21L.A.81 Scope

Regulation (EU) 2022/1358

This Subpart establishes the procedure for natural or legal persons other than the holder of that type certificate for applying for the approval of major changes to type certificates, issued under Annex I (Part 21) or this Annex, of products within the scope of point 21L.A.21, provided that the changed product is still within the scope of that point, and establishes the rights and obligations of the applicants for, and holders of, those certificates.

GM1 21L.A.81 Scope

ED Decision 2023/013/R

The term ‘changes to the type certificate’ is consistently used in Subparts D and E of Part 21 Light, as well as in the related AMC and GM. This term does not refer to changing the document that reflects the type certificate (TC) but to changing the elements of the TC as defined in point 21L.B.47(b). Therefore, the processes contained in Subparts D and E of Part 21 Light should be used for the approval of changes to the elements listed in point 21L.B.47(b).

21L.A.82 Eligibility

Regulation (EU) 2022/1358

Any natural or legal person who has demonstrated, or is in the process of demonstrating, or have declared, their design capability in accordance with point 21L.A.83 may apply for a supplemental type certificate under the conditions laid down in this Subpart.

21L.A.83 Demonstration of design capability

Regulation (EU) 2022/1358

An applicant for a supplemental type certificate shall demonstrate their design capability by:

(a) holding a design organisation approval with terms of approval that cover the respective category of product, issued by the Agency in accordance with Subpart J of Section A of Annex I (Part 21); or

(b) declaring their design capability for the scope of the product in accordance with Subpart J of this Annex.

GM1 21L.A.83(a) Demonstration of design capability

ED Decision 2023/013/R

TERMS OF APPROVAL COVERING THE RESPECTIVE CATEGORY OF THE PRODUCT

If an applicant has a design organisation approval (DOA) issued under Subpart J of Annex I (Part 21) and it wishes to use this approval to meet the eligibility criteria of point 21L.A.83, it will need to apply for a change to the Terms of Approval to include the new aircraft type within the list of products.

GM1 21L.A.83(b) Demonstration of design capability

ED Decision 2023/013/R

DECLARATION OF PRODUCT CATEGORY

Organisations that have declared their design capability under Subpart J of Annex Ib (Part 21 Light) should update their declaration of design capability to include the new product when submitting a new application for a type certificate (see point 21L.A.173(c) ‘Declaration of design capability’).

21L.A.84 Application for a supplemental type certificate

Regulation (EU) 2022/1358

(a) An application for a supplemental type certificate shall be made in a form and manner established by the Agency.

(b) When applying for a supplemental type certificate, the applicant shall:

1. include in the application the information required by point 21L.A.65(b;)

2. specify whether the certification data has been or will be prepared completely by the applicant or on the basis of an arrangement with the owner of the type-certification data.

AMC1 21L.A.84(a) Application for a supplemental type certificate

ED Decision 2023/013/R

FORM AND MANNER

The applicant should file an application using the web-based ‘EASA Applicant Portal’⁸⁵https://ap.easa.europa.eu (accessed: 20 October 2023) or the application form for a supplemental type certificate (STC), which may be downloaded from the EASA website.

If the form is filled in offline, it should be completed in accordance with the instructions embedded at the bottom of the application form and sent to EASA by email or regular mail following the information provided on the EASA website⁸⁶https://www.easa.europa.eu/document-library/application-forms/certifica… https://ap.easa.europa.eu (accessed: 20 October 2023).

AMC1 21L.A.84(b)(1) Application for a supplemental type certificate

ED Decision 2023/013/R

CERTIFICATION BASIS

Point 21L.A.65(b) ‘a proposal for the type-certification basis and the applicable environmental protection requirements, prepared in accordance with the requirements and options specified in point 21L.B.101’.

The proposed type-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.

21L.A.85 Demonstration of compliance

Regulation (EU) 2022/1358

(a) The applicant for a supplemental type certificate shall demonstrate compliance with the applicable type-certification basis and the applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with point 21L.B.101 and shall provide the Agency with the means by which such compliance has been demonstrated.

(b) The applicant for a supplemental type certificate shall provide the Agency with a recorded justification of the means of compliance within compliance documents according to the compliance demonstration plan.

(c) When carrying out testing and inspections to demonstrate compliance in accordance with point (a), the applicant shall have verified and documented this verification prior to carrying out any test:

1. for the test specimen, that:

(i the materials and processes adequately conform to the specifications for the proposed changed type design;

(ii) the constituent parts of the products adequately conform to the drawings in the proposed changed type design;

(iii) the manufacturing processes, construction and assembly adequately conform to those specified in the proposed changed type design; and

2. that the test and measuring equipment used for the test were adequate for the test and appropriately calibrated.

(d) The flight testing for the purpose of obtaining a supplemental type certificate shall be conducted in accordance with the methods for such flight testing specified by the Agency. The applicant for a supplemental type certificate shall make all the flight tests necessary to determine compliance with the applicable type-certification basis.

(e) An applicant for a supplemental type certificate shall allow the Agency to:

1. review any data and information related to the demonstration of compliance;

2. witness or carry out any test or inspection conducted for the purpose of the demonstration of compliance; and

3. conduct a physical inspection of the first article of that product in the final changed configuration to verify the compliance of the design with the type-certification basis and the applicable environmental protection requirements.

(f) Upon completion of the compliance demonstration, the applicant for a supplemental type certificate shall declare to the Agency that:

1. it has demonstrated compliance with the type-certification basis and the applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with points 21L.B.101, according to the compliance demonstration plan; and

2. no feature or characteristic has been identified that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested.

AMC1 21L.A.85 Demonstration of compliance

ED Decision 2023/013/R

DEMONSTRATION OF COMPLIANCE FOR A SUPPLEMENTAL TYPE CERTIFICATE

The description of the design change should include an explanation of the purpose of the change, the pre-modification and post-modification configuration(s) of the product, schematics/pictures, and any other detailed features and boundaries of the physical change (this may be supplemented by drawings or outlines of the design, if this helps to understand the design change), as well as the identification of the changes in areas of the product that are functionally affected by the change, and the identification of any changes to the approved manuals.

The applicant should identify any reinvestigations that are necessary to demonstrate compliance. This is a list of any affected items of the applicable certification basis for which a new demonstration is necessary, together with the means (e.g. calculation, test or analysis) by which it is proposed to demonstrate compliance.

(a) Compliance documentation for the demonstration of compliance under point 21L.A.85(a) comprises one or more test or inspection programmes/plans, reports, drawings, design data, specifications, calculations, analyses, etc., and provides a record of the means by which compliance with the applicable type-certification basis and environmental protection requirements is demonstrated.

(b) Each compliance document should typically contain:

—       the reference of the certification specifications, special conditions or environmental protection requirements addressed by the document;

—       substantiation data demonstrating compliance (except test or inspection programmes/plans);

—       a statement by the applicant declaring that the document provides the proof of compliance for which it has been created; and

—       the appropriate authorised signature.

(c) Each compliance document should be unequivocally identified by its reference and issue date. The various issues of a document should be controlled and comply with point 21L.A.7.

The level of detail of the compliance documentation that is referred to in point 21L.A.85(a) should be the same regardless of whether the change is approved by EASA or under a design organisation approval (DOA) privilege, to allow the change to be assessed in the frame of the DOA surveillance.

For major changes (STCs) approved by a design organisation approval (DOA) holder on the basis of its privileges as per point 21.A.263(c)(8) of Annex I (Part 21), the process described in AMC No 2 to 21.A.263(c)(5), (8) and (9) applies.

AMC1 21L.A.85(b) Demonstration of compliance

ED Decision 2023/013/R

COMPLIANCE-DEMONSTRATION PLAN

The compliance-demonstration plan is a document that allows the applicant and EASA to manage and control the evolving supplemental type certificate design, as well as the process of compliance demonstration by the applicant and its verification by EASA when required.

In particular, the following information should typically be expected:

—      identification of the relevant personnel that make decisions affecting airworthiness and environmental protection, and that will interface with EASA during the critical design review prior to issuance of the flight conditions and during the first-article inspection (if required), unless otherwise identified to EASA (e.g. within the design organisation procedures);

—      a project schedule, including major milestones;

—      subcontracting arrangements for design, environmental protection and/or production.

The applicant should provide detailed information about the proposed means of compliance with the applicable airworthiness and environmental protection requirements identified under point 21L.B.101. The information provided should be sufficient for EASA to easily determine the means of compliance used.

This should include the following:

—      a compliance checklist addressing each requirement, the proposed means of compliance (see Appendix A to AMC1 21L.A.85 below for the relevant codes), and the related compliance document(s);

—      identification of industry standards (Society of Automotive Engineers (SAE), American Society for Testing and Materials (ASTM), European Organisation for Civil Aviation Equipment (EUROCAE), AeroSpace and Defence Industries Association of Europe (ASD), etc.), methodology documents, handbooks, technical procedures, technical documents and specifications specified in the type certificate data sheet, certification memoranda, policy statements, guidance material, etc., that are proposed in the demonstration of compliance;

—      when the compliance demonstration involves testing (point 21L.A.85(c) and (d)), a description of the ground- and flight-test article(s), test method(s), test location(s), test schedule, test house(s), test conditions (e.g. limit load, ultimate load), as well as of the intent/objective(s) of the testing; and

—      when the compliance demonstration involves analyses/calculations, a description/ identification of the tools (e.g. name and version/release of the software programs) and methods used, the associated assumptions, limitations and/or conditions, as well as of the intended use and purpose; furthermore, the validation and verification of such tools and methods should be addressed.

For every aspect mentioned above, the applicant should clearly identify whether the demonstration of compliance involves any method (analysis or test) which is novel or unusual for the applicant. In addition, the applicant should identify any deviations from the published AMC to the relevant CSs.

Appendix A to AMC1 21L.A.85 Demonstration of compliance

ED Decision 2023/013/R

MEANS-OF-COMPLIANCE CODES

AMC1 21L.A.85(a);(b) Demonstration of compliance

ED Decision 2023/013/R

COMPLIANCE DOCUMENTATION

(a) Compliance documentation comprises one or more test or inspection programmes/plans, reports, drawings, design data, specifications, calculations, analyses, etc., and provides a record of the means by which compliance with the applicable type-certification basis and environmental protection requirements is demonstrated.

(b) Each compliance document should typically contain:

—       the reference of the certification specifications, special conditions or environmental protection requirements addressed by the document;

—       substantiation data demonstrating compliance (except test or inspection programmes/plans);

—       a statement by the applicant declaring that the document provides the proof of compliance for which it has been created; and

—       the appropriate authorised signature.

(c) Each compliance document should be unequivocally identified by its reference and issue date. The various issues of a document should be controlled and comply with point 21L.A.7.

AMC1 21L.A.85(c) Demonstration of compliance

ED Decision 2023/013/R

INSPECTIONS AND TESTS

Proposed type design: this term defines the type design (or the portion of the type design) as it is determined at the time when the testing and inspections are carried out.

Verification document (also known as ‘statement of conformity’): before each testing and inspection, the verification document must confirm that the test specimen conforms with the proposed design, the test and measuring equipment is adequate for the test, and the sensors and measuring system are appropriately calibrated.

Conformity of the test specimen: the documented verification is intended to ensure that the manufactured test specimen, even in the presence of non-conformities, adequately represents the proposed type design. Possible types of non-conformity may be the following:

—      Non-conformity between the design of the test specimen and the proposed type design at the time of the test. These are typically identified in the early stage of the testing and inspection planning, and should be addressed as early as possible (e.g. in the test plan). There may be several reasons for such a non-conformity: to account for interfaces with the test equipment, to conservatively cover several or future design configurations, etc.

—      Non-conformity between the manufactured test specimen and the design of the test specimen. Such a non-conformity may be the result of the manufacturing of the test specimen.

While it is convenient to define any possible non-conformity as early as possible, the applicant does not need to make the distinction between the two types of non-conformity above as long as they are explicitly addressed, justified in the verification document or by cross reference to the test plan or other documents. However, testing for the demonstration compliance with the applicable environmental protection requirements should be conducted in the final design of the product having incorporated the change.

Type certification is typically an iterative process in which the design is under continuous evolution.
If the type design evolves after the time of the testing and inspections, then the final type design should be checked against the proposed type design (as it was at the time of the testing and inspections), and the differences (if any) should be analysed to ensure that the testing and inspection results are representative of the final configuration. However, such changes made to the type design may lead to the invalidation of the testing and inspection results and the need to repeat the testing and inspections. It is recommended that the design organisation should have a thorough configuration management process to track the evolving type design.

Conformity of test and measuring equipment: the configuration of the test and measuring equipment should be defined in the test plan and include the following:

—      definition/design of the test equipment (relevant tools, mechanical parts, electronic components used to execute the test); and

—      definition of the measuring equipment:

—      type/model of sensors, together with their technical characteristics;

—      position and orientation of exciters and sensors; and

—      electronic measuring equipment (in some cases, this may also include the acquisition and post-processing of data).

The configuration of the test and measuring equipment should be defined and controlled through certification test plans and supporting documentation, according to the design assurance system, if applicable. The test plan should also include the following elements:

—      the test cases, methods, and procedures for test execution;

—      the pass–fail criteria; and

—      pre-, during- and post-test inspections.

The verification document should confirm that the test and measuring equipment conforms to its purpose, and that the sensors and measuring system are appropriately calibrated. Any non-conformity should be assessed, and it should be justified that it will not compromise the test purpose and results. This may be done either in the verification document or by cross reference to other documents (test minutes of meetings, test notes, etc.).

Use of the term ‘adequate’: the test specimen, as well as the test and measuring equipment, is considered ‘adequate’ as long as the test execution on the manufactured test specimen (including any non-conformity) and the use of the installed test set-up do not compromise the test purpose and results (for example, by providing better performance than the proposed type design, or masking any potential failure mode or behaviour).

Changes that affect the validity of the verification document: if changes need to be introduced to the test specimen or to the test and measurement equipment after the verification is documented (and before the test is undertaken), then the verification document must be updated. The updated verification document must be made available to EASA before the test if EASA has informed the applicant that it will witness or carry out the tests or inspections.

Development versus certification tests: sometimes, tests of specimens that conform to a preliminary design, but are not intended for certification (known as development tests), are performed as part of a risk control strategy and to develop knowledge of a subject. Problems and failures found during development are part of the process of increasing the understanding of the design, including its failure modes and the potential for optimisation. Such development tests do not need to meet the requirements of point 21L.A.85(c).

Any planned test event should be classified in advance as either a development test or a certification test. Tests that support the compliance demonstration should be classified as certification tests.

It is acceptable for a development test to finally form part of the compliance demonstration, and it may be declared afterwards to be a certification test as long as it meets the requirements of point 21L.A.85(c). For this reason, it is important to keep the configuration of such tests under control.

If the test specimen used for a certification test has already undergone a series of previous tests that may affect or ultimately invalidate its acceptance as required by point 21L.A.85(c), this aspect should be considered when documenting the verification, and specific analyses or inspections may be required.

Because of the above aspects, EASA advises applicants to inform EASA if they intend to conduct a campaign of development tests that may eventually be used as certification tests to establish whether EASA would wish to witness the tests.

GM1 21L.A.85(d) Demonstration of compliance

ED Decision 2023/013/R

FLIGHT TESTING

Detailed material on flight testing for compliance demonstration is included in the applicable CSs and GM. Information on flight testing for compliance demonstration with the applicable environmental protection requirements, especially in terms of aircraft noise, may be found in Volumes I, II and III of Annex 16 to the Chicago Convention and in ICAO Doc 9501 ‘Environmental Technical Manual’.

AMC1 21L.A.85(e)(1) Demonstration of compliance

ED Decision 2023/013/R

REVIEW OF DATA AND INFORMATION RELATED TO THE DEMONSTRATION OF COMPLIANCE

Availability of compliance data (see point 21L.A.85(e): data and information required to be provided by the applicant should be made available to EASA in a reliable and efficient way as agreed with EASA.

AMC1 21L.A.85(e)(2) Demonstration of compliance

ED Decision 2023/013/R

TESTS AND INSPECTIONS

The applicant should inform EASA sufficiently in advance about the execution of tests and inspections that:

—      are used for compliance demonstration purposes; and

—      have been identified as being of particular interest to EASA during the review and approval of the compliance demonstration plan

in order to permit EASA the opportunity to witness or carry out these inspections or tests.

The applicant may propose to EASA to witness or carry out flight or other tests of particular aspects of the product during its development and before the type design is fully defined.

However, in case of flight tests, the applicant should perform the tests before EASA witnesses or performs them to ensure that no features of the product preclude the safe conduct of the evaluation requested. EASA may require any such tests to be repeated once the type design is fully defined to ensure that subsequent changes have not adversely affected the conclusions from any earlier evaluation.

A verification document as per point 21L.A.85(c) is required for the above tests.

AMC1 21L.A.85(e)(3) Demonstration of compliance

ED Decision 2023/013/R

PHYSICAL INSPECTION OF THE FIRST ARTICLE

The applicant should be prepared for any additional investigations as notified by EASA according to point 21L.B.102(c).

Refer to AMC1 21L.A.25(e)(3) for the description of the compliance activities of the first-article inspection.

GM1 21L.A.85(f) Demonstration of compliance

ED Decision 2023/013/R

DECLARATION OF COMPLIANCE

All compliance-demonstration activities conducted in accordance with the compliance-demonstration plan, including all the testing and inspections conducted in accordance with point 21L.A.85(c) and all flight testing conducted in accordance with point 21L.A.85(d) and those necessary to determine compliance with the applicable environmental protection requirements should be completed before the issuance of the final declaration of compliance.

‘No feature or characteristic’ that may make the product unsafe in point 21L.A.85(f)(2) means the following: while every effort is made to address in the applicable certification basis all the risks to product safety that may be caused by the product, experience shows that safety‑related events may occur with products in service, even though compliance with the certification basis is fully demonstrated. One of the reasons may be that some existing risks are not properly addressed in the certification basis. Therefore, the applicant should declare that it has not identified any such feature or characteristic.

‘No feature or characteristic’ that may make the changed product environmentally incompatible (point 21L.A.85(f)(2)):

It is assumed that environmental compatibility is demonstrated when the changed product complies with the applicable environmental protection requirements. Therefore, the applicant, when declaring that the changed product complies with the applicable environmental protection requirements under point 21L.A.85(f)(1), should also declare that they have not identified any such feature or characteristic.

21L.A.86 Requirements for approval of a supplemental type certificate

Regulation (EU) 2022/1358

(a) In order to be issued with a supplemental type certificate, the applicant shall:

1. demonstrate their design capability in accordance with point 21L.A.83;

2. demonstrate that the change to a type certificate and the areas affected by the change comply with the type-certification basis and the applicable environmental protection requirements, as established by the Agency in accordance with point 21L.B.101;

3. demonstrate compliance in accordance with point 21L.A.85;

4. if the applicant has specified that they provided certification data on the basis ofan arrangement with the owner of the type-certification data in accordance with point 21L.A.84(b), demonstrate that the type-certificate holder:

(i) has no technical objection to the information submitted under point 21L.A.65; and

(ii) has agreed to collaborate with the applicant to ensure the discharge of all the obligations for continued airworthiness of the changed product through compliance with points 21L.A.28 and 21L.A.88;

5. demonstrate that there are no unresolved issues from the physical inspection of the first article of that product in the final changed configuration carried out by the Agency in accordance with point 21L.A.85(e)(3).

(b) A supplemental type certificate shall be limited to the specific configuration(s) in the type certificate to which the related major change relates.

AMC1 21L.A.86 Requirements for approval of a supplemental type certificate

ED Decision 2023/013/R

(a) For supplemental type certificates (STCs) approved by EASA, the AMC and GM to point 21L.A.25 should be followed by the applicant.

(b) In accordance with point 21L.A.86(b), the compliance-demonstration process must always cover the specific configuration(s) in the type certificate (TC) to which the STC under approval is applied. This (these) configuration(s) should be defined by the change to the type certificate considering the type certificate data sheet (TCDS) and the relevant optional installations. The demonstration of compliance covers this (these) applicable specific configuration(s). Consequently, the approval of the STC excludes any other configurations, in particular those that already exist, but are not considered in the compliance-demonstration process, as well as those that may be certified in the future.

(c) For STCs approved by the design organisation approval (DOA) holder under its privilege as per point 21.A.263(c)(9) of Annex I (Part 21), the process described under AMC No 2 to 21.A.263(c)(5), (8) and (9) applies.

AMC1 21L.A.86(a)(5) Requirements for approval of a supplemental type certificate

ED Decision 2023/013/R

For the demonstration by the applicant that there are no unresolved issues, see AMC1 21L.A.27(d).

21L.A.87 Approval of a supplemental type certificate under a privilege

Regulation (EU) 2022/1358

(a) The approval of a supplemental type certificate for a major change it has designed may be issued by an approved design organisation without an application according to point 21L.A.84 in accordance with the scope of its privileges provided for in point (9) of point 21.A.263(c) of Annex I (Part 21) instead of the Agency, as recorded in the terms of approval.

(b) When issuing a supplemental type certificate in accordance with point (a), the design organisation shall:

1. ensure that all the substantiation data and justifications are available;

2. ensure that the compliance of the change with the type-certification basis and the applicable environmental protection requirements has been demonstrated and declared;

3. confirm that it has not found:

(i) any non-compliances with the type-certification basis or, where applicable, with the applicable environmental protection requirements, or with the certification specifications chosen;

(ii) any feature or characteristic of the change that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested;

4. limit the approval of the supplemental type certificate to the specific configuration(s) in the type certificate to which the change relates.

21L.A.88 Obligations of a holder of a supplemental type certificate

Regulation (EU) 2022/1358

Each holder of a supplemental type certificate shall undertake the obligations of a supplemental type‑certificate holder set forth in Subpart A of this Annex and shall continue to comply with the eligibility requirement under point 21L.A.82.

21L.A.89 Transferability of a supplemental type certificate

Regulation (EU) 2022/1358

A supplemental type certificate may be transferred to a new holder, provided that the Agency has verified that the natural or legal person to whom the certificate is intended to be transferred is eligible in accordance with point 21L.A.83 to hold a supplemental type certificate and is able to undertake the obligations of a supplemental type-certificate holder under point 21L.A.88.

21L.A.90 Continued validity of a supplemental type certificate

Regulation (EU) 2022/1358

(a) A supplemental type certificate shall remain valid as long as:

1. the supplemental type certificate is not surrendered by the holder;

2. the holder of the supplemental type certificate remains in compliance with the relevant requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, taking into account the provisions related to the handling of findings as specified under point 21L.B.21;

3. the supplemental type certificate is not revoked by the Agency in accordance with point 21L.B.22.

(b) Upon surrender or revocation, the type certificate shall be returned to the Agency.

21L.A.91 Changes to a part of a product covered by a supplemental type certificate

Regulation (EU) 2022/1358

(a) A minor change to a part of a product covered by a supplemental type certificate shall be approved in accordance with Subpart D of this Annex.

(b) A major change to that part of a product covered by a supplemental type certificate shall be approved as a separate supplemental type certificate in accordance with this Subpart.

(c) By way of derogation from point (b), a major change to that part of a product covered by a supplemental type certificate submitted by the supplemental type-certificate holder may be approved as a change to the existing supplemental type certificate in accordance with points 21L.A.63 to 21L.A.69.