Commission Delegated Regulation (EU) 2024/1108 of 13 March 2024 amending Regulation (EU) No 748/2012 as regards the initial airworthiness of unmanned aircraft systems subject to certification and Delegated Regulation (EU) 2019/945 as regards unmanned aircraft systems and third-country operators of unmanned aircraft systems

Image omitted; see official source	Official Journal of the European Union	EN L series
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	2024/1108	23.5.2024

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 [^ntr1-L_202401108EN.000101-E0001] and in particular Article 58(1) and point (d) of Article 61(1) thereof,

Whereas:

• (1) Article 56 of Regulation (EU) 2018/1139 on the compliance of unmanned aircraft, considering the nature of and risk entailed by unmanned aircraft operations, establishes that, depending on such risk and nature, a certificate may be required for the design, production and maintenance of unmanned aircraft and their engines, propellers, parts, non-installed equipment and equipment to control them remotely.

• (2) In accordance with Article 56 of Regulation (EU) 2018/1139, Article 40 of Commission Delegated Regulation (EU) 2019/945 [^ntr2-L_202401108EN.000101-E0002] lays down the requirements for the certification of unmanned aircraft systems.

• (3) Point (b) of Article 58(1) of Regulation (EU) 2018/1139 provides that the conditions and procedures for issuing the certificate required under Article 55 of that Regulation may be based on, or consist of, the essential requirements for the design as set out in Annex IX of Regulation (EU) 2018/1139 and environmental performance requirements set out in Annex III of the same Regulation.

• (4) Commission Regulation (EU) No 748/2012 [^ntr3-L_202401108EN.000101-E0003] laying down requirements for the design and production of civil aircraft, as well as of engines, propellers and parts to be installed therein, should be adapted to address the specificities of unmanned aircraft systems.

• (5) Such specificities include the equipment to control unmanned aircraft remotely, as defined by Article 3 of Regulation (EU) 2018/1139. That equipment is defined as ‘control and monitoring unit’ by Commission Implementing Regulation (EU) 2024/1110 [^ntr4-L_202401108EN.000101-E0004].

• (6) The safe operations of unmanned aircraft that are subject to certification requires the control and monitoring unit to be subject to the same procedures under which certificates are issued for unmanned aircraft, determining that the same certification process applies to unmanned aircraft systems since they are composed of the unmanned aircraft and its control and monitoring unit.

• (7) Lighter-than-air unmanned aircraft systems pose an intrinsic risk to third parties, albeit lower than other unmanned aircraft configurations, and therefore may be operated without the need to issue a certificate for the design.

• (8) The verification of the design of unmanned aircraft systems specifically designed or modified for research, experimental or scientific purposes may be conducted without the need to issue a type certificate because they are typically operated in lower risk environment.

• (9) The continuing airworthiness of unmanned aircraft systems for which a type certificate is required should comply with Commission Delegated Regulation (EU) 2024/1107 [^ntr5-L_202401108EN.000101-E0005], while compliance is not required for those unmanned aircraft systems that are intended to be used in operations for which a type certificate is not mandated in accordance with point (d) of Article 40(1) of Regulation (EU) 2019/945, even if the manufacturer has elected to apply for it.

• (10) In order to provide stakeholders with sufficient time to ensure compliance with the new framework for the initial airworthiness of certified unmanned aircraft systems (UAS), this Regulation shall apply from 1 May 2025,

HAS ADOPTED THIS REGULATION:

Article 1

Amendments to Regulation (EU) No 748/2012

Regulation (EU) No 748/2012 is amended as follows:

• (1) the title is replaced by the following:

‘ Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness and environmental certification or declaration of compliance of aircraft and related products, parts, appliances, control and monitoring units and control and monitoring unit components, as well as for the capability requirements of design and production organisations (recast) ’;

• (2) Article 1 is amended as follows:

• (a) paragraph 1 is amended as follows:

• (i) the introductory sentence is replaced by the following:

‘This Regulation lays down, in accordance with Articles 19, 58 and 62 of Regulation (EU) 2018/1139[^ntr*1-L_202401108EN.000101-E0006], common technical requirements and administrative procedures for the airworthiness and environmental certification or declaration of compliance of products, parts, appliances, control and monitoring units and control and monitoring unit components specifying:

[^ntr*1-L_202401108EN.000101-E0006]: Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1, ELI: http://data.europa.eu/eli/reg/2018/1139/oj)’;"

• (ii) points (f) and (g) are replaced by the following:

• ‘(f) the identification of products, parts, appliances, control and monitoring units and control and monitoring unit components;

• (g) the certification of certain parts, appliances and control and monitoring unit components;’;

• (b) paragraph 2 is amended as follows:

• (i) points (c) and (d) are replaced by the following:

• ‘(c) ‘Part 21’ means the requirements and procedures for the certification of aircraft and related products, parts, appliances, control and monitoring units and control and monitoring unit components, and of design and production organisations laid down in Annex I to this Regulation;

• (d) ‘Part 21 Light’ means the requirements and procedures for the certification or declaration of design compliance of aircraft other than unmanned aircraft intended primarily for sports and recreational use and of related products and parts, and declaration of design and production capability of organisations laid down in Annex Ib (Part 21 Light) to this Regulation;’;

• (ii) point (f) is replaced by the following:

• ‘(f) ‘article’ means any part and appliance to be used on civil aircraft and any control and monitoring unit component;’;

• (iii) point (h) is replaced by the following:

• ‘(h) ‘EPA’ stands for European Part Approval. The European Part Approval of an article means that the article has been produced in accordance with approved design data not belonging to the type-certificate holder of the related product and control and monitoring unit, except for ETSO articles;’;

• (iv) the following points (l), (m), (n), (o) and (p) are added:

• ‘(l) ‘control and monitoring unit (CMU)’ means the equipment to control and monitor unmanned aircraft remotely, as defined in Article 3(32) of Regulation (EU) 2018/1139;

• (m) ‘control and monitoring unit component’ means any element of the control and monitoring unit;

n) ‘control and monitoring unit installation’ means the process to integrate the control and monitoring unit components in a physical environment eligible for that purpose according to a set of installation and testing instructions, such that the installed control and monitoring unit can be used to operate an unmanned aircraft;

• (o) ‘unmanned aircraft system (UAS)’ means an unmanned aircraft, as defined in Article 3(30) of Regulation (EU) 2018/1139, and its control and monitoring unit;

• (p) ‘VTOL-capable aircraft’ (VCA) means a power-driven, heavier-than-air aircraft other than aeroplane or rotorcraft, capable of performing vertical take-off and landing by means of lift and thrust units used to provide lift during the take-off and landing.’;

• (3) Article 2 is amended as follows:

• (1) the heading is replaced by the following:

‘Certification of products, parts, appliances, control and monitoring unit and control and monitoring unit components’

• (2) paragraph 1 is replaced by the following:

‘1.   Products, parts, appliances, control and monitoring units and control and monitoring unit components shall be issued with certificates as specified in Annex I (Part 21).’

;

• (3) in paragraph 2, the introductory sentence is replaced by the following:

‘By way of derogation from paragraph 1, certificates may be alternatively issued as specified in Annex I (b) (Part 21 Light) for the following products other than unmanned aircraft:’;

• (4) in paragraph 3, the introductory sentence is replaced by the following:

‘By way of derogation from paragraphs 1 and 2, a declaration of design compliance may alternatively be made, as specified in Annex Ib (Part 21 Light), for the following products other than unmanned aircraft:’;

• (4) Article 8 is amended as follows:

• (1) paragraph 1 is replaced by the following:

‘1.   An organisation responsible for the design of products, parts, appliances, control and monitoring units and control and monitoring unit components, or for changes or repairs thereto, shall demonstrate its capability in accordance with Annex I (Part 21).’

;

• (2) in paragraph 5, the introductory sentence is replaced by the following:

‘By way of derogation from paragraph 1, an organisation whose principal place of business is in a non-Member State may demonstrate its capability by holding a certificate issued by that State for the product, part, appliance, control and monitoring unit and control and monitoring unit component for which it applies in accordance with Annex I (Part 21), provided:’;

• (5) Article 9 is amended as follows:

• (1) paragraphs 1 and 2 are replaced by the following:

‘1.   An organisation responsible for the manufacture of products, parts, appliances, control and monitoring units and control and monitoring unit components shall demonstrate its capability in accordance with Annex I (Part 21). This demonstration of capability is not required for the parts, appliances or control and monitoring unit components that an organisation manufactures which, in accordance with Annex I (Part 21), are eligible for installation in a type-certified product without the need to be accompanied by an authorised release certificate (EASA Form 1).t

1. By way of derogation from paragraph 1, a manufacturer whose principal place of business is in a non-Member State may demonstrate its capability by holding a certificate issued by that State for the product, part, appliance, control and monitoring unit and control and monitoring unit component for which it applies, provided that both of the following conditions are fulfilled:

• (a) that State is the State of manufacture;

• (b) the Agency has determined that the system of that State includes the same independent level of checking of compliance as provided for by this Regulation, either through an equivalent system of approvals of organisations or through direct involvement of the competent authority of that State.’

;

• (2) in paragraph 8, point (a) is replaced by the following:

• ‘(a) the manufacture of parts, appliances and control and monitoring unit components that are eligible, in accordance with Annex I (Part 21), for installation in a type-certified product without the need to be accompanied by an authorised release certificate (EASA Form 1);’;

• (6) Annex I (Part 21) is amended in accordance with Annex I to this Regulation.

Article 2

Amendments to Delegated Regulation (EU) 2019/945

Delegated Regulation (EU) 2019/945 is amended as follows:

• (1) Article 3 is amended as follows:

• (a) point (3) is replaced by the following:

• ‘(3) ‘unmanned aircraft system’ (‘UAS’) means an unmanned aircraft, as defined in Article 3 point (30) of Regulation (EU) 2018/1139[^ntr*2-L_202401108EN.000101-E0007], and its control and monitoring unit;

[^ntr*2-L_202401108EN.000101-E0007]: Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1, ELI: http://data.europa.eu/eli/reg/2018/1139/oj)’;"

• (b) point (38) is replaced by the following:

• ‘(38) ‘control and monitoring unit’ (‘CMU’) means the equipment to control and monitor unmanned aircraft remotely, as defined in Article 3 point (32) of Regulation (EU) 2018/1139;’;

• (c) point (39) is replaced by the following:

• ‘(39) ‘C2 link’ means the data link between the unmanned aircraft and the CMU for the purposes of managing the flight;’;

• (2) Article 40 is amended as follows:

• (a) paragraph 1 is replaced by the following:

‘1.   The design, production and maintenance of UAS that meets any of the following conditions shall be certified:

• (a) it has a characteristic dimension of 3 m or more, and is designed to be operated over assemblies of people unless the UA is lighter than air;

• (b) it is designed for transporting people;

• (c) it is designed for the purpose of transporting dangerous goods and requiring a high level of robustness to mitigate the risks to third parties in case of an accident;

• (d) it is intended to be used in the ‘specific’ category of operations as defined in Article 5 of Implementing Regulation (EU) 2019/947 and the competent authority has concluded, in accordance with Article 12(1) of Regulation (EU) 2019/947, on the basis of the risk assessment conducted by UAS operator in accordance with Article 11 of that Regulation, that the risk of the operation cannot be adequately mitigated without the certification of the UAS.’

;

• (b) the following paragraph 1a is inserted:

‘1a.   Paragraph 1 does not apply to UAS that are specifically designed or modified for research, experimental or scientific purposes, and are likely to be produced in very limited numbers. The operation of such UAS will be subject to a permit to fly in accordance with Subpart B of Annex I of Regulation (EU) No 748/2012.’

;

• (c) paragraph 2 is replaced by the following:

‘2.   An UAS that meets the conditions specified in paragraph 1 shall comply with the applicable requirements laid down in Commission Regulation (EU) No 748/2012[^ntr3-L_202401108EN.000101-E0008], Commission Regulation (EU) 2015/640[^ntr4-L_202401108EN.000101-E0009] and Commission Delegated Regulation (EU) 2024/1107[^ntr*5-L_202401108EN.000101-E0010].

[^ntr*3-L_202401108EN.000101-E0008]: Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness and environmental certification or declaration of compliance of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations (recast) (OJ L 224, 21.8.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/748/oj)."

[^ntr*4-L_202401108EN.000101-E0009]: Commission Regulation (EU) 2015/640 of 23 April 2015 on additional airworthiness specifications for a given type of operations and amending Regulation (EU) No 965/2012 (OJ L 106, 24.4.2015, p. 18, ELI: http://data.europa.eu/eli/reg/2015/640/oj)."

[^ntr*5-L_202401108EN.000101-E0010]: Commission Delegated Regulation (EU) 2024/1107 of 13 March 2024 supplementing Regulation (EU) No 2018/1139 of the European Parliament and of the Council by laying down detailed rules for the continuing airworthiness of certified unmanned aircraft systems and their components, and on the approval of organisations and personnel involved in these tasks (OJ L, 2024/1107, 17.5.2024, ELI: http://data.europa.eu/eli/reg_del/2024/1107/oj).’ "

;

• (d) the following paragraph 2a is inserted:

‘2a.   UAS certified for reasons other than those specified in paragraph 1 shall comply with the applicable requirements laid down in Regulation (EU) No 748/2012 and in Regulation (EU) 2015/640.’

;

• (3) the Annex is amended in accordance with Annex II to this Regulation.

Article 3

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 May 2025.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 13 March 2024.

For the Commission

The President

Ursula VON DER LEYEN

[^ntr1-L_202401108EN.000101-E0001]: OJ L 212, 22.8.2018, p. 1.

[^ntr2-L_202401108EN.000101-E0002]: Commission Delegated Regulation (EU) 2019/945 of 12 March 2019 on unmanned aircraft systems and on third-country operators of unmanned aircraft systems (OJ L 152, 11.6.2019, p. 1, ELI: http://data.europa.eu/eli/reg_del/2019/945/oj).

[^ntr3-L_202401108EN.000101-E0003]: 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) (OJ L 224, 21.8.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/748/oj).

[^ntr4-L_202401108EN.000101-E0004]: Commission Implementing Regulation (EU) 2024/1110 of 10 April 2024 amending Regulation (EU) No 748/2012 as regards the initial airworthiness of unmanned aircraft systems subject to certification and Implementing Regulation (EU) 2019/947 as regards the rules and procedures for the operation of unmanned aircraft (OJ L, 2024/1110, 17.5.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/1110/oj).

[^ntr5-L_202401108EN.000101-E0005]: Commission Delegated Regulation (EU) 2024/1107 of 13 March 2024 supplementing Regulation (EU) 2018/1139 of the European Parliament and of the Council by laying down detailed rules for the continuing airworthiness of certified unmanned aircraft systems and their components, and on the approval of organisations and personnel involved in these tasks (OJ L, 2024/1107, 17.5.2024, ELI: http://data.europa.eu/eli/ reg_del/2024/1107/oj).

ANNEX I

Annex I to Regulation (EU) No 748/2012 is amended as follows:

• (1) the title of Part 21 is replaced by the following:

‘Certification of aircraft and related products, parts, appliances, control and monitoring units and control and monitoring unit components, and of design and production organisations’;

• (2) the table of contents (‘Contents’) is amended as follows:

• (a) the title of point 21.A.2 is replaced by the following:

• ‘21.A.2 Undertaking by a person other than the applicant for, or holder of, a certificate’;

• (b) the title of point 21.A.35 is replaced by the following:

‘Flight tests’;

• (c) the title of point 21.A.115 is replaced by the following:

• ‘21.A.115 Requirements for the approval of major changes in the form of a supplemental type certificate’;

• (d) the title of point 21.A.128 is replaced by the following:

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

• (e) The title of Subpart K in Section A is replaced by the following:

‘SUBPART K — PARTS, APPLIANCES, AND CONTROL AND MONITORING UNIT (CMU) COMPONENTS’;

• (f) the title of point 21.A.303 is replaced by the following:

• ‘21.A.303 Compliance with the applicable requirements’;

• (g) the title of point 21.A.305 is replaced by the following:

• ‘21.A.305 Approval of parts, appliances, and control and monitoring unit (CMU) components’;

• (h) the following new title of point 21.A.308 is added:

• ‘21.A.308 Eligibility of a component for installation on a control and monitoring unit (CMU)’;

• (i) the title of Subpart Q in Section A is replaced by the following:

‘SUBPART Q — IDENTIFICATION OF PRODUCTS, PARTS, APPLIANCES, CONTROL AND MONITORING UNITS (CMUs) AND CMU COMPONENTS’;

• (j) the title of point 21.A.801 is replaced by the following:

• ‘21.A.801 Identification of products and control and monitoring units (CMUs)’;

• (k) the title of point 21.A.804 is replaced by the following:

• ‘21.A.804 Identification of parts, appliances and control and monitoring unit (CMU) components’;

• (l) the title of Subpart K in Section B is replaced by the following:

‘SUBPART K — PARTS, APPLIANCES AND CONTROL AND MONITORING UNIT (CMU) COMPONENTS’;

• (m) the title of Subpart Q in Section B is replaced by the following:

‘SUBPART Q — IDENTIFICATION OF PRODUCTS, PARTS, APPLIANCES, CONTROL AND MONITORING UNITS (CMUs) AND CMU COMPONENTS’;

• (3) point 21.A.2 is replaced by the following:

‘21.A.2   Undertaking by a person other than the applicant for, or holder of, a certificate

The actions and obligations required to be undertaken by the applicant for, or holder of, a certificate for a product, part, appliance, control and monitoring unit (CMU) or CMU component under this Section may be undertaken on their behalf by any other natural or legal person, provided the applicant for, or holder of, that certificate can show that they have made an agreement with the other person to ensure that the certificate holder’s obligations are and will be properly discharged.’;

• (4) point 21.A.3A is amended as follows:

• (a) point (a) is replaced by the following:

• ‘(a) Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council[^ntr*1-L_202401108EN.000701-E0001] and its delegated and implementing acts, all natural or legal persons that have applied for or hold a type-certificate, restricted type-certificate, supplemental type-certificate, European Technical Standard Order (ETSO) authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation shall:

• 1. establish and maintain a system for collecting, investigating and analysing occurrence reports in order to identify adverse trends or to address deficiencies and to extract occurrences whose reporting is mandatory in accordance with point 3 and those which are reported voluntarily. When the principal place of business is located in a Member State, a single system may be established to meet the requirements of Regulation (EU) No 376/2014 of the European Parliament and of the Council and its implementing acts and of Regulation (EU) 2018/1139 and its delegated and implementing acts. The reporting system shall include:

• (i) reports of and information related to failures, malfunctions, defects or other occurrences which cause or might cause adverse effects on the continuing airworthiness of the product, part, appliance, UAS, CMU or CMU component covered by the type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or by any other relevant approval deemed to have been issued under this Regulation;

• (ii) errors, near misses and hazards that do not fall under point (i);

• 1. make available to known operators of the product, part, appliance, UAS, CMU or CMU component and, on request, to any person authorised under other implementing or delegated acts the information about the system established in accordance with point 1, and on how to provide reports of and information related to failures, malfunctions, defects or other occurrences referred to in point l(i);

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

[^ntr*1-L_202401108EN.000701-E0001]: Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18).’;"

• (b) point (b) is replaced by the following:

• ‘(b) Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, any natural or legal person that holds or has applied for a production organisation approval certificate under Subpart G of this Section, or that produces a product, part, appliance, UAS, CMU or CMU component under Subpart F of this Section, shall:

• 1. establish and maintain a system for collecting and assessing occurrence reports, including reports on errors, near misses and hazards, in order to identify adverse trends or to address deficiencies and extract occurrences whose reporting is mandatory in accordance with points 2 and 3 of this point and those which are reported voluntarily. For organisations that have their principal place of business in a Member State, a single system may be established to meet the requirements of Regulation (EU) No 376/2014 and its implementing acts and of Regulation (EU) 2018/1139 and its delegated and implementing acts;

• 1. report to the responsible design approval holder all the cases where products, parts, appliances, UAS, CMUs or CMU components have been released by the production organisation and possible deviations from the applicable design data have been subsequently identified, and investigate with the design approval holder to identify those deviations which could lead to an unsafe condition;

• 1. report to the competent authority of the Member State responsible in accordance with point 21.1 and the Agency the deviations that have been identified in accordance with point 21.A.3A(b)2 and which could lead to an unsafe condition;

• 1. if the production organisation acts as a supplier to another production organisation, also report to that other organisation all the cases where it has released products, parts, appliances, UAS, CMUs or CMU components to that organisation and the possible deviations from the applicable design data that have been subsequently identified.’;

• (5) point 21.A.3B is replaced by the following:

‘21.A.3B   Airworthiness directives

• (a) An airworthiness directive means a document issued or adopted by the Agency which mandates actions to be performed on an aircraft or on a CMU to restore an acceptable level of safety, when evidence shows that the safety level of the aircraft, UAS or CMU may otherwise be compromised.

• (b) The Agency shall issue an airworthiness directive when:

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

• 1. that condition is likely to exist or develop in other aircraft, UAS or CMUs.

• (c) When an airworthiness directive has to be issued by the Agency to correct the unsafe condition referred to in point (b), or to require the performance of an inspection, the holder of the type-certificate, restricted type-certificate, supplemental type-certificate, major repair design approval, ETSO authorisation or any other relevant approval deemed to have been issued under this Regulation, shall:

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

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

• (d) An airworthiness directive shall contain at least the following information:

• 1. an identification of the unsafe condition;

• 1. an identification of the affected aircraft or CMU;

• 1. the action(s) required;

• 1. the compliance time for the required action(s);

• 1. the date of entry into force of the airworthiness directive.’;

• (6) in point 21.A.4, point (b) is replaced by the following:

• ‘(b) the proper support of the continued airworthiness of the product, part, appliance, UAS, CMU or CMU component.’;

• (7) in point 21.A.5, points (a), (b) and (c) are replaced by the following:

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

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

• (c) with regard to permits to fly:

• 1. maintain the documents that are produced to establish and justify the flight conditions, and make them available to the Agency and to their competent authority of the Member State in order to provide the information that is necessary to ensure the continued airworthiness of the aircraft, the UAS and the CMU;

• 1. when they issue a permit to fly under the privilege of approved organisations, maintain the documents associated with it, including inspection records and documents that support the approval of the flight conditions and the issuance of the permit to fly itself, and make them available to the Agency and to their competent authority of the Member State responsible for the oversight of the organisation in order to provide the information that is necessary to ensure the continued airworthiness of the aircraft, the UAS and the CMU;’;

• (8) point 21.A.6 is replaced by the following:

‘21.A.6   Manuals

The holder of a type-certificate, restricted type-certificate, or supplemental type-certificate shall:

• ‘(a) produce, maintain and update master copies of all manuals or variations in the manuals required by the applicable type-certification basis, the applicable operational suitability data certification basis and the applicable environmental protection requirements for the product, UAS, CMU or article, and provide copies, on request, to the Agency;

• (b) for unmanned aircraft, determine whether the installation of a CMU in a physical environment is necessary, and provide the operator with all the necessary instructions for the installation of the CMU and for its installation to be released in accordance with Annex I (Part-ML.UAS) to Commission Delegated Regulation (EU) 2024/1107’;

• (9) points 21.A.7 is replaced by the following:

‘21.A.7   Instructions for continued airworthiness

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

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

• 1. a type-certificate or restricted type-certificate to each known owner of one or more products, UAS or CMUs upon their delivery or upon the issuance of the first certificate of airworthiness or restricted certificate of airworthiness for the affected aircraft, whichever occurs later;

• 1. a supplemental type-certificate or design change approval to all known operators of the product, the UAS or the CMU affected by the change upon the release to service of the modified product or modified CMU;

• 1. a repair design approval to all known operators of the product or the CMU affected by the repair upon the release to service of the product or the CMU in which the repair design is embodied; the repaired product, part, appliance, CMU or CMU component may be released into service before the related instructions for continued airworthiness have been completed, but this shall be for a limited service period, and in agreement with the Agency.

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

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

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

• (10) in point 21.A.9, point (a) is replaced by the following:

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

• (11) point 21.A.11 is replaced by the following:

‘21.A.11   Scope

This Subpart establishes the procedure for issuing type-certificates for products and CMUs and restricted type-certificates for aircraft, and establishes the rights and obligations of the applicants for, and holders of, those certificates.’;

• (12) point 21.A.15, is amended as follows:

• (a) point (b) is replaced by the following:

• ‘(b) An application for a type-certificate or restricted type-certificate shall include, as a minimum, preliminary descriptive data of the product, the UAS or the CMU, and the kind of operations for which certification is requested. In addition, it 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 all of the following:

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

• 1. the proposed operating characteristics and limitations;

• 1. the intended use of the product, the UAS or the CMU, and the kind of operations for which certification is requested;

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

• 1. 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;

• 1. a proposal for the assessment of the meaningful groups of compliance demonstration activities and data, addressing the likelihood of an unidentified non-compliance with the type-certification basis, operational suitability data certification basis or environmental protection requirements and the potential impact of that non-compliance on product and UAS safety or environmental protection 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;

• 1. a project schedule including major milestones.’;

• (b) point (e) is replaced by the following:

• ‘(e) An application for a type-certificate or restricted type-certificate for a large aeroplane or a large rotorcraft shall be valid for 5 years and an application for any other type-certificate or restricted type-certificate shall be valid for 3 years, unless the applicant demonstrates at the time of application that its product, UAS or CMU requires a longer period of time to demonstrate and declare compliance and the Agency agrees to that longer period of time.’;

• (13) point 21.A.19 is replaced by the following:

‘21.A.19   Changes requiring a new type-certificate

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

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.’;

• (14) in point 21.A.20(d), point 2 is replaced by the following:

• ‘2. 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.’;

• (15) point 21.A.21 is replaced by the following:

‘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.’;

• (16) point 21.A.31 is replaced by the following:

‘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.’;

• (17) in point 21.A.33(b)(1), point (ii) is replaced by the following:

• ‘(ii) the parts of the products and the CMU components adequately conform to the drawings in the proposed type design; and’;

• (18) point 21.A.35 is amended as follows:

• (a) point (b) is replaced by the following:

• ‘(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.’;

• (b) point (f) is replaced by the following:

• ‘(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.’;

• (19) point 21.A.41 is replaced by the following:

‘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.’;

• (20) in point 21.A.90B(a), point 1 is replaced by the following:

• ‘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;’;

• (21) point 21.A.91 is replaced by the following:

‘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, operational suitability data, or other characteristics affecting the airworthiness of the product or of the UAS, or its environmental characteristics, 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.’;

• (22) in point 21.A.93, point (b) is replaced by the following:

• ‘(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 product or UAS safety or environmental protection 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.’;

• (23) point 21.A.95 is amended as follows:

• (a) in point (b), point 4 is replaced by the following:

• ‘4. 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.’;

• (b) point (d) is replaced by the following:

• ‘(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.’;

• (24) in point 21.A.97, point (c) is replaced by the following:

• ‘(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.’;

• (25) in point 21.A.101, points (a) and (b) are replaced by the following:

• ‘(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.’;

• (26) in point 21.A.108, point (a) is replaced by the following:

• ‘(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’;

• (27) point 21.A.115 is amended as follows:

• (a) in point (b)(5), point (ii) is replaced by the following:

• ‘(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.’;

• (b) point (c) is replaced by the following:

• ‘(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.’;

• (28) point 21.A.117 is replaced by the following:

‘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.’;

• (29) in point 21.A.118A(a), point 2 is replaced by the following:

• ‘2. implicit in the collaboration with the type-certificate holder under point 21.A.115(b)(5)(ii);’;

• (30) point 21.A.120B(a) is replaced by the following:

• ‘(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’;

• (31) point 21.A.121 is replaced by the following:

‘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.’;

• (32) point 21.A.122 is amended as follows:

• (a) the introductory sentence is replaced by the following:

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

• (b) point (a) is replaced by the following:

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

• (33) point 21.A.124 is replaced by the following:

‘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).’;

• (34) point 21.A.125A is amended as follows:

• (a) the introductory sentence is replaced by the following:

‘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:’;

• (b) point (a) is replaced by the following:

• ‘(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;’;

• (35) in point 21.A.125C(a), point 3 is replaced by the following:

• ‘3. 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;’;

• (36) point 21.A.126 is amended as follows:

• (a) point 1 of point (a) is replaced by the following:

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

• (b) point 3 of point (a) is replaced by the following:

• ‘3. 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;’;

• (c) point 4 of point (a) is replaced by the following:

• ‘4. 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.’;

• (d) points 4 and 5 of point (b) are replaced by the following:

• ‘4. 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;’;

• (37) point 21.A.128 is replaced by the following:

‘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).’;

• (38) point 21.A.129 is replaced by the following:

‘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.’;

• (39) point 21.A.130 is replaced by the following:

‘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.’;

• (40) point 21.A.131 is replaced by the following:

‘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.’;

• (41) point 21.A.139(d) is amended as follows:

• (a) point 1 is replaced by the following:

• ‘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;’;

• (b) in point 2, point (iii) is replaced by the following:

• ‘(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;’;

• (42) point 21.A.147 is replaced by the following:

‘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 protection 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.’;

• (43) point 21.A.151 is replaced by the following:

‘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.’;

• (44) in point 21.A.159(a), point 3 is replaced by the following:

• ‘3. 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;’;

• (45) point 21.A.163 is amended as follows:

• (a) point (b) is replaced by the following:

• ‘(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;’;

• (b) point (c) is replaced by the following:

• ‘(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;’;

• (46) point 21.A.165 is amended as follows:

• (a) point (c) is amended as follows:

• (i) point 2 is replaced by the following:

• ‘2. determine that other products, parts, appliances, CMUs or CMU components are complete and conform to the approved design data and are in a condition for safe operation before issuing an EASA Form 1 to certify their conformity to approved or declared design data and that they are in a condition for safe operation;’;

• (ii) point 4 is replaced by the following:

• ‘4. determine that other products, parts, appliances, CMUs or CMU components conform to the applicable data before issuing an EASA Form 1 as a conformity certificate;’;

• (b) point (d) is replaced by the following:

• ‘(d) provide assistance to the holder of the type-certificate or other design approval 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) in dealing with any continuing airworthiness actions that are related to the products, parts, appliances, UAS, CMUs or CMU components that have been produced;’;

• (47) in point 21.A.174, point (b) is replaced by the following:

• ‘(b) Each application for a certificate of airworthiness or a restricted certificate of airworthiness shall include:

• 1. the class of the airworthiness certificate for which an application has been made;

• 1. with regard to new aircraft:

• (i) a statement of conformity:

• — issued under point 21.A.163(b); or

• — issued under point 21.A.130 and validated by the competent authority; or

• — for an imported aircraft, a statement of conformity issued under point 21.A.163(b) or, in the case of an aircraft imported in accordance with Article 9(2) of this Regulation, a statement signed by the exporting authority that the aircraft conforms to a design approved by the Agency;

• (ii) a weight and balance report with a loading schedule when required by the applicable certification specifications for the particular aircraft; and

• (iii) the flight manual, when required by the applicable certification specifications for the particular aircraft;

• 1. with regard to used aircraft originating from: