in a revision to the product’s certification basis on the amended TCDS or STC. In case of a significant change, EASA will document the resulting certification basis in CRI A-01.

5.9.3.2 EASA will document the certification basis of each product model on all STCs, including approved model list STCs.

5.10. Incorporation of STCs into the Type Design.

The incorporation of STCs into the product type design may generate an additional major change when that change is needed to account for incompatibility between several STCs that were initially not intended to be applied concurrently.

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5.10.1 If the incorporation of the STC(s) does not generate an additional major change, the incorporation is not evaluated pursuant to point 21.A.101. The existing certification basis should be updated to include the later amendments of the STC(s) being incorporated.

5.10.2 If the incorporation of the STC(s) generates an additional major change, the change must be evaluated pursuant to point 21.A.101, and the existing certification basis should be updated to include the amendments resulting from the application of point 21.A.101.

5.11. Removing changes.

Approved changes may be removed after incorporation in an aeronautical product. These changes will most commonly occur via an STC or a service bulletin kit.

5.11.1 The applicant should identify a product change that they intend at its inception to be removable as such, and should develop instructions for its removal during the initial certification. EASA will document the certification basis for both the installed and removed configuration separately on the TCDS or STC.

5.11.2 If specific removal instructions and a certification basis corresponding to the removed condition are not established at the time of the initial product change approval certification, the removal of changes or portions of those changes may constitute a significant change to type design. A separate STC or an amended TC may be required to remove the modifications and the resulting certification basis established for the changed product.

5.12. The certification basis is part of the change.

A new change may be installed in a product during its production or via a service bulletin or STC. In terms of point 21.A.101, each of the approved changes has its own basis of certification. If an applicant chooses to remove an approved installation (e.g. an interior installation, avionics equipment) and install a new installation, a new type-certification basis and a new OSD certification basis may be required for the new installation, depending on whether the change associated with the new installation is considered significant compared to the baseline configuration that the applicant chooses. If the new installation is a not significant change, the unmodified product’s type-certification basis and OSD certification basis may be used (not the previous installation type-certification basis and OSD certification basis), provided the type-certification basis and OSD certification basis are is adequate. For example, a large aeroplane is certified in a ‘green’ configuration. The aeroplane certification basis does not include CS 25.562. An interior is installed under an STC, and the applicant elects to include CS 25.562 (dynamic seats) in the certification basis to meet specific operational requirements. At a later date, the aeroplane is sold to another operator who does not have the same operational requirements. A new interior is installed; there will be no requirement for CS 25.562 to be included in the new certification basis.

5.13. Sequential changes — cumulative effects.

5.13.1 Any applicant who intends to accomplish a product change by incorporating several changes in a sequential manner should identify this to EASA up front when the first application is made. In addition, the cumulative effects arising from the initial change, and from all of the follow-on changes, should be included as part of the description of the change in the initial proposal. The classification of the intended product change will not be evaluated solely on the basis of the first application, but rather on the basis of all the required changes needed to

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accomplish the intended product change. If EASA determines that the current application is a part of a sequence of related changes, then EASA will re-evaluate the determination of significance and the resulting type-certification basis and OSD certification basis as a group of related changes.

5.13.2 Example: Cumulative effects — advancing the type-certification basis and OSD certification basis.

The type certificate for aeroplane model X lists three models, namely X-300, X-200, and X-100. The X-300 is derived from the X-200, which is derived from the original X-100 model. An applicant proposes a change to the X-300 aeroplane model. During the review of the X-300 certification basis and the certification specifications affected by the proposed change, it was identified that one certification specification, CS 25.571 (damage tolerance requirements), remained at the same amendment level as in the X-100 existing original certification basis (exception reversion granted on the X-200). Since the amendment level for this particular certification specification was not changed for the two subsequent aeroplane models (X-200 and X-300), the applicant must now examine the cumulative effects of these two previous changes that are related to the proposed change and the damage tolerance requirements to determine whether the amendment level of the certification specification needs to advance.

Appendix A to GM 21.A.101 Classification of design changes

The following tables of ‘substantial’, ‘significant’, and ‘not significant’ changes are adopted by the FAA, Agência Nacional de Aviação Civil (ANAC), the European Aviation Safety Agency (EASA), and Transport Canada Civil Aviation (TCCA) through international collaboration. The classification may change due to cumulative effects and/or combinations of individual changes.

A.1 Examples of Substantial, Significant, and Not Significant Changes for Small Aeroplanes (CS-23).

A.1.1 Table A-1 contains examples of changes that are ‘substantial’ for small aeroplanes (CS-23).

Table A-1. Examples of Substantial Changes for Small Aeroplanes (CS-23)

Example Description of Change Notes

1. Change to wing location (tandem, forward, canard, high/low).

Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

2. Fixed wing to tilt wing. Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

3. A change to the number of engines. Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

4. Replacement of piston or turboprop engines with turbojet or turbofan engines.

Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

5. Change to engine configuration (tractor/pusher). Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

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6. Increase from subsonic to supersonic flight regime.

7. Change from an all-metal to all-composite aeroplane.

Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

8. Certifying a CS-23 (or predecessor basis, such as JAR-23) aeroplane into another certification category, such as CS-25.

—

A.1.2 Table A-2 contains examples of changes that are ‘significant’ for small aeroplanes (CS-23).

Table A-2. Examples of Significant Changes for Small Aeroplanes (CS-23)

Example Description of change

Is there a change to the general configuration? 21.A.101(b)(1)(i)

Is there a change to the principles of construction? 21.A.101(b)(1)(ii)

Have the assumptions used for certification been invalidated? 21.A.101(b)(1)(iii)

Notes

[…] […] […] […] […] […]

26. Conversion from normal category Level 3 to commuter category Level 4 aeroplane as defined in CS 23.2005(b).

Yes No Yes Requires compliance with all commuter Level 4 certification specifications regulatory standards and means of compliance. In many cases, this change could be considered a substantial change to the type design. Therefore, a proposed change of this nature would be subject to EASA determination under 21.A.19.

[…] […] […] […] […] […]

A.1.3 Table A-3 contains examples of changes that are ‘not significant’ for small aeroplanes (CS-23).

Table A-3. Examples of Not Significant Changes for Small Aeroplanes (CS-23)

Example Description of change

Is there a change to the general configuration? 21.A.101(b)(1)(i)

Is there a change to the principles of construction? 21.A.101(b)(1)(ii)

Have the assumptions used for certification been invalidated? 21.A.101(b)(1)(iii)

Notes

[…] […] […] […] […] […]

21. A change to the maximum take-off massweight of less than 5 per cent, unless assumptions made in justification of the design are thereby invalidated.

No No No Although a major change to the aeroplane, likely the original general configuration, principles of construction, and certification assumptions remain valid.

[…] […] […] […] […] […]

42. Modification to ice protection systems.

No No No Recertification required, but certification basis should be evaluated for adequacy.

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A.2 Examples of Substantial, Significant, and Not Significant Changes for Large Aeroplanes (CS-25).

A.2.1 Table A-4 contains examples of changes that are ‘substantial’ for large aeroplanes (CS-25).

Table A-4. Examples of Substantial Changes for Large Aeroplanes (CS-25)

Example Description of Change Notes

1. Change to the number or location of engines, e.g. four to two wing-mounted engines or two wing-mounted to two body-mounted engines.

Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

2. Change from a high-wing to low-wing configuration.

Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

3. Change from an all-metal to all-composite aeroplane.

Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

4. Change of empennage configuration for larger aeroplanes (cruciform vs ‘T’ or ‘V’ tail).

Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

5. Increase from subsonic to supersonic flight regime.

Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

A.2.2 Table A-5 contains examples of changes that are ‘significant’ for large aeroplanes (CS-25).

Table A-5. Examples of Significant Changes for Transport Large Aeroplanes (CS-25)

Example Description of change

Is there a change to the general configuration? 21.A.101(b)(1)(i)

Is there a change to the principles of construction? 21.A.101(b)(1)(ii)

Have the assumptions used for certification been invalidated? 21.A.101(b)(1)(iii)

Notes

[…] […] […] […] […] […]

9. Changing the number of axles or number of landing gear done in context with a product change that involves changing the aeroplane’s gross weight.

Yes No No This type of landing gear change with an increase in gross weight is significant since it requires changes to aircraft structure, affects aircraft systems, and requires AFM changes, which invalidate the certification assumptions.

[…] […] […] […] […] […]

11. An increase in design massweight of more than 10 per cent.

No No Yes Design massweight increases of more than 10 per cent result in significant design load increase that invalidates the assumptions used for certification, requiring re-substantiation of aircraft structure, aircraft performance, and flying qualities and associated systems.

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A.2.3 Table A-6 contains examples of changes that are ‘not significant’ for large aeroplanes (CS-

25).

Table A-6. Examples of Not Significant Changes for Large Aeroplanes (CS-25)

Example Description of change

Is there a change to the general configuration? 21.A.101(b)(1)(i)

Is there a change to the principles of construction? 21.A.101(b)(1)(ii)

Have the assumptions used for certification been invalidated? 21.A.101(b)(1)(iii)

Notes

[…] […] […] […] […] […]

7. Modification to ice protection systems.

No No No Recertification required, but certification basis is adequate.

8. Brakes: design or material change, e.g. steel to carbon.

No No No Recertification required, but certification basis is adequate.

[…] […] […] […] […] […]

16. Airframe life extension.

No No No This does not include changes that involve changes to design loads, such as pressurisation or massweight increases. Also, this does not include changing from safe life to damage tolerance.

[…] […] […] […] […] […]

A.3 Examples of Substantial, Significant, and Not Significant Changes for Rotorcraft (CS-27 and CS-29).

A.3.1 Table A-7 contains examples of changes that are ‘substantial’ for rotorcraft (CS-27 and CS-

29).

Table A-7. Examples of Substantial Changes for Rotorcraft (CS-27 and 29)

Example Description of Change Notes

1. Change from the number and/or configuration of rotors (e.g. main & tail rotor system to two main rotors).

Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

2. Change from an all-metal rotorcraft to all- composite rotorcraft.

Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

A.3.2 Table A-8 contains examples of changes that are ‘significant’ for rotorcraft (CS-27 and CS-

29).

Table A-8. Examples of Significant Changes for Rotorcraft (CS-27 and CS-29)

Example Description of change

Is there a change to the general configuration? 21.A.101(b)(1)(i)

Is there a change to the principles of construction? 21.A.101(b)(1)(ii)

Have the assumptions used for certification been invalidated? 21.A.101(b)(1)(iii)

Notes

[…] […] […] […] […] […]

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A.3.3 Table A-9 contains examples of changes that are ‘not significant’ changes for rotorcraft (CS-27 and CS-29).

Table A-9. Examples of Not Significant Changes for Rotorcraft (CS-27 and CS-29)

Example Description of change

Is there a change to the general configuration? 21.A.101(b)(1)(i)

Is there a change to the principles of construction? 21.A.101(b)(1)(ii)

Have the assumptions used for certification been invalidated? 21.A.101(b)(1)(iii)

Notes

[…] […] […] […] […] […]

5. Expanded limitations with minimal or no design changes, following further tests/justifications or different mix of limitations (CG limits, oil temperatures, altitude, minimum/maximum weightmass, minimum/ maximum external temperatures, speed, engine ratings).

No No No Changes to an operating envelope (such as operating altitude and temperature) and mission profile (such as passenger-carrying operations to external-load operations, flight over water, or operations in snow conditions) that are not so different that the original certification assumptions remain valid.

[…] […] […] […] […] […]

19. An ETSO C-127 dynamic seat installed in a helicopter with an existing certification basis prior to addition of CS 29.562, Emergency landing dynamic conditions.

No No No

A.4 Examples of Substantial, Significant, and Not Significant Changes for Engines (CS-E)

A.4.1 Table A-10 contains examples of changes that are ‘substantial’ for engines (CS-E).

Table A-10. Examples of Substantial Changes for Engines (CS-E)

Example Description of Change Notes

Turbine Engines

1. Traditional turbofan to geared-fan engine. Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

2. Low-bypass ratio engine to high-bypass ratio engine with an increased inlet area.

Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

3. Turbojet to turbofan. Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

4. Turboshaft to turbo-propeller. Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

5. Conventional ducted fan to unducted fan. Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

6. Turbine engine for subsonic operation to afterburning engine for supersonic operation.

Proposed change to design is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required.

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A.4.2 Table A-11 contains examples of changes that are ‘significant’ for engines (CS-E).

Table A-11. Examples of Significant Changes for Engines (CS-E)

Example Description of change

Is there a change to the general configuration? 21.A.101(b)(1)(i)

Is there a change to the principles of construction? 21.A.101(b)(1)(ii)

Have the assumptions used for certification been invalidated? 21.A.101(b)(1)(iii)

Notes

Turbine Engines

[…] […] […] […] […] […]

Piston Engines

[…] […] […] […] […] […]

A.4.3 Table A-12 contains examples of changes that are ‘not significant’ for engines (CS-E).

Table A-12. Examples of Not Significant Changes for Engines (CS-E)

Example Description of change

Is there a change to the general configuration? 21.A.101(b)(1)(i)

Is there a change to the principles of construction? 21.A.101(b)(1)(ii)

Have the assumptions used for certification been invalidated? 21.A.101(b)(1)(iii)

Notes

Turbine Engines

[…] […] […] […] […] […]

Piston Engines

[…] […] […] […] […] […]

A.5 Examples of Substantial, Significant, and Not Significant Changes for Propellers (CS-P).

A.5.1 Table A-13 contains an example of a change that is ‘substantial’ for propellers (CS-P).

[…]

A.5.2 Table A-14 contains examples of changes that are ‘significant’ for propellers (CS-P).

Table A-14. Examples of Significant Changes for Propellers (CS-P)

Example Description of change

Is there a change to the general configuration? 21.A.101(b)(1)(i)

Is there a change to the principles of construction? 21.A.101(b)(1)(ii)

Have the assumptions used for certification been invalidated? 21.A.101(b)(1)(iii)

Notes

[…] […] […] […] […] […]

A.5.3 Table A-15 contains examples of changes that are ‘not significant’ for propellers (CS-P).

Table A-15. Examples of Not Significant Changes for Propellers (CS-P)

Example Description of change

Is there a change to the general configuration? 21.A.101(b)(1)(i)

Is there a change to the principles of construction? 21.A.101(b)(1)(ii)

Have the assumptions used for certification been invalidated? 21.A.101(b)(1)(iii)

Notes

[…] […] […] […] […] […]

5. Change to the intended usage, such as normal to category.

No No No Propeller’s operating characteristics and inherent strength require re-evaluation.

[…] […] […] […] […] […]

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Appendix B to GM 21.A.101 Application charts for changed product rule

Table A-16. Application Chart for 21.A.101(a) and (b) and 21.A.19

Substantial (21.A.19)

Significant (21.A.101(a) and (b))

Not Significant (21.A.101)(b)(1))

Substantially changed product

Compliance with all latest CSs required

for product certification.

Previously approved type design and compliance data

may be allowed if valid for the changed

product.

Affected area (Changed and/or affected areas)

New demonstration of compliance is required. Previously approved type design and compliance data may be allowed if

valid for the changed product.

Unaffected area No new

demonstration of compliance is

required. Unaffected area

continues to comply with the

existing type- certification

basis and OSD certification

basis.

Affected area (Changed and/or affected

areas) New demonstration of compliance is required. The

applicant may propose a type- certification basis and OSD certification basis using an earlier amendment but not

earlier than in the existing TC basis. Previously approved

type design and compliance data may be allowed if valid

for the changed product.

Unaffected area No new

demonstration of compliance is

required. Unaffected area

continues to comply with the

existing type- certification

basis and OSD certification

basis.

Compliance with the latest amendment materially contributes to safety

No material contribution to safety

Practical —

Impractical The applicant may

propose a type- certification basis and OSD certification basis using earlier CS(s), but

not earlier than the existing TC basis.

The applicant may propose a type-

certification basis and OSD certification basis using earlier CS(s), but

not earlier than the existing TC basis.

Type-Certification Basis and OSD Certification Basis Proposed by the Applicant

New type-certification basis and OSD certification basis using latest CSs.

CSs at earlier amendments with supporting rationale.

Existing type- certification

basis and OSD certification

basis.

Existing type-certification basis and OSD certification basis

including ‘elects to comply’.

Existing type- certification

basis and OSD certification

basis.

EASA Resultant Type-Certification Basis

New type-certification basis and OSD certification basis using the latest CSs, and

special conditions if required.

New type-certification basis and OSD certification basis using the CSs at earlier approved

amendments, and special conditions if required.

Existing type- certification

basis and OSD certification

basis.

Existing type-certification basis and OSD certification basis (if

adequate); if not, first appropriate later

amendment(s) and/or special conditions including ‘elects to

comply’.

Existing type- certification

basis and OSD certification

basis.

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Table A-17. Application Chart for 21.A.101(c) Excepted Products

Affected area (Changed areas and/or unchanged but affected) New demonstration of compliance is required.

Previously approved type design and compliance data may be allowed if valid for the changed product.

Unaffected area No new demonstration of

compliance is required. Unaffected area continues to be

compliant with the existing TC basis and OSD certification basis.

Type-Certification Basis and OSD Certification Basis Proposed by the Applicant

The existing TC type-certification basis and OSD certification basis, including ‘elects to comply’. The existing TC basis and OSD

certification basis.

Found by EASA to be ‘significant in an area’. Not ‘significant in an area’.

Compliance with a later amendment materially contributes to safety. No material contribution to safety.

Practical Impractical

EASA Resultant Type-Certification Basis and OSD Certification Basis

The latest amendment designated by EASA including special conditions and

including ‘elects to comply’.

The existing TC basis and OSD certification basis. If inadequate, the first appropriate later amendment. If not appropriate, add special conditions, including ‘elects to comply’.

The existing TC basis and OSD certification basis.

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Appendix C. to GM 21.A.101 A method to determine the changed and affected areas

C.1 Overview.

C.1.1 When a product is changed, some areas may change physically, while others may change functionally. EASA refers to this combination as changed and affected areas. For example, an extension to the wing of a fixed-wing aircraft would physically change the wing tip and likely other wing structure. Some areas of the airframe may have sufficient strength for the increase in load and would change functionally, i.e. they would carry greater load, but they would not change physically. These areas have associated certification specifications, which become part of the certification basis for the change.

C.1.2 Figure C-1 below provides an overview of one method that applicants may use to determine the changed and affected areas and the applicable certification specifications.

Figure C-1. Method to Determine the Changed and Affected Areas

C.2 Physical Changes.

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C.2.1 Steps.

Step 1. Make a list of the physical changes.

Step 2. List the corresponding certification specifications applicable to the physical changes.

Step 3. List the certification specifications’ amendment levels recorded in on the existing certification basis of the baseline product and the certification specifications’ amendments on the date of application.

C.2.2 Example.

The change is adding a winglet to a fixed-wing aircraft and a change to the leading-edge slats for a performance increase. As part of the change, an electrically driven slat actuator is modified by changing the mounting structure of the actuator used to connect the actuator to the slat. The actuator structure is changed. The electrical system in the actuator is not affected. The applicant would list certification specifications applicable to the actuator. The applicant would not list the certification specifications applicable to the electrical system of the actuator. See Table C-1 below for an example of how to chart a physical change and the associated certification specifications.

Table C-1. Example of Associating a Physical Change with the Applicable Certification Specifications

Physical Change Applicable Certification

Specifications* Amendment of Existing Type-Certification Basis

Amendment on Application Date

Structural change to slat actuator

25.xxx 25-aaa 25-ddd

25.yyy 25-bbb 25-eee

25.zzz 25-ccc 25-fff

* These would be certification specifications related to structural aspects only.

C.3 Functional Changes.

C.3.1 Steps.

Step 1. Describe each change.

Step 2. Describe the effects of the change (e.g. structural, performance, electrical, etc.).

Step 3. List the areas, systems, parts, and appliances that are affected by those effects.

Step 4. List the certification specifications associated with the effects for each area, system, part, or appliance.

Step 5. List the certification specifications’ amendment levels recorded in on the existing certification basis of the baseline product and the certification specifications’ amendment levels on the date of application.

C.3.2 Example.

The change is adding a winglet to a fixed-wing aircraft and a change to the leading-edge slats for a performance increase. The wing root bending moment has increased. The loads in the wing box are increased but the wing box has sufficient structural margins to carry the higher loads. Thus, the wing box is not physically changed but its function has changed because it carries greater loads. See Table C-2 below for an example of how to chart a functional change, its effects, and the affected areas (steps 1 through 3 above). See Table C-3 below for an example of how to chart an area affected by a functional change and the associated certification specifications (steps 4 and 5 above).

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Table C-2. Example of a Functional Change, Affected Areas, and Associated Effects

Description of Change Effects Affected Areas

Installation of winglet Increased loads in wing structure Wing spars

Wing skins

Effect 2* Area 1

Area 2

Effect 3* Area 3

* There may be other effects as well. Table C-3. Example of Associating Affected Areas with the Applicable Certification Specifications

Impacted Area Applicable Certification

Specifications* Amendment of Existing Type-Certification Basis

Amendment on Application Date

Wing spar 25.xxx 25-aaa 25-ddd

25.yyy 25-bbb 25-eee

25.zzz 25-ccc 25-fff

* These would be structural certification specifications only. There could be other certification specifications applicable to the wing box. But since the effect is structural, then only the structural certification specifications are applicable.

C.4 Combine the Lists.

C.4.1 EASA typically presents the type-certification basis and OSD certification basis for a product by certification specification and not by area. The next step is to combine these two lists. However, since only a portion of the product is being changed, the changed and affected areas of the new certification basis need to be identified. The unchanged area is not required to comply with the certification specifications in effect on at the date of application. (See point 21.A.101(b)(2))

C.4.2 When the change is quite extensive, applicants will save time by listing all the certification specifications applicable to the category of product they are certifying. They can use Table C-4 below in the next step where they will identify any other exceptions that they would like EASA to consider.

C.4.3 Example. If we use the examples above for the combined list for the actuator structural changes and the wing box functional change, then the type-certification basis would be listed as shown in Table C-4 below.

Table C-4. Example of a Combined List of Physical and Functional Changes with Applicable Certification Specifications

Certification Specification

Certification Specification Amendment Levels

Changed and Affected Area Amendment of Existing Type-Certification Basis

Amendment on Application Date

25.xxx* 25-aaa 25-ddd - Wing spar - Leading-edge actuator - Wing loads

25.yyy* 25-bbb 25-eee

25.zzz* 25-ccc 25-fff

* These represent structural certification specifications.

Appendix D. to GM 21.A.101 Other guidance for affected areas

D.1 Sample Questions in Determining Affected Areas.

Below are sample questions to assist in determining whether an area is affected by the change. If the answer to any of these questions is yes, then the area is considered to be affected.

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1. Is the area changed from the identified baseline product?

2. Is the area impacted by a significant product-level change?

3. Is there a functional effect on the unchanged area by a change to the system or system function that it is a part of?

4. Does the unchanged area need to comply with a system or product-level certification specification that is part of the change?

5. Are the product-level characteristics affected by the change?

6. Is the existing compliance for the area invalidated?

D.2 Sub-Areas within an Affected Area.

Within areas affected by a change, there may be ‘sub-areas’ of the area that are not affected. For those sub-areas, the certification specifications’ amendment levels inat the existing certification basis remain valid, along with the previous compliance findings. For example, if a passenger seat fitting is changed as part of a significant change, then the structure of the seat is affected. Thus, the certification specifications’ amendment level for CS 25.561 and CS 25.562, along with other applicable structural certification specifications, would be at the certification specifications’ amendment level on the date of application (unless an exception is granted). However, the seat fabric is not affected, so the certification specification amendment level for CS 25.853 (flammability) may remain the same as the one inat the existing certification basis, and a new compliance finding would not be required.

Appendix E. to GM 21.A.101 Procedure for evaluating material contribution to safety or impracticality of applying latest certification specifications to a changed product

E.1 Introduction.

E.1.1 The basic principle of enhancing the level of safety of changed aeronautical products is to apply the latest certification specifications for significant changes to the greatest extent practical. In certain cases, the cost of complying fully with a later certification specification may not be commensurate with the small safety benefit achieved. These factors form the basis where compliance with the latest certification specification standard may be considered impractical, thereby allowing compliance with an earlier certification specification. This Appendix gives one method of determining whether compliance with a later certification specification is impractical; however, it does not preclude the use of other methods for improving the safety of aeronautical products.

E.1.2 EASA recognises that other procedures can be used and have historically been accepted on a case-by-case basis. The acceptance of results through the use of these procedures may vary from state to state. Consequently, they may not be accepted through all bilateral certification processes. Regardless of which method is used, the process must show that a proposed type- certification basis and OSD certification basis areis able to achieve a positive safety benefit for the overall product.

E.1.3 Regarding impracticality, any method used must encourage the incorporation of safety enhancements that will have the most dramatic impact on the level of safety of the aircraft while considering the effective use of resources. This important point is illustrated graphically

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in Figure E-1 below. This Figure notionally shows the interrelation between the total resources required for incorporating each potential safety enhancement with the corresponding net increase in safety benefit.

Figure E-1. Safety Benefits versus Resources

E.1.4 Typically, it is found that, for impractical type-certification basis or OSD certification basis changes, there are proposals that can achieve a positive safety benefit that are resource- effective. Conversely, there are proposals that may achieve a small safety benefit at the expense of a large amount of resources to implement them. Clearly, there will be a point where a large percentage of the potential safety benefit can be achieved with a reasonable expenditure of resources. The focus of the methods used should be to determine the most appropriate certification specifications standards relative to the respective incremental cost to reach this point.

E.1.5 This Appendix provides procedural guidance for determining the material contribution to the level of safety, or the practicality of applying a certification specification standard at a particular amendment level to a changed product. The procedure is generic in nature and describes the steps and necessary inputs that may be used on any project to develop a position.

E.1.6 The procedure is intended to be used, along with good engineering judgment, to evaluate the relative merits of a changed product complying with the latest certification specifications standards. It provides a means, but not the only means, for applicants to present their position regarding an exception under point 21.A.101(b)(3).

E.1.7 The applicable certification basis for a change to a product will not be must not be of an earlier level than the existing certification basis at an amendment level earlier than the existing certification basis.

Safety benefit of the

certification standard

specification

Resources to implement

the certification standard

specification

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E.2 Procedure for evaluating the material contribution or impracticality of applying the latest certification specifications to a changed product.

The following are steps to determine the material contribution or impracticality of applying a certification specification at a particular amendment level.

E.2.1 Step 1: Identify the regulatory change being evaluated.

In this step, applicants should document:

E.2.1.1 The specific certification specification standard (e.g. CS 25.365),

E.2.1.2 The amendment level of the certification specification or predecessor standard in the existing certification basis for the standards, and

E.2.1.3 The latest amendment level of the certification specification.

E.2.2 Step 2: Identify the specific hazard that the certification specification addresses.

E.2.2.1 Each certification specification and its subsequent amendments addresses a hazard or hazards. In this step, the specific hazard(s) is (are) identified. This identification will allow for a comparison of the effectiveness of the amendment levels of the certification specification in addressing the hazard.

E.2.2.2 In many cases, the hazard and the cause of the hazard will be obvious. When the hazard and its related cause are not immediately obvious, it may be necessary to review the explanatory note (EN) and/or the impact assessment (IA) in the ED Decision by which the certification specification or its amendment was adopted. It may also be helpful to discuss the hazard with the responsible EASA team.

E.2.3 Step 3: Review the consequences of the hazard(s).

E.2.3.1 Once the hazard is identified, it is possible to identify the types of consequences that may occur due to the hazard. More than one consequence can be attributed to the same hazard. Typical examples of consequences would include but are not limited to:

incidents where only injuries occurred,

accidents where a total hull loss occurred,

accidents where less than 10 per cent of the passengers died,

accidents where 10 per cent or more passengers died, and

engine- and propeller-specific hazards.

E.2.3.2 The explanatory note (EN) and/or the impact assessment (IA) in the ED Decision may provide useful information regarding the consequences of the hazard that the certification specification addresses.

E.2.4 Step 4: Identify the historical and predicted frequency of each consequence.

E.2.4.1 Another source for determining impracticality is the historical record of the consequences of the hazard that led to a certification specification or an amendment to a certification specification. From these data, a frequency of occurrence for the hazard can be determined. It is important to recognise that the frequency of occurrence may be higher or lower in the future. Therefore, it also is necessary to predict the frequency of future occurrences.

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E.2.4.2 More than one consequence can be attributed to the same hazard. Therefore, when applicable, the combination of consequences and frequencies of those consequences should be considered together.

E.2.4.3 The explanatory note (EN) and/or the impact assessment (IA) in the ED Decision may provide useful information regarding the frequency of an occurrence.

E.2.5 Step 5: Determine how effective full compliance with the latest amendment of the certification specification would be in addressing the hazard.

E.2.5.1 When each amendment is issued, it is usually expected that compliance with the certification specification would be completely effective in addressing the associated hazard for the designs and technology envisioned at the time. It is expected that the hazard would be eliminated, avoided, or mitigated. However, experience has shown that this may not always be the case. It is also possible that earlier amendment levels of the certification specifications may have addressed the hazard but were not completely effective. A product may also contain a design feature(s) that provides a level of safety that approaches that of the latest certification specifications, yet is not fully compliant with the latest certification specifications. Therefore, in comparing the benefits of compliance with a certification specification from the existing type-certification basis or OSD certification basis to the latest amendment level of that certification specification, it is useful to estimate the effectiveness of both amendment levels in dealing with the hazard.

E.2.5.2 It is recognised that the determination of levels of effectiveness is normally of a subjective nature. Therefore, prudence should be exercised when making these determinations. In all cases, it is necessary to document the assumptions and data that support the determination.

E.2.5.3 The following five levels of effectiveness are provided as a guideline:

1. Fully effective in all cases. Compliance with the certification specification eliminates the hazard or provides a means to avoid the hazard completely.

2. Considerable potential for eliminating or avoiding the hazard. Compliance with the certification specification eliminates the hazard or provides a means to completely avoid the hazard for all probable or likely cases, but it does not cover all situations or scenarios.

3. Adequately mitigates the hazard. Compliance with the certification specification eliminates the hazard or provides a means to avoid the hazard completely in many cases. However, the hazard is not eliminated or avoided in all probable or likely cases. Usually this action only addresses a significant part of a larger or broader hazard.

4. Hazard only partly addressed. In some cases, compliance with the certification specification partly eliminates the hazard or does not completely avoid the hazard. The hazard is not eliminated or avoided in all probable or likely cases. Usually this action only addresses part of a hazard.

5. Hazard only partly addressed but action has a negative side effect. Compliance with the certification specification does not eliminate or avoid the hazard or may have negative safety side effects. The action is of questionable benefit.

E.2.5.4 If it is determined that compliance with the latest certification specifications does not contribute materially to the product’s level of safety, applicants should skip Step 6 of this

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Appendix and go directly to Step 7 to document the conclusion. If it is determined that complying with the latest amendment of the certification specification contributes materially to the product’s level of safety, applicants should continue to Step 6 of this Appendix.

E.2.6 Step 6: Determine the incremental resource costs and cost avoidance.

E.2.6.1 There is always cost associated with complying with a certification specification. This cost may range from minimal administrative efforts to the resource expenditures that support full-scale testing or the redesign of a large portion of an aircraft. However, there are also potential cost savings from compliance with a certification specification. For example, compliance with a certification specification may avoid aircraft damage or accidents and the associated costs to the manufacturer for investigating accidents. Compliance with the latest amendment of a certification specification may also help a foreign authority to certify a product.

E.2.6.2 When determining the impracticality of applying a certification specification at the latest amendment level, only the incremental costs and safety benefits from complying with the existing certification basis should be considered.

E.2.6.3 When evaluating the incremental cost, it may be beneficial for applicants to compare the increase in cost of complying with the latest certification specifications with the cost of incorporating the same design feature in a new aircraft. In many cases, an estimate for the cost of incorporation in a new aircraft is provided by EASA in the regulatory impact assessment, which was presented when the corresponding certification specification was first issued. Incremental costs of retrofit/incorporation on existing designs may be higher than that for production. Examples of costs may include but are not limited to the following:

Costs

The accuracies of fleet size projections, utilisation, etc., may be different from those experienced for derived product designs and must be validated.

Labour: work carried out in the design, fabrication, inspection, operation, or maintenance of a product for the purpose of incorporating or demonstrating compliance with a proposed action. Non-recurring labour certification specifications, including training, for the applicant supporting development and production of the product, should be considered.

Capital: construction of new, modified, or temporary facilities for design, production, tooling, training, or maintenance.

Material: costs associated with product materials, product components, inventory, kits, and spares.

Operating costs: costs associated with fuel, oil, fees, training, and expendables.

Revenue/utility loss: costs resulting from earning/usage capability reductions from departure delays, product downtime, and performance loss due to seats, cargo, range, or airport restrictions.

The cost of changing compliance documentation and/or drawings in itself is not an acceptable reason for an exception.

Cost Avoidance.

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Avoiding costs of accidents, including investigation of accidents, lawsuits, public relations activities, insurance, and lost revenue.

Foreign certification: conducting a single effort that would demonstrate compliance with the certification specifications of most certifying authorities, thus minimising certification costs.

E.2.7 Step 7: Document the conclusion.

With the information from the previous steps documented and reviewed, the applicant’s position and rationale regarding whether complying with the latest certification specifications contributes materially to the product’s level of safety or its practicality can be documented. EASA records the determination of whether the conditions for the proposed exception were met. That determination is based on the information and analysis provided by the applicant in the preceding steps. If the determination to grant the exception is based on the product’s design features, those features are documented at a high level in the TCDS. Documentation in the TCDS is required so that the features are maintained during subsequent changes to the product, therefore, maintaining the product’s agreed level of safety. If the results of this analysis are inconclusive, then further discussions with EASA are warranted.

E.3 Examples of how to certify changed aircraft.

[…]

Appendix F. to GM 21.A.101 The use of service experience in the exception process

F.1 Introduction.

Service experience may support the application of an earlier certification specification pursuant to point 21.A.101(b)(3) if, in conjunction with the applicable service experience and other compliance measures, the earlier certification specification provides a level of safety comparable to that provided by the latest certification specification. The applicant must provide sufficient substantiation to allow EASA to make this determination. A statistical approach may be used, subject to the availability and relevance of data, but sound engineering judgment must be used. For service history to be acceptable, the data must be both sufficient and pertinent. The essentials of the process involve:

A clear understanding of the certification specification change and the purpose for the change,

A determination based on detailed knowledge of the proposed design feature,

The availability of pertinent and sufficient service experience data, and

A comprehensive review of that service experience data.

F.2 Guidelines.

The CRI process (either as a stand-alone CRI or included in the CRI A-01) would be used, and the applicant should provide documentation to support the following:

F.2.1 The identification of the differences between the certification specification in the existing certification basis and the certification specification as amended, and the effect of the change to the specification.

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F.2.2 A description as to what aspect(s) of the latest certification specifications the proposed changed product would not meet.

F.2.3 Evidence showing that the proposed type-certification basis and OSD certification basis for the changed product, together with applicable service experience, relative to the hazard, provides a level of safety that approaches the latest certification specification, is not fully compliant with the latest certification specifications.

F.2.4 A description of the design feature and its intended function.

F.2.5 Data for the product pertinent to the requirement.

F.2.5.1 Service experience from such data sources, such as:

Accident reports,

Incident reports,

Service bulletins,

Airworthiness directives,

Repairs,

Modifications,

Flight hours/cycles for fleet leader and total fleet,

World airline accident summary data,

Service difficulty reports,

Accident Investigation Board reports, and

Warranty, repair, and parts usage data.

F.2.5.2 Show that the data presented represent all relevant service experience for the product, including the results of any operator surveys, and is comprehensive enough to be representative.

F.2.5.3 Show that the service experience is relevant to the hazard.

F.2.5.4 Identification and evaluation of each of the main areas of concern with regard to:

Recurring and/or common failure modes,

Cause,

Probability by qualitative reasoning, and

Measures already taken and their effects.

F.2.5.5 Relevant data pertaining to aircraft of similar design and construction may be included.

F.2.5.6 Evaluation of failure modes and consequences through analytical processes. The analytical processes should be supported by:

A review of previous test results,

Additional detailed testing as required, or

A review of aircraft functional hazard assessments (FHA) and any applicable system safety assessments (SSA) as required.

F.2.6 A conclusion that draws together the data and the rationale.

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F.2.7 These guidelines are not intended to be limiting, either in setting the required minimum elements or in precluding alternative forms of submission. Each case may be different, based on the particulars of the system being examined and the requirement to be addressed.

F.3 […]

Appendix G. to GM 21.A.101 Changed product rule (CPR) decision record

CHANGED PRODUCT RULE (CPR) DECISION RECORD TC/STC No: Click here to enter text. Project Number: Click here to enter text.

Step 1: Identify the proposed type design changes to the aeronautical product. (See paragraph 3.2 of GM 21.A.101)

The proposed type design changes are identified here or in the following document(s): Click here to enter text.

Note: The CRI process is used to track/document the decisions at Step 2 and Steps 5 through 8 as required.

Step 2: Is the proposed type design change substantial? (See paragraph 3.3 of GM 21.A.101)

☐ Yes New Type Certificate: Proceed to point 21.A.19. Point 21.A.101 does not apply. A Certification Review Item CRI A-01 will be used to establish and document the certification basis.

☐ No Proceed to Step 3.

Step 3: Will you use the latest certification specifications standards? (See paragraph 3.4 of GM 21.A.101)

☐ Yes Latest certification specifications standards: Propose a certification basis using the CSs in effect on at the date of application. Proceed to Step 8.

☐ No Proceed to Step 4.

Step 4: Arrange changes into related and unrelated groups. (See paragraph 3.5 of GM 21.A.101)

Note: For multiple groupings, continuation of this process should be split into separate decision records. Groupings may be rationalised and recorded in separate documents: Click here to enter text.

Step 5: Is each related or unrelated group a significant change? (See paragraph 3.6 of GM 21.A.101)

☐ Yes Proceed to Step 6.

☐ No Earlier certification specifications Standards: Propose a certification basis using the CSs in effect before the date of application but not earlier than the existing certification basis. Certification basis to be defined and documented as indicated (below). Proceed to Step 8.

Step 6: Prepare your Certification Basis List. (See paragraph 3.9 of GM 21.A.101) Affected Areas:

The Affected Area(s) is (are) detailed here or in the following Certification Basis List document number(s): Click here to enter text.

Process and propose each applicable certification specification individually. Proceed to Step 7.

Not Affected Areas: Existing certification specifications standards: You may continue using the existing certification basis.

Step 7: Do the latest certification specifications standards contribute materially to the level of safety and are they practical? (See paragraph 3.10 of GM 21.A.101)

☐ Yes Latest certification specifications Standards: Propose a certification basis using the CSs in effect on the date of application.

☐ No Earlier certification specifications Standards: You may propose a certification basis using the CSs in effect before the date of application but not earlier than the existing certification basis. Certification basis defined or documented as indicated below.

☐ Continuation Sheet(s) Attached Note: Several CSs may apply to each affected area, and the assessment may differ from specifications to specifications. Indicate ‘Yes’ if compliance with any latest certification specification(s) standard(s) is required. Indicate ‘No’ only if earlier certification specification(s) standard(s) is (are) proposed.

Note: You may submit a proposal for the decision in Step 7; however, EASA will make the final certification basis determination.

Step 8: Ensure the proposed certification basis is adequate. (See paragraph 3.11 of GM 21.A.101)

If you deem that the certification basis is adequate, submit the proposed certification basis to EASA. If not, consult EASA. CRI A-01 may be needed to document the certification basis.

Certification Basis: The certification basis is detailed here or in the following document(s): Click here to enter text.

Based on the information provided above, I am proposing the certification basis with the following classification for the type design change. (check one)

☐ Significant, pursuant to point 21.A.101. ☐ Not significant, pursuant to point 21.A.101.

Click here to enter text. Click here to enter text.

Printed Name/Title Signature Date

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Appendix H. to GM 21.A.101 Examples of documenting the proposed certification basis list

H.1 Example 1.

H.1.1 This optional tool may be used to establish the applicable airworthiness and OSD certification specifications that will become part of the type-certification basis for airworthiness or and OSD certification basis. For a significant change, the applicant must demonstrate compliance for the change and the area affected by the change with the certification specifications that were in effect on at the date of application. However, in some cases earlier or later certification specifications can be used, as allowed in point 21.A.101.

In addition, the applicant must demonstrate compliance with the applicable environmental protection requirements in accordance with point 21.A.101(a).

H.1.2 In order to efficiently determine and agree upon a certification basis with EASA, the following information is useful to understand the applicant’s position:

H.1.2.1 The scope of the change. This includes a high-level description of the physical and functional changes and performance/functional characteristics, which are changed as a result of the physical or functional change, and the certification specifications for which compliance demonstration is required as a result of the change.

H.1.2.2 The amendment level of all the applicable certification specifications and of the applicable environmental protection requirements on at the date of application.

H.1.2.3 The proposed certification basis, including amendment levels.

H.1.2.4 Applicants who propose a certification basis that includes certification specifications with amendment levels earlier than what was in effect on at the date of application should include the exception as outlined in point 21.A.101 and their justification if needed.

H.1.3 Exceptions.

H.1.3.1 Unrelated changes that are not significant (point 21.A.101(b)(1)).

H.1.3.2 Not affected by the change (point 21.A.101(b)(2)).

H.1.3.3 Compliance with the certification specification would not contribute materially to the level of safety (point 21.A.101(b)(3)).

H.1.3.4 Compliance with the certification specification would be impractical (point 21.A.101(b)(3)).

H.1.4 One easy way to document the proposed type-certification basis and OSD certification basis is using a tabular form as shown in the Ttable below.

Table H-1. Tabular Form for Documenting a Proposed Type-Certification Basis and OSD Certification Basis

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Certification Specification Amendment Levels Applicant Justification for

Lower Amendment Level and Comments

Affected Area Existing TCDS Amendment

Amendment at Date of

Application

Proposed Amendment

Level

Subpart A — General

Subpart B — Flight

H.1.5 Best Practices.

H.1.5.1 Account for all certification specifications, even if they are not applicable.

H.1.5.2 Mark certification specifications that are not applicable as ‘N/A’.

H.1.5.3 If more than one amendment level of the certification specifications is used depending on the area of the product, list all areas and amendment levels at each area with proper justification.

H.1.5.4 If the justification is long, provide the justification below the table and only place the certification specification reference and note in the comment field.

H.1.5.5 Include airworthiness and OSD standards required by other EU regulations (e.g. Part-26) of affected areas.

H.1.6 Environmental protection requirements

The applicant for the approval of a change should provide references to the environmental protection requirements applicable to the changed product, for example ‘Section [XX] of Chapter [XX] of Part [XX] of Amendment [XX] to Volume [XX] of Annex 16 to the Chicago Convention’.

H.2 Example 2.

Pages 129 through 135 of this Appendix contain The below provides another example for documenting a proposed certification basis.

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TITLE OF DESIGN CHANGE

Product Name or Change to Type Certificate [XXXX]

Proposed Certification Basis Pursuant to point 21.A.101

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1. INTRODUCTION.

1.1 REFERENCE DOCUMENTS.

Reference Title

[1] Point 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

[2] GM 21.A.101-1B Establishing the Ccertification Bbasis of Cchanged Aaeronautical Pproducts

[3] XXXX Application letter

[4] Type Certificate YYYY Product type-certification basis

[5] Document ZZZZ Certification plan

[6]

<The above-referenced documents are examples. Each applicant should reference documents appropriate to their products and procedures.>

1.2 ACRONYMS.

Acronym Meaning

AFM Aircraft Flight Manual

AMC Acceptable Means of Compliance

CRI Certification Review Item

ELOS Equivalent Level of Safety

ESF Equivalent Safety Finding

GM Guidance Material

MOC Means of Compliance

SC Special Condition

TC Type Certificate

<This section constitutes a representative list of acronyms. Each applicant should provide an acronym list appropriate for their product and document.>

1.3 PURPOSE OF THE DOCUMENT.

The purpose of this document is to propose the certification basis applicable to [Product Design Change] in accordance with point 21.A.101.

2. DESIGN DEFINITION.

2.1 BASELINE PRODUCT.

The type design to be changed, which is also known as the ‘baseline product,’ is the Model Series___ (this should be a specific product configuration, such as a specific serial number or line number).

The reference product certification basis is TCDS No. [XXXX], issued on [DATE].

2.2 DESIGN CHANGE AND BASELINE PRODUCT COMPARISON SUMMARY.

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<Example table where the product is an aeroplane. This is a representative set of data that may be provided by the applicant.>

Specification Model Series X Model Series Y

Max Taxi Weight — MTW (lb) A1 A2

Max Take-off Weight — MTOW (lb) B1 B2

Max Landing Weight — MLW (lb) C1 C2

Max Zero Fuel Weight — MZFW (lb) D1 D2

Max Length (ft, in) E1 E2

Max Height (ft, in) F1 F2

Wing Span (ft, in) G1 G2

Horizontal Tail Span (ft, in) H1 H2

Fuel Capacity (gal) I1 I2

Total Cargo Volume (ft3) J1 J2

Max Passenger Limit — one class seating (occupants) K1 K2

Engine Types L1 & M1 L2

Maximum Engine Thrust T1 T2

2.3 DESCRIPTION OF DESIGN CHANGE, GROUPING AND CLASSIFICATION.

2.3.1 SIGNIFICANT CHANGE(S).

The following group of changes is proposed as significant based on [GM 21.A.101-1, Appendix A, ‘[Description of Change in Appendix A]] or [the general configuration is not retained, principles of construction are not retained, or assumptions for certification of the product to be changed do not remain valid].

Changes Related to [Title of Significant Change X]:

[Title of High-Level Change C1]

The areas of physical change are:

— [design change xx] — [design change yy] — [design change zz]

The areas unchanged but affected by the change are:

— [affected area aaa] — [affected area bbb] — [affected area ccc]

[Title of High-Level Change C2]…

2.3.2 UNRELATED NOT-SIGNIFICANT CHANGES.

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<Describe here the not significant stand-alone changes or change groupings that are part of the modification but are unrelated to any of the significant changes described in paragraph 2.3.1.>

[Title of High-Level Change D1]. [Description].

<The description must be just detailed enough to serve its purpose, which is to identify why each of those changes is not significant and unrelated.>

[Title of High-Level Change D2]. [Description]…

3. IDENTIFICATION OF APPLICABLE CERTIFICATION STANDARDS BASIS.

3.1 PROPOSED CERTIFICATION BASIS.

Based on the effective application date, [date], under the provisions of 21.A.101, the applicable certification specifications standards and the applicable environmental protection requirements for the [Title of Design Change] are proposed as follows. The proposed certification basis includes exceptions to earlier amendments (reversions), deviations, special conditions, and equivalent (level of) safety findings.

3.1.1 Certification specifications effective on at the date of application.

Applicable certification specifications in effect on the date of the application are:

<List the applicable parts and amendment levels here.>

Example for large aeroplanes:

A. Airworthiness:

— CS-25, — CS-AWO.

B. Operational Suitability Data:

— CS-CCD, — CS-FCD, — CS-MCSD (to be published), — CS-MMEL, — CS-SIMD.

C. Environmental Protection:

CS-34,

CS-36.

3.1.2 Point 21.A.101 exception rationale.

The completed rationale for each does not contribute materially to the level of safety (DCMLS) or impracticality exception is provided in this section.

Exception 1: …

Exception 2: …

3.1.3 Optional cCertification specifications standards

Applicable certification specifications in effect on the date of the application are:

<List the applicable parts and amendment levels here.>

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Example for large aeroplanes:

— CS 25.803, Emergency evacuation, Amendment 12, — CS 25.1810, Emergency egress assisting means and escape routes, Amendment 17.

3.1.4 Design-related requirements from other aviation domains.

Applicable certification specifications in effect on the date of the application are:

<List the applicable parts and amendment levels here.>

Example for large aeroplanes:

— CS-ACNS Communications, Navigation and Surveillance, Initial Issue, dated 17 December 2013, Subpart D Sections 2/3.,

CS-26.

3.1.5 Proposed Special Conditions.

Special Condition (or TBD)

Title Effective Date

(or TBD)

3.1.6 Equivalent Safety Findings.

ELOS Memo No (or TBD)

Title Applicable Standard

3.1.7 Deviations.

Deviation No (or TBD)

Title Applicable Standard Date Issued

(or TBD)

3.1.8 Elect to comply

Elect to Comply No (or TBD)

Title Applicable Standard Date Issued

(or TBD)

3.1.9 Environmental protection requirements

The applicant for the approval of a change should propose the references to the environmental protection requirements applicable to the changed product, for example ‘Section [XX] of Chapter [XX] of Part [XX] of Amendment [XX] to Volume [XX] of Annex 16 to the Chicago Convention’.

Example from the FAA for a FAR Part 25 aeroplane:

Proposed Certification Basis

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The certification basis is a complete extract from the applicable FAA 14 CFR part [A] and it references the certification basis [B]. Column [C] identifies the amendment level for the specific requirement on the date of application. The changed product’s certification basis is proposed in last column [D]. References to FAR sections and amendments are kept.

Example for a Part 25 aeroplane:

[A] Requirement

Title (or

subparagraph)

[B] Existing

Certification Basis

Amendment Level

[C] Amendment

Level on Application

Date

[D] Proposed

Amendment for Changed

Product

Applicable Area

Notes

25.25 Weight limits

25-23 25-63 25-63 Product

25.33

Propeller speed and pitch limits

N/A 25-72 N/A —

Not applicable to Changed Product (Jet Aircraft)

25.1309(a)

Equipment, systems, and installations

25-41 15-123 25-123

Changed and Affected Areas

25-41 25-123 25-41 Exception — Not Affected

See example 1 in section 3.1.2

25.1703

Function and installation: EWIS

N/A 25-124 N/A Exception — Product

See example 2 in section 3.2.1

Appendix I. to GM 21.A.101 Related documents

[…]

Appendix J. to GM 21.A.101 Definitions and terminologiesy

J.1 Aeronautical product or product.

The terms ‘aeronautical product’ or ‘product’ used in this guidance material include type- certified aircraft, engines, or propellers and, for the purpose of this GM, an ETSO-authorised A’d APU.

J.2 Assumptions used for certification.

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The assumptions used for certification are the evaluations and decisions that led to the approval of the baseline product’s characteristics. Examples of the product’s baseline characteristics include but are not limited to the following:

— Design methodologies, methods of compliance, specifications and standards used to achieve compliance with the certification specifications making up the type-certification basis and the OSD certification basis;

— Structural, mechanical, electrical, propulsion, aerodynamic, performance, operational, and maintenance characteristics;

— Operational and flight envelopes defining the product performance and capabilities at specified masses weights, speeds, altitudes, load factors, and centres of gravity;

— Crashworthiness; — Role or mission; — Airworthiness and operational limitations; or — Pilot training, if necessary.

J.3 Baseline product.

It is an aeronautical product with a specific, defined approved configuration and certification basis that the applicant proposes to change.

J.4 Certification basis.

The combination of the:

— airworthiness type-certification specifications as provided for in point 21.B.80; — OSD certification specifications as provided for in point 21.B.82; and — applicable 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 compatibility protection characteristics, etc. (see point 21.A.41 and GM to 21.A.90A)).

References to ‘change’ include the change to the product and areas affected by the change pursuant to point 21.A.101.

J.6 Design change.

The term ‘design change’ refers to a change to the type design (as defined in point 21.A.31) of an aeronautical product. In the context of this document, the terms ‘change to the type design’, ‘modification’, ‘design change’, and ‘type design change’ are synonymous.

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J.7 Earlier certification specifications standards.

The certification specifications or previous standards in effect prior to the date of application for the change, but not prior to the ones in the existing certification basis.

J.8 Existing certification basis.

The certification basis specifications or previous standards incorporated by reference in the type certificate of the baseline product to be changed.

J.9 Latest certification specifications standards.

The certification specifications in effect on the date of application for the change.

J.10 Previous relevant design changes.

Previous design changes, the cumulative effect of which could result in a product significantly or substantially different from the original product or model, when considered from the last time the latest certification specifications standards were applied.

J.11 Product-level change.

A change or combination of changes that makes the product distinct from other models of the product (e.g. range, payload, speed, design philosophy). Product-level change is defined at the aircraft, aircraft engine, or propeller level of change.

J.12 Secondary change.

A change that is part of a significant physical change that does not contribute materially to the level of safety. Guidance is contained in paragraph 3.10.1.4 of this GM.

J.13 Significant change.

A change to the type certificate to the extent that it changes one or more of the following, but not to the extent to be considered a substantial change: the general configuration, principles of construction, or the assumptions used for certification. The significance of the change is considered in the context of all previous relevant design changes and all related revisions to the applicable certification specifications standards. Not all product-level changes are significant.

J.14 Significant change to area.

For aircraft excepted under point 21.A.101(c) only: a change to an area is significant if the general configuration or the principles of construction in that area are not retained, or the assumptions used for the certification of that area do not remain valid.

J.15 Substantial change.

A change that is so extensive that a substantially complete investigation of compliance with the applicable certification basis is required, and consequently a new type certificate is required pursuant to point 21.A.19.

AMC1 21.A.101(e)(1)(ii) Type-certification basis, operational suitability data certification basis and applicable environmental protection requirements for a major change to a type-certificate

APPROVAL OF A MAJOR CHANGE REQUIRED AS A CORRECTIVE ACTION OF AN UNSAFE CONDITION

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(a) General

Under point 21.A.3B(c)(1), when EASA has issued an airworthiness directive, the design approval holder shall propose appropriate corrective action. This corrective action might be the embodiment of a change to the type-certificate; as such, it needs to be approved by EASA in accordance with point 21.A.97.

There are continued airworthiness issues where the initial design is affected by non-compliance. Experience has shown that, for necessary practical reasons, compliance is proposed to be re- established by more than one type-certificate change, implemented in a sequential manner. In such cases, compliance with point 21.A.97(b)(1) cannot be demonstrated until the last of the correcting changes to the type-certificate is implemented. However, each of these sequential changes to the type-certificate that provide an ‘alleviating action’ (as used in GM 21.A.3B(d)(4)4.1(i) and 4.2(i)) should be permitted to be approved, to mitigate a potential unsafe condition and to maintain an adequate level of safety (according to GM 21.A.3B(d)(4) 2.5(a)).

(b) Applicability

This AMC is applicable for the approval of changes to a type-certificate that are required because: — in-service experience reveals non-compliance with the product’s type-certification basis

or OSD certification basis, leading to an unsafe condition; and — the corrective actions consist of more than one change to the type-certificate, which

will be implemented in line with GM 21.A.3B(d)(4) but in a sequential manner, to restore an acceptable level of safety as soon as possible; and

— each of the correcting changes to the type-certificate contributes to the restoration of compliance with the same parts of the type-certification basis or OSD certification basis, but each change on its own does not provide full compliance at the product level.

The applicable type-certification basis and OSD certification basis of a change include all parts

of the type-certification basis and OSD certification basis that are affected by the change at the

product level.

Under the condition of point 21.A.3B(c)(1) and as described in paragraph (b) above,

point 21.A.97(b)(1) is considered fulfilled if all the following conditions are met:

1. the change to the type-certificate is demonstrated to increase the level of safety in the affected area of change; and

2. the complementing corrective actions necessary to restore full compliance with the applicable type-certification basis and OSD certification basis at the product level are identified and planned by the TC, RTC or STC holder by identifying the affected type- certification basis and OSD certification basis and referring to the complementing corrective changes. These complementing corrective changes are to be proposed to EASA for acceptance. The complementing corrective changes will be approved at a later stage, according to a timescale that is to be accepted by the Agency (see GM 21.A.3B(d)(4)); and

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3. The residual non-compliance at the product level should be covered by additional mitigating means as described in GM 21.A.3B(d)(4) points 4.1(i) and 4.2(i).

GM No 1 to 21.A.101(g) Establishment of the operational suitability data (OSD) certification basis for 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 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 non- significant, 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 21.A.101(b)(3) apply or unless the OSD change can be classified as minor as per 21.A.91. The guidance of GM 21.A.101 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 it is 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 CSs.

e. Reserved.

f. Reserved.

g. Point 21.A.101(c) provides an exception from the requirements of 21.A.101(a) for a change to the OSD of certain aircraft 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 lbs) or less maximum weight, or for a non-turbine-powered rotorcraft of 1 361 kg (3 000 lbs) 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 4.1 (GM 21.A.101) for specific guidance on this requirement.

Note: Refer to GM No 1 to 21.A.15(d) for the applicability of the OSD to other-than-complex motor- powered aircraft.

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GM1 to 21.A.112B Demonstration of capability

DEMONSTRATION OF CAPABILITY FOR SUPPLEMENTAL TYPE-CERTIFICATE (STC) CASES

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

The following examples of major changes to type design (ref.: 21.A.91) are classified in two groups. Group 1 contains cases where a design organisation approved under Part 21 Subpart J (‘Subpart J DOA’) should be required, and Group 2 cases where the alternative procedure may be accepted. They are typical examples, but each STC case should be addressed on its merits and there would be exceptions in practice. This classification is valid for new STCs, not for evolution of STCs, and may depend upon the nature of the STC (complete design or installation).

Product Discipline Kind of STC Group

[…]

CS-23 (products where a Subpart J DOA is required for TC)

[…]

Equipment […] Aeromedical system installations 21

[…]

[…]

CS-27 or CS-29 All disciplines

Note: 2/1 means that an assessment of consequences in terms of handling qualities and performance may lead to classification in Group 1.

Replacement of main rotor or tail rotor blades 1

Autopilot 1

Engine type change 1

GPS installation 2

Jettisonable overhead raft installation 2

Utility basket installation 2/1

Nose or side mount camera installation 2/1

Passenger access step installation 2/1

Protection net & handle installation (parachuting) 2

VIP cabin layout 2

Navigation system installation 2

Fuel boost pump automatic switch-on installation 2

Decrease of maximum seating capacity 2

Agricultural spray kit installation 2/1

Long exhaust pipe installation 2

Flotation gear installation 2/1

Wipers installation 2

Engine oil filter installation 2

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Product Discipline Kind of STC Group

Skid gear covering installation 2/1

Gutter installation (top pilot door) 2

Cable cutter installation 2

Auxiliary fuel tank fixed parts installation 2

Cabin doors windows replacement 2

Radio altimeter aural warning installation 2

Standby horizon autonomous power supply 2

Fire attack system 2/1

Hoisting system installation 2/1

External loads hook installation 2

Emergency flotation gear installation 2/1

Heating/demisting (P2 supply) 2

General

Extension or introduction of new operational capabilities (e.g. NVFR, IFR, PBN, NVG, HEC, NHEC)

Cabin Safety

Replacement of cabin door windows:

(1) If: — the window is an emergency exit; or — a mechanical mechanism for latching and

locking is used; or — a flight test is necessary.

(2) In all other cases. 2

Decrease of maximum seating capacity:

(1) If it involves any of the following: — dynamic seat testing; — exceeding the seat ETSO limitations; — evaluation of rotorcraft structure, e.g.

attachment to bulkhead, use of seat adapter plate;

— modification of the evacuation path; — minor obstructions in the access region of

the emergency exit; — exit derating; — blocking of exits; — modification of the emergency exit

opening/jettisoning mechanism; — restricting access to some emergency exits

for some passengers; — modifications of primary structural

elements or critical parts; — modifications requiring a flight test to

demonstrate compliance with CS 27.251 or CS 29.251.

(2) In all other cases. 2

Emergency flotation gear installation:

(1) If it involves any of the following: 1

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Product Discipline Kind of STC Group

— buoyancy analysis, if the alternative procedure for DOA (ADOA) holder has no experience in the domain;

— modifications of primary structural elements or critical parts;

— first certification of emergency flotation capability for the rotorcraft;

— irregular wave testing; — modification of the location of the existing

emergency flotation gear; — a flight test for in-flight deployment

demonstration; — a flight test for handling qualities or

performance demonstration of the undeployed and deployed emergency flotation system.

(2) In all other cases. 2

Flotation gear installation:

(1) If it involves any of the following: — buoyancy analysis if the alternative

procedure for DOA (ADOA) holder has no experience in this domain;

— modifications of primary structural elements or critical parts;

— first certification of flotation capability for the rotorcraft;

— modification of the location of the existing flotation gear;

— a flight test for in-flight deployment demonstration;

— a flight test for handling qualities or performance demonstration of the undeployed and deployed flotation system.

(2) In all other cases. 2

Ditching certification 1

HEMS installation 1

Life raft installation:

(1) Life raft stowed or carried on board the rotorcraft;

(2) Life raft integrated with the rotorcraft structure and remotely deployable;

Passenger access step installation:

(1) If it involves any of the following: — potential interaction with life raft or

flotation deployment; — modification of primary structural

elements or critical parts; — modifications that could impact the

energy absorption capability of the landing gear and/or invalidate the drop

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Product Discipline Kind of STC Group

test result in terms of resulting load factor or gear deformation.

(2) In all other cases. 2

Protection net and handle installation (parachuting)

VIP cabin layout:

(1) If it involves any of the following: — dynamic seat testing; — exceeding the seat ETSO limitations; — evaluation of rotorcraft structure; — modification of the evacuation path; — minor obstructions in the access region of

the emergency exit; — exit derating; — blocking of exits; — modification of the emergency exit

opening/jettisoning mechanism; — restricting access to some emergency exits

for some passengers; — modifications of primary structural

elements or critical parts; — modifications requiring a flight test to

demonstrate compliance with CS 27.251 or CS 29.251.

(2) In all other cases. 2

Avionics

Autopilot 1

Installation of global navigation satellite system (GNSS) equipment used as primary navigation means

Radio-altimeter aural warning installation 2

Installation of radio-altimeter in IFR rotorcraft 1

HTAWS 1

Installation of Mode S transponder 1

ADS-B Out 1

Installation of new integrated modular avionics (IMA) equipment

Installation of TCAS I or TAS or ADS-B In 1

Installation of ACAS or TCAS II 1

Installation of new communications equipment 2

Weather radar 2

Electronic flight bag (EFB) installed resources 2

Installation or modification, including relocation, of large external antenna and (only for IFR rotorcraft) of transmitting antenna

Mobile phone installations 1

SATCOM installation 2

Installations with an effective Class 3B and 4 LASER emission to the exterior (IEC 60825-1)

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Product Discipline Kind of STC Group

Cockpit voice recorder or flight data recorder 2

LPV/PBN 1

Tracking device (interface with the flight crew, avionics, new active antenna)

Powerplant and Fuel

Fuel tank installation 1

Fixed elements of an auxiliary fuel tank installation:

(1) If the demonstration of compliance with crashworthiness requirements (i.e. CS 27.952, CS 29.952) is not affected;

(2) In all other cases. 1

Modification of the fuel system installation, including changes of fuel lines that alter the routing

Engine oil filter installation 2

Change of engine type or model 1

Long exhaust pipe installation 2

Inlet barrier filter 1

Engine parameter displays:

Primary displays 1

Additional displays for special purposes 2

Fire-extinguishing system 1

Structures

Replacement of main rotor blades or tail rotor blades

Installation of a manual scissor cable cutter in the cabin

Fixed external wire cutter installation 1

Bearpaws, skis or other skid gear covering installation:

(1) If it involves any of the following: — modification of primary structural

elements or critical parts; — flight testing.

(2) In all other cases. 2

Gutter installation (on the top of a door):

(1) If it involves modifications of primary structural elements or critical parts;

(2) In all other cases. 2

Hydromechanical Systems, Flight Control Systems, Doors

Door modifications:

(1) If the latching/locking mechanism or its monitoring/indication in a CS-29 rotorcraft is affected.

(2) In all other cases. 2

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Product Discipline Kind of STC Group

Flight control system modification 1

Electric landing gear installation (retraction/extension and brakes)

Hoisting system installation 1

Environmental Systems and Icing Protection

Wiper installation 2

Heating/demisting (P2 supply) 2

Medical oxygen installation 1

Air-conditioning system installation 2

External Installations

External installations with negligible impact on handling qualities, performance, vibration level or fatigue spectrum

Utility basket or cargo platform installation 1

Complex personnel-carrying device system (PCDS) (see CS 27.865(c), CS 29.865(c))

Simple personnel-carrying device system (PCDS) (see AMC No 3 to CS 27.865, AMC No 2 to CS 29.865)

External load hook installation:

(1) If: — the use of the hook is limited to NHEC;

and — the aircraft is already certified for external

carriage of NHEC loads; and — there is no increase in the already

certified external load weight; and — there is no modification of primary

structural elements or critical parts; and — the demonstration of compliance with

crashworthiness requirements (i.e. CS 27.952, CS 29.952) is not affected.

(2) In all other cases. 1

Nose or side mount camera installation 1

External mirror installation 1

Agricultural spray kit installation

(1) If: — the aircraft is already certified for

underslung loads; and — no passengers are carried; and — flights always happen inside the safe flight

area of the H/V diagram.

(2) In all other cases. 1

Fire attack system 1

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GM1 21.A.133(a) Eligibility – Approval appropriate for showing conformity

APPROVAL APPROPRIATE FOR SHOWING CONFORMITY

‘Appropriate’ should be understood as follows:

— The applicant produces or intends to produce aeronautical products, parts and/or appliances intended for airborne use as part of a type-certificated product (this excludes simulators, ground equipment and tools).

— The applicant will be required to show a need for an approval, normally based on one or more of the following criteria:

1. Production of aircraft, engines or propellers (except if the competent authority considers a POA inappropriate).

2. Production of ETSO articles and parts marked EPA.

3. Direct delivery to users, such as owners’ or operators’ maintenance organisations, with the need for exercising the privileges of issuing Authorised Release Certificates – EASA Form 1.

4. Participation in an international co-cooperation programme where working under an approval is considered necessary by the competent authority.

5. Criticality and technology involved in the part or appliance being manufactured. Approval in this case may be found by the competent authority as the best tool to exercise its duty in relation to airworthiness control.

6. Where an approval is otherwise determined by the competent authority as being required to satisfy the essential requirements of Annex II to the Regulation (EC) No 216/2008(EU) 2018/1139.

— It is not the intent of the competent authority to issue approvals to manufacturing firms organisations that perform only sub-subcontracted work for main manufacturers of products and are consequently placed under their direct surveillance.

— It is not the intent of the competent authority to issue a production organisation approval to a company that fully subcontracts all its manufacturing activities. When the requested scope of work includes products, it is expected that the applicant’s facilities will include the final assembly line(s) for the respective products.

— Where standard parts, materials, processes or services are included in the applicable design data (see guidance on applicable design data in GM 21.A.131) their standards should be controlled by the POA holder in a manner which is satisfactory for the final use of the item on the product, part or appliance. Accordingly, the manufacturer or provider of the following will not at present be considered for production organisation approval: — consumable materials — raw materials — standard parts — parts identified in the product support documentation as ‘industry supply’ or ‘no hazard’ — non-destructive testing or inspection

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— processes (heat treatment, surface finishing, shot peening, etc.)

AMC1 21.A.139(d)(1) Production management system

AIRCRAFT SOFTWARE HANDLING WITHIN PRODUCTION ORGANISATIONS

(a) General

Software can be received by a POA holder from a DOA holder or another POA holder, and can

be installed by the POA holder in aircraft systems and/or aircraft components. Software can

also be duplicated and/or delivered to the customer by the POA holder (i.e. released with EASA

Form 1).

Note 1: The term ‘(aircraft) software’ used in this AMC refers to the software included in the

type design definition of the aircraft, aircraft change or aircraft repair.

Note 2: Software described within this AMC is stored on a physical device (e.g. CD, USB

device).

Note 3: This AMC also applies to the software for engines and/or ETSO parts.

The following points list the main activities related to software handling within a POA holder:

(1) software incoming verification;

(2) software installation and/or duplication;

(3) software installation/duplication verification; and

(4) software release.

Data and media authenticity and integrity need to be ensured in accordance with the

applicable design data until delivery to the final customer.

Software handling within the POA needs to be documented, traceable, recorded and archived

in accordance with the relevant POA procedures.

Where the software installation results in a hardware index increase, the data plate and/or

label should be renewed and/or updated in accordance with the applicable design data.

(b) Software incoming verification

When the software is received by the production organisation, an appropriate incoming check

should be performed in accordance with the relevant POA procedures. These incoming

procedures may also need to take into account considerations stemming from Delegated

Regulation (EU) 2022/1645 for the proper management of information security risks.

In the frame of this acceptance check, the POA needs to ensure that the software is clearly

identified by software configuration (e.g. part number (PN) identification). If the software is

available on a device (USB device, CD, etc.), this device should be identified (e.g. serial number,

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version number, hologram, etc.) and examined for deterioration or damage (e.g. packing, seal,

etc.).

When software is received by the POA, all necessary design data need to be available. These

include, as applicable:

— loading instructions (including integrity check instructions);

— design approval for software;

— software and media identification;

— hardware and software compatibility (eligibility).

Any software in the environment of the POA should be installed in accordance with applicable

design data (e.g. loading instructions, appropriate installation means, etc.). The POA should

check that the software identification is correct for the specific configuration of the aircraft

system or equipment (‘configuration check’).

The software installation process shall be accomplished in a suitable environment and with the

appropriate means.

Any duplication of software should be done from the master file or the master copy (provided

by the DOA). The duplication of software should be accomplished with suitable IT equipment

on suitable software storage devices/media in accordance with the applicable design data.

Any software copy should be clearly identified using an appropriate tracing system.

(d) Software installation/duplication verification

The following verifications should be performed:

— verification of the software installation (e.g. check of version, built-in test equipment (BITE)

test, checksum test);

— compliant operation of the system in accordance with the installation instructions (e.g.

system or functional check, ground or flight acceptance test).

After each duplication process, the software should be checked for completeness and

correctness in accordance with the applicable design data (e.g. checksum test, BITE test,

readability check, data conformity check).

Invalid/corrupt software should be handled as non-conformity in accordance with the relevant

POA procedures.

(e) Software release

Software leaving the POA environment should be accompanied by appropriate documents (e.g. EASA Form 1, installation information, etc.).

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Release of the software media follows the approved POA process related to the issuance of an airworthiness release certificate.

AMC2 21.A.145(a) Resources

STAFF NUMBER AND COMPETENCE

[…]

(d) The competence evaluation should include, where appropriate, verification that specific

qualification standards have been implemented, for example, for welding, for non-destructive

testing (NDT), etc. For example, for NDT, the European Standard EN 4179 is the relevant

standard recognised by EASA.

[…]

GM 21.A.151 Terms of approval – Scope and categories

[…]

FOR PRODUCTS:

1. General area, similar to the titles of the corresponding certification codes.

2. Type of Product, in accordance with the type-certificate.

FOR PARTS AND APPLIANCES:

1. General area, showing the expertise, e.g., mechanical, metallic structure.

2. Generic type, e.g., wing, landing gear, tyres.

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SCOPE OF WORK RATING PRODUCTS/CATEGORIES

A1 Large Aeroplanes A2 Small Aeroplanes A3 Large Helicopters A4 Small Helicopters A5 Gyroplanes A6 Sailplanes A7 Motor Gliders A8 Manned Balloons A9 Airships A10 Light Sport Aeroplanes A11 Very Light Aeroplanes A12 Other

State types ‘ ‘ ‘ ‘ ‘ ‘ ‘ ‘ ‘ ‘ ‘

B1 Turbine Engines B2 Piston Engines B3 APUs’s B4 Propellers B5 Other

‘ ‘ ‘ ‘ ‘

C1 Appliances: C2 Parts:

State appliance generic types (e.g., Tyres, Altimeter, etc.) Examples include: Avionic, Com/Nav/Pulse Computer System, Aircraft/Engine/Avionic Instruments, Mechanical/Electrical/Gyroscopic/Electronic Mechanical/Hydraulic/Pneumatic State part generic types (e.g., Wing, Landing Gear, etc.) Examples include: Structural, Metallic/non-metallic Mechanical/Hydraulic/Pneumatic Electrical Electronic

D1 Maintenance D2 Issue of permit to fly

State aircraft types State aircraft types

AMC2 21.A.163(c) Completion of EASA Form 1

[…]

EASA Form 1 Block 12 ‘Remarks’

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

— When the certificate is used for prototype purposes the following statement must be entered at the beginning of block 12:

‘NOT ELIGIBLE FOR INSTALLATION ON IN-SERVICE TYPE-CERTIFICATED AIRCRAFT’.

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— Re-certification of items from ‘prototype’ (conformity only to non-approved data) to ‘new’ (conformity to approved data and in a condition for safe operation) once the applicable design data is approved.

The following statement must be entered in block 12:

‘RE-CERTIFICATION OF ITEMS FROM ‘PROTOTYPE’ TO ‘NEW’:

THIS DOCUMENT CERTIFIES THE APPROVAL OF THE DESIGN DATA [insert TC/STC number, revision level], DATED [insert date if necessary for identification of revision status], TO WHICH THIS ITEM (THESE ITEMS) WAS (WERE) MANUFACTURED.

PREVIOUS RELATED CERTIFICATE IS: [enter original tracking number] DATED [enter original issuance date]’

— When a new certificate is issued to correct error(s) the following statement must be entered in block 12:

‘THIS CERTIFICATE CORRECTS THE ERROR(S) IN BLOCK(S) [enter block(s) corrected] OF THE CERTIFICATE [enter original tracking number] DATED [enter original issuance date] AND DOES NOT COVER CONFORMITY/ CONDITION/RELEASE TO SERVICE’.

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 service bulletins. — 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 reassembly after delivery. — References to aid traceability, such as batch numbers. — In the case of an engine, if the competent authority has granted an exemption from the

applicable engine environmental protection requirements, the record: ‘ENGINE EXEMPTED FROM [REFERENCE TO THE TYPE OF EMISSION] EMISSIONS ENVIRONMENTAL PROTECTION REQUIREMENT’.

AMC1 21.A.239(d)(3) Design management system

PARTNERS AND SUBCONTRACTORS — INDUSTRY STANDARDS

Compliance with subcontractor acceptance requirements in point 21.A.239(d)(3) may be demonstrated by the use and application of the industry standard contained in the ASD-STAN technical report TR 9255, Acceptance of supplier’s design capabilities and management of design organisation authorisations, edition P1, dated 31 August 2022.

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AMC1 21.A.303(b) Compliance with applicable requirements

INSTALLATION APPROVAL

An equipment-level approval, issued under the ETSO authorisation procedures of Subpart O, does not

represent an approval for installing the respective part or appliance on a certified product. The

installation approval should consider the installation aspects, the product environment, the type-

certification basis, the OSD certification basis and the environmental protection requirements. Such

an approval is issued following the certification procedures in Subpart B (for (restricted) type-

certificates), Subpart D (changes to the (restricted) type-certificates) and Subpart E (supplemental

type-certificates).

GM1 21.A.307 The eligibility of parts and appliances for installation

EASA FORM 1

EASA Form 1 is the authorised release certificate issued to an aircraft part that permits its installation

in an aircraft registered in an EU Member State (or subassembly) during maintenance. The issue of

this form associated with a part is established by Regulation (EU) No 748/2012 in the case of new parts

and Regulation (EU) No 1321/2014 in the case of used parts.

Standard parts and certain new parts fulfilling the conditions described in point 21.A.307(b) of this

Annex are exempt from requiring this form.

Some bilateral agreements signed between the European Union and a third country recognise a

certificate issued in accordance with the third country regulation as equivalent to an EASA Form 1,

enabling the installation of a part accompanied by the equivalent form on an aircraft registered in an

EU Member State.

GM1 21.A.307(c) The eligibility of parts and appliances for installation

ACCEPTABLE DOCUMENTATION FOR CERTAIN PARTS

According to point 21.A.307(c), in order to be eligible for installation in a type-certified product, the

part subject to the derogation in point 21.A.307(b) shall be accompanied by a document issued by the

manufacturer of the respective part. Such a document might be issued in various ways (e.g. certificate

of conformity, delivery note) but should contain the information required in point 21.A.307(c).

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AMC1 21.A.606(b) Requirements for the issuance of an ETSO authorisation

DEMONSTRATION OF COMPLIANCE

A. Non-ETSO function

A non-ETSO function is a function provided by an article that is not covered by ETSO-approved minimum operational performance standards (MOPS) and does not support or affect the hosting article’s ETSO function(s).

An ETSO article may host:

(1) functions covered by the ETSO standards the applicant has applied for; and

(2) functions not covered by any ETSO standards (non-ETSO functions).

Functions in (1) are the ETSO functions subject to the authorisation.

Functions in (2) are considered accepted (not approved) on a non-interference basis, which means that the applicant shall show that they do not detrimentally affect ETSO function performance and compliance with the standard. These functions shall be listed in the installation manual and in the declaration of design and performance (DDP).

Note: EASA will authorise articles only where the ETSO functions represent the core functions of the article.

If there are functions hosted in the article that are subject to an ETSO standard for which the applicant has not applied, one of the following two situations may exist.

(a) The additional functions are mostly covered by an existing standard, ETSO-Cxyz, and therefore they cannot be qualified as non-ETSO functions. As a result, the applicant should also apply and show compliance with the existing standard, ETSO-Cxyz. Consequently, the functions fall under category (1) above. A ‘non-ETSO’ function can only be a function for which no ETSO standard exists.

(b) They do not meet the intent of the standard, and therefore they are non-ETSO functions, falling under category (2) above.

Example: A flight data recording function embedded on an ETSO-C113 display, without any crash-protecting measure, is not required to apply ETSO-C124 or ETSO-2C197.

It should be noted that standards sometimes overlap. In such a case, the applicant is required to apply

only for the most appropriate one. For example, ETSO-C201 (Attitude and Heading Reference Systems)

is more stringent, and therefore more appropriate, than ETSO-C3d (Turn and Slip Instrument), ETSO-

C4c (Bank and Pitch Instruments) and ETSO-C5e/C6e (Direction Instrument — stabilised). Similarly,

ETSO-C106 A1 (Air Data Computer) is more stringent, and therefore more appropriate, than ETSO-C2d

(Airspeed Instruments), ETSO-C8e (Vertical Velocity Instrument), ETSO-C10b (Aircraft Altimeter),

ETSO-C43c (Temperature Instruments), ETSO-C46a (Maximum Allowable Airspeed Indicator Systems)

and ETSO-C95a (Mach Meters).

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In accepting a non-ETSO function, EASA has an acceptable means of compliance equivalent to that

set out in FAA AC 21-46A, Section 5-5.

(1) The non-ETSO functions should be declared in the certification programme, and demonstration that they cannot adversely affect the performance of the ETSO function and its compliance with the MOPS is required. Only if these are declared and demonstrated is the hosting article eligible for an ETSOA.

(2) The requirements and performance of the non-ETSO functions are not assessed for the ETSOA, but the applicant needs to apply a development process consistent with the ETSO article and its targeted environment as a whole.

Note: Non-ETSO functions’ descriptive or substantiation data that are not needed to show

compliance with the ETSO MOPS are evaluated during the aircraft installation design approval

(e.g. TC/STC).

(3) The non-ETSO functions should be listed in the DDP and in the installation manual. Non-ETSO functions are considered ‘accepted’, in the frame of the ETSO authorisation, only on a non- interference basis, meaning that it is demonstrated and stated in the DDP that they cannot detrimentally affect the performance of the ETSO functions.

B. Incomplete ETSO article

An incomplete ETSO article is one that provides only part of the performance and/or functionality specified in the applicable ETSO.

EASA accepts applications for incomplete ETSO articles under the following conditions.

(1) The incomplete article provides a major and independent function of that specified in the ETSO standard. There should be ETSO requirement(s) that are specific to the function that is provided (i.e. in addition to general requirements for software, airborne electronic hardware or environmental qualification). It should be possible to meet the complete ETSO requirement(s) with additional articles.

The MOPS requirements that cover the functions hosted in the ETSO article should be complete and properly identified in the certification programme.

Examples are provided below.

(a) Example of an incomplete article that contains major and independent ETSO functions: an electronic flight instrument system (EFIS) that may be used in accordance with ETSO-C4 (Bank and Pitch Instruments). The EFIS displays ‘bank and pitch’ information but does not include a vertical gyro. Since the EFIS constitutes a major part and independent function of the ETSO- C4 functions with specific requirements pertaining to the display, an incomplete ETSOA to ETSO-C4 may be granted.

(b) Example of an incomplete article that contains no major and independent ETSO functions: a cooling fan for a global positioning system under ETSO-C196 (Airborne Supplemental Navigation Sensors for Global Positioning System Equipment Using Aircraft-Based

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Augmentation). Since the cooling fan does not constitute a major part of the ETSO-C196 functions, no partial ETSOA can be granted.

(2) The ETSO MOPS specifically provide appropriate and adequate standards for evaluation of the article as an incomplete article. The ETSO compliance report must identify and show compliance with all the specific performance requirements in the ETSO standard that are applicable to the incomplete article.

(3) Installation drawings and/or installation manuals must contain detailed instructions and limitations for the installation and use of the incomplete article. For example, company ‘ABC’ manufactures — under ETSO-C119 (Airborne Collision Avoidance System II (ACAS II) Version 7.1 with Hybrid Surveillance) — a traffic alert and collision avoidance system (TCAS) antenna with an interface that is interoperable with a company ‘XYZ’ model ‘123’ TCAS computer. The installer must substantiate the interoperability when showing compliance with the applicable airworthiness requirements.

(4) The DDP and the installation manual shall list the specific MOPS that the article meets.

This should be provided by referencing the specific paragraphs (a single reference to a parent paragraph and all its subparagraphs can frequently be used). This information will assist the installer of the ETSO article in knowing the limitations of the article’s capabilities.

AMC1 21.A.606(d) Declaration requirements for the issuance of an ETSO authorisation

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.

The above declaration should be included in the Declaration of Design and Performance (see point 21.A.608 and AMC1 21.A.608).

Note: An equipment level approval, issued under the ETSO authorisation procedures of Subpart O, does not represent an approval for installing the respective part or appliance on a certified product. The installation approval should consider the installation aspects, the product environment, the type-certification basis, the OSD certification basis and the environmental protection requirements. Such an approval is issued following the certification procedures in Subpart B (for (restricted) type-certificates), Subpart D (changes to the (restricted) type- certificates) and Subpart E (supplemental type-certificates).

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AMC1 21.A.608 Declaration of Design and Performance (DDP)

Note 1: If certain sections of the DDP are not applicable for the ETSO article in question, please state ‘N/A’ in those sections (but keep the section numbering).

Note 2: The DDP template has been designed with consideration of the possibility that the ETSOA applicant/holder is different from the manufacturer. If this is not the case, Section 1 may be simplified, with just the single entity being stated.

STANDARD FORM

Declaration of Design and Performance

DDP No. ……………………………

ISSUE No. ………………………….

Date: ………………………………..

1. Name and address of manufacturer the ETSOA applicant/holder.

Name and address of the manufacturer, if different from the ETSO applicant/holder.

2. Description and identification of article including:

Article designation: …………………………………..

Model/Type No: ………………………………………

Modification Standard

Master drawing record

Weight and overall dimensions

Part number(s): ………………………….. (including eventual provision for minor changes, modification standard if any)

Note: When several articles constitute the approved part, the part number of each article should be listed. In particular, for articles embedding software for which the configuration is not set by the hosting hardware part number, the software loadable part number(s) should be identified. A compatibility matrix or equivalent information should be provided showing the authorised configurations.

When the part number includes open brackets, the DDP should also list the individual approved part numbers covered by the open brackets. The DDP should address the performance of these individual part numbers.

3. Specification reference, i.e., ETSO No. and Manufacturer’s design specification.

3. List of ETSO functions and non-ETSO functions (when present).

Identification of the article functions, making clear the distinction between the ETSO functions and the non-ETSO functions.

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4. The rated performance of the article directly or by reference to other documents.

4. Specification reference, (i.e. ETSO standard and applicable CS-ETSO amendment and/or the aircraft manufacturer design specification, if applicable).

ETSO-…..

5. Particulars of approvals held for the equipment.

5. Master drawing reference: ……………

Note: Optionally add article marking drawing reference, if not already specified in the certification programme.

6. Reference to qualification test report.

6. The rated performance of the article directly or by reference to other documents.

Equipment type, class, etc.

Weight and overall dimensions

Limits of accuracy of measuring instruments

7. Service and Instruction Manual reference number.

7. A statement of the assumed failure condition classification used as a design input (see CS-ETSO Subpart A).

8. Statement of compliance with the appropriate ETSO and any deviations therefrom.

8. A statement of the software level(s) used (or ‘None’ if not applicable), along with the applicable development assurance standards and/or other means of compliance with their version.

(Note: For Software levels (software development assurance levels (DAL)) are those define in the industry document referred in the latest edition of AMC 20-115) and applicable standard, refer to CS-ETSO subpart A)

For those articles containing software, and as required per the software standard, references to:

— plan for software aspects of certification; — software configuration index; — software accomplishment summary.

9. A statement of the level of compliance with the ETSO in respect of the ability of the article to withstand various ambient conditions or to exhibit various properties.

The following are examples of information to be given under this heading depending on the nature

of the article and the specifications of the ETSO.

(a) Environmental Qualification

i. Temperature and Altitude

ii. Temperature Variation

iii. Humidity

iv. Operational Shocks and Crash Safety

v. Vibration

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vi. Explosion Proofness

vii. Waterproofness

viii. Fluids Susceptibility

ix. Sand and Dust

x. Fungus Resistance

xi. Salt Spray

xii. Magnetic Effect

xiii. Power Input

xiv. Voltage Spike

xv. Audio Frequency Conducted Susceptibility - Power Inputs

xvi. Induced Signal Susceptibility

xvii. Radio Frequency Susceptibility (Radiated and Conducted)

xviii. Emission of Radio Frequency Energy

xix. Lightning Induced Transient Susceptibility

xx. Lightning Direct Effects

xxi. Icing

xxii. Electrostatic Discharge

xxiii. Fire, Flammability

(Note: The manufacturer should list environmental categories for each of the sections of the issue of EUROCAE ED-14/RTCA DO-160 that was used to qualify the article.)

(b) For radio transmitters the transmitting frequency band, maximum transmitting power, and emission designator.

(d) Time rating (e.g., continuous, intermittent) or duty cycle.

(e) Limits of accuracy of measuring instruments.

(f) Any other known limitations which may limit the application in the aircraft e.g., restrictions in mounting attitude.

9. For airborne electronic hardware, a statement of design assurance level for the complex hardware used, or ‘None’, if not applicable, along with the applicable development assurance standards and/or other means of compliance with their version.

Note: For design assurance levels, refer to CS-ETSO Subpart A.

For those articles containing complex electronic hardware, as required by the airborne electronic hardware standard, references to:

— plan for hardware aspects of certification; — hardware configuration index;

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— hardware accomplishment summary.

10. A statement of the software level(s) used or ‘None’ if not applicable.

(Note: Software levels (software development assurance levels (DAL)) are those defined in the industry document referred in the latest edition of AMC 20-115)

10. Any other known limitations (including open problem reports for SW and AEH) that may limit the application on the aircraft, for example restrictions in mounting attitude or non-compliance with the article specification, or installation limitation.

Note 1: If the ETSO article has no limitations, this should be explicitly stated (i.e. ‘None’) in this section.

Note 2: For software and airborne electronic hardware, the open problem report’s description should follow the applicable guidelines (as introduced in ED-94C DP #9).

11. A statement of design assurance level for complex hardware or a statement indicating whether complex hardware is embedded or not in the product.

(Note: Complex hardware design assurance levels are those defined in the applicable issue of EUROCAE ED–80/RTCA DO-254.)

11. Deviations from ETSO standard(s) (if applicable).

Note 1: Deviations that have already been published should be referenced with their publication number (such as ‘Deviation ETSO-Cxxx#yy published in ETSO.DevP.zz’).

Note 2: If the ETSO article has no deviation from the ETSO standard, this should be explicitly stated (i.e. ‘None’) in this section.

12. The declaration in this document is made under the authority of

12. A statement of the level of compliance of the article with the ability to withstand various environmental conditions, in the form of an environmental qualification form.

With a reference to the environmental qualification test plan and report(s) (refer to EUROCAE ED-14/RTCA document DO-160).

13. For radio transmitters the transmitting frequency band, maximum transmitting power, and emission designator (European Telecommunications Standards Institute (ETSI) or US Federal Communications Commission (FCC)).

14. Approvals held for the article

(i.e. foreign TSO authorisations, initial approval, other non-airworthiness certification approval).

15. Reference to the certification programme for the article, with identification of the deviations from the certification programme.

16. Reference to ETSO compliance reports (compliance matrix, test plans/reports, other qualification reports).

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17. Reference to the safety documents (failure mode effect analysis, single event effects analysis, system safety analysis) relevant to the article.

18. Service and instruction, installation, maintenance and operation manuals reference number (CMM, IM, OM).

19. It is hereby declared that:

(a) the article(s) described in this document has been designed in compliance with Part 21, Subpart O (reference: 21.A.605(a)(2));

(b) in accordance with the certification programme, the article(s) comply(ies) with the referenced applicable ETSO standard(s) (reference: 21.A.605(a)(3)):

— without limitations / with the limitations listed in Section 9;

— without deviations / with the deviations listed in Section 10;

— the non-ETSO functions listed in Section 11 do not interfere with the ETSO functions.

(c) no feature or characteristic (including non-ETSO functions) has been identified that may make the article unsafe for the uses for which certification is requested (reference: 21.A.606(d)).

The This declaration in this document is made under the authority of

……………………………………………………………(name of manufacturer) (name of ETSOA applicant/holder)

(Manufacturer’s name) (Name of ETSOA applicant/holder) cannot accept responsibility for

equipment used outside the limiting conditions stated above without their agreement.

Date: ………….Signed………………………………………….....(Manufacturer’s aAuthorised representative of ETSOA applicant/holder; alternative procedure for DOA reference number)

GM 21.A.719 Transfer of a permit to fly

Except for permits to fly issued under 21.A.701(a)(15), like aircraft without TC holder, a permit to fly

is issued based upon the applicant’s declaration of many aspects of the proposed flight or flights, some

of which are specific to the applicant. Accordingly, the basis upon which a permit to fly has been issued

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necessarily is no longer fully in place when the holder of a permit to fly changes, ownership changes,

and/or there is a change of register. Such changes necessitate a new application under 21.A.707.

For permits to fly issued under point 21.A.701(a)(15) where ownership of an aircraft has changed,

unless there is a change to the configuration of the aircraft that invalidates the permit to fly or flight

conditions, the permit to fly and the related approved flight conditions remain valid and the permit to

fly should be transferred to the new owner.

The transfer of the permit to fly, when possible (see above), includes a transfer of the obligations in

accordance with point 21.A.727.

The flight conditions are linked with the specific aircraft serial number(s) and therefore do not have a

holder and are not subject to transfer. In addition, there are no direct obligations linked with a flight

conditions approval. The permit-to-fly holder has the obligation to ensure that the flight conditions

are met.

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AMC1 21.A.807(a) Identification of ETSO articles

(a) Manufacturer name and address

An ETSO authorisation applicant/holder may demonstrate their production capability not by holding a production organisation approval (POA) but by establishing an agreement under point 21.A.2 with a different legal entity that holds a POA.

In such a case, the ETSO article marking should include both companies’ names and addresses.

(b) Electronic marking

Electronic marking is an alternative to physical marking for electronic hardware articles. Through this marking method, the identification information is embedded within the electronic hardware component itself (using software). For EASA to accept electronic marking, the following conditions should be observed:

— the identification information is readily accessible without the use of special tools or equipment;

— the identification information is stored in non-volatile memory;

— the electronic identification system is verifiable on board the aircraft, when the aircraft is on the ground at any geographical location; and

— the electronic identification system provides the specific information required by point 21.A.807(a).

For conditions to accept an application for ETSO authorisation for an incomplete article, refer to AMC1 21.A.606(b). When not obvious from the component, the ETSOA article should be permanently and legibly marked with at least ‘INCOMP’ adjacent to the ETSO number marking (e.g. ‘ETSO-C69c INCOMP’) and include detailed instructions in the installation drawings or installation manual. Marking an article ‘INCOMP’ or ‘Incomplete’ will eliminate ambiguity about the article’s level of compliance.

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

1. […]

2. […]

3. […]

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4. […]

5. […]

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.

Note: When prescribing special conditions, EASA will also review the special conditions already published and establish their applicability to the new product.

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

[…]

5. ALTERNATIVE MEANS OF COMPLIANCE (see point 21.B.82(a)(23))

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 Annexes II, IV and V 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’.

[…]

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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. […]

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 21.A.9, 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. […]

3.1. […]

3.2. […]

3.3. Criticality

[…]

The potential impact of a non-compliance within a CDI should be classified as critical if, for example:

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— 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).; or

— the installation or activation of, or a change to, a function, component or system that, when subjected to an intentional unauthorised electronic interaction (IUEI) with that function, component or system, may contribute to a condition that has an adverse effect on the safety at the aircraft level.

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 continued-airworthiness process.

[…]

3.45. Determination of EASA’s LoI

[…]

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’.

[…]

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. […]

5. […]

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

[…]

1. Principles

[…]

2. Determination of EASA’s LoI

[…]

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.

[…]

3. The process of determining EASA’s LoI

[…]

Note: For a minor change, this process does not apply; in that case, EASA’s LoI review consists of an assessment of the minor change classification, an update of the certificate, and, when needed, an assessment of the DDP and all affected compliance documents.

GM1 21.B.433(d) Findings and corrective actions; observations

EXTENSION, ESCALATION AND DE-ESCALATION OF FINDINGS

Findings can be extended, escalated from level 2 to level 1 and de-escalated from level 1 to level 2 under certain prerequisites:

(a) Only level 2 findings can be extended based on an agreed corrective action plan. Such findings can be extended more than once when the competent authority agrees to an updated corrective action plan.

(b) Level 2 findings should be escalated to level 1 findings when the prerequisites of point 21.B.433(d)(2)(iii) apply, i.e. when the organisation fails to submit an acceptable corrective action plan, or fails to perform the corrective action within the time period accepted or extended by the competent authority.

(1) Ref. point 21.B.433(b): The nature of the non-compliance is no longer uncontrolled and potentially unsafe. Further actions needed to fully correct the non-compliance can then

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be governed under a level 2 finding with appropriate change of deadline and under a corrective action plan acceptable to the competent authority.

(2) Ref. point 21.B.433(b)(1): Not applicable.

(3) Ref. point 21.B.433(b)(2): Not applicable.

(4) Ref. point 21.B.433(b)(3): Not applicable.

(5) Ref. point 21.B.433(b)(4): The head of the design organisation acceptable to the competent authority has been appointed, but for example procedures need to be updated to properly reflect the required appointment process and criteria.

(6) Ref. point 21.B.433(d)(2)(iii):

(i) For not submitting a corrective action plan acceptable to the competent authority:

The organisation submitted a corrective action plan acceptable to the competent authority.

(ii) For the failure to perform the corrective actions within the time period accepted by the competent authority:

The subsequent performance of these corrective actions would close the level 1 finding or an updated corrective action plan acceptable to the competent authority would allow for de-escalation to a level 2 finding.

Note: The de-escalation of level 1 findings is specific to DOA holders as the applicable requirement imposes a strict timeframe for addressing the level 1 finding (i.e. 21 working days). Consequently, keeping a finding at level 1, even if the conditions for level 1 classification no longer exist, may affect proper implementation of further corrective and preventive actions requiring a longer implementation period.