1.

The holder of a type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation shall report to the Agency any failure, malfunction, defect or other occurrence of which it is aware related to a product, part, or appliance covered by the type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation, and which has resulted in or may result in an unsafe condition.

2.

These reports shall be made in a form and manner established by the Agency, as soon as practicable and in any case dispatched not later than 72 hours after the identification of the possible unsafe condition, unless exceptional circumstances prevent this.

1.

When an occurrence reported under point (b), or under points 21.A.129(f)(2) or 21.A.165(f)(2) results from a deficiency in the design, or a manufacturing 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 manufacturer as appropriate, shall investigate the reason for the deficiency and report to the Agency the results of its investigation and any action it is taking or proposes to take to correct that deficiency.

2.

If the Agency finds that an 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 manufacturer as appropriate, shall submit the relevant data to the Agency.

1.

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

2.

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

1.

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

2.

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.

1.

an identification of the unsafe condition;

2.

an identification of the affected aircraft;

3.

the action(s) required;

4.

the compliance time for the required action(s);

5.

the date of entry into force.

1.

an ELA2 aircraft;

2.

an engine or propeller installed in ELA2 aircraft;

3.

a piston engine;

4.

a fixed or adjustable pitch propeller.

1.

an ELA1 aircraft;

2.

an engine or propeller installed in an ELA1 aircraft.

1.

the product has novel or unusual design features relative to the design practices on which the applicable airworthiness code is based; or

2.

the intended use of the product is unconventional; or

3.

experience from other similar products in service or products having similar design features, has shown that unsafe conditions may develop.

1.

the applicable airworthiness code established by the Agency that is effective on the date of application for that certificate unless:

2.

any special condition prescribed in accordance with point 21.A.16B(a).

1.

file a new application for a type-certificate and comply with all the provisions of point (a) applicable to an original application; or

2.

file for an extension of the original application and comply with the applicable airworthiness codes that were effective on a date, to be selected by the applicant, not earlier than the date which precedes the date of issue of the type-certificate by the time limit established under point (b) for the original application.

1.

for subsonic jet aeroplanes, in Volume I, Part II, Chapters 2, 3 and 4, as applicable;

2.

for propeller-driven aeroplanes, in Volume I, Part II, Chapters 3, 4, 5, 6 and 10, as applicable;

3.

for helicopters, in Volume I, Part II, Chapters 8 and 11, as applicable; and

4.

for supersonic aeroplanes, in Volume I, Part II, Chapter 12, as applicable.

1.

for prevention of intentional fuel venting, in Volume II, Part II, Chapter 2;

2.

for emissions of turbo-jet and turbofan engines intended for propulsion only at subsonic speeds, in Volume II, Part III, Chapter 2; and

3.

for emissions of turbo-jet and turbofan engines intended for propulsion only at supersonic speeds, in Volume II, Part III, Chapter 3.

1.

the product to be certificated meets the applicable type-certification basis and environmental protection requirements designated in accordance with points 21.A.17 and 21.A.18;

2.

any airworthiness provisions not complied with are compensated for by factors that provide an equivalent level of safety;

3.

no feature or characteristic makes it unsafe for the uses for which certification is requested; and

4.

the type-certificate applicant has expressly stated that it is prepared to comply with point 21.A.44.

1.

complying with the appropriate type-certification basis established by the Agency ensuring adequate safety with regard to the intended use of the aircraft, and with the applicable environmental protection requirements;

2.

expressly stating that it is prepared to comply with point 21.A.44.

1.

have a type-certificate issued or determined in accordance with this Regulation; or

2.

have been shown to be in compliance with the certification specifications necessary to ensure safe flight of the aircraft.

1.

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;

2.

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

3.

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

4.

any other data necessary to allow by comparison, the determination of the airworthiness, the characteristics of noise, fuel venting, and exhaust emissions (where applicable) of later products of the same type.

1.

for the test specimen:

2.

that the test equipment and all measuring equipment used for tests are adequate for the test and are appropriately calibrated.

1.

the applicant shall submit to the Agency a statement of compliance with point (b); and

2.

no change relating to the test that would affect the statement of compliance may be made to a product, part or appliance between the time compliance with point (b) is shown and the time it is presented to the Agency for test.

1.

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

2.

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,

1.

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

2.

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

1.

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

2.

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

1.

in relation to:

2.

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

3.

that are not in conflict with TC holders data.

1.

all parts of the type design and the approved manuals affected by the change; and

2.

the certification specifications and environmental protection requirements with which the change has been designed to comply in accordance with point 21.A.101.

1.

submit to the Agency substantiating data together with any necessary descriptive data for inclusion in the type design;

2.

demonstrate that the changed product complies with applicable certification specifications and environmental protection requirements, as specified in point 21.A.101;

3.

comply with points 21.A.20(b), (c) and (d); and

4.

where the applicant holds an appropriate design organisation approval, make the declaration referred to in point 21.A.20(d) according to the provisions of Subpart J;

5.

comply with point 21.A.33 and, where applicable, point 21.A.35.

1.

A change that the Agency finds not to be significant. In determining whether a specific change is significant, the Agency considers the change in context with all previous relevant design changes and all related revisions to the applicable certification specifications incorporated in the type-certificate for the product. Changes that meet one of the following criteria are automatically considered significant:

2.

Each area, system, part or appliance that the Agency finds is not affected by the change.

3.

Each area, system, part or appliance that is affected by the change, for which the Agency finds that compliance with an airworthiness code described in point (a) would not contribute materially to the level of safety of the changed product or would be impractical.

1.

file a new application for a change to the type-certificate and comply with all the provisions of point (a) applicable to an original application for a change; or

2.

file for an extension of the original application and comply with the provisions of point (a) for an effective date of application, to be selected by the applicant, not earlier than the date which precedes the date of approval of the change by the time period established under this point for the original application for the change.

1.

submitting the declaration referred to in point 21.A.20(d); and

2.

it is demonstrated that:

1.

the changed product meets the applicable certification specifications and environmental protection requirements, as specified in point 21.A.101;

2.

any airworthiness provisions not complied with are compensated for by factors that provide an equivalent level of safety; and

3.

no feature or characteristic makes the product unsafe for the uses for which certification is requested.

1.

the type-certificate holder has advised that it has no technical objection to the information submitted under point 21.A.93; and

2.

the type-certificate holder has agreed to collaborate with the supplemental type-certificate holder to ensure discharge of all obligations for continued airworthiness of the changed product through compliance with points 21.A.44 and 21.A.118A.

1.

laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.105, 21.A.119 and 21.A.120;

2.

implicit in the collaboration with the type-certificate holder under point 21.A.115(c)(2);

1.

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

2.

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

1.

evidence which demonstrates, where applicable, that:

2.

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

1.

a description of the production inspection system required under point (a);

2.

a description of the means for making the determination of the production inspection system;

3.

a description of the tests required in points 21.A.127 and 21.A.128, and the names of persons authorised for the purpose of point 21.A.130(a);

1.

a level one finding is any non-compliance with this Annex I (Part 21) which could lead to uncontrolled non-compliances with applicable design data and which could affect the safety of the aircraft;

2.

a level two finding is any non-compliance with this Annex I (Part 21) which is not classified as level one.

1.

in case of a level one finding, the holder of the letter of agreement shall demonstrate corrective action to the satisfaction of the competent authority within a period of no more than 21 working days after written confirmation of the finding;

2.

in case of level two findings, the corrective action period granted by the competent authority shall be appropriate to the nature of the finding but in any case initially shall not be more than three months. In certain circumstances and subject to the nature of the finding, the competent authority may extend the three months period subject to the provision of a satisfactory corrective action plan agreed by the competent authority;

3.

a level three finding shall not require immediate action by the holder of the letter of agreement.

1.

the holder of the letter of agreement fails to demonstrate compliance with the applicable requirements of this Subpart; or

2.

there is evidence that the manufacturer cannot maintain satisfactory control of the manufacture of products, parts, or appliances under the agreement; or

3.

the manufacturer no longer meets the requirements of point 21.A.122; or

4.

the letter of agreement has been surrendered, revoked under point 21.B.145, or has expired.

1.

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

2.

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

3.

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;

4.

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

1.

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

2.

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

3.

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

4.

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

5.

materials and parts that are withheld because of departures from design data or 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 determined by this procedure to be serviceable shall be properly identified and reinspected if rework or repair is necessary. Materials and parts rejected by this procedure shall be marked and disposed of to ensure that they are not incorporated in the final product;

6.

records produced under the production inspection system are maintained, identified with the completed product or part where practicable, and retained by the manufacturer in order to provide the information necessary to ensure the continued airworthiness of the product.

1.

a check on handling qualities;

2.

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

3.

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

4.

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

5.

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

6.

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

1.

report to the holder of the type-certificate, restricted type-certificate or design approval, all cases where products, parts or appliances have been released by the manufacturer and subsequently identified to have deviations from the applicable design data, and investigate with the holder of the type-certificate, restricted type-certificate or design approval to identify those deviations which could lead to an unsafe condition;

2.

report to the Agency and the competent authority of the Member State the deviations which could lead to an unsafe condition identified according to point (1). Such reports shall be made in a form and manner established by the Agency under point 21.A.3A(b)(2) or accepted by the competent authority of the Member State;

3.

where the manufacturer acts as supplier to another production organisation, report also to that other organisation all cases where it has released products, parts or appliances to that organisation and subsequently identified them to have possible deviations from the applicable design data.

1.

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;

2.

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

3.

for each engine, or variable pitch propeller, a statement that the engine or propeller has been subjected by the manufacturer to a final functional test, in accordance with point 21.A.128, and additionally in case of engines, a determination according to data provided by the engine type-certificate holder that each completed engine is in compliance with the applicable emissions requirements current at the date of manufacture of the engine.

1.

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

2.

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

3.

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

1.

as applicable within the scope of approval, control procedures for:

The control procedures need to include specific provisions for any critical parts.

2.

An independent quality assurance function to monitor compliance with, and adequacy of, the documented procedures of the quality system. This monitoring shall include a feedback system to the person or group of persons referred to in point 21.A.145(c)(2) and ultimately to the manager referred to in point 21.A.145(c)(1) to ensure, as necessary, corrective action.

1.

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;