for Section A, Subpart A,

for Section A, Subparts B, D, E, J, K, M, O and Q, the Agency;

for Section A, Subparts F and G:

for Section A, Subpart H and I, the authority designated by the Member State where the aircraft is registered or will be registered:

for Section A, Subpart P:

Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council ( 3 ) and its delegated and implementing acts, all natural or legal persons that have applied for or hold a type-certificate, restricted type-certificate, supplemental type-certificate, European Technical Standard Order (ETSO) authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation shall:

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:

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, when reporting in accordance with points (a)(3), (b)(2), (b)(3) and (b)(4), shall appropriately protect the confidentiality of the person who reports and of the person(s) mentioned in the report.

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 shall make the reports referred to in points (a)(3) and (b)(3) in a form and manner established by the Agency or the competent authority, respectively, and dispatch them as soon as practicable and in any case not later than 72 hours after the natural or legal person has identified that the occurrence may lead to a possible unsafe condition, unless exceptional circumstances prevent this.

Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, if an occurrence reported under point (a)(3) or under point (b)(3) results from a deficiency in the design or a production deficiency, the holder of the type-certificate, restricted type-certificate, supplemental type-certificate, major repair design approval, ETSO authorisation or any other relevant approval deemed to have been issued under this Regulation, or the production organisation as appropriate, shall investigate the reason for the deficiency and report to the competent authority of the Member State responsible in accordance with point 21.1 and to the Agency the results of its investigation and any action it intends to take or proposes to be taken to correct that deficiency.

If the competent authority finds that action is required to correct the deficiency, the holder of the type-certificate, restricted type-certificate, supplemental type-certificate, major repair design approval, ETSO authorisation or any other relevant approval deemed to have been issued under this Regulation, or the production organisation as appropriate, shall submit the relevant data to the competent authority upon its request.

an unsafe condition has been determined by the Agency to exist in an aircraft, as a result of a deficiency in the aircraft, or an engine, propeller, part or appliance installed on this aircraft; and

that condition is likely to exist or develop in other aircraft.

propose the appropriate corrective action or required inspections, or both, and submit details of these proposals to the Agency for approval;

following the approval by the Agency of the proposals referred to under point (1), make available to all known operators or owners of the product, part or appliance and, on request, to any person required to comply with the airworthiness directive, appropriate descriptive data and accomplishment instructions.

an identification of the unsafe condition;

an identification of the affected aircraft;

the action(s) required;

the compliance time for the required action(s);

the date of entry into force.

the satisfactory coordination of design and production required by 21A.122, 21A.130(b)(3) and (4), 21A.133 and 21A.165(c)(2) and (3) as appropriate, and

the proper support of the continued airworthiness of the product, part or appliance.

when they design a product, part or appliance or changes or repairs thereto, establish a record-keeping system and maintain the relevant design information/data; that information/data shall be made available to the Agency in order to provide the information/data that is necessary to ensure the continued airworthiness of the product, part or appliance, the continued validity of the operational suitability data, and compliance with the applicable environmental protection requirements;

when they produce a product, part or appliance, record the details of the production process relevant to the conformity of the product, part or appliances with the applicable design data, and the requirements imposed on their partners and suppliers, and make that data available to their competent authority in order to provide the information that is necessary to ensure the continuing airworthiness of the product, part or appliance;

with regard to permits to fly:

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.239(c), 21.A.245(a) or 21.A.245(e)(1), of the personnel that are involved in the following functions:

retain records of the authorisation of personnel, when they employ personnel that:

The holder of a type-certificate, restricted type-certificate, supplemental type-certificate, design change or repair design approval shall develop or reference the instructions which are necessary for ensuring that the airworthiness standard related to the aircraft type and any associated part is maintained throughout the operational life of the aircraft, when demonstrating compliance with the applicable type-certification basis established and notified by the Agency in accordance with point 21.B.80.

At least one set of complete instructions for continued airworthiness shall be provided by the holder of:

Thereafter, those design approval holders shall make those instructions available on request to any other person required to comply with those instructions.

By way of derogation from point (b), the type-certificate holder or restricted type-certificate holder may delay the availability of a part of the instructions for continued airworthiness, dealing with long lead accomplishment instructions of a scheduled nature, until after the product or modified product has entered into service, but shall make those instructions available before the use of this data is required for the product or modified product.

The design approval holder, who is required to provide instructions for continued airworthiness in accordance with point (b), shall also make available changes to those instructions to all known operators of the product affected by the change and, on request, to any other person required to comply with those changes. That design approval holder shall demonstrate to the Agency, on request, the adequacy of the process of making changes to the instructions for continued airworthiness available in accordance with this point.

grant the competent authority access to any facility, product, part and appliance, document, record, data, process, procedure or to any other material in order to review any report, make any inspection, or perform or witness any flight and ground test, as necessary, in order to verify the initial and continued compliance of the organisation with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts.;

make arrangements to ensure the competent authority has access, as provided for in point (a), also in respect of the natural or legal person’s partners, suppliers and subcontractors.

an ELA2 aircraft;

an engine or propeller installed in ELA2 aircraft;

a piston engine;

a fixed or adjustable pitch propeller.

an ELA1 aircraft; or

an engine or propeller installed in ELA1 aircraft.

a detailed description of the type design, including all the configurations to be certified;

the proposed operating characteristics and limitations;

the intended use of the product and the kind of operations for which certification is requested;

a proposal for the initial type-certification basis, operational suitability data certification basis and environmental protection requirements, prepared in accordance with the requirements and options specified in points 21.B.80, 21.B.82 and 21.B.85;

a proposal for a breakdown of the certification programme into meaningful groups of compliance demonstration activities and data, including a proposal for the means of compliance and related compliance documents;

a proposal for the assessment of the meaningful groups of compliance demonstration activities and data, addressing the likelihood of an unidentified non-compliance with the type-certification basis, operational suitability data certification basis or environmental protection requirements and the potential impact of that non-compliance on product safety or environmental protection. The proposed assessment shall take into account at least the elements set out in subpoints (1) to (4) of point 21.B.100(a). Based on this assessment, the application shall include a proposal for the Agency's involvement in the verification of the compliance demonstration activities and data; and

a project schedule including major milestones.

submit a new application and comply with the type-certification basis, operational suitability data certification basis and environmental protection requirements, as established and notified by the Agency in accordance with points 21.B.80, 21.B.82 and 21.B.85 for the date of the new application; or

apply for an extension of the time period provided for in point (e) and propose a new date for the issuance of the type-certificate or restricted type-certificate. In that case, the applicant shall comply with the type-certification basis, operational suitability data certification basis and environmental protection requirements, as established and notified by the Agency in accordance with points 21.B.80, 21.B.82 and 21.B.85 for a date to be selected by the applicant. However, that date shall not precede the new date proposed by the applicant for the issuance of the type-certificate or restricted type-certificate by more than five years for an application for a type-certificate or restricted type-certificate for a large aeroplane or a large rotorcraft, and by more than three years for an application for any other type-certificate or restricted type certificate.

Following the acceptance of the certification programme by the Agency, the applicant shall demonstrate compliance with the type certification basis, operational suitability data certification basis and environmental protection requirements, as established and notified to the applicant by the Agency in accordance with points 21.B.80, 21.B.82, 21.B.85, and shall provide the Agency with the means by which such compliance has been demonstrated.

The applicant shall report to the Agency any difficulty or event encountered during the process of demonstration of compliance that may have an appreciable effect on the risk assessment under point 21.A.15(b)(6) or on the certification programme, or may otherwise necessitate a change to the level of involvement of the Agency previously notified to the applicant in accordance with point 21.B.100(c).

The applicant shall record justifications of compliance within the compliance documents as referred to in the certification programme.

After completion of all demonstrations of compliance in accordance with the certification programme, including any inspections and tests in accordance with point 21.A.33, and after all flight tests in accordance with point 21.A.35, the applicant shall declare that:

The applicant shall submit to the Agency the declaration of compliance provided for in point (d). Where the applicant holds an appropriate design organisation approval, the declaration of compliance shall be made in accordance with Subpart J and submitted to the Agency.

In order to be issued a product type certificate or, when the aircraft does not meet the essential requirements of Annex II to Regulation (EU) 2018/1139 an aircraft restricted type certificate, the applicant shall:

By derogation from point (a)(2), at the applicant's request included in the declaration referred to in point 21.A.20(d), the applicant is entitled to have the aircraft type-certificate or restricted type-certificate issued before the applicant has demonstrated compliance with the operational suitability data certification basis, provided that the applicant demonstrates such compliance before the date at which those data are to be actually used.

the drawings and specifications, and a listing of those drawings and specifications, necessary to define the configuration and the design features of the product shown to comply with the applicable type-certification basis and environmental protection requirements;

information on materials and processes and on methods of manufacture and assembly of the product necessary to ensure the conformity of the product;

an approved airworthiness limitations section of the instructions for continued airworthiness as defined by the applicable certification specifications; and

any other data allowing by comparison the determination of the airworthiness and, if relevant, the environmental characteristics of later products of the same type.

(Reserved)

Before each test is undertaken during the demonstration of compliance required by point 21.A.20, the applicant shall have verified:

On the basis of the verifications carried out in accordance with point (b), the applicant shall issue a statement of conformity listing any potential non-conformity, together with a justification that this will not affect the test results, and shall allow the Agency to make an inspection it considers necessary to check the validity of that statement.

The applicant shall allow the Agency to:

For all the tests and inspections witnessed or carried out by the Agency in accordance with point (d)(2):

to determine compliance with the applicable type-certification basis and environmental protection requirements; and

to determine whether there is reasonable assurance that the aircraft, its parts and appliances are reliable and function properly for aircraft to be certificated under this Annex I (Part 21), except for,

for aircraft incorporating turbine engines of a type not previously used in a type-certificated aircraft, at least 300 hours of operation with a full complement of engines that conform to a type-certificate; and

for all other aircraft, at least 150 hours of operation.

undertake the obligations laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.9, 21.A.62 and 21.A.65, and, for this purpose, shall continue to meet the qualification requirements for eligibility under point 21.A.13;

specify the marking in accordance with Subpart Q.

the holder remaining in compliance with this Annex 1 (Part 21); and

the certificate not being surrendered or revoked under the applicable administrative procedures established by the Agency.

at least one set of complete operational suitability data prepared in accordance with the applicable operational suitability certification basis, to all known EU operators of the aircraft, before the operational suitability data must be used by a training organisation or an EU operator; and

any change to the operational suitability data to all known EU operators of the aircraft; and

on request, the relevant data referred to in points (a) and (b) above, to:

in relation to:

that follow design data included in the certification specifications issued by the Agency, containing acceptable methods, techniques and practices for carrying out and identifying standard changes, including the associated instructions for continued airworthiness; and

that are not in conflict with TC holders data.

Stand-alone changes to the instructions for continued airworthiness are changes that are not directly prepared as a result of a change to the type design or repair design.

Stand-alone changes to the instructions for continued airworthiness can only be made by the holder of the design approval for which those instructions have been established.

Points 21.A.91 to 21.A.109 shall not apply to stand-alone changes to the instructions for continued airworthiness that:

Stand-alone changes to the instructions for continued airworthiness referred to in point (c) shall be approved by the design approval holder under procedures agreed with the Agency.

Only the type-certificate holder may apply for approval of a major change to a type-certificate under this Subpart; all other applicants for a major change to a type-certificate shall apply under Subpart E.

Any natural or legal person may apply for approval of a minor change to a type-certificate under this Subpart.

An application for approval of a change to a type-certificate shall be made in a form and manner established by the Agency.

An application shall include, or be supplemented after the initial application by, a certification programme for the demonstration of compliance in accordance with point 21.A.20, consisting of:

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An application for a change to a type-certificate of a large aeroplane or a large rotorcraft shall be valid for five years and an application for a change to any other type-certificate shall be valid for three years. In the case where the change has not been approved, or it is evident that it will not be approved, within the time limit provided for in this point, the applicant may:

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Minor changes to a type-certificate shall be classified and approved by:

A minor change to a type-certificate shall only be approved:

By derogation from point (1) in point (b), certification specifications which became applicable after those incorporated by reference in the type-certificate can be used for approval of a minor change, provided they do not affect the demonstration of compliance.

By derogation from point (a), at the applicant's request included in the declaration referred to in point 21.A.20(d), a minor change to an aircraft type-certificate may be approved 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 actually used.

The applicant shall submit to the Agency the substantiation data for the change and a statement that compliance has been demonstrated in accordance with point (b).

An approval of a minor change to a type-certificate shall be limited to the specific configuration(s) in the type-certificate to which the change relates.

Major changes to a type-certificate shall be classified and approved by:

A major change to a type-certificate shall only be approved:

By derogation from points (2) and (3) of point (b), at the applicant's request included in the declaration referred to in point 21.A.20(d), a major change to an aircraft type-certificate may be approved 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 actually used.

An approval of a major change to a type-certificate shall be limited to the specific configuration(s) in the type-certificate to which the change relates.

A major change to a type-certificate and areas affected by the change shall comply with either the certification specifications applicable to the changed product on the date of the application for the change or certification specifications which 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 in accordance with point 21.B.85.

Except as provided in point (h), by derogation from point (a), an earlier amendment to a certification specification referred to in point (a) and to any other certification specification which is directly related may be used in any of the 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:

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By 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 weight, or to a non-turbine rotorcraft of 1 361  kg (3 000 lb) or less maximum weight, the change and areas affected by the change shall comply with the type-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 amendment to a certification specification of the type-certification basis incorporated by reference in the type-certificate and with any other certification specification which 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.

If the Agency finds that the certification specifications applicable on the date of the application for 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 change.

By 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:

If an applicant chooses to comply with a certification specification set out in an amendment that becomes applicable after submitting the application for 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.

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).

For large aeroplanes subject to point 26.300 of Annex I to Commission Regulation (EU) 2015/640 ( 4 ), the applicant shall comply 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, except for applicants for supplemental type-certificates who are not required to take into account point 26.303.

at least one set of changes to the operational suitability data prepared in accordance with the applicable operational suitability certification basis, to all known EU operators of the changed aircraft, before the operational suitability data must be used by a training organisation or an EU operator; and

any further change to the affected operational suitability data, to all known EU operators of the changed aircraft; and

on request, the relevant parts of the changes in points (a) and (b) above, to:

undertake the obligations laid down in points 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.9 and 21.A.108;

specify the marking, including EPA (European Part Approval) letters, in accordance with point 21.A.804(a).

include in the application the information required by point 21.A.93(b);

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.

Supplemental type certificates shall be issued by:

A supplemental type-certificate shall only be issued when:

By derogation from points (3) and (4) of point (b), at the applicant's request included in the declaration referred to in point 21.A.20(d), the applicant is entitled to have a supplemental type-certificate for an aircraft issued before the applicant has demonstrated compliance with the operational suitability data certification basis, provided that the applicant demonstrates such compliance before the date at which those data are to be actually used.

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

undertake the obligations:

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and for this purpose continue to meet the criteria of point 21.A.112B;

specify the marking, including EPA letters, in accordance with point 21.A.804(a).

the holder remaining in compliance with this Annex I (Part 21); and

the certificate not being surrendered or revoked under the applicable administrative procedures established by the Agency.

at least one set of changes to the operational suitability data prepared in accordance with the applicable operational suitability certification basis, to all known EU operators of the changed aircraft, before the operational suitability data must be used by a training organisation or an EU operator; and

any further change to the affected operational suitability data, to all known EU operators of the changed aircraft; and

on request, the relevant parts of the changes in points (a) and (b) above, to:

it holds or has applied for an approval covering the design of that product, part or appliance; or

it has ensured satisfactory coordination between production and design, through an appropriate arrangement with the applicant for, or holder of, an approval of such a design.

evidence which demonstrates, where applicable, that:

an outline of the information required in point 21.A.125A(b).

An organisation may use any alternative means of compliance to establish compliance with this Regulation.

If an organisation wishes to use an alternative means of compliance, it shall, prior to using it, provide the competent authority with a full description. The description shall include any revisions to manuals or procedures that may be relevant, as well as an explanation indicating how compliance with this Regulation is achieved.

The organisation may use those alternative means of compliance subject to prior approval from the competent authority.

having established a production inspection system that ensures that each product, part or appliance conforms to the applicable design data and is in condition for safe operation;

having provided a manual that contains:

demonstrating that it is able to provide assistance in accordance with points 21.A.3A and 21.A.129(d).

After receipt of the notification of findings in accordance with point 21.B.125, the holder of a letter of agreement shall:

The actions referred to in point (a) shall be performed within the period agreed with that competent authority in accordance with point 21.B.125.

The observations received in accordance with point 21.B.125(e) shall be given due consideration by the holder of the letter of agreement. The organisation shall record the decisions taken in respect of those observations.

The letter of agreement shall be issued for a limited period of time that in any case shall not exceed 1 year. It shall remain valid subject to the organisation’s compliance with all the following conditions:

Upon surrender, revocation or expiry, the letter of agreement shall be returned to the competent authority.

incoming materials, and bought or subcontracted parts, used in the finished product are as specified in the applicable design data;

incoming materials, and bought or subcontracted parts, are properly identified;

processes, manufacturing techniques and methods of assembly affecting the quality and safety of the finished product are accomplished in accordance with specifications accepted by the competent authority;

design changes, including material substitutions, have been approved under Subpart D or E and controlled before being incorporated in the finished product.

parts in process are inspected for conformity with the applicable design data at points in production where accurate determinations can be made;

materials subject to damage and deterioration are suitably stored and adequately protected;

current design drawings are readily available to manufacturing and inspection personnel, and used when necessary;

rejected materials and parts are segregated and identified in a manner that precludes installation in the finished product;

materials and parts that are withheld because of deviations from type design or production specifications, and that are to be considered for installation in the finished product, are subjected to an approved engineering and manufacturing review procedure. Those materials and parts that have been found in that procedure to be serviceable shall be properly identified and reinspected if it is necessary to be reworked or repaired. Materials and parts rejected in that procedure shall be marked and disposed of to ensure that they are not incorporated in the final product;

a check on handling qualities;

a check on flight performance (using normal aircraft instrumentation);

a check on the proper functioning of all aircraft equipment and systems;

a determination that all instruments are properly marked, and that all placards and required flight manuals are installed after flight test;

a check of the operational characteristics of the aircraft on the ground;

a check on any other items peculiar to the aircraft being tested.

make each product, part or appliance available for inspection by the competent authority;

maintain at the place of manufacture the technical data and drawings necessary to determine whether the product conforms to the applicable design data;

maintain the production inspection system that ensures that each product conforms to the applicable design data and is in condition for safe operation;

provide assistance to the holder of the type-certificate, restricted type-certificate or design approval in dealing with any continuing airworthiness actions that are related to the products, parts or appliances that have been produced;

comply with Subpart A of this Section.

for each product, part or appliance, a statement that the product, part or appliance conforms to the approved design data and is in condition for safe operation;

for each aircraft, a statement that the aircraft has been ground- and flight-checked in accordance with point 21.A.127(a);

for each engine, or variable pitch propeller, a statement that the engine or variable pitch propeller has been subjected by the manufacturer to a final functional test in accordance with point 21.A.128;

additionally, in the case of environmental protection requirements:

upon the initial transfer by it of the ownership of such a product, part or appliance; or

upon application for the original issue of an aircraft certificate of airworthiness; or

upon application for the original issue of an airworthiness release document for an engine, a propeller, a part or appliance,

the procedure for the issuance of a production organisation approval for a production organisation showing conformity of products, parts and appliances with the applicable design data;

the rules governing the rights and obligations of the applicant for, and holders of, such approvals.

justify that, for a defined scope of work, an approval under this Subpart is appropriate for the purpose of showing conformity with a specific design; and

hold or have applied for an approval of that specific design; or

have ensured, through an appropriate arrangement with the applicant for, or holder of, an approval of that specific design, satisfactory coordination between production and design.

An organisation may use any alternative means of compliance to establish compliance with this Regulation.

If an organisation wishes to use an alternative means of compliance, it shall, prior to using it, provide the competent authority with a full description. The description shall include any revisions to manuals or procedures that may be relevant, as well as an explanation indicating how compliance with this Regulation is achieved.

The organisation may use those alternative means of compliance subject to prior approval from the competent authority.

The production organisation shall establish, implement and maintain a production management system that includes a safety management element and a quality management element, with clearly defined accountability and lines of responsibility throughout the organisation.

The production management system shall:

As part of the safety management element of the production management system, the production organisation shall:

As part of the quality management element of the production management system, the production organisation shall:

The production organisation shall establish, as part of the production management system, an independent monitoring function to verify compliance of the organisation with the relevant requirements of this Annex as well as compliance with and adequacy of the production management system. Monitoring shall include feedback to the person or group of persons referred to in point 21.A.145(c)(2) and to the manager referred to in point 21.A.145(c)(1) to ensure, where necessary, the implementation of corrective action.

If the production organisation holds one or more additional organisation certificates within the scope of Regulation (EU) 2018/1139, the production management system may be integrated with that required under the additional certificate(s) held.

a statement signed by the accountable manager confirming that the production organisation exposition and any associated manuals which define the approved organisation’s compliance with this Subpart will be complied with at all times;

the title(s) and names of managers accepted by the competent authority in accordance with point 21.A.145(c)(2);

the duties and responsibilities of the manager(s) as required by point 21.A.145(c)(2) including matters on which they may deal directly with the competent authority on behalf of the organisation;

an organisational chart showing associated chains of responsibility of the managers as required by point 21.A.145(c)(1) and (2);

a list of certifying staff as referred to in point 21.A.145(d);

a general description of man-power resources;

a general description of the facilities located at each address specified in the production organisation’s certificate of approval;

a general description of the production organisation’s scope of work relevant to the terms of approval;

the procedure for the notification of organisational changes to the competent authority;

the amendment procedure for the production organisation exposition;

a description of the production management system, the policy, processes and procedures as provided for in point 21.A.139(c);

a list of the outside parties referred to in point 21.A.139(d)(1);

if flight tests are to be conducted, a flight test operations manual defining the organisation's policies and procedures in relation to flight test. The flight test operations manual shall include:

the facilities, working conditions, equipment and tools, processes and associated materials, number and competence of staff, and the general organisation are adequate to discharge its obligations under point 21.A.165;

with regard to all the necessary airworthiness and environmental protection data:

with regard to management and staff:

with regard to certifying staff authorised by the production organisation to sign the documents issued under point 21.A.163 within the scope of the terms of approval:

After receipt of the notification of findings in accordance with point 21.B.225, the holder of the production organisation approval certificate shall:

The actions referred to in point (a) shall be performed within the period agreed with that competent authority in accordance with point 21.B.225.

The observations received in accordance with 21.B.225(e) shall be given due consideration by the holder of the production organisation approval certificate. The organisation shall record the decisions taken in respect of those observations.

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:

Upon surrender or revocation, the production organisation approval certificate shall be returned to the competent authority.

perform production activities under this Annex I (Part 21);

in the case of complete aircraft and upon presentation of a statement of conformity (EASA Form 52) under point 21.A.174, obtain an aircraft certificate of airworthiness and a noise certificate without further showing;

in the case of other products, parts or appliances, issue authorised release certificates (EASA Form 1) without further showing;

maintain a new aircraft that it has produced and issue a certificate of release to service (EASA Form 53) in respect of that maintenance;

under procedures agreed with its competent authority for production, for an aircraft it has produced and when the production organisation itself is controlling under its POA the configuration of the aircraft and is attesting conformity with the design conditions approved for the flight, to issue a permit to fly in accordance with point 21.A.711(c) including approval of the flight conditions in accordance with point 21.A.710(b).

ensure that the production organisation exposition furnished in accordance with point 21.A.143 and the documents to which it refers, are used as basic working documents within the organisation;

maintain the production organisation in conformity with the data and procedures approved for the production organisation approval;

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provide assistance to the holder of the type-certificate or other design approval in dealing with any continuing airworthiness actions that are related to the products, parts or appliances that have been produced;

where, under its terms of approval, the holder of a production organisation approval intends to issue a certificate of release to service, determine, prior to issuing the certificate, that each completed aircraft has been subjected to necessary maintenance and is in condition for safe operation;

where applicable, under the privilege set out in point 21.A.163(e), determine the conditions under which a permit to fly can be issued;

where applicable, under the privilege set out in point 21.A.163(e), establish compliance with points 21.A.711(c) and (e) before issuing an aircraft with a permit to fly;

comply with Subpart A of this Section.

certificates of airworthiness shall be issued to aircraft which conform to a type-certificate that has been issued in accordance with this Annex I (Part 21);

restricted certificates of airworthiness shall be issued to aircraft:

the class of airworthiness certificate applied for;

with regard to new aircraft:

with regard to used aircraft originating from:

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if it remains on the same register, the certificate of airworthiness, or the restricted certificate of airworthiness conforming to a restricted type-certificate only, shall be transferred together with the aircraft;

if the aircraft is registered in another Member State, the certificate of airworthiness, or the restricted certificate of airworthiness conforming to a restricted type-certificate only, shall be issued:

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the aircraft continues to comply with the applicable type design and continued airworthiness requirements; and

the aircraft remaining on the same register; and

the type-certificate or restricted type-certificate under which it is issued not being previously invalidated under point 21.A.51;

the certificate has not been revoked by the competent authority under point 21.B.65, or surrendered by the certificate holder.

with regard to new aircraft:

with regard to used aircraft:

if the aircraft remains on the same register, the noise certificate shall be transferred together with the aircraft; or

if the aircraft moves to the register of another Member State, the noise certificate shall be issued upon presentation of the former noise certificate.

the aircraft continues to comply with the applicable type design and continued airworthiness requirements; and

the aircraft remaining on the same register; and

the type-certificate or restricted type-certificate under which it is issued not being previously invalidated under point 21.A.51;

the certificate has not been revoked by the competent authority under point 21.B.65, or surrendered by the certificate holder.

in accordance with points 21.A.14, 21.A.112B, 21.A.432B or 21.A.602B; or

for approval of minor changes or minor repair design, when requested for the purpose of obtaining privileges under point 21.A.263.

The design organisation shall establish, implement and maintain a design management system that includes a safety management element and a design assurance element with clearly defined accountability and lines of responsibility throughout the organisation.

The design management system shall:

As part of the safety management element of the design management system, the design organisation shall:

As part of the design assurance element of the design management system, the design organisation shall:

The design organisation shall establish, as part of the design management system, an independent monitoring function to verify compliance of the organisation with the relevant requirements of this Annex as well as the compliance with and adequacy of the design management system. Monitoring shall include feedback to the person or the group of persons referred to in point 21.A.245(b) and to the manager referred to in point 21.A.245(a) to ensure, where necessary, the implementation of corrective action.

If the design organisation holds one or more additional organisation certificates within the scope of Regulation (EU) 2018/1139, the design management system may be integrated with that required under the additional certificate(s).

As part of the design management system, the design organisation shall create and furnish to the Agency a handbook that describes, directly or by cross reference, the organisation, its relevant policies, processes and procedures, the type of design work, and the categories of products, parts and appliances for which the design organisation holds a design organisation approval, as identified in the terms of approval issued in accordance with point 21.A.251 and, where relevant, the interfaces with and the control of its partners or subcontractors.

If flight tests are to be conducted, a flight test operations manual that defines the organisation’s policies and procedures in relation to flight tests shall also be created and furnished to the Agency. The flight test operations manual shall include:

Where any parts or appliances or any changes to the products are designed by partner organisations or subcontractors, the handbook shall include a statement of how the design organisation is able to demonstrate, for all parts and appliances, the compliance in accordance with point 21.A.239(d)(2), and shall contain, directly or by cross reference, descriptions of and information on the design activities and the organisation of those partner organisations or subcontractors, as necessary to establish the statement.

The handbook shall be amended as necessary to remain an up-to-date description of the organisation, and copies of the amendments shall be provided to the Agency.

The design organisation shall establish and maintain a statement of the qualifications and experience of the management staff and of other persons in the organisation that are responsible for making decisions that affect airworthiness, operational suitability data and environmental protection matters. It shall submit that statement to the competent authority.

The organisation shall appoint a head of the design organisation with the authority to ensure that, within the organisation, all design activities are performed to the required standards and that the design organisation is continuously in compliance with the requirements of the design management system referred to in point 21.A.239 and the procedures specified in the handbook referred to in point 21.A.243.

The head of the design organisation shall nominate and specify the extent of authority of:

By way of derogation from point 21.A.245(b)(1), the airworthiness function referred to in point 21.A.239(d)(1)(i) may be performed under the direct supervision of the head of the design organisation in either of the following cases:

The person or group of persons nominated pursuant to point (b) shall:

The design organisation shall ensure that:

After the receipt of the notification of findings in accordance with point 21.B.433, the holder of the design organisation approval shall:

The actions referred to in point (a) shall be performed within the period agreed by the Agency in accordance with point 21.B.433.

The observations received in accordance with point 21.B.433(e) shall be given due consideration by the holder of the design organisation approval. The organisation shall record the decisions taken in respect of those observations.

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:

Upon surrender or revocation, the certificate shall be returned to the Agency.

(Reserved)

(Reserved)

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The holder of a design organisation approval shall be entitled, within the scope of its terms of approval issued under point 21.A.251 and under the relevant procedures of the design management system:

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maintain the handbook required under point 21.A.243 in conformity with the design assurance system;

ensure that this handbook or the relevant procedures included by cross-reference are used as a basic working document within the organisation;

determine that the design of the products, or of the changes or repairs thereto, complies with the applicable type-certification basis, operational suitability data certification basis, and the environmental protection requirements, and have no unsafe features;

provide the Agency with statements and associated documentation confirming compliance with point (c), except for approval processes carried out in accordance with point 21.A.263(c);

provide to the Agency data and information related to the actions required under point 21.A.3B;

determine, in accordance with point 21.A.263(c)(6), the flight conditions under which a permit to fly can be issued;

establish, in accordance with point 21.A.263(c)(7), compliance with points (b) and (e) of point 21.A.711 before issuing a permit to fly to an aircraft;

designate data and information issued under the authority of the approved design organisation within the scope of its terms of approval as established by the Agency with the following statement: ‘The technical content of this document is approved under the authority of the DOA ref. EASA. 21J.[XXXX]’;

comply with Subpart A of this Section.

in conjunction with the type-certification procedures of Subpart B, D or E for the product in which it is to be installed; or

where applicable, under the ETSO authorisation procedures of Subpart O; or

in the case of standard parts, in accordance with officially recognised Standards.

A part or appliance is eligible for installation in a type-certified product when it is in a condition for safe operation, marked in accordance with Subpart Q and accompanied by an authorised release certificate (EASA Form 1), certifying that the item was manufactured in conformity with approved design data.

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:

Parts and appliances listed in point (b) are eligible for installation in a type-certified 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.

in relation to:

that follow design data included in certification specifications issued by the Agency, containing acceptable methods, techniques and practices for carrying out and identifying standard repairs, including the associated instructions for continued airworthiness; and

that are not in conflict with TC holders data.

An application for a repair design approval shall be made in a form and manner established by the Agency.

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An application for a major repair design approval shall include, or be supplemented after the initial application by, a certification programme containing:

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A repair design shall only be approved:

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The applicant shall submit to the Agency the declaration referred to in point (a)(2) and, on request by the Agency, all necessary substantiation data.

A repair design shall be classified as either ‘major’ or ‘minor’ in accordance with the criteria set out in point 21.A.91 for a change to the type-certificate.

A repair design shall be classified and approved by:

under Subpart F; or

by an organisation appropriately approved in accordance with Subpart G; or

by an appropriately approved maintenance organisation.

by the Agency; or

by an appropriately approved design organisation under a procedure agreed with the Agency.

undertake the obligations:

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specify the marking, including EPA letters, in accordance with point 21.A.804(a).

undertake the obligations laid down in points 21.A.4, 21.A.5 and 21.A.7;

specify the marking, including EPA letters, in accordance with point 21.A.804(a).

for production, by holding a production organisation approval, issued in accordance with Subpart G, or through compliance with Subpart F procedures; and

for design:

by way of derogation from points 21.A.9, 21.A.603, 21.A.610 and 21.A.621, the following points shall apply: points 21.A.15, 21.A.20, 21.A.21, 21.A.31, 21.A.33, 21.A.44, 21.A.47, 21.B.75 and 21.B.80. However, an ETSO authorisation shall be issued in accordance with point 21.A.606 instead of the type-certificate;

by way of derogation from point 21.A.611, the requirements of Subpart D shall apply to the approval of design changes by the APU ETSO authorisation holder and design changes from other applicants classified as a minor change, and the requirements of Subpart E shall apply to the approval of design changes by other applicants classified as a major change. Where the requirements of Subpart E apply, a separate ETSO authorisation shall be issued instead of a supplemental type certificate; and

the requirements of Subpart M shall apply to the approval of repair designs.

The applicant shall submit to the Agency the following documents:

The applicant shall report to the Agency any difficulty or event encountered during the approval process that may significantly impact the ETSO authorisation.

demonstrate its capability in accordance with point 21.A.602B;

demonstrate that the article complies with the technical conditions of the applicable ETSO or with deviations therefrom approved in accordance with point 21.A.610, if any;

comply with the requirements of this Subpart; and

declare that no feature or characteristic has been identified that may make the article unsafe for the uses for which certification is requested.

information corresponding to point 21.A.31(a) and (b), identifying the article and its design and testing standard;

the rated performance of the article, where appropriate, either directly or by reference to other supplementary documents;

a statement of compliance certifying that the article has met the appropriate ETSO;

reference to relevant test reports;

reference to the appropriate Maintenance, Overhaul and Repair Manuals;

the levels of compliance, where various levels of compliance are allowed by the ETSO;

list of deviations accepted in accordance with point 21.A.610.

manufacture each article in accordance with Subpart G or Subpart F that ensures that each completed article conforms to its design data and is safe for installation;

prepare and maintain, for each model of each article for which an ETSO authorisation has been issued, an updated set of complete technical data and records in accordance with point 21.A.5;

prepare, maintain and update master copies of all manuals required by the applicable airworthiness specifications for the article;

make available to users of the article and to the Agency on request those maintenance, overhaul and repair manuals necessary for the usage and maintenance of the article, and changes to those manuals;

mark each article in accordance with point 21.A.807;

comply with points 21.A.3A, 21.A.3B, 21.A.4 and 21.A.9;

continue to meet the qualification requirements of point 21.A.602B.

An ETSO authorisation shall be issued for an unlimited period of time. It shall remain valid subject to compliance with all the following conditions:

Upon surrender or revocation, the ETSO authorisation shall be returned to the Agency.

development;

showing compliance with regulations or certification specifications;

design organisations or production organisations crew training;

production flight testing of new production aircraft;

flying aircraft under production between production facilities;

flying the aircraft for customer acceptance;

delivering or exporting the aircraft;

flying the aircraft for Authority acceptance;

market survey, including customer’s crew training;

exhibition and air show;

flying the aircraft to a location where maintenance or airworthiness review are to be performed, or to a place of storage;

flying an aircraft at a weight in excess of its maximum certificated takeoff weight for flight beyond the normal range over water, or over land areas where adequate landing facilities or appropriate fuel is not available;

record breaking, air racing or similar competition;

flying aircraft meeting the applicable airworthiness requirements before conformity to the environmental requirements has been found;

for non-commercial flying activity on individual non-complex aircraft or types for which a certificate of airworthiness or restricted certificate of airworthiness is not appropriate;

flying an aircraft for troubleshooting purposes or to check the functioning of one or more systems, parts or appliances after maintenance.

the purpose(s) of the flight(s), in accordance with point 21.A.701;

the ways in which the aircraft does not comply with the applicable airworthiness requirements;

the flight conditions approved in accordance with point 21.A.710.

the configuration(s) for which the permit to fly is requested;

any condition or restriction necessary for safe operation of the aircraft, including:

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the substantiation that the aircraft is capable of safe flight under the conditions or restrictions of point (b);

the method used for the control of the aircraft configuration, in order to remain within the established conditions.

when approval of the flight conditions is related to the safety of the design, to the Agency in a form and manner established by the Agency; or

when approval of the flight conditions is not related to the safety of the design, to the competent authority in a form and manner established by that authority.

the proposed flight conditions;

the documentation supporting these conditions; and

a declaration that the aircraft is capable of safe flight under the conditions or restrictions of point 21.A.708(b).

the Agency; or

an appropriately approved design organisation, under the privilege of point 21.A.263(c)(6).

the organisation continues to comply with the conditions and restrictions associated with the permit to fly as set out in point 21.A.711(e);

the holder or any of its partners, suppliers or subcontractors acknowledge that the competent authority may carry out investigations in accordance with point 21.A.9;

the permit to fly has not been revoked by the competent authority under point 21.B.65, or surrendered by its holder;

the aircraft remains on the same register.

the manufacturer’s name;

the product designation;

the manufacturer’s serial number;

the ‘EXEMPT’ mark in case of an engine, when the competent authority has granted an exemption from the environmental protection requirements;

any other information the Agency finds appropriate.

remove, change, or place the identification information referred to in point 21.A.801(a) on any aircraft, engine, propeller, propeller blade, or propeller hub, or in point 21.A.807(a) on an APU; or

remove an identification plate referred to in point 21.A.801, or point 21.A.807 for an APU, when necessary during maintenance operations.

Each part or appliance which is eligible for installation in a type-certified product shall be marked permanently and legibly with:

By way of derogation from point (a), if the Agency agrees that a part or appliance is too small or that it is otherwise impractical to mark a part or appliance with any of the information required by point (a), the authorised release document accompanying the part or appliance or its container shall include the information that could not be marked on the part or appliance.

the name and address of the manufacturer;

the name, type, part number or model designation of the article;

the serial number or the date of manufacture of the article or both; and

the applicable ETSO number.

The competent authority of the Member State shall notify the Agency in case of any significant problems with the implementation of Regulation (EU) 2018/1139 and its delegated and implementing acts within 30 days from the time the competent authority became aware of the problem.

Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, the competent authority of the Member State shall provide the Agency as soon as possible with any safety-significant information stemming from the occurrence reports stored in the national database pursuant to Article 6(6) of Regulation (EU) No 376/2014.

Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, the competent authority shall implement a system to appropriately collect, analyse and disseminate safety information.

The Agency shall implement a system to appropriately analyse any relevant safety information received and, without undue delay, provide the relevant authority of the Member States and the Commission with any information, including recommendations or corrective actions to be taken, that is necessary for them to react in a timely manner to a safety problem involving products, parts, appliances, persons or organisations that are subject to Regulation (EU) 2018/1139 and its delegated and implementing acts.

Upon receiving the information referred to in points (a) and (b), the competent authority shall take adequate measures to address the safety problem.

The competent authority shall immediately notify measures taken under point (c) to all persons or organisations which need to comply with them under Regulation (EU) 2018/1139 and its delegated and implementing acts. The competent authority of the Member State shall also notify those measures to the Agency and, when combined action is required, to the other Member States concerned.

The competent authority shall establish and maintain a management system, including as a minimum:

The competent authority shall, for each field of activity, including the management system, appoint one or more persons with the overall responsibility for the management of the relevant task(s).

The competent authority shall establish procedures for the participation in a mutual exchange of all necessary information and assistance with any other competent authorities concerned, whether from the same Member State or from other Member States, including on:

A copy of the procedures related to the management system of the competent authority of the Member State and their amendments shall be made available to the Agency for the purpose of standardisation.

The competent authority may allocate tasks related to the initial certification or to the continuing oversight of products and parts, as well as of natural or legal persons subject to Regulation (EU) 2018/1139 and its delegated and implementing acts to qualified entities. When allocating tasks, the competent authority shall ensure that it has:

The competent authority shall ensure that the internal audit process and safety risk management process established pursuant to point 21.B.25(a)(5) cover all the certification and continuing oversight tasks performed by the qualified entity on its behalf.

The competent authority shall have a system in place to identify the changes that affect its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU) 2018/1139 and its delegated and implementing acts. That system shall enable the competent authority to take action necessary to ensure that its management system remains adequate and effective.

The competent authority shall update in a timely manner its management system to reflect any changes to Regulation (EU) 2018/1139 and its delegated and implementing acts so as to ensure its effective implementation.

The competent authority of the Member State shall notify the Agency of any changes affecting its capability to perform its tasks and discharge its responsibilities as provided for in Regulation (EU) 2018/1139 and its delegated and implementing acts.

The competent authority shall establish a record-keeping system that allows the adequate storage, accessibility and reliable traceability of:

The competent authority shall include in the record-keeping:

The competent authority shall maintain a list of all the certificates, approvals, authorisations and letters of agreement it has issued.

All the records referred to in points (a), (b) and (c) shall be kept for a minimum period of 5 years, subject to applicable data protection law.

All the records referred to in points (a), (b) and (c) shall be made available, upon request, to a competent authorities of another Member State or to the Agency.

suspend a certificate, approval, permit to fly, authorisation or letter of agreement when it considers that there are reasonable grounds that such action is necessary to prevent a credible threat to aircraft safety;

suspend, revoke or limit a certificate, approval, permit to fly, authorisation or letter of agreement if such action is required pursuant to points 21.B.125, 21.B.225 or 21.B.433;

suspend or revoke a certificate of airworthiness or a noise certificate upon evidence that some of the conditions specified in points 21.A.181(a) or 21.A.211(a) are not met;

suspend or limit in whole or in part a certificate, approval, permit to fly, authorisation or letter of agreement if unforeseeable circumstances outside the control of the competent authority prevent its inspectors from discharging their oversight responsibilities over the oversight planning cycle.

The Agency shall prescribe special detailed technical specifications, named ‘special conditions, for a product if the related certification specifications do not contain adequate or appropriate safety standards for the product because:

Special conditions contain such safety standards as the Agency finds necessary in order to establish a level of safety equivalent to that of the applicable certification specifications.