Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations (recast) Text with EEA relevance

Any natural or legal person proposing a change to a UAS or a CMU shall apply for a new type-certificate if the Agency finds that the change in the design is so extensive that a substantially complete investigation of compliance with the applicable type-certification basis is required.

21.A.20   Demonstration of compliance with the type certification basis, operational suitability data certification basis and environmental protection requirements

• (a) 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.

• (b) 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).

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

• (d) 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:
• 1. it has demonstrated compliance with the type-certification basis, operational suitability data certification basis and environmental protection requirements, as established and notified by the Agency, following the certification programme as accepted by the Agency; and
• 1. no feature or characteristic has been identified that may make the product, the UAS or the CMU unsafe for the uses for which certification is requested.

• (e) 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.

21.A.21   Requirements for the issuance of a type certificate or restricted type certificate

• (a) In order to be issued with a product or a CMU type certificate, or with an aircraft restricted type certificate for the aircraft that does not meet the essential requirements laid down in Annex II to Regulation (EU) 2018/1139,, the applicant shall:
• 1. demonstrate its capability in accordance with point 21.A.14;
• 1. demonstrate compliance in accordance with point 21.A.20;
• 1. for an aircraft type certificate or restricted type certificate, demonstrate that the engine or propeller, or both, if installed on the aircraft:
• (i) has/have a type certificate issued or determined in accordance with this Regulation; or
• (ii) is/are compliant with the aircraft type-certification basis established for aircraft other than unmanned aircraft, or with the UAS type-certification basis for unmanned aircraft, and the environmental protection requirements designated and notified by the Agency as necessary to ensure the safe flight of the aircraft;
• 1. for an unmanned aircraft type certificate or restricted type certificate:
• (i) demonstrate compliance with the UAS type-certification basis in accordance with point 21.B.80;
• (ii) demonstrate that the CMU has a type certificate issued in accordance with this Regulation, if the CMU has been certified separately from the unmanned aircraft.

• (b) By way of 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 applicable operational suitability data certification basis, provided that the applicant demonstrates such compliance before the date on which this data is to be actually used.

21.A.31   Type design

• (a) The type design shall consist of:
• 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, the UAS or the CMU shown to comply with the applicable type-certification basis and environmental protection requirements;
• 1. information on the materials and processes and on the methods of manufacture and assembly of the product and the CMU necessary to ensure the conformity of the product and the CMU;
• 1. an approved airworthiness limitations section of the instructions for continued airworthiness as defined by the applicable certification specifications; and
• 1. any other data that allows by comparison the determination of the airworthiness and, if relevant, the environmental characteristics of later products andCMUs of the same type.

• (b) Each type design shall be adequately identified.

21.A.33   Inspections and tests

• (a) (Reserved)

• (b) Before each test is undertaken during the demonstration of compliance required by point 21.A.20, the applicant shall have verified:
• 1. for the test specimen, that:
• (i) the materials and processes adequately conform to the specifications for the proposed type design;
• (ii) the parts of the products and the CMU components adequately conform to the drawings in the proposed type design; and
• (iii) the manufacturing processes, construction and assembly adequately conform to those specified in the proposed type design; and
• 1. for the test and measuring equipment to be used for the test, that those are adequate for the test and appropriately calibrated.

• (c) 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.

• (d) The applicant shall allow the Agency to:
• 1. review any data and information related to the demonstration of compliance; and
• 1. witness or carry out any test or inspection conducted for the purpose of the demonstration of compliance.

• (e) For all the tests and inspections witnessed or carried out by the Agency in accordance with point (d)(2):
• 1. the applicant shall submit to the Agency a statement of conformity provided for in point (c); and
• 1. no change that affects the validity of the statement of conformity shall be made to the test specimen, or the test and measuring equipment, between the time the statement of conformity provided for in point (c) was issued and the time the test specimen is presented to the Agency for test.

21.A.35   Flight Tests

• (a)Flight testing for the purpose of obtaining a type-certificate shall be conducted in accordance with conditions for such flight testing specified by the Agency.

• (b)The applicant shall perform all flight tests that the Agency finds necessary to determine:

• 1. compliance with the applicable type-certification basis and environmental protection requirements; and

• 1. whether there is reasonable assurance that the aircraft, its parts, appliances, the UAS orthe CMU are reliable and function properly for aircraft, UAS and CMUs to be certified under this Annex, except for:
• (i) sailplanes, other than unmanned sailplanes, and powered sailplanes, other than unmanned powered sailplanes;
• (ii) balloons and airships defined in ELA1 or ELA2;
• (iii) aeroplanes, other than unmanned aeroplanes, with a maximum take-off mass (MTOM) of 2 722 kg or less.

• (c)(Reserved)

• (d)(Reserved)

• (e)(Reserved)

• (f)The flight tests prescribed in point (b)(2) shall include:

• 1. for aircraft other than unmanned aircraft:
• (i) the flight hours that the Agency finds necessary to ensure that its safe operation is demonstrated before the aircraft enters into service and shall be at least 150 hours;
• (ii) in particular, for aircraft incorporating turbine engines of a type not previously used in a type-certified aircraft, at least 300 hours of operation with a full complement of engines that conform to a type-certificate;

• 1. for UAS and CMUs, the flight hours that the Agency finds necessary, considering the degree of complexity of the design of the aircraft and the CMU and their risk on safety, to ensure that their safe operation is demonstrated before the aircraft and the CMU enter into service.

21.A.41   Type-certificate

The type-certificate and restricted type-certificate shall include the type design, the operating limitations, the instructions for continued airworthiness, the type-certificate data sheet for airworthiness and emissions, the applicable type-certification basis and environmental protection requirements with which the Agency records compliance, and any other conditions or limitations prescribed for the product, the UAS orthe CMU in the applicable certification specifications and environmental protection requirements. The aircraft type-certificate and restricted type-certificate shall include in addition the applicable operational suitability data certification basis, the operational suitability data and the type-certificate data sheet for noise. The aircraft type-certificate and restricted type-certificate data sheet shall include the record of CO2 emissions compliance, and the engine type-certificate data sheet shall include the record of exhaust emissions compliance.

21.A.44   Obligations of the holder

Each holder of a type-certificate or restricted type-certificate shall:

• (a) 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;

• (b) specify the marking in accordance with Subpart Q.

As from 18 May 2022, the obligation to comply with the obligations listed under point (a) shall be understood as referring to points 21.A.3A, 21.A.3B, 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.62 and 21.A.65; and, for this purpose, each holder of a type-certificate or restricted type-certificate shall continue to meet the qualification requirements for eligibility under point 21.A.14.

21.A.47   Transferability

The transfer of a type-certificate or a restricted type-certificate or an ETSO authorisation for an auxiliary power unit may only be made to a natural or legal person that is able to undertake the obligations laid down in point 21.A.44, and, for this purpose, has demonstrated its capability in accordance with point 21.A.14.

21.A.51   Duration and continued validity

• (a)A type-certificate and restricted type-certificate shall be issued for an unlimited duration. They shall remain valid subject to:

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

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

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

21.A.62   Availability of operational suitability data

The holder of the type-certificate or restricted type-certificate shall make available:

• (a) 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

• (b) any change to the operational suitability data to all known EU operators of the aircraft; and

• (c) on request, the relevant data referred to in points (a) and (b) above, to:
• 1. the competent authority responsible for verifying conformity with one or more elements of this set of operational suitability data; and
• 1. any person required to comply with one or more elements of this set of operational suitability data.

21.A.65   Continuing structural integrity for aeroplanes structures

The holder of the type-certificate or restricted type-certificate for a large aeroplane shall ensure that the continuing structural integrity programme remains valid throughout the operational life of the aeroplane, taking into account service experience and current operations

(SUBPART C — NOT APPLICABLE)

SUBPART D —   CHANGES TO TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES

21.A.90A   Scope

This Subpart establishes the procedure for the approval of changes to type-certificates, and establishes the rights and obligations of the applicants for, and holders of, those approvals. This Subpart also defines standard changes that are not subject to an approval process under this Subpart. In this Subpart, references to type-certificates include type-certificate and restricted type-certificate.

21.A.90B   Standard changes

• (a)Standard changes are changes to a type-certificate:

• 1. in relation to:
• (i) aeroplanes with a maximum take-off mass (MTOM) of 5 700 kg or less;
• (ii) rotorcraft with a MTOM of 3 175 kg or less;
• (iii) sailplanes, powered sailplanes, balloons and airships, as defined in ELA1 or ELA2;
• (iv) VTOL-capable aircraft with a MTOM of 5 700 kg or less;

• 1. 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

• 1. that are not in conflict with TC holders data.

• (b)Points 21.A.91 to 21.A.109 are not applicable to standard changes.

21.A.90C   Stand-alone changes to the Instructions for Continued Airworthiness

• (a) 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.

• (b) 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.

• (c) Points 21.A.91 to 21.A.109 shall not apply to stand-alone changes to the instructions for continued airworthiness that:
• 1. do not affect the airworthiness limitations section of the instructions for continued airworthiness, and
• 1. do not require the design approval holder to perform any additional demonstration of compliance with the certification basis.

• (d) 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.

21.A.91   Classification of changes to a type certificate

Changes to a type certificate shall be classified as ‘minor’ and ‘major’. A ‘minor change’ has no appreciable effect on the mass, balance, structural strength, reliability, operational characteristics, certified noise or emissions levels, operational suitability data, or other characteristics affecting the airworthiness or the environmental compatibility of the product or of the UAS, or no appreciable effect on the reliability, operational characteristics, or other characteristics affecting the airworthiness of the CMU. Without prejudice to point 21.A.19, all other changes shall be considered ‘major changes’ under this Subpart. Major and minor changes shall be approved in accordance with points 21.A.95 or 21.A.97, as appropriate, and shall be adequately identified.

21.A.92   Eligibility

• (a) 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.

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

21.A.93   Application

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

• (b) 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:
• 1. a description of the change identifying:
• (i) the configuration(s) of the product, the UAS or the CMU in the type certificate upon which the change is to be made;
• (ii) all areas of the product, the UAS or the CMU in the type certificate, including the approved manuals, which are changed or affected by the change; and
• (iii) when the change affects the operational suitability data, any necessary changes to the operational suitability data;
• 1. an identification of any reinvestigations necessary to demonstrate compliance of the change, and of the areas affected by the change, with the applicable type-certification basis, operational suitability data certification basis and environmental protection requirements; and
• 1. for a major change to a type certificate:
• (i) 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 point 21.A.101;
• (ii) 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;
• (iii) 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 applicable type-certification basis, operational suitability data certification basis or environmental protection requirements and the potential impact of that non-compliance on the product or UAS safety or environmental compatibility or on the safety of the CMU; the proposed assessment shall take into account at least the elements set out in points 1 to 4 of point 21.B.100(a). Based on that assessment, the application shall include a proposal for the Agency’s involvement in the verification of the compliance demonstration activities and data; and
• (iv) a project schedule including major milestones.

• (c) 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:
• 1. submit a new application for a change to the type-certificate and comply with the type-certification basis, operational suitability data certification basis and environmental protection requirements, as established by the Agency in accordance with point 21.A.101 and notified in accordance with point 21.B.105 for the date of the new application; or
• 1. apply for an extension of the time period provided for in the first sentence of point (c) for the original application and propose a new date for the issuance of the approval. In that case, the applicant shall comply with the type-certification basis, operational suitability data certification basis and environmental protection requirements, as established by the Agency in accordance with point 21.A.101 and notified in accordance with point 21.B.105, 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 approval by more than five years for an application for a change to type-certificate or restricted type-certificate for a large aeroplane or a large rotorcraft, and by more than three years for an application for a change to any other type-certificate or restricted type certificate.

21.A.95   Requirements for approval of a minor change

• (a) Minor changes to a type-certificate shall be classified and approved by:
• 1. the Agency; or
• 1. an approved design organisation within the scope of its privileges provided for in points (1) and (2) of point 21.A.263(c), as recorded in the terms of approval.

• (b) A minor change to a type-certificate shall only be approved:
• 1. when it has been demonstrated that the change and areas affected by the change comply with the type-certification basis and the environmental protection requirements incorporated by reference in the type-certificate;
• 1. in the case of a change affecting the operational suitability data, when it has been demonstrated that the necessary changes to the operational suitability data comply with the operational suitability data certification basis incorporated by reference in the type-certificate;
• 1. when compliance with the type-certification basis and the environmental protection requirements that apply in accordance with point 1 has been declared and the justifications of compliance have been recorded in the compliance documents; and
• 1. when no feature or characteristic has been identified that may make the product or the CMU unsafe for the uses for which certification is requested.

• (c) 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.

• (d) By way of 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 applicable operational suitability data certification basis has been demonstrated, provided that the applicant demonstrates such compliance before the date on which this data is actually used.

• (e) 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).

• (f) 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.

21.A.97   Requirements for approval of a major change

• (a) Major changes to a type-certificate shall be classified and approved by:
• 1. the Agency; or
• 1. an approved design organisation within the scope of its privileges provided for in points (1) and (8) of point 21.A.263(c), as recorded in the terms of approval.

• (b) A major change to a type-certificate shall only be approved:
• 1. when it has been demonstrated that the change and areas affected by the change comply with the type-certification basis and environmental protection requirements, as established by the Agency in accordance with point 21.A.101;
• 1. in the case of a change affecting the operational suitability data, when it has been demonstrated that the necessary changes to the operational suitability data meet the operational suitability data certification basis, as established by the Agency in accordance with point 21.A.101; and
• 1. when compliance with points (1) and (2) has been demonstrated in accordance with point 21.A.20, as applicable to the change.

• (c) By way of 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 applicable operational suitability data certification basis has been demonstrated, provided that the applicant demonstrates such compliance before the date on which this data is actually used.

• (d) 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.

21.A.101   Type-certification basis, operational suitability data certification basis and environmental protection requirements for a major change to a type-certificate

• (a) A major change to a type-certificate and the areas affected by the change shall comply with either the certification specifications applicable to the changed product, UAS or CMU on the date of the application for the change or the certification specifications which became applicable after that date in accordance with point (f). The validity of the application shall be determined in accordance with point 21.A.93(c). In addition, the changed product or the changed UAS shall comply with the environmental protection requirements designated by the Agency in accordance with point 21.B.85.

• (b) Except as provided for in point (h), by way of 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 on which the corresponding certification specifications incorporated by reference in the type-certificate became applicable:
• 1. a change that the Agency does not find to be significant; in determining whether a specific change is significant, the Agency shall consider the change in the context of all previous relevant design changes and all related revisions to the applicable certification specifications incorporated by reference in the type-certificate for the product or the CMU; changes that meet one of the following criteria shall automatically be considered significant:
• (i) the general configuration or the principles of construction are not retained;
• (ii) the assumptions used for the certification of the product, the UAS or the CMU to be changed do not remain valid;
• 1. each area, system, part, appliance or CMU component that the Agency finds not to be affected by the change;
• 1. each area, system, part, appliance or CMU component that is affected by the change for which the Agency finds that compliance with the certification specifications referred to in point (a) does not contribute materially to the level of safety of the changed product, changed UAS or changed CMU, or is impractical.

• (c) 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.

• (d) 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.

• (e) 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:
• 1. in the case of a type-certificate:
• (i) equivalent to that of the certification specifications designated by the Agency under (a), (b) or (c) above; or
• (ii) compliant with the essential requirements of Annex II to Regulation (EU) 2018/1139;
• 1. in the case of a restricted type-certificate, adequate with regard to the intended use.

• (f) 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.

• (g) When the application for a change to a type-certificate for an aircraft includes, or is supplemented after the initial application to include, changes to the operational suitability data, the operational suitability data certification basis shall be established in accordance with points (a)-(f).

• (h) For large aeroplanes subject to point 26.300 of Annex I to Commission Regulation (EU) 2015/640 ([^E0006]), 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.

21.A.108   Availability of operational suitability data

In the case of a change affecting the operational suitability data, the holder of the minor change approval shall make available:

• (a) at least one set of changes to the operational suitability data prepared in accordance with the applicable operational suitability data 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

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

• (c) on request, the relevant parts of the changes in points (a) and (b) above, to:
• 1. the competent authority responsible for verifying conformity with one or more elements of the affected operational suitability data; and
• 1. any person required to comply with one or more elements of this set of operational suitability data.

21.A.109   Obligations and EPA marking

The holder of a minor change approval to a type-certificate shall:

• (a) 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;

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

SUBPART E —   SUPPLEMENTAL TYPE-CERTIFICATES

21.A.111   Scope

This Subpart establishes the procedure for the approval of major changes to the type-certificate under supplemental type-certificate procedures, and establishes the rights and obligations of the applicants for, and holders of, those certificates. In this Subpart, the references to type-certificates include type-certificates and restricted type-certificates.

21.A.112A   Eligibility

Any natural or legal person that has demonstrated, or is in the process of demonstrating, its capability in accordance with point 21.A.112B may apply for a supplemental type-certificate in accordance with the conditions laid down in this Subpart.

21.A.112B   Demonstration of capability

• (a)An applicant for a supplemental type-certificate shall demonstrate its capability by holding a design organisation approval, issued by the Agency in accordance with Subpart J.

• (b)By way of derogation from point (a), as an alternative procedure to demonstrate its capability, an applicant may seek Agency agreement for the use of procedures setting out the specific design practices, resources and sequence of activities necessary to comply with this Subpart.

• (c)By way of derogation from point (a), in the case of products referred to in point 21.A.14(c), an applicant may demonstrate its capability by obtaining the Agency's acceptance of its certification programme established in accordance with point 21.A.93(b).

21.A.113   Application for a supplemental type-certificate

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

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

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

• (ii) 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.

• (c)Point 21.A.93(c) applies to the requirements for the time limits of the application effectivity as well as the requirements related to the need to update the type-certification basis, operational suitability data certification basis and environmental protection requirements, when the change has not been approved or it is evident that it will not be approved within the time limit established.

21.A.115   Requirements for approval of major changes in the form of a supplemental type-certificate

• (a) Supplemental type certificates shall be issued by:
• 1. the Agency; or
• 1. an approved design organisation within the scope of its privileges provided for in points (1) and (9) of point 21.A.263(c), as recorded in the terms of approval.

• (b) A supplemental type-certificate shall only be issued when:
• 1. the applicant has demonstrated its capability in accordance with point 21.A.112B;
• 1. it has been demonstrated that the change to a type-certificate and areas affected by the change comply with the type-certification basis and the environmental protection requirements, as established by the Agency in accordance with point 21.A.101;
• 1. in the case of a supplemental type-certificate affecting the operational suitability data, it has been demonstrated that the necessary changes to the operational suitability data meet the operational suitability data certification basis, as established by the Agency in accordance with point 21.A.101;
• 1. compliance with points (2) and (3) has been demonstrated in accordance with point 21.A.20, as applicable to the change; and
• 1. in case the applicant has specified that it provided certification data on the basis of an arrangement with the owner of the type-certification data in accordance with point 21.A.113(b):
• (i) the type-certificate holder has indicated that it has no technical objection to the information submitted under point 21.A.93; and
• (ii) the type-certificate holder has agreed to collaborate with the supplemental type-certificate holder to ensure the discharge of all the obligations as regards the continued airworthiness of the changed product, changed UAS or the changed CMU through compliance with points 21.A.44 and 21.A.118A.

• (c) By way of 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 applicable operational suitability data certification basis, provided that the applicant demonstrates such compliance before the date on which this data is to be actually used.

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

21.A.116   Transferability

A supplemental type-certificate shall only be transferred to a natural or legal person that is able to undertake the obligations of point 21.A.118A and for this purpose has demonstrated its ability to qualify under the criteria of point 21.A.112B except for ELA1 aircraft for which the natural or legal person has sought the Agency agreement for the use of procedures setting out its activities to undertake these obligations.

21.A.117   Changes to that part of a product covered by a supplemental type-certificate

• (a) Minor changes to that part of a product, an UAS or a CMU that is covered by a supplemental type-certificate shall be classified and approved in accordance with Subpart D.

• (b) Each major change to that part of a product, an UAS or a CMU that is covered by a supplemental type-certificate shall be approved as a separate supplemental type-certificate in accordance with this Subpart.

• (c) By way of derogation from point (b), a major change to that part of a product, an UAS or a CMU that is covered by a supplemental type-certificate submitted by the supplemental type-certificate holder itself may be approved as a change to the existing supplemental type-certificate.

21.A.118A   Obligations and EPA marking

Each holder of a supplemental type-certificate shall:

• (a) undertake the obligations:
• 1. 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 and 21.A.120B;
• 1. implicit in the collaboration with the type-certificate holder under point 21.A.115(b)(5)(ii); and for this purpose continue to meet the criteria of point 21.A.112B;

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

21.A.118B   Duration and continued validity

• (a)A supplemental type-certificate shall be issued for an unlimited duration. It shall remain valid subject to:

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

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

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

21.A.120B   Availability of operational suitability data

In the case of a change affecting the operational suitability data, the holder of the supplemental type-certificate shall make available:

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

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

• (c) on request, the relevant parts of the changes in points (a) and (b) above, to:
• 1. the competent authority responsible for verifying conformity with one or more elements of the affected operational suitability data; and
• 1. any person required to comply with one or more elements of this set of operational suitability data.

SUBPART F —   PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL

21.A.121   Scope

• (a) This Subpart establishes the procedure for demonstrating conformity with the applicable design data of a product, part, appliance, CMU and CMU component that are intended to be manufactured without a production organisation approval under Subpart G.

• (b) This Subpart establishes the obligations of the manufacturer of a product, part, appliance CMU and CMU component manufactured under this Subpart.

21.A.122   Eligibility

Any natural or legal person may apply to show conformity of individual products, parts, appliances, CMUs and CMU components under this Subpart, if:

• (a) it holds or has applied for an approval that covers the design of that product, part, appliance, CMU and CMU component; or

• (b) 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.

21.A.124   Application

• (a) Each application for an agreement to the showing of conformity of individual products, parts, appliances, CMUs and CMU components under this Subpart shall be made in a form and manner established by the competent authority.

• (b) Such application shall contain:
• 1. evidence which demonstrates, where applicable, that:
• (i) the issuance of a production organisation approval under Subpart G would be inappropriate; or
• (ii) the certification or approval of a product, part, appliance, UAS, CMU or CMU component under this Subpart is required pending the issuance of a production organisation approval under Subpart G;
• 1. an outline of the information required under point 21.A.125A(b).

21.A.124A   Means of compliance

• (a) An organisation may use any alternative means of compliance to establish compliance with this Regulation.

• (b) 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.

21.A.125A   Issuance of a letter of agreement

The applicant shall be entitled to have a letter of agreement issued by the competent authority agreeing to the showing of conformity of individual products, parts, appliances, CMUs or CMU components under this Subpart, after:

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

• (b) having provided a manual that contains:
• 1. a description of the production inspection system required under point (a);
• 1. a description of the means for making the determination of the production inspection system;
• 1. 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);

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

21.A.125B   Findings and observations

• (a) After receipt of the notification of findings in accordance with point 21.B.125, the holder of a letter of agreement shall:
• 1. identify the root cause(s) of, and contributing factor(s) to, the non-compliance;
• 1. define a corrective action plan;
• 1. demonstrate the implementation of the corrective action to the satisfaction of the competent authority.

• (b) 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.

• (c) 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.

21.A.125C   Duration and continued validity

• (a) 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:
• 1. the production organisation continues to comply with the applicable requirements of this Annex;
• 1. the production organisation or any of its partners, suppliers or subcontractors acknowledges that the competent authority may carry out investigations in accordance with point 21.A.9;
• 1. the production organisation is able to provide the competent authority with evidence showing that it maintains satisfactory control of the manufacture of products, parts, appliances, CMUs or CMU components under the letter of agreement;
• 1. the letter of agreement has not been revoked by the competent authority under point 21.B.65, has not been surrendered by the production organisation, and its duration has not expired.

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

21.A.126   Production inspection system

• (a)The production inspection system required under point 21.A.125A(a) shall provide a means for determining that:

• 1. incoming materials and bought or subcontracted parts are as specified in the applicable design data;

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

• 1. processes, manufacturing techniques and methods of assembly affecting the quality and safety of the finished product, part, appliance, UAS, CMU or CMU component are accomplished in accordance with the specifications accepted by the competent authority;

• 1. design changes, including material substitution, have been approved under this Annex and controlled before being incorporated in the finished product part, appliance, UAS, CMU or CMU component.

• (b)The production inspection system required by point 21.A.125A(a), shall also be such as to ensure that:

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

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

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

• 1. rejected materials and parts are segregated and identified in a manner that precludes their installation in the finished product, part, appliance, CMU or CMU component;

• 1. 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, part, appliance, CMU or CMU component 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;

21.A.127   Tests: aircraft

• (a)Each manufacturer of an aircraft manufactured under this Subpart shall establish an approved production ground and flight test procedure and check-off forms, and in accordance with those forms, test each aircraft produced, as a means of establishing relevant aspects of compliance with point 21.A.125A(a).

• (b)Each production test procedure shall include at least the following:

• 1. a check on handling qualities;

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

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

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

• 1. a check of the operational characteristics of the aircraft on the ground;

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

21.A.128   Tests: engines, propellers, and control and monitoring units (CMUs)

Each manufacturer of engines, propellers or CMUs manufactured under this Subpart shall subject each engine, variable pitch propeller, or CMU to an acceptable functional test as specified in the type-certificate holder’s documentation, to determine whether it operates properly throughout the range of operation for which it is type certified, as a means of establishing relevant aspects of compliance with point 21.A.125A(a).

21.A.129   Obligations of the production organisation

Each manufacturer of a product, part, appliance, CMU or CMU component manufactured under this Subpart shall:

• (a) make each product, part, appliance, CMU or CMU component available for inspection by the competent authority;

• (b) maintain at the place of manufacture the technical data and drawings necessary to determine whether the product, part, appliance, CMU or CMU component conforms to the applicable design data;

• (c) maintain the production inspection system which ensures that each product, part, appliance, CMU or CMU component conforms to the applicable design data and is in a condition for safe operation;

• (d) 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, appliances, CMUs or CMU components that have been produced;

• (e) comply with Subpart A of this Section.

21.A.130   Statement of conformity

• (a) Each manufacturer of a product, part, appliance, CMU or CMU component manufactured under this Subpart shall present a statement of conformity, an EASA Form 52 (see Appendix VIII), for complete aircraft, or an EASA Form 1 (see Appendix I), for other products, parts or appliances, CMUs or CMU components. This statement shall be signed by an authorised person who holds a responsible position in the manufacturing organisation.

• (b) A statement of conformity shall include all of the following:
• 1. for each product, part, appliance, CMU or CMU component, a statement that the product, part, appliance, CMU or CMU component conforms to the approved design data and is in a condition for safe operation;
• 1. for each aircraft, a statement that the aircraft has been ground- and flight-checked in accordance with point 21.A.127(a);
• 1. for each engine, variable pitch propeller or CMU, a statement that the engine, variable pitch propeller or CMU has been subjected by the manufacturer to a final functional test in accordance with point 21.A.128;
• 1. additionally, in the case of environmental protection requirements:
• (i) a statement that the completed engine is in compliance with the applicable engine exhaust emissions requirements on the date of manufacture of the engine; and
• (ii) a statement that the completed aeroplane is in compliance with the applicable CO2 emissions requirements on the date its first certificate of airworthiness is issued.

• (c) Each manufacturer of a product, part, appliance, CMU or CMU component referred to in point (a) shall present a current statement of conformity for validation by the competent authority in any of the following situations:
• 1. upon the initial transfer by it of the ownership of such a product, part, appliance, CMU or CMU component;
• 1. upon application for the original issue of an aircraft certificate of airworthiness;
• 1. upon application for the original issue of an airworthiness release document for an engine, a propeller, a part, an appliance, a CMU and a CMU component.

• (d) The competent authority shall validate by countersignature the statement of conformity if it finds after inspection that the product, part, appliance, CMU or CMU component conforms to the applicable design data and is in a condition for safe operation.

SUBPART G —   PRODUCTION ORGANISATION APPROVAL

21.A.131   Scope

This Subpart establishes:

• (a) the procedure for the issuance of a production organisation approval for a production organisation that shows the conformity of products, parts, appliances, CMUs or CMU components with the applicable design data;

• (b) the rights and obligations of the applicant for, and holder of, such approvals.

21.A.133   Eligibility

Any natural or legal person (‘organisation’) shall be eligible as an applicant for an approval under this Subpart. The applicant shall:

• (a) 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

• (b) hold or have applied for an approval of that specific design; or

• (c) have declared or intends to declare compliance of that specific design in accordance with Subpart C of Section A of Annex Ib (Part 21 Light); or

• (d) have ensured satisfactory coordination between production and design, through an appropriate arrangement with:
• (1) the applicant for, or holder of, an approval of that specific design issued in accordance with this Regulation; or
• (2) the natural or legal person who made a declaration of compliance of that specific design in accordance with Subpart C of Section A of Annex Ib (Part 21 Light).

21.A.134   Application

Each application for a production organisation approval shall be made to the competent authority in a form and manner established by that authority, and shall include an outline of the information required by point 21.A.143 and the terms of approval requested to be issued under point 21.A.151.

21.A.134A   Means of compliance

• (a) An organisation may use any alternative means of compliance to establish compliance with this Regulation.

• (b) 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.

21.A.135   Issuance of production organisation approval

An organisation shall be entitled to have a production organisation approval issued by the competent authority when it has demonstrated compliance with the applicable requirements under this Subpart.

21.A.139   Production management system

• (a) 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.

• (b) The production management system shall:
• 1. correspond to the size of the organisation, and to the nature and complexity of its activities, taking into account the hazards and associated risks inherent in those activities;
• 1. be established, implemented and maintained under the direct accountability of a single manager appointed pursuant to point 21.A.145(c)(1).

• (c) As part of the safety management element of the production management system, the production organisation shall:
• 1. establish, implement and maintain a safety policy and the corresponding related safety objectives;
• 1. appoint key safety personnel in accordance with point 21.A.145(c)(2);
• 1. establish, implement and maintain a safety risk management process to identify safety hazards entailed by its aviation activities, evaluate them and manage associated risks, including taking actions to mitigate the risks and verify their effectiveness;
• 1. establish, implement and maintain a safety assurance process that includes:
• (i) the measurement and monitoring of the organisation’s safety performance;
• (ii) the management of changes in accordance with point 21.A.147;
• (iii) the principles for the continuous improvement of the safety management element;
• 1. promote safety in the organisation through:
• (i) training and education;
• (ii) communication;
• 1. establish an occurrence reporting system in accordance with point 21.A.3A in order to contribute to the continuous improvement of safety.

• (d) as part of the quality management element of the production management system, the production organisation shall:
• 1. ensure that each product, part, appliance, CMU or CMU component produced by the 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, thus enabling the exercise of the privileges set out in point 21.A.163;
• 1. establish, implement and maintain, as appropriate, within the scope of the approval, control procedures for:
• (i) document issue, approval or change;
• (ii) vendor and subcontractor assessment audit and control;
• (iii) verifying that incoming products, parts, materials, equipment, CMUs or CMU components, including items supplied new or used by the buyers of the 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) the calibration of tools, jigs, and test equipment;
• (viii) non-conforming item control;
• (ix) airworthiness coordination with:
• (A) the applicant for, or holder of, the design approval;
• (B) the natural or legal person who made a declaration of design compliance in accordance with Subpart C of Section A of Annex Ib (Part 21 Light);
• (x) the completion and retention of records;
• (xi) 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 within the terms of approval performed at any location other than the approved facilities;
• (xvi) work performed after the completion of production but prior to delivery, to maintain the aircraft in a condition for safe operation;
• (xvii) the issue of a permit to fly and approval of the associated flight conditions.
• 1. include specific provisions in the control procedures for any critical parts.

• (e) 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.

• (f) 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.

21.A.139A   Information security management system

In addition to the production management system required by point 21.A.139, the production organisation shall establish, implement and maintain an information security management system in accordance with Commission Delegated Regulation (EU) 2022/1645 ([^E0007]) in order to ensure the proper management of information security risks which may have an impact on aviation safety.

21.A.143   Production organisation exposition

• (a)The production organisation shall establish and maintain a production organisation exposition (POE) that provides directly or by cross reference the following information related to the production management system as described in point 21.A.139:

• 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;

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

• 1. 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;

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

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

• 1. a general description of man-power resources;

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

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

• 1. the procedure for the notification of organisational changes to the competent authority;

• 1. the amendment procedure for the production organisation exposition;

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

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

• 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:
• (i) a description of the organisation's processes for flight test, including the flight test organisation involvement into the permit to fly issuance process;
• (ii) crewing policy, including composition, competency, currency and flight time limitations, in accordance with Appendix XII to this Annex I (Part 21), where applicable;
• (iii) procedures for the carriage of persons other than crew members and for flight test training, when applicable;
• (iv) a policy for risk and safety management and associated methodologies;
• (v) procedures to identify the instruments and equipment to be carried;
• (vi) a list of documents that need to be produced for flight test.

• (b)The initial issue of the POE shall be approved by the competent authority.

• (c)The POE shall be amended as necessary so that it remains an up-to-date description of the organisation. Copies of any amendments shall be supplied to the competent authority.

21.A.145   Resources

The production organisation shall demonstrate that:

• (a) 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;

• (b) with regard to all the necessary airworthiness and environmental protection data:
• 1. the production organisation is in receipt of such data from the Agency and from the holder of, or applicant for, the type certificate, restricted type certificate or design approval issued in accordance with this Regulation or a natural or legal person who made a declaration of design compliance under Subpart C of Section A of Annex Ib (Part 21 Light), including any exemption granted against the environmental protection requirements, to determine conformity with the applicable design data;
• 1. the production organisation has established a procedure to ensure that the airworthiness and environmental protection data are correctly incorporated in its production data;
• 1. such data is kept up to date and made available to all personnel that need access to such data to perform their duties;

• (c) with regard to management and staff:
• 1. an accountable manager has been appointed by the production organisation with the authority to ensure that, within the organisation, all production is performed to the required standards and that the production organisation is continuously in compliance with the requirements of the production management system referred to in point 21.A.139, and the data and procedures identified in the POE referred to in point 21.A.143;
• 1. a person or group of persons has/have been nominated by the accountable manager to ensure that the organisation is in compliance with the requirements of this Annex, and are identified, together with the extent of their authority; such person or group of persons shall be responsible to the accountable manager and have direct access to him. The person or group of persons shall have the appropriate knowledge, background and experience to discharge their responsibilities;
• 1. staff at all levels have been given the appropriate authority to be able to discharge their allocated responsibilities and that there is full and effective coordination within the production organisation in respect of airworthiness and environmental protection data matters;

• (d) 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:
• 1. they have the appropriate knowledge, background (including other functions in the organisation) and experience to discharge their allocated responsibilities;
• 1. they are provided with evidence of the scope of their authorisation.

21.A.147   Changes in the production management system

After the issue of a production organisation approval certificate, each change in the production management system that is significant for the demonstration of conformity or the airworthiness and environmental compatibility characteristics of the product, part, appliance, UAS, CMU or CMU component shall be approved by the competent authority before being implemented. The production organisation shall submit an application for approval to the competent authority demonstrating that it will continue to comply with this Annex.

21.A.148   Changes of location

A change of the location of the manufacturing facilities of the approved production organisation shall be deemed of significance and therefore shall comply with point 21.A.147.

21.A.149   Transferability

Except as a result of a change in ownership, which is deemed significant for the purposes of point 21.A.147, a production organisation approval is not transferable.

21.A.151   Terms of approval

The terms of approval shall identify the scope of work, the products or the categories of parts and appliances, or both, the CMUs or the CMU components, or both, for which the holder is entitled to exercise the privileges under point 21.A.163.

Those terms shall be issued as part of a production organisation approval.

21.A.153   Changes to the terms of approval

Each change to the terms of approval shall be approved by the competent authority. An application for a change to the terms of approval shall be made in a form and manner established by the competent authority. The applicant shall comply with the applicable requirements of this Subpart.

21.A.158   Findings and observations

• (a) After receipt of the notification of findings in accordance with point 21.B.225, the holder of the production organisation approval certificate shall:
• 1. identify the root cause(s) of, and contributing factor(s) to, the non-compliance;
• 1. define a corrective action plan;
• 1. demonstrate the implementation of the corrective action to the satisfaction of the competent authority.

• (b) 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.

• (c) 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.

21.A.159   Duration and continued validity

• (a) A production organisation approval certificate shall be issued for an unlimited period of time. It shall remain valid subject to the production organisation’s compliance with all the following conditions:
• 1. the production organisation continues to comply with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts;
• 1. the competent authority is permitted by the production organisation or by any of its partners, suppliers or subcontractors to perform the investigations in accordance with point 21.A.9;
• 1. the production organisation is able to provide the competent authority with evidence showing that it maintains satisfactory control of the manufacture of products, parts, appliances, CMUs or CMU components under the approval;
• 1. the production organisation approval certificate has not been revoked by the competent authority under point 21.B.65, or surrendered by the production organisation.

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

21.A.163   Privileges

Pursuant to the terms of approval issued under point 21.A.135, the holder of a production organisation approval may:

• (a) perform production activities under this Annex or Annex Ib (Part 21 Light);

• (b) in the case of complete type-certified aircraft and upon presentation, for aircraft and UAS, of a statement of conformity (EASA Form 52) issued under point 21.A.174 and 21.A.204 of this Annex or under points 21L.A.143(c) and 21.L.A163 of Annex Ib (Part 21 Light), obtain an aircraft certificate of airworthiness and a noise certificate without further showing;

• (c) in the case of other products, parts, appliances, CMUs or CMU components, issue authorised release certificates (EASA Form 1) under Subpart G of this Annex or under Subpart G of Annex Ib (Part 21 Light) without further showing;

• (d) in the case of an aircraft that is subject to a declaration of design compliance under point 21L.A.43 of Annex Ib (Part 21 Light) and upon presentation of a statement of conformity (EASA Form 52B) issued under points 21L.A.143(d) and 21L.A.163 of Annex Ib (Part 21 Light), obtain an aircraft restricted certificate of airworthiness and a restricted noise certificate without further showing;

• (e) in the case of products or parts to be installed on an aircraft that is subject to a declaration of design compliance under point 21L.A.43 of Annex Ib (Part 21 Light), issue authorised release certificates (EASA Form 1) under Annex Ib (Part 21 Light) without further showing;

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