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Commission Delegated Regulation (EU) 2022/1358 of 2 June 2022 amending Regulation (EU) No 748/2012 as regards the implementation of more proportionate requirements for aircraft used for sport and recreational aviation

Type Delegated Regulation

Publication 2022-08-05

State In force

Text As published

Department European Commission, MOVE

Source EUR-Lex

articles 2

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

Reform history JSON API

1. any other conditions or limitations prescribed for the aircraft in the applicable detailed technical specifications and the applicable environmental protection requirements with which the declarant declares compliance.

(d) The declarant that designs a major change shall submit the declaration referred to in point (c) to the Agency. Together with this declaration, the declarant shall provide to the Agency:

1. a description of the major change;

1. basic data about the major change, including the operating characteristics, design features and any limitations;

1. a compliance demonstration plan detailing the means for compliance demonstration that was followed during the compliance demonstration;

1. recorded justifications of compliance within the compliance data obtained from the compliance activities that have been conducted according to the compliance demonstration plan;

1. the means by which such compliance with the applicable detailed technical specifications and applicable environmental protection requirements in point 21L.B.61 has been demonstrated;

1. where compliance is demonstrated by carrying out tests, recorded justification of the conformity of the test articles and equipment, demonstrating:

(i) for the test specimen, that:

(A) the materials and processes adequately conformed to the specifications for the design;

(B) the constituent parts of the products adequately conformed to the drawings in the design; and

(ii) that the test and measuring equipment used for the test were adequate for the test and appropriately calibrated;

1. reports, results of inspections or tests that the declarant found necessary to determine that the aircraft complies with the applicable detailed technical specifications and applicable environmental protection requirements.

(e) The declaration of a major change to a declaration of design compliance shall be limited to the specific configuration(s) in the declaration of design compliance to which the change relates.

21L.A.108 Compliance activities for declaring compliance of a major change

Prior to making a declaration of compliance in accordance with point 21L.A.107, the declarant shall, for that specific design:

(a) establish a compliance demonstration plan detailing the means for compliance demonstration that shall be followed during the compliance demonstration. This document shall be updated as necessary;

(b) record the justification of compliance within compliance documents according to the compliance demonstration plan;

(d) ensure and record the conformity of the test articles and equipment and ensure that the test specimen conforms to the specifications, drawings, manufacturing processes, construction and assembly means in the design;

(e) ensure that the test and measuring equipment to be used for testing are adequate for testing and appropriately calibrated;

(f) allow the Agency to conduct or participate in any inspections or tests of aircraft in the final or suitably mature design and production configuration that are necessary to determine that the changed product has no feature or characteristic that makes the aircraft unsafe or environmentally incompatible for the intended use;

(g) carry out flight testing, in accordance with the methods for such flight testing specified by the Agency, as necessary to determine that the aircraft complies with the applicable detailed technical specifications and the applicable environmental protection requirements.

SUBPART G – DECLARED PRODUCTION ORGANISATIONS

21L.A.121 Scope

(a) This Subpart establishes:

1. the procedures for declaring the production capability of natural and legal persons showing the conformity of products and parts with the applicable design data;

1. the rights and obligations of the natural and legal persons making a declaration of production capability referred to in point (1).

(b) The following categories of products and parts may be produced by organisations which have made a declaration of production capability in accordance with this Subpart:

1. products and parts the design of which has been certified in accordance with this Annex;

1. aircraft the design of which is covered by a declaration made in accordance with this Annex, and their engines, propellers and parts.

21L.A.122 Eligibility

Any natural or legal person (‘organisation’) may declare their production capability under this Subpart, if that person:

(a) has applied or intends to apply for the approval of the design of the product or part in accordance with this Annex; or

(b) has declared or intends to declare the compliance of an aircraft design in accordance with this Annex; or

(c) is collaborating with the applicant for, or holder of, an approval of the design of the product to be issued or issued in accordance with this Annex, or with the organisation that has declared or intends to declare the compliance of that aircraft design in accordance with this Annex, in order to ensure that the manufactured product or part is in conformity to that design, and to ensure the continued airworthiness of the product or part.

21L.A.123 Declaration of production capability

(a) Prior to producing any products or parts, an organisation intending to show the conformity of those products or parts with the applicable design data shall declare its production capability.

(b) The declaration, and any subsequent changes thereto, shall be made in a form and manner established by the competent authority.

(c) The declaration shall include the information necessary for the competent authority to become familiar with the organisation and the intended scope of work, and shall include at least the following:

1. the registered name of the organisation;

1. the contact details of the organisation’s registered address of their principal place of business and, where applicable, the contact and the operating sites of the organisation;

1. the names and contact details of the accountable manager of the organisation nominated in accordance with point (c)(1) of point 21L.A.125;

1. the intended scope of work;

1. the date of the intended commencement of production;

1. a statement confirming that the organisation:

(i) has a management system for production in accordance with point (a) of point 21L.A.124; and

(ii) will maintain the management system for production in compliance with this Subpart;

1. a statement confirming that the organisation will adhere to the processes and procedures established in accordance with point (d) of point 21L.A.124;

1. a statement that the organisation agrees to undertake the obligations of a declared production organisation in accordance with point 21L.A.127.

(d) The declaration of production capability shall be submitted to the competent authority.

21L.A.124 Management system for production

(a) The declared production organisation shall establish, implement, and maintain a management system for production with clear accountability and lines of responsibility throughout the organisation that:

1. corresponds to the nature and complexity of its activities and the size of the organisation, and takes into account the hazards and associated risks inherent in these activities;

1. is established under the accountability of an accountable manager nominated according to point (c)(1) of point 21L.A.125.

(b) The management system for production shall include a means to manage quality by maintaining a quality system that shall:

1. ensure that each product or part produced by the declared production organisation or by its partners, or supplied from or subcontracted to outside parties, conforms to the applicable design data and is in a condition for safe operation;

1. establish, implement, and maintain, as appropriate, within the scope of their activities, control procedures for:

(i) document issue, approval, or change;

(ii) vendor and subcontractor assessment, audit and control;

(iii) verification that incoming products, parts, materials, and equipment, including items supplied new or used by buyers of products, are as specified in the applicable design data;

(iv) identification and traceability;

(v) manufacturing processes;

(vi) inspection and testing, including production flight tests;

(vii) calibration of tools, jigs, and test equipment;

(viii) non-conforming item control;

(ix) the collaboration with the applicant for, or holder of, the design approval or the declarant of a declaration of design compliance;

(x) the completion and retention of records;

(xi) ensuring the competence and qualifications of personnel;

(xii) the issue of airworthiness release documents;

(xiii) handling, storage and packing;

(xiv) internal quality audits and the resulting corrective actions;

(xv) work performed at any location other than the operating sites included in the declaration;

(xvi) work carried out after the completion of production but prior to delivery, to maintain the aircraft in a condition for safe operation;

(xvii) the request for the issuance of permits to fly and the approval of associated flight conditions;

1. include specific provisions in the control procedures for any critical parts.

(c) The declared production organisation shall establish, as part of their management system for production, an independent function to monitor the compliance of the organisation with the relevant requirements, and compliance with, and the adequacy of, the production management system. This monitoring shall include a system to provide feedback to the person or group of persons referred to in points (c)(1) and (2) of point 21L.A.125 to ensure, as necessary, corrective action.

(d) The declared production organisation shall establish, maintain and keep updated, as part of their management system for production, processes and procedures that ensure the compliance of products that are produced with the applicable design data. The declared production organisation shall make documentary evidence of these processes and procedures available to the competent authority upon request.

(e) The declared production organisation shall have procedures in place to ensure that newly manufactured aircraft are maintained in accordance with the applicable maintenance instructions and are kept in an airworthy condition and, if applicable, that a certificate of release to service is issued for any maintenance that has been completed.

(f) If the declared production organisation holds (an)other organisation certificate(s) issued on the basis of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, the production organisation may integrate the production management system with the management system that is required for the issuance of the other certificate(s).

21L.A.125 Resources of the declared production organisation

The declared production organisation shall ensure that:

(a) the facilities, working conditions, equipment and tools, processes and associated materials, the number and competence of staff, and the general organisation are adequate to discharge its obligations under point 21L.A.127;

(b) with regard to all necessary airworthiness and environmental protection data:

1. it is in receipt of such data from the Agency, and from the declarant of design compliance or the holder of, or the applicant for, the type certificate, or design approval, to determine its conformity with the applicable design data;

1. it has established a procedure to ensure that airworthiness and environmental compatibility data is correctly incorporated into its production data;

1. such data is kept up to date and made available to all personnel who need access to such data to perform their duties;

1. an accountable manager has been nominated by the declared production organisation with authority to ensure that, within the organisation, all production is performed to the required standards and that the declared production organisation is continuously in compliance with the requirements of the management system for production referred to in point (a) of point 21L.A.124, and the processes and the procedures identified in point (d) of point 21L.A.124;

1. a person or group of persons has or have been nominated by the accountable manager to ensure that the organisation is in compliance with the requirements of this Subpart, and is (are) identified, together with the extent of their authority. Such a person or group of persons shall be responsible to the accountable manager and have direct access to them. They shall have the appropriate knowledge, background and experience to discharge their responsibilities;

1. staff at all levels have been given appropriate authority to be able to discharge their allocated responsibilities and that there is full and effective coordination within the declared production organisation in respect of airworthiness and environmental compatibility data matters;

1. the organisational structure of the organisation along with the key personnel who are responsible for ensuring that the organisation is in compliance with this Subpart is documented and kept updated;

(d) with regard to certifying staff, authorised by the declared production organisation to sign the documents issued under point 21L.A.126 within the scope of declared production activities:

1. the knowledge, background (including other functions in the organisation), and experience of the certifying staff are appropriate to discharge their allocated responsibilities;

1. certifying staff are provided with evidence of the scope of their authorisation. A list of certifying staff shall be maintained by the declared production organisation.

21L.A.126 Scope of work

(a) A declared production organisation is entitled to show the conformity of the products and parts that are within the scope of this Section and that it has produced within the declared scope of work, with the applicable design data.

(b) A declared production organisation is entitled, for a complete aircraft, after presentation of an aircraft statement of conformity (EASA Form 52B), to apply:

1. for an aircraft that conforms to a type design approved in accordance with Subpart B of Section B of this Annex, for a certificate of airworthiness and a noise certificate;

1. for an aircraft that conforms to a design for which compliance has been declared in accordance with Subpart C of this Annex, for a restricted certificate of airworthiness and a restricted noise certificate.

(c) A declared production organisation is entitled to issue authorised release certificates (EASA Form 1) for engines, propellers and parts that either conform to:

1. approved design data issued in accordance with Subparts B, D, E or M of Section B of this Annex;

1. declared design data for which design compliance has been declared in accordance with Subparts C, F or N of this Annex;

1. production data based upon all the necessary approved design data as provided by a repair design approval holder.

(d) A declared production organisation is entitled to recommend the conditions for an aircraft that it has produced and for which it has attested conformity with the applicable design data, under which a permit to fly can be issued by the competent authority under Subpart P of Annex I (Part 21).

(e) A declared production organisation is entitled to maintain a new aircraft that it has produced, as necessary to keep it in an airworthy condition, unless Regulation (EU) No 1321/2014 requires the maintenance to be performed under such rules, and to issue a certificate of release to service (EASA Form 53B) in respect of that maintenance.

21L.A.127 Obligations of the declared production organisation

(a) The declared production organisation shall work in accordance with clearly defined procedures, practices and processes.

(b) If the declared production organisation intends to conduct flight tests, then it shall prepare, maintain and keep updated an operations manual that includes a description of the organisation’s policies and processes for flight testing. The declared production organisation shall make this manual available to the competent authority upon request.

(c) For completed aircraft, prior to submitting an aircraft statement of conformity (EASA Form 52B) to the competent authority, the declared production organisation shall ensure that the aircraft is in a condition for safe operation and conforms to:

1. the approved type design of a type-certified product issued in accordance with Subpart B of Section B of this Annex, or

1. the design data of an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex.

(d) For products (other than complete aircraft) and parts, the declared production organisation shall ensure prior to issuing an authorised release certificate (EASA Form 1) that the product or part is in a condition for safe operation and conforms to the approved type design of a type-certified product issued in accordance with Subpart B, D, E or M of Section B of this Annex or conforms to the design data of an aircraft for which design compliance has been declared in accordance with Subpart C, F or M of this Annex.

(e) For engines, the declared production organisation shall ensure that the completed engine is in compliance with the applicable engine exhaust emissions requirements applicable on the date of production of the engine.

(f) The declared production organisation shall include, in any authorised release certificates (EASA Form 1) that are issued by it, the reference number issued by the competent authority in accordance with point 21L.B.142 for this declared production organisation.

(g) The declared production organisation shall ensure that the organisation records the details of any work that is completed.

(h) The declared production organisation shall provide, to the design holder or the declarant of a declaration of design compliance, continuing airworthiness support for any products or parts that they have produced.

(i) The declared production organisation shall have an archiving system that records the requirements that have been placed on other organisations, such as suppliers and subcontractors. The declared production organisation shall make the archived data available to the competent authority for continuing airworthiness purposes.

(j) For the production of new aircraft, the declared production organisation shall ensure that the aircraft is kept in an airworthy condition and that maintenance is performed, including any necessary repairs in accordance with the applicable design data, prior to the issuance of an aircraft statement of conformity (EASA Form 52B).

(k) Where the declared production organisation issues a certificate of release to service after such maintenance, it shall determine that each completed aircraft has been subjected to the necessary maintenance and is in a condition for safe operation, prior to issuing that certificate.

(l) The declared production organisation shall comply with the requirements in Subpart A of this Annex applicable to a declared production organisation.

21L.A.128 Notification of changes and cessation of activities

The declared production organisation shall notify the competent authority without undue delay of the following:

(a) any changes to the information that has been declared in accordance with point (c) of point 21L.A.123;

(b) any changes to the management system for production that are significant to the showing of conformity or to the airworthiness and environmental compatibility characteristics of the product or part;

SUBPART H – CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS

21L.A.141 Scope

This Subpart establishes the procedure for applying for a certificate of airworthiness or a restricted certificate of airworthiness for an aircraft whose design has been certified or declared in accordance with this Annex, and establishes the rights and obligations of the applicants for, and holders of, those certificates.

21L.A.142 Eligibility

Any natural or legal person under whose name an aircraft is registered or will be registered in a Member State (‘Member State of registry’) may apply for a certificate of airworthiness or for a restricted certificate of airworthiness for that aircraft under the conditions laid down in this Subpart.

21L.A.143 Application for a certificate of airworthiness or a restricted certificate of airworthiness

(a) A natural or legal person shall apply for a certificate of airworthiness or a restricted certificate of airworthiness in a form and manner established by the competent authority of the Member State of registry.

(b) A natural or legal person may apply for:

1. a certificate of airworthiness for aircraft which conform to a type certificate that has been issued by the Agency in accordance with Subpart B of Section B of this Annex; or

1. a restricted certificate of airworthiness for aircraft which conform to a declaration of design compliance in accordance with Subpart C of this Annex which is registered by the Agency in accordance with point 21L.B.63 at the time of application.

(c) For a new aircraft that conforms to a type certificate issued by the Agency, the applicant shall include in the application:

1. an aircraft statement of conformity (EASA Form 52 or EASA Form 52B) that is either issued or signed by:

(i) a production organisation that has declared their production capability under Subpart G of this Annex and has been registered by the competent authority in accordance with point 21L.B.142; or

(ii) a production organisation approval holder under the privileges of point (b) of point 21.A.163 of Annex I (Part 21);

1. a weight and balance report with a loading schedule;

1. the flight manual if required by the applicable type-certification basis.

(d) For a new aircraft that conforms to a declaration of design compliance which is registered by the Agency, the applicant shall include in the application:

1. an aircraft statement of conformity (EASA Form 52B) that is either issued or signed by:

(i) a natural or legal person in accordance with Subpart R of this Annex;

(ii) a production organisation that has declared their production capability under Subpart G of this Annex and has been registered by the competent authority in accordance with point 21L.B.142; or

(iii) a production organisation approval holder under the privileges of point (d) of point 21.A.163 of Annex I (Part 21);

1. a weight and balance report with a loading schedule;

1. the flight manual if required by the applicable detailed technical specifications for the declaration of design compliance.

(e) For a used aircraft originating from a Member State, the applicant shall include in the application an airworthiness review certificate issued in accordance with Annex I (Part-M) or Annex Vb (Part-ML) to Regulation (EU) No 1321/2014.

(f) For a used aircraft originating from a non-Member State, the applicant shall include in the application:

1. a statement from the competent authority of the State where the aircraft is, or was, registered, reflecting the airworthiness status of the aircraft at the time of transfer;

1. the historical records to establish the production, modification, and maintenance standard of the aircraft;

1. a weight and balance report with a loading schedule;

1. the flight manual;

1. a recommendation for the issuance of a certificate of airworthiness or restricted certificate of airworthiness and for an airworthiness review certificate pursuant to an airworthiness review in accordance with Annex I (Part-M) to Regulation (EU) No 1321/2014 or an airworthiness review certificate in accordance with Annex Vb (Part-ML) to Regulation (EU) No 1321/2014.

(g) Unless otherwise agreed, the statements referred to in points (c)(1), (d)(1) and (f)(1) shall be issued no more than 60 days before the presentation of the aircraft to the competent authority of the Member State of registry.

21L.A.144 Obligations of the applicant for a certificate of airworthiness or a restricted certificate of airworthiness

The applicant for a certificate of airworthiness or for a restricted certificate of airworthiness shall:

(a) present the manuals, placards, listings, and instrument markings and other necessary information required by the applicable type-certification basis or by the applicable detailed technical specifications for declarations of design compliance in one or more of the official language(s) of the European Union acceptable to the competent authority of the Member State of registry;

(b) demonstrate that their aircraft is identified in accordance with Subpart Q of this Annex;

(c) arrange for inspections of the competent authority of the Member State of registry to assess whether the aircraft has any non-conformities that could affect the safety of the aircraft.

21L.A.145 Transferability and re-issuance of a certificate of airworthiness and of a restricted certificate of airworthiness within Member States

Where the ownership of an aircraft has changed:

(a) if it remains on the same register, the certificate of airworthiness, or the restricted certificate of airworthiness issued in accordance with Subpart H of Section B of this Annex, shall be transferred together with the aircraft;

(b) if the aircraft is intended to be registered in another Member State, the natural or legal person under whose name the aircraft will be registered shall apply to the competent authority of the new Member State of registry for a new certificate of airworthiness or a restricted certificate of airworthiness and shall include in this application the former certificate of airworthiness or restricted certificate of airworthiness issued in accordance with Subpart H of Section B of this Annex and a valid airworthiness review certificate issued in accordance with Annex I (Part-M) or Annex Vb (Part-ML) to Regulation (EU) No 1321/2014.

21L.A.146 Continued validity of a certificate of airworthiness and of a restricted certificate of airworthiness

(a) A certificate of airworthiness or a restricted certificate of airworthiness shall remain valid as long as:

1. the aircraft remains on the same register;

1. the certificate has not been surrendered by the holder;

1. the aircraft remains in compliance with the relevant requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof and with the applicable type design or with the applicable design data of an aircraft for which design compliance has been declared, and with the continuing airworthiness requirements, taking into account the provisions related to the handling of findings as specified under point 21L.B.21;

1. the certificate has not been revoked by the competent authority of the Member State of registry under point 21L.B.22.

(b) Upon surrender or revocation, the certificate shall be returned to the competent authority of the Member State of registry.

SUBPART I – NOISE CERTIFICATES AND RESTRICTED NOISE CERTIFICATES

21L.A.161 Scope

This Subpart establishes the procedure for applying for a noise certificate or a restricted noise certificate for an aircraft whose design has been certified or declared in accordance with this Annex and establishes the rights and obligations of the applicants for, and holders of, those certificates.

21L.A.162 Eligibility

Any natural or legal person under whose name an aircraft is registered or will be registered in a Member State may apply for a noise certificate or a restricted noise certificate for that aircraft under the conditions laid down in this Subpart.

21L.A.163 Application

(a) A natural or legal person shall apply for a noise certificate or a restricted noise certificate in a form and manner established by the competent authority of the Member State of registry.

(b) A natural or legal person may apply for:

1. a noise certificate for aircraft which conform to a type certificate that has been issued by the Agency in accordance with Subpart B of Section B of this Annex; or

1. a restricted noise certificate for aircraft which conform to a declaration of design compliance submitted in accordance with Subpart C of this Annex which is registered by the Agency in accordance with point 21L.B.63 at the time of application.

1. with regard to new aircraft:

(i) an aircraft statement of conformity (EASA Form 52 or EASA Form 52B) that is either issued or signed by:

(A) a natural or legal person in accordance with Subpart R of this Annex;

(B) a production organisation that has declared their production capability under Subpart G of this Annex and has been registered by the competent authority in accordance with point 21L.B.142; or

(ii) the reference to the noise record within the Agency database of noise levels reflecting the noise information determined in accordance with the applicable noise requirements;

1. with regard to used aircraft:

(i) the reference to the noise record within the Agency database of noise levels reflecting the noise information determined in accordance with the applicable noise requirements; and

(ii) the historical records to establish the production, modification, and maintenance standard of the aircraft.

(d) Unless otherwise agreed, the statements referred to in point (c)(1)(i) shall be issued no more than 60 days before the presentation of the aircraft to the competent authority of the Member State of registry.

21L.A.164 Transferability and re-issuance of noise certificates and restricted noise certificates within Member States

Where the ownership of an aircraft has changed:

(a) if the aircraft remains on the same register, the noise certificate, or the restricted noise certificate issued in accordance with Subpart I of Section B of this Annex, shall be transferred together with the aircraft;

(b) if the aircraft is intended to be registered in another Member State, the natural or legal person under whose name the aircraft will be registered shall apply to the competent authority of the new Member State of registry for a new noise certificate or restricted noise certificate and shall include in this application the former noise certificate or restricted noise certificate issued in accordance with Subpart I of Section B of this Annex.

21L.A.165 Continued validity of a noise certificate and of a restricted noise certificate

(a) A noise certificate or a restricted noise certificate shall remain valid as long as:

1. the aircraft remains on the same register;

1. the certificate has not been surrendered by the holder;

1. the aircraft remains in compliance with the applicable environmental protection requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof and with the applicable type design or with the applicable design data of an aircraft for which design compliance has been declared, taking into account the provisions related to the handling of findings as specified under point 21L.B.21;

1. the certificate has not been revoked by the competent authority of the Member State of registry under point 21L.B.22.

(b) Upon surrender or revocation, the certificate shall be returned to the competent authority of the Member State of registry.

SUBPART J – DECLARED DESIGN ORGANISATIONS

21L.A.171 Scope

This Subpart establishes:

(a) the procedure for declaring the design capability by natural and legal persons who design products under this Section; and

(b) the rights and obligations of the persons making declarations of design capability referred to in point (a).

21L.A.172 Eligibility

Any natural or legal person (‘organisation’ in this Subpart) required by point 21L.A.22, point 21L.A.82 or point 21L.A.204 to demonstrate their design capability may declare their capability under the conditions laid down in this Subpart.

21L.A.173 Declaration of design capability

(a) Prior to or at the same time as applying for a design approval under this Section, or prior to submitting the application for the approval of flight conditions in accordance with point 21.A.710 of Annex I (Part 21) of a product designed by it, whatever comes first, the organisation shall submit a declaration of design capability to the Agency.

(b) The declaration, and any subsequent changes thereto, shall be made in a form and manner established by the Agency.

(c) The declaration shall include the information necessary for the Agency to become familiar with the organisation and the intended scope of work, and shall include at least the following:

1. the registered name of the organisation;

1. the contact details of the organisation’s registered address of the principal place of business and, where applicable, of the operating sites of the organisation;

1. the names and contact details of the head of the design organisation;

1. the intended scope of work;

1. a statement confirming that the organisation:

(i) has a management system for design in accordance with point (a) of point 21L.A.174; and

(ii) will maintain the management system for design in compliance with this Subpart;

1. a statement confirming that the organisation will adhere to the processes and procedures established in accordance with point (d) of point 21L.A.174;

1. a statement that the organisation agrees to undertake the obligations of a declared design organisation in accordance with point 21L.A.177.

(d) The declaration of design capability shall be submitted to the Agency.

21L.A.174 Management system for design

(a) The declared design organisation shall establish, implement, and maintain a management system for design with clear accountability and lines of responsibility throughout the organisation that:

1. corresponds to the nature and complexity of its activities and the size of the organisation, and takes into account the hazards and associated risks inherent in these activities;

1. is established under the accountability of a single manager nominated as the head of the design organisation according to point (a) of point 21L.A.175.

(b) The declared design organisation shall have, as part of their management system for design, a means to provide design assurance by establishing, implementing and maintaining a system for the control and supervision of the design, and of design changes and repairs, of products. This system shall:

1. include an airworthiness function responsible for ensuring that the designs of products and the designs of changes and repairs thereto comply with the applicable type-certification basis and the applicable environmental protection requirements;

1. establish, implement and maintain an independent function to verify the demonstration of compliance on the basis of which the organisation declares compliance with the applicable type-certification basis and with the applicable environmental protection requirements;

1. specify the manner in which the design assurance system accounts for the acceptability of the parts that are designed or the tasks that are performed by partners or subcontractors according to methods which are the subjects of written procedures.

(c) The declared design organisation shall establish, as part of their management system for design, an independent function to monitor the compliance of the organisation with the relevant requirements, and compliance with, and adequacy of, the management system for design. This monitoring shall include a system to provide feedback to the person or a group of persons referred to in point (b) of point 21L.A.175, and to the accountable manager referred to in point (a) of point 21L.A.175 to ensure, as necessary, corrective action.

(d) The declared design organisation shall establish, maintain and keep updated processes and procedures that ensure the design compliance of products with the applicable type-certification basis, applicable detailed technical specifications and applicable environmental protection requirements. The declared design organisation shall make documentary evidence of these processes and procedures available to the Agency upon request.

(e) Where any parts or any changes to the products are designed by partner organisations or subcontractors, the processes and procedures in point (d) shall include a description of how the design organisation is able to give, for all parts, the assurance of compliance required by point (b)(2), and shall contain, directly or by cross-reference, descriptions and information on the design activities and organisation of those partners or subcontractors.

(f) If the declared design organisation holds (an)other organisation certificate(s) issued on the basis of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, the declared design organisation may integrate the design management system with the management system that is required for the issuance of the other certificate(s).

21L.A.175 Resources of the declared design organisation

(a) The declared design organisation shall nominate a head of the design organisation with the authority for ensuring that, within the organisation, all design activities are performed to the required standards and that the declared design organisation is continuously in compliance with the requirements for the management system for design referred to in points (a) to (c) of point 21L.A.174 and the processes and procedures referred to in point (d) of point 21L.A.174.

(b) The head of the design organisation shall nominate and identify key personnel within the organisation that are responsible for:

1. ensuring that the designs of products and the designs of changes and repairs thereto comply with the applicable type-certification basis, applicable detailed technical specifications and applicable environmental protection requirements;

1. the independent monitoring of the compliance and adequacy function; and

1. depending on the size of the organisation, any other person or group of persons who is or are needed to ensure that the organisation is in compliance with the requirements of this Section.

1. be responsible to the head of the design organisation and have direct access to them;

1. have the appropriate knowledge, background and experience to discharge their allocated responsibilities.

(d) The declared design organisation shall ensure that:

1. the staff in all technical departments are of sufficient numbers and experience and have been given the appropriate authority to be able to discharge their allocated responsibilities and that these, together with the accommodation, facilities and equipment, are adequate to enable the staff to ensure that the products designed are airworthy and environmentally compatible;

1. there is full and efficient coordination within the declared design organisation in respect of airworthiness and environmental compatibility matters.

(e) The declared design organisation shall document the organisational structure of their organisation, along with the key personnel who are responsible for ensuring that the organisation is in compliance with this Subpart, keep them updated and make them available to the Agency upon request.

21L.A.176 Scope of work

The declared design organisation shall identify the types of design work, the categories of products for which design activities are conducted, and the functions and duties that the organisation performs in regard to the airworthiness and environmental compatibility of products.

21L.A.177 Obligations of the declared design organisation

A declared design organisation shall:

(a) work in accordance with clearly defined procedures, practices and processes;

(b) if the declared design organisation intends to conduct flight testing, maintain and keep updated an operations manual that provides a description of the organisation’s policies and processes for flight testing and make this manual available to the Agency upon request;

(c) determine whether the designs of products, including changes and repairs, do not have any unsafe features and comply with the applicable type-certification basis, and with the applicable environmental protection requirements, and provide the Agency with statements/documentation confirming this;

(d) provide the Agency with information or instructions relating to continued airworthiness actions;

(e) comply with the requirements in Subpart A of this Annex applicable to declared design organisations.

21L.A.178 Notification of changes and cessation of activities

The declared design organisation shall notify the Agency without undue delay of the following:

(a) any changes to the information that has been declared in accordance with point (c) of point 21L.A.173;

(b) changes to the management system for design that are significant for the demonstration of compliance of the product designed by them;

SUBPART K – PARTS

21L.A.191 Scope

This Subpart establishes how the compliance of parts with the airworthiness requirements shall be shown.

21L.A.192 Showing of compliance

(a) The showing of compliance with the airworthiness requirements of parts to be installed in a type-certified product or an aircraft for which design compliance has been declared shall be made:

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

1. in conjunction with the declaration of design compliance procedures of Subpart C or F of this Annex for the product in which it is to be installed; or

1. under the ETSO authorisation procedure of Subpart O of Section A of Annex I (Part 21); or

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

(b) In all cases where the approval of a part is explicitly required by Union law or Agency measures, the part shall comply with the applicable ETSO or with the specifications recognised as equivalent by the Agency in the particular case.

21L.A.193 Release of parts for installation

(a) A part or product shall only be installed in a product when it is identified by the holder of a type certificate, supplemental type certificate, design change, repair design approval or with a declaration of design compliance as being suitable for installation, and when it is:

1. in a condition for safe operation;

1. marked in accordance with Subpart Q of this Annex; and

1. accompanied by an authorised release certificate (EASA Form 1) certifying that the item was manufactured in conformity with the applicable design data.

(b) By way of derogation from point (a)(3) and provided that the conditions in point (c) are met, the following parts do not require an authorised release certificate (EASA Form 1) in order to be installed in a type-certified product or in an aircraft for which design compliance has been declared:

1. a standard part;

1. a part that is:

(i) not life limited, nor part of the primary structure, nor part of the flight controls;

(ii) identified for installation in the specific aircraft by the holder of a type certificate, supplemental type certificate, design change, repair design approval or a declaration of design compliance;

(iii) to be installed in an aircraft whose owner has verified compliance with the applicable conditions in (i) and (ii), and has accepted responsibility for this compliance;

1. a part for which the consequences of a non-conformity with its approved design data or declared design data has a negligible safety effect on the product and which is identified as such by the holder of the design approval or the declarant of design compliance in the instructions for continued airworthiness. In order to determine the safety effects of a non-conforming part, the design approval holder or declarant of a declaration of design compliance may establish in the instructions for continued airworthiness specific verification activities to be conducted by the installer of the part on the product;

1. in the case of the embodiment of a standard change as per point 21L.A.102 or a standard repair as per point 21L.A.202, a part for which the consequences of a non-conformity with its design data have a negligible safety effect on the product, and the part is identified as such in the certification specifications for standard changes and standard repairs issued in accordance with point 21.B.70 of Annex I (Part 21). In order to determine the safety effects of a non-conforming part, specific verification activities to be conducted by the person that installs the part in the product may be established in these certification specifications;

1. a part that is exempted from an airworthiness approval in accordance with Commission Regulation (EU) No 965/2012 ⁷; and

1. a part that is an item of a higher assembly identified in points (b)(1) to (b)(5).

(c) Parts listed in point (b) are eligible for installation in a type-certified product or in an aircraft for which design compliance has been declared 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, which declares the name of the part, the part number, and the conformity of the part with its design data, and which contains the date of issuance.

SUBPART M – DESIGN OF REPAIRS TO TYPE-CERTIFIED PRODUCTS

21L.A.201 Scope

This Subpart establishes:

(a) the procedure for applying for the approvals of repair designs to type-certified products;

(b) the rights and obligations of the applicants for, and holders of, those approvals referred to in point (a);

21L.A.202 Standard repairs

(a) Standard repairs are repair designs to a type-certified product approved in accordance with Subpart B of Section B of this Annex and which:

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

1. are not in conflict with the data of the holder of that type certificate.

(b) Points 21L.A.203 to 21L.A.211 are not applicable to standard repairs.

21L.A.203 Classification of repair designs to a type-certified product

(a) Repair designs to a type-certified product shall be classified as minor or major.

(b) A ‘minor repair’ is a repair design that has no appreciable effect on the mass, balance, structural strength, reliability, certified noise or emissions level, operational characteristics, or other characteristics affecting the airworthiness or the environmental compatibility of the product.

(d) The requirements for the approval of minor repair designs are those established in point 21L.A.207.

(e) The requirements for the approval of major repair designs are those established in point 21L.A.208.

21L.A.204 Eligibility

(a) Any natural or legal person who has demonstrated, or is in the process of demonstrating, their design capability in accordance with point 21L.A.23, may apply for the approval of a major repair design to a type-certified product under the conditions laid down in this Subpart.

(b) Any natural or legal person may apply for the approval of a minor repair design to a type-certified product under the conditions laid down in this Subpart.

21L.A.205 Application for the approval of a repair design to a type-certified product

(a) An application for an approval of a repair design to a type-certified product shall be made in a form and manner established by the Agency.

(b) For the approval of a major repair design, the applicant shall include in the application, or submit after the initial application, a compliance demonstration plan:

1. containing a description of the damage and the repair design, identifying the configuration of the type design upon which the repair design is made;

1. identifying all the areas of the type design and the approved manuals that are changed or affected by the repair design;

1. identifying any reinvestigations necessary to demonstrate the compliance of the repair design and the areas affected by the repair design with the type-certification basis and the applicable environmental protection requirements, incorporated by reference in, as applicable, either the type certificate or the supplemental type certificate;

1. identifying any proposed amendments to the type-certification basis incorporated by reference in, as applicable, either the type certificate or supplemental type certificate;

1. specifying 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.

21L.A.206 Demonstration of compliance

(a) The applicant for the approval of a major repair design shall demonstrate compliance with the applicable type-certification basis and applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with point 21L.B.201 and shall provide the Agency with the means by which such compliance has been demonstrated.

(b) The applicant for the approval of a major repair design 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 type design;

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

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

1. 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 an approval of a major repair design shall be conducted in accordance with methods for such flight testing specified by the Agency. The applicant shall make all the flight tests necessary to determine compliance with the applicable type-certification basis and the applicable environmental protection requirements.

(e) An applicant for the approval of a major repair design shall allow the Agency to:

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

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

1. if it is considered necessary, conduct a physical inspection of the repaired product 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 shall declare to the Agency that:

1. they have 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.201, according to the compliance demonstration plan; and

1. no feature or characteristic has been identified that may make the product with the repair design unsafe or environmentally incompatible for the uses for which certification is requested.

21L.A.207 Requirements for the approval of a minor repair design

In order to be issued with an approval of a minor repair design to a type-certified product, the applicant shall:

(a) demonstrate that the repair design and the areas affected by the repair design comply:

1. with the type-certification basis and the applicable environmental protection requirements incorporated by reference in the type certificate; or

1. if the applicant chooses to, with the certification specifications that are applicable to the product on the date of the application for the approval of the repair design;

(b) declare compliance with the type-certification basis and the applicable environmental protection requirements that apply in accordance with point (a)(1), or with the certification specifications chosen in accordance with point (a)(2), record the justifications of compliance in the compliance documents, and record that 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;

21L.A.208 Requirements for the approval of a major repair design

In order to be issued with an approval of a major repair design to a type-certified product, the applicant shall:

(a) demonstrate that the repair design and the areas affected by the repair design comply with the 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.201;

(b) demonstrate compliance in accordance with point 21L.A.206;

(c) if the applicant has specified that they provided certification data on the basis of an arrangement with the owner of the type-certification data in accordance with point 21L.A.205(b)(5), demonstrate that the type-certificate holder:

1. has no technical objection to the information submitted under point 21L.A.205; and

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

(d) demonstrate that there are no unresolved issues from the physical inspection of the first article of that product with the repair design in the final changed configuration carried out by the Agency in accordance with point 21L.A.206(e)(3).

21L.A.209 Approval of a repair design under a privilege

(a) The approval of a repair design that it has designed may be issued by an approved design organisation without an application according to point 21L.A.205 in accordance with the scope of its privileges provided for in points (2) and (5) 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 repair approval in accordance with point (a), the design organisation shall:

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

1. ensure that the compliance of the change with the type-certification basis and the applicable environmental protection requirements according to point (a) of point 21L.A.207 or point (a) of point 21L.A.208 has been demonstrated and declared in accordance with point 21L.A.206;

1. 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 repair that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested;

1. limit the approval of a repair to a type certificate to the specific configuration(s) in the type certificate to which the repair relates.

21L.A.210 Obligations of a holder of a repair design approval

The holder of a repair design approval shall:

(a) if they are not the type-certificate or supplemental type-certificate holder, and certification data has been supplied in accordance with 21L.A.205 (b)(5), establish an arrangement with the relevant holder;

(b) provide to the organisation performing the repair all the necessary instructions to install or embody the repair design;

(c) support any production organisation producing parts for the repair design, and ensure that those parts are produced using production data that is based upon the design data that is provided by the repair design approval holder;

(d) ensure that the repair design includes all the necessary instructions and limitations, if a repair design is approved subject to limitations. These instructions and limitations shall be transmitted to the operator by the holder of the repair design approval in accordance with a procedure agreed with the Agency;

(e) undertake the obligations of a repair design approval holder of Subpart A of this Annex.

21L.A.211 Unrepaired damage

Damage to a product, the design of which has been approved in accordance with Section B, may not require a repair design if an evaluation of the airworthiness consequences justifies it. Such an evaluation is to be made by either the Agency or by a design organisation which is appropriately approved in accordance with Subpart J of Section A of Annex I (Part 21), under a procedure accepted by the Agency. If the evaluation concludes that the unrepaired damage requires limitations, those shall be processed in accordance with point (d) of point 21L.A.210.

SUBPART N – DESIGN OF REPAIRS TO AIRCRAFT FOR WHICH DESIGN COMPLIANCE HAS BEEN DECLARED

21L.A.221 Scope

This Subpart establishes:

(a) the procedure for declaring the compliance of repair designs to an aircraft which was subject to a declaration made in accordance with Subpart C of this Annex;

(b) the rights and obligations of the declarant making a declaration of compliance of the change referred to in point (a);

21L.A.222 Standard repairs

(a) Standard repairs are repair designs to an aircraft which was subject to a declaration made in accordance with Subpart C of this Annex and which:

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

1. are not in conflict with the design data covered by the declaration of aircraft design compliance made in accordance with Subpart C of this Annex.

(b) Points 21L.A.223 to 21L.A.229 are not applicable to standard repairs.

21L.A.223 Classification of repair designs to an aircraft for which design compliance has been declared

(a) Repair designs to an aircraft which was subject to a declaration made in accordance with Subpart C of this Annex shall be classified as either a major or minor, using the criteria laid down in points (b) and (c) of 21L.A.203.

(b) The design compliance of a minor repair design shall be declared in accordance with point 21L.A.225.

21L.A.224 Eligibility

(a) A declarant who made a declaration of aircraft design compliance in accordance with Subpart C of this Annex may declare compliance of a minor repair design of that aircraft under the conditions laid down in this Subpart. In addition, such a declaration of compliance may be also made, under the conditions laid down in this Subpart, by a design organisation approved in accordance with point (c)(3) of point 21.A.263 of Annex I (Part 21).

(b) Only the declarant who made a declaration of aircraft design compliance in accordance with Subpart C of this Annex may declare the compliance of a major repair design to an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex, under the conditions laid down in this Subpart.

(c) By derogation from point (b), if the declarant who made a declaration of aircraft design compliance in accordance with Subpart C of this Annex is no longer active or is unresponsive to requests for repair designs, the compliance of a changed aircraft design may also be declared in accordance with Subpart C of this Annex by a design organisation approved in accordance with point (c)(2) of point 21.A.263 of Annex I (Part 21) within the scope of their terms of approval, or by any other natural or legal person who is able to undertake the obligations laid down in point 21L.A.47 with respect to that changed aircraft.

21L.A.225 Declaration of design compliance for minor repair designs

(a) Prior to incorporating or embodying or agreeing with a production organisation to incorporate or embody a minor repair design to an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex, the declarant or the organisation that has designed the minor repair shall declare that the minor repair design complies with the detailed technical specifications and the applicable environmental protection requirements with which compliance had been declared according to point 21L.A.43.

(b) The declaration of design compliance shall be made in a form and manner established by the Agency.

(c) The declarant or the organisation that has designed the minor change shall maintain a register of minor repair designs to aircraft for which design compliance has been declared, and make any declaration made in accordance with point (a) available to the Agency upon request.

21L.A.226 Declaration of design compliance of major repair designs

(a) Prior to incorporating or embodying or agreeing with a production organisation to incorporate or embody a major repair design to an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex, the declarant shall declare that the design of the major repair complies with the detailed technical specifications and the applicable environmental protection requirements with which compliance had been declared according to point 21L.A.43.

(b) The declaration of design compliance shall be made in a form and manner established by the Agency.

1. the name of the person submitting the declaration, and their address/place of business;

1. the declaration reference number of the aircraft to which the major repair design relates;

1. a unique reference for identifying the major repair design;

1. indication of the detailed technical specifications and the applicable environmental protection requirements with which the compliance of the aircraft had been declared by the declarant according to point 21L.A.43;

1. a signed statement made under the sole responsibility of the person making the declaration that the design of the major repair is in compliance with the detailed technical specifications and the applicable environmental protection requirements referred to in point (4), according to the compliance demonstration plan referred to in point (d)(3);

1. a signed statement made under the sole responsibility of the person making the declaration that no features or characteristics have been identified by that person that may make the aircraft unsafe or environmentally incompatible for the intended use;

1. a description of the damage and the repair design identifying the configuration of the type design upon which the repair is made;

1. identification of all the areas of the type design and the approved manuals that are changed or affected by the repair design.

(d) The declarant that designs a major repair shall submit the declaration referred to in point (c) to the Agency. Together with this declaration, the declarant shall provide to the Agency:

1. a description of the major repair;

1. basic data about the major repair, including the operating characteristics, design features and any limitations;

1. a compliance demonstration plan detailing the means for compliance demonstration that was followed during the compliance demonstration;

1. recorded justifications of compliance within compliance data obtained from the compliance activities that have been conducted according to the compliance demonstration plan;

1. the means by which compliance with the detailed technical specifications and the applicable environmental protection requirements with which the declarant had declared that aircraft compliance according to point 21L.A.43 has been demonstrated;

1. where compliance is demonstrated by carrying out tests, a recorded justification of the conformity of the test articles and equipment, demonstrating:

(i) for the test specimen, that:

(A) the materials and processes adequately conformed to the specifications for the design;

(B) the constituent parts of the products adequately conformed to the drawings in the design; and

(ii) that the test and measuring equipment used for the tests were adequate for the tests and appropriately calibrated;

1. reports, results of inspections or tests that the declarant found necessary to determine that the aircraft complies with the detailed technical specifications and the applicable environmental protection requirements.

(e) The declaration of a major repair to a declaration of design compliance shall be limited to the specific configuration(s) in the declaration of design compliance to which the change relates.

21L.A.227 Compliance activities for declaring compliance of a major repair design

Prior to making a declaration of compliance in accordance with point 21L.A.226, the declarant shall, for that specific design:

(a) establish a compliance demonstration plan detailing the means for compliance demonstration that shall be followed during the compliance demonstration. This document shall be updated as necessary;

(b) record the justification of compliance within compliance documents according to the compliance demonstration plan;

(d) ensure and record the conformity of the test articles and equipment and ensure that the test specimen conforms to the specifications, drawings, manufacturing processes, construction and assembly means in the design;

(e) ensure that the test and measuring equipment to be used for testing are adequate for testing and appropriately calibrated;

(f) allow the Agency to conduct or participate in any inspections or tests of aircraft in the final or suitably mature design and production configuration that are necessary to determine that the product with the repair design has no feature or characteristic that makes the aircraft unsafe or environmentally incompatible for the intended use;

(g) carry out flight testing, in accordance with the flight conditions for such flight testing specified by the Agency, as necessary in order to determine that the aircraft complies with the applicable detailed technical specifications and the applicable environmental protection requirements.

21L.A.228 Obligations of the declarant of a declaration of design compliance of a repair design

The declarant of a declaration of design compliance shall:

(a) for minor repair designs maintain a register of those declarations and shall make those declarations available to the Agency upon request;

(b) provide to the organisation performing the repair all the necessary instructions to install or embody the repair design;

(c) support any production organisation producing parts for the repair design, and ensure that those parts are produced using production data that is based upon the design data that is provided by the declarant;

(d) if a repair design is declared subject to limitations, transmit these limitations to the operator using a documented procedure that is made available to the Agency upon request;

(e) undertake the obligations of a declarant of design compliance of a repair design of Subpart A of this Annex.

21L.A.229 Unrepaired damage

The declarant of design compliance of an aircraft in accordance with Subpart C of this Annex or an approved design organisation with privileges provided in accordance with point (c)(3) of point 21.A.263 of Annex I (Part 21) and with the appropriate scope of approval shall conduct an evaluation of the airworthiness and environmental compatibility consequences of any damage to such aircraft that is left unrepaired and that is not covered by previously declared data. Any necessary limitations shall be processed in accordance with point (d) of point 21L.A.228.

SUBPART O – EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS

(Reserved)

SUBPART P – PERMIT TO FLY

21L.A.241 Permit to fly and flight conditions

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