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

Article 1

Scope and definitions

• (a) the issue of type certificates, restricted type certificates, supplemental type certificates and changes to those certificates;

• (b) the issue of certificates of airworthiness, restricted certificates of airworthiness, permits to fly and authorised release certificates;

• (c) the issue of repair design approvals;

• (d) the showing of compliance with environmental protection requirements;

• (e) the issue of noise certificates and restricted noise certificates;

• (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;

• (h) the certification of design and production organisations;

• (i) the issue of airworthiness directives;

• (j) the making of declarations of design compliance and changes to those declarations;

• (k) the making of declarations of design and production capability.

• (a) ‘JAA’ means the ‘Joint Aviation Authorities’;

• (b) ‘JAR’ means ‘Joint Aviation Requirements’;

• (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;

• (e) ‘principal place of business’ means the head office or registered office of the undertaking within which the principal financial functions and operational control of the activities referred to in this Regulation are exercised;

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

• (g) ‘ETSO’ means European Technical Standard Order. The European Technical Standard Order is a detailed airworthiness specification issued by the European Union Aviation Safety Agency (the ‘Agency’) to ensure compliance with the requirements of this Regulation as a minimum performance standard for specified articles;

• (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;

• (ha) ‘complex motor-powered aircraft’ means:
• (i) an aeroplane
• — with a maximum certificated take-off mass exceeding 5 700 kg, or
• — certificated for a maximum passenger seating configuration of more than nineteen, or
• — certificated for operation with a minimum crew of at least two pilots, or
• — equipped with (a) turbojet engine(s) or more than one turboprop engine, or
• (ii) a helicopter certificated:
• — for a maximum take-off mass exceeding 3 175 kg, or
• — for a maximum passenger seating configuration of more than nine, or
• — for operation with a minimum crew of at least two pilots, or
• (iii) a tilt rotor aircraft;

• (i) ‘ELA1 aircraft’ means the following manned European Light Aircraft:
• (i) an aeroplane with a maximum take-off mass (MTOM) of 1 200 kg or less that is not classified as complex motor-powered aircraft;
• (ii) a sailplane or powered sailplane of 1 200 kg MTOM or less;
• (iii) a balloon with a maximum design lifting gas or hot air volume of not more than 3 400 m3 for hot air balloons, 1 050 m3 for gas balloons, 300 m3 for tethered gas balloons;
• (iv) an airship designed for not more than four occupants and a maximum design lifting gas or hot air volume of not more than 3 400 m3 for hot air airships and 1 000 m3 for gas airships;

• (j) ‘ELA2 aircraft’ means the following manned European Light Aircraft:
• (i) an aeroplane with a maximum take-off mass (MTOM) of 2 000 kg or less that is not classified as complex motor-powered aircraft;
• (ii) a sailplane or powered sailplane of 2 000 kg MTOM or less;
• (iii) a balloon;
• (iv) a hot air airship;
• (v) a gas airship complying with all of the following characteristics:
• — 3 % maximum static heaviness,
• — non-vectored thrust (except reverse thrust),
• — conventional and simple design of structure, control system and ballonet system,
• — non-power assisted controls;
• (vi) a rotorcraft with an MTOM not exceeding 600 kg which is of a simple design, designed to carry not more than two occupants, not powered by turbine and/or rocket engines; restricted to VFR day operations;

• (k) ‘operational suitability data (OSD)’ means data, which is part of an aircraft type certificate, restricted type certificate or supplemental type certificate, consisting of all of the following:
• (i) the minimum syllabus of pilot type rating training, including determination of type rating;
• (ii) the definition of scope of the aircraft validation source data to support the objective qualification of simulators or the provisional data to support their interim qualification;
• (iii) the minimum syllabus of maintenance certifying staff type rating training, including determination of type rating;
• (iv) determination of type or variant for cabin crew and type-specific data for cabin crew;
• (v) the master minimum equipment list;

• (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.

Article 2

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

• (a) an aeroplane with a maximum take-off mass (MTOM) of 2 000 kg or less and a maximum operational seating configuration of four persons;

• (b) a sailplane or powered sailplane of 2 000 kg MTOM or less;

• (c) a balloon;

• (d) a hot air airship;

• (e) a passenger gas airship designed for not more than four persons;

• (f) a rotorcraft of 1 200 kg MTOM or less and a maximum operational seating configuration of four persons;

• (g) a piston engine or fixed pitch propeller that is intended to be installed on an aircraft referred to in points (a) to (f); or

• (h) a gyroplane.

• (a) an aeroplane of 1 200 kg MTOM or less that is not jet-powered and with a maximum operational seating configuration of two persons;

• (b) a sailplane or a powered sailplane of 1 200 kg MTOM or less;

• (c) a balloon designed for not more than four persons;

• (d) a hot air airship designed for not more than four persons.

Article 2a

Transitional arrangements for certificates previously issued under Annex I (Part 21)

Article 3

Continued validity of type-certificates and related certificates of airworthiness

• (a) the product shall be deemed to have a type-certificate issued in accordance with this Regulation when:
• (i) its type-certification basis was:
• — the JAA type-certification basis, for products that have been certificated under JAA procedures, as defined in their JAA data sheet, or
• — for other products, the type-certification basis as defined in the type-certificate data sheet of the State of design, if that State of design was: — a Member State, unless the Agency determines, taking into account, in particular, certification specifications used and service experience, that such type-certification basis does not provide for a level of safety equivalent to that required by Regulation (EU) 2018/1139 and this Regulation, or — a State with which a Member State had concluded a bilateral airworthiness agreement or similar arrangement under which such products have been certificated on the basis of the certification specifications of that State of design, unless the Agency determines that such certification specifications or service experience or the safety system of that State of design do not provide for a level of safety equivalent to that required by Regulation (EU) 2018/1139 and this Regulation. The Agency shall make a first evaluation of the implication of the provisions of the second indent in view of producing an opinion to the Commission including possible amendments to this Regulation;
• (ii) the environmental protection requirements were those laid down in Annex 16 to the Chicago Convention, as applicable to the product;
• (iii) the applicable airworthiness directives were those of the State of design;

• (b) the design of an individual aircraft, which was on the register of a Member State before 28 September 2003, shall be deemed to have been approved in accordance with this Regulation when:
• (i) its basic type design was part of a type-certificate referred to in point (a);
• (ii) all changes to this basic type design, which were not under the responsibility of the type-certificate holder, had been approved; and
• (iii) the airworthiness directives issued or adopted by the Member State of registry before 28 September 2003 were complied with, including any variations to the airworthiness directives of the State of design agreed by the Member State of registry.

• (a) if a product is under certification by several Member States, the most advanced project shall be used as the reference;

• (b) points 21.A.15(a), (b) and (c) of Annex I (Part 21) shall not apply;

• (c) by way of derogation from point 21.B.80 of Annex I (Part 21), the type-certification basis shall be that established by the JAA or, where applicable, the Member State at the date of application for the approval;

• (d) compliance findings made under JAA or Member State procedures shall be deemed to have been made by the Agency for the purposes of compliance with points 21.A.20(a) and (d) of Annex I (Part 21).

• (a) if an approval process is being carried out by several Member States, the most advanced project shall be used as the reference;

• (b) point 21.A.93 of Annex I (Part 21) shall not apply;

• (c) the applicable type-certification basis shall be that established by the JAA or, where applicable, the Member State at the date of application for the approval of change;

• (d) compliance findings made under JAA or Member State procedures shall be deemed to have been made by the Agency for the purposes of compliance with point 21.B.107 of Annex I (Part 21).

Article 4

Continued validity of supplemental type-certificates

• (a) if a certification process was being carried out by several Member States, the most advanced project shall be used as the reference;

• (b) point 21.A.113 (a) and (b) of Annex I (Part 21) shall not apply;

• (c) the applicable certification basis shall be that established by the JAA or, where applicable, the Member State at the date of application for the supplemental type-certificate or the major change approval;

• (d) the compliance findings made under JAA or Member State procedures shall be deemed to have been made by the Agency for the purpose of complying with point 21.A.115(a) of Annex I (Part 21).

Article 6

Continued validity of parts and appliances certificates

• (a) if an authorisation process was being carried out by several Member States, the most advanced project shall be used as the reference;

• (b) point 21.A.603 of Annex I (Part 21) shall not apply;

• (c) the applicable data requirements laid down in point 21.A.605 of Annex I (Part 21) shall be those established by the relevant Member State, at the date of application for the approval or authorisation;

• (d) compliance findings made by the relevant Member State shall be deemed to have been made by the Agency for the purpose of complying with point 21.A.606(b) of Annex I (Part 21).

Article 7

Permit to fly

The conditions determined before 28 March 2007 by the Member States for permits to fly or other airworthiness certificate issued for aircraft which did not hold a certificate of airworthiness or restricted certificate of airworthiness issued under this Regulation, are deemed to have been determined in accordance with this Regulation, unless the Agency has determined before 28 March 2008 that such conditions do not provide for a level of safety equivalent to that required by Regulation (EC) No 216/2008 or this Regulation.

Article 7a

Operational suitability data

Article 8

Design organisations

Where after 7 March 2025, the organisation has not closed such findings, the approval certificate shall be revoked, limited or suspended in whole or in part.

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

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

Article 9

Production organisations

• (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.

Where after 7 March 2025 the organisation has not closed those findings, the approval certificate shall be revoked, limited or suspended in whole or in part.

Article 10

Agency measures

Article 11

Repeal

Regulation (EC) No 1702/2003 is repealed.

References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex III.

Article 12

Entry into force

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

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

ANNEX I

PART 21

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

Contents	Contents
21.1	Competent authority
21.2	Scope
SECTION A – TECHNICAL REQUIREMENTS	SECTION A – TECHNICAL REQUIREMENTS
SUBPART A – GENERAL PROVISIONS	SUBPART A – GENERAL PROVISIONS
21.A.1	Scope
21.A.2	Undertaking by a person other than the applicant for, or holder of, a certificate
21.A.3A	Reporting system
21.A.3B	Airworthiness directives
21.A.4	Coordination between design and production
21.A.5	Record-keeping
21.A.6	Manuals
21.A.7	Instructions for continued airworthiness
21.A.9	Access and investigation
SUBPART B – TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES	SUBPART B – TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES
21.A.11	Scope
21.A.13	Eligibility
21.A.14	Demonstration of capability
21.A.15	Application
21.A.19	Changes requiring a new type-certificate
21.A.20	Demonstration of compliance with the type-certification basis, operational suitability data certification basis and environmental protection requirements
21.A.21	Requirements for the issuance of a type certificate or restricted type certificate
21.A.31	Type design
21.A.33	Inspections and tests
21.A.35	Flight tests
21.A.41	Type-certificate
21.A.44	Obligations of the holder
21.A.47	Transferability
21.A.51	Duration and continued validity
21.A.62	Availability of operational suitability data
21.A.65	Continuing structural integrity for aeroplanes structures
(SUBPART C – NOT APPLICABLE)	(SUBPART C – NOT APPLICABLE)
SUBPART D – CHANGES TO TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES	SUBPART D – CHANGES TO TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES
21.A.90A	Scope
21.A.90B	Standard changes
21.A.90C	Stand-alone changes to the instructions for continued airworthiness
21.A.91	Classification of changes to a type certificate
21.A.92	Eligibility
21.A.93	Application
21.A.95	Requirements for approval of a minor change
21.A.97	Requirements for approval of a major change
21.A.101	Type-certification basis, operational suitability data certification basis and environmental protection requirements for a major change to a type-certificate
21.A.108	Availability of operational suitability data
21.A.109	Obligations and EPA marking
SUBPART E – SUPPLEMENTAL TYPE-CERTIFICATES	SUBPART E – SUPPLEMENTAL TYPE-CERTIFICATES
21.A.111	Scope
21.A.112A	Eligibility
21.A.112B	Demonstration of capability
21.A.113	Application for a supplemental type-certificate
21.A.115	Requirements for the approval of major changes in the form of a supplemental type certificate
21.A.116	Transferability
21.A.117	Changes to that part of a product covered by a supplemental type-certificate
21.A.118A	Obligations and EPA marking
21.A.118B	Duration and continued validity
21.A.120B	Availability of operational suitability data
SUBPART F – PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL	SUBPART F – PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL
21.A.121	Scope
21.A.122	Eligibility
21.A.124	Application
21.A.124A	Means of compliance
21.A.125A	Issuance of a letter of agreement
21.A.125B	Findings and observations
21.A.125C	Duration and continued validity
21.A.126	Production inspection system
21.A.127	Tests: aircraft
21.A.128	Tests: engines, propellers, and control and monitoring units (CMUs)
21.A.129	Obligations of the production organisation
21.A.130	Statement of conformity
SUBPART G – PRODUCTION ORGANISATION APPROVAL	SUBPART G – PRODUCTION ORGANISATION APPROVAL
21.A.131	Scope
21.A.133	Eligibility
21.A.134	Application
21.A.134A	Means of compliance
21.A.135	Issuance of production organisation approval
21.A.139	Production management system
21.A.139A	Information security management system
21.A.143	Production organisation exposition
21.A.145	Resources
21.A.147	Changes in the production management system
21.A.148	Changes of location
21.A.149	Transferability
21.A.151	Terms of approval
21.A.153	Changes to the terms of approval
21.A.158	Findings and observations
21.A.159	Duration and continued validity
21.A.163	Privileges
21.A.165	Obligations of the holder
SUBPART H – CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS	SUBPART H – CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS
21.A.171	Scope
21.A.172	Eligibility
21.A.173	Classification
21.A.174	Application
21.A.175	Language
21.A.177	Amendment or modification
21.A.179	Transferability
21.A.181	Duration and continued validity
21.A.182	Aircraft identification
SUBPART I – NOISE CERTIFICATES	SUBPART I – NOISE CERTIFICATES
21.A.201	Scope
21.A.203	Eligibility
21.A.204	Application
21.A.207	Amendment or modification
21.A.209	Transferability and re-issuance within Member States
21.A.211	Duration and continued validity
SUBPART J – DESIGN ORGANISATION APPROVAL	SUBPART J – DESIGN ORGANISATION APPROVAL
21.A.231	Scope
21.A.233	Eligibility
21.A.234	Application
21.A.235	Issue of design organisation approval
21.A.239	Design management system
21.A.239A	Information security management system
21.A.243	Handbook
21.A.245	Resources
21.A.247	Changes in the design management system
21.A.249	Transferability
21.A.251	Terms of approval
21.A.253	Changes to the terms of approval
21.A.258	Findings and observations
21.A.259	Duration and continued validity
21.A.263	Privileges
21.A.265	Obligations of the holder
SUBPART K — PARTS, APPLIANCES, AND CONTROL AND MONITORING UNIT (CMU) COMPONENTS	SUBPART K — PARTS, APPLIANCES, AND CONTROL AND MONITORING UNIT (CMU) COMPONENTS
21.A.301	Scope
21.A.303	Compliance with the applicable requirements
21.A.305	Approval of parts, appliances, and control and monitoring unit (CMU) components
21.A.307	The eligibility of parts and appliances for installation
21.A.308	Eligibility of a component for installation on a control and monitoring unit (CMU)
(SUBPART L – NOT APPLICABLE)	(SUBPART L – NOT APPLICABLE)
SUBPART M – REPAIRS	SUBPART M – REPAIRS
21.A.431A	Scope
21.A.431B	Standard repairs
21.A.432A	Eligibility
21.A.432B	Demonstration of capability
21.A.432C	Application for a repair design approval
21.A.433	Requirements for approval of a repair design
21.A.435	Classification and approval of repair designs
21.A.439	Production of repair parts
21.A.441	Repair embodiment
21.A.443	Limitations
21.A.445	Unrepaired damage
21.A.451	Obligations and EPA marking
(SUBPART N – NOT APPLICABLE)	(SUBPART N – NOT APPLICABLE)
SUBPART O – EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS	SUBPART O – EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS
21.A.601	Scope
21.A.602A	Eligibility
21.A.602B	Demonstration of capability
21.A.603	Application
21.A.604	ETSO authorisation for an auxiliary power unit (APU)
21.A.605	Data requirements
21.A.606	Requirements for issuance of an ETSO authorisation
21.A.607	ETSO authorisation privileges
21.A.608	Declaration of design and performance (DDP)
21.A.609	Obligations of holders of ETSO authorisations
21.A.610	Approval for deviation
21.A.611	Design changes
21.A.619	Duration and continued validity
21.A.621	Transferability
SUBPART P – PERMIT TO FLY	SUBPART P – PERMIT TO FLY
21.A.701	Scope
21.A.703	Eligibility
21.A.707	Application for permit to fly
21.A.708	Flight conditions
21.A.709	Application for approval of flight conditions
21.A.710	Approval of flight conditions
21.A.711	Issuance of a permit to fly
21.A.713	Changes
21.A.715	Language
21.A.719	Transferability
21.A.723	Duration and continued validity
21.A.725	Renewal of permit to fly
21.A.727	Obligations of the holder of a permit to fly
SUBPART Q — IDENTIFICATION OF PRODUCTS, PARTS, APPLIANCES, CONTROL AND MONITORING UNITS (CMUs) AND CMU COMPONENTS	SUBPART Q — IDENTIFICATION OF PRODUCTS, PARTS, APPLIANCES, CONTROL AND MONITORING UNITS (CMUs) AND CMU COMPONENTS
21.A.801	Identification of products and control and monitoring units (CMUs)
21.A.803	Handling of identification data
21.A.804	Identification of parts, appliances and control and monitoring unit (CMU) components
21.A.805	Identification of critical parts
21.A.807	Identification of ETSO articles
SECTION B – PROCEDURES FOR COMPETENT AUTHORITIES	SECTION B – PROCEDURES FOR COMPETENT AUTHORITIES
SUBPART A – GENERAL PROVISIONS	SUBPART A – GENERAL PROVISIONS
21.B.10	Oversight documentation
21.B.15	Information to the Agency
21.B.20	Immediate reaction to a safety problem
21.B.20A	Immediate reaction to an information security incident or vulnerability with an impact on aviation safety
21.B.25	Management system
21.B.30	Allocation of tasks
21.B.35	Changes in the management system
21.B.55	Record-keeping
21.B.65	Suspension, limitation and revocation
SUBPART B – TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES	SUBPART B – TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES
21.B.70	Certification specifications
21.B.75	Special conditions
21.B.80	Type-certification basis for a type-certificate or a restricted type-certificate
21.B.82	Operational suitability data certification basis for an aircraft type certificate or a restricted type-certificate
21.B.85	Applicable environmental protection requirements for a type certificate or restricted type certificate
21.B.100	Level of involvement
21.B.103	Issuance of a type-certificate or a restricted type-certificate
(SUBPART C – NOT APPLICABLE)	(SUBPART C – NOT APPLICABLE)
SUBPART D – CHANGES TO TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES	SUBPART D – CHANGES TO TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES
21.B.105	Type-certification basis, environmental protection requirements and operational suitability data certification basis for a major change to a type certificate
21.B.107	Issuance of an approval of a change to a type-certificate
SUBPART E – SUPPLEMENTAL TYPE-CERTIFICATES	SUBPART E – SUPPLEMENTAL TYPE-CERTIFICATES
21.B.109	Type-certification basis, environmental protection requirements and operational suitability data certification basis for a supplemental type certificate
21.B.111	Issuance of a supplemental type-certificate
SUBPART F – PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL	SUBPART F – PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL
21.B.115	Means of compliance
21.B.120	Initial certification procedure
21.B.125	Findings and corrective actions; observations
21.B.135	Maintenance of the letter of agreement
21.B.140	Amendment of a letter of agreement
SUBPART G – PRODUCTION ORGANISATION APPROVAL	SUBPART G – PRODUCTION ORGANISATION APPROVAL
21.B.215	Means of compliance
21.B.220	Initial certification procedure
21.B.221	Oversight principles
21.B.222	Oversight programme
21.B.225	Findings and corrective actions; observations
21.B.240	Changes in the production management system
21.B.240A	Changes to the information security management system
SUBPART H – CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS	SUBPART H – CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS
21.B.320	Investigation
21.B.325	Issuance of airworthiness certificate
21.B.326	Certificate of airworthiness
21.B.327	Restricted certificate of airworthiness
SUBPART I – NOISE CERTIFICATES	SUBPART I – NOISE CERTIFICATES
21.B.420	Investigation
21.B.425	Issuance of noise certificates
SUBPART J – DESIGN ORGANISATION APPROVAL	SUBPART J – DESIGN ORGANISATION APPROVAL
21.B.430	Initial certification procedure
21.B.431	Oversight principles
21.B.432	Oversight programme
21.B.433	Findings and corrective actions; observations
21.B.435	Changes in the design management system
21.B.435A	Changes to the information security management system
SUBPART K — PARTS, APPLIANCES AND CONTROL AND MONITORING UNIT (CMU) COMPONENTS	SUBPART K — PARTS, APPLIANCES AND CONTROL AND MONITORING UNIT (CMU) COMPONENTS
(SUBPART L – NOT APPLICABLE)	(SUBPART L – NOT APPLICABLE)
SUBPART M – REPAIRS	SUBPART M – REPAIRS
21.B.450	Amendments to the type-certification basis for a repair design approval
21.B.453	Issuance of a repair design approval
(SUBPART N – NOT APPLICABLE)	(SUBPART N – NOT APPLICABLE)
SUBPART O – EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS	SUBPART O – EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS
21.B.480	Issuance of an ETSO authorisation
SUBPART P – PERMIT TO FLY	SUBPART P – PERMIT TO FLY
21.B.520	Investigation
21.B.525	Issuance of a permit to fly
SUBPART Q — IDENTIFICATION OF PRODUCTS, PARTS, APPLIANCES, CONTROL AND MONITORING UNITS (CMUs) AND CMU COMPONENTS	SUBPART Q — IDENTIFICATION OF PRODUCTS, PARTS, APPLIANCES, CONTROL AND MONITORING UNITS (CMUs) AND CMU COMPONENTS
Appendices	Appendices
	Appendix I – EASA Form 1 – Authorised Release Certificate
	Appendix II – Reserved
	Appendix III – EASA Form 20a – Permit to Fly
	Appendix IV – EASA Form 20b – Permit to Fly (issued by approved organisations)
	Appendix V – EASA Form 24 – Restricted Certificate of Airworthiness
	Appendix VI – EASA Form 25 – Certificate of Airworthiness
	Appendix VII– EASA Form 45 – Noise Certificate
	Appendix VIII – EASA Form 52 – Aircraft statement of conformity
	Appendix IX – EASA Form 53 – Certificate of Release to Service
	Appendix X – EASA Form 55 – Production organisation approval certificate
	Appendix XI – EASA Form 65 – Letter of Agreement for production without production organisation approval
	Appendix XII – Categories of flight tests and associated flight test crew qualification.

21.1.   Competent authority

For the purpose of this Annex, the ‘competent authority’ shall be:

• (a) for Section A, Subpart A,
• 1. for design organisations, the Agency;
• 1. for production organisations that have their principal place of business in a territory for which a Member State is responsible under the Convention on International Civil Aviation, signed in Chicago on 7 December 1944 (‘the Chicago Convention’), the authority designated by that Member State or by another Member State in accordance with Article 64 of Regulation (EU) 2018/1139, or the Agency if the responsibility has been reallocated to the Agency in accordance with Article 64 or 65 of Regulation (EU) 2018/1139;
• 1. for production organisations that have their principal place of business outside a territory for which a Member State is responsible under the Chicago Convention, the Agency;

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

• (c) for Section A, Subparts F and G:
• 1. for natural or legal persons that have their principal place of business in a territory for which a Member State is responsible under the Chicago Convention, the authority designated by that Member State or by another Member State in accordance with Article 64 of Regulation (EU) 2018/1139, or the Agency if the responsibility has been reallocated to the Agency in accordance with Article 64 or, as regards Subpart G, Article 65 of Regulation (EU) 2018/1139;
• 1. for natural or legal persons that have their principal place of business outside a territory for which a Member State is responsible under the Chicago Convention, the Agency;

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

• (e) for Section A, Subpart P:
• 1. for aircraft registered in a Member State, the authority designated by the Member State of registry;
• 1. for unregistered aircraft, the authority designated by the Member State which prescribed the identification marks;
• 1. for the approval of the flight conditions related to the safety of the design, the Agency.

21.2.   Scope

Section A of this Annex establishes the provisions that lay down the rights and obligations of the applicant for, and holder of, any certificate issued or to be issued in accordance with this Annex.

Section B of this Annex establishes the conditions for conducting the certification oversight and enforcement tasks as well as the administrative and management system requirements to be complied with by the competent authority that is responsible for the implementation of Section A of this Annex.

SECTION A

TECHNICAL REQUIREMENTS

SUBPART A —   GENERAL PROVISIONS

21.A.1   Scope

This Subpart establishes the general rights and obligations of the applicant for, and holder of, any certificate that has been issued or is to be issued in accordance with this Annex.

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.

21.A.3A   Reporting system

• (a) Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council ([^E0005]) 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.

• (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.

• (c) Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, any natural or legal person, when reporting in accordance with points (a)(3), (b)(2), (b)(3) and (b)(4), shall appropriately protect the confidentiality of the person who reports and of the person(s) mentioned in the report.

• (d) Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, any natural or legal person shall make the reports referred to in points (a)(3) and (b)(3) in a form and manner established by the Agency or the competent authority, respectively, and dispatch them as soon as practicable and in any case not later than 72 hours after the natural or legal person has identified that the occurrence may lead to a possible unsafe condition, unless exceptional circumstances prevent this.

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

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

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.

21.A.4   Coordination between design and production

Each holder of a type-certificate, restricted type-certificate, supplemental type- certificate, ETSO authorisation, approval of a change to type-certificate or approval of a repair design, shall collaborate with the production organisation as necessary to ensure:

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

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

21.A.5   Record-keeping

All natural or legal persons that hold or have applied for a type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, design or repair approval, permit to fly, production organisation approval certificate or letter of agreement under this Regulation shall:

• (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;

• (d) retain records of the competence and qualifications, referred to in points 21.A.139(c), 21.A.145(b), 21.A.145(c), 21.A.239(c), 21.A.245(a) or 21.A.245(e)(1), of the personnel that are involved in the following functions:
• 1. design or production;
• 1. independent monitoring of the compliance of the organisation with the relevant requirements;
• 1. safety management;

• (e) retain records of the authorisation of personnel, when they employ personnel that:
• 1. exercise the privileges of the approved organisation pursuant to points 21.A.163 and/or 21.A.263, as appropriate;
• 1. carry out the independent function to monitor the compliance of the organisation with the relevant requirements pursuant to points 21.A.139(e) and/or 21.A.239(e), as appropriate;
• 1. carry out the independent verification function of the demonstration of compliance pursuant to point 21.A.239(d)(2).

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.

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.

21.A.9   Access and investigation

Any natural or legal person that holds or has applied for a type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, design change or repair approval, certificate of airworthiness, noise certificate, permit to fly, design organisation approval, production organisation approval certificate or letter of agreement under this Regulation, shall:

• (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;

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

SUBPART B —   TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES

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.

21.A.13   Eligibility

Any natural or legal person that has demonstrated, or is in the process of demonstrating, its capability in accordance with point 21.A.14 shall be eligible as an applicant for a type-certificate or a restricted type-certificate under the conditions laid down in this Subpart.

21.A.14   Demonstration of capability

• (a)An applicant for a type-certificate or restricted 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 the agreement of the Agency for the use of procedures setting out the specific design practices, resources and sequence of activities necessary to comply with this Annex I (Part 21), when the product is one of the following:

• 1. an ELA2 aircraft;

• 1. an engine or propeller installed in ELA2 aircraft;

• 1. a piston engine;

• 1. a fixed or adjustable pitch propeller.

• (c)By way of derogation from point (a), an applicant may demonstrate its capability by obtaining the Agency's acceptance of its certification programme established in accordance with point 21.A.15(b), where the product to be certified is:

• 1. an ELA1 aircraft; or

• 1. an engine or propeller installed in ELA1 aircraft.

21.A.15   Application

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

• (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 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;

• 1. a project schedule including major milestones.

• (c)After its initial submission to the Agency, the certification programme shall be updated by the applicant when there are changes to the certification project affecting any of the points 1 to 7 of point (b).

• (d)An application for a type-certificate or restricted type-certificate for an aircraft shall include, or be supplemented after the initial application by, an application supplement for approval of the operational suitability data.

• (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.

• (f)In the case where a type-certificate or restricted type-certificate has not been issued, or it is evident that it will not be issued, within the time limit provided for in point (e), the applicant may:

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

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

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.