02012R0748 — EN — 23.03.2020 — 008.001

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►B 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) (OJ L 224 21.8.2012, p. 1)

Amended by:





Corrected by:









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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

1. This Regulation lays down, in accordance with Article 5(5) and Article 6(3) of Regulation (EC) No 216/2008, common technical requirements and administrative procedures for the airworthiness and environmental certification of products, parts and appliances specifying:

(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;

(f) the identification of products, parts and appliances;

(g) the certification of certain parts and appliances;

(h) the certification of design and production organisations;

(i) the issue of airworthiness directives.

2. For the purpose of this Regulation, the following definitions shall apply:

(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 and appliances, and of design and production organisations laid down in Annex I to this Regulation;

(d) ‘Part M’ means the applicable continuing airworthiness requirements adopted in pursuance of Regulation (EC) No 216/2008;

(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;

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

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

(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 4 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 Very Light Rotorcraft;

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(k) ‘Operational Suitability Data (OSD)’ means data, which are 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.

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Article 2

Products, parts and appliances certification

1. Products, parts and appliances shall be issued certificates as specified in Annex I (Part 21).

2. By way of derogation from point 1, aircraft, including any installed product, part and appliance, which are not registered in a Member State shall be exempted from the provisions of Subparts H and I of Annex I (Part 21). They shall also be exempted from the provisions of Subpart P of Annex I (Part 21) except when aircraft identification marks are prescribed by a Member State.

Article 3

Continued validity of type-certificates and related certificates of airworthiness

1. With regard to products which had a type-certificate, or a document allowing the issuing of a certificate of airworthiness, issued before 28 September 2003 by a Member State, the following provisions shall apply:

(a) the product shall be deemed to have a type-certificate issued in accordance with this Regulation when: ▼M2 (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 (EC) No 216/2008 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 (EC) No 216/2008 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; ▼B (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.

2. With regard to products for which a type-certification process was proceeding through the JAA or a Member State on 28 September 2003, the following shall apply:

(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;

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(c) by way of derogation from point 21.A.17A 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 purpose of complying with points 21.A.20(a) and (d) of Annex I (Part 21).

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3. With regard to products that have a national type-certificate, or equivalent, and for which the approval process of a change carried out by a Member State was not finalised at the time when the type-certificate had to be in accordance with this Regulation, the following shall apply:

(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 purpose of complying with points 21.A.103(a)(2) and (b) of Annex I (Part 21).

4. With regard to products that had a national type-certificate, or equivalent, and for which the approval process of a major repair design carried out by a Member State was not finalised at the time when the type-certificate had to be determined in accordance with this Regulation, 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.433(a) of Annex I (Part 21).

5. A certificate of airworthiness issued by a Member State attesting conformity with a type-certificate determined in accordance with point 1 shall be deemed to comply with this Regulation.

Article 4

Continued validity of supplemental type-certificates

1. With regard to supplemental type-certificates issued by a Member State under JAA procedures or applicable national procedures and with regard to changes to products proposed by persons other than the type-certificate holder of the product, which were approved by a Member State under applicable national procedures, if the supplemental type-certificate, or change, was valid on 28 September 2003, the supplemental type-certificate, or change shall be deemed to have been issued under this Regulation.

2. With regard to supplemental type-certificates for which a certification process was being carried out by a Member State on 28 September 2003 under applicable JAA supplemental type-certificate procedures and with regard to major changes to products, proposed by persons other than the type-certificate holder of the product, for which a certification process was being carried out by a Member State on 28 September 2003 under applicable national procedures, the following shall apply:

(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).

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Article 6

Continued validity of parts and appliances certificates

1. Approvals of parts and appliances issued by a Member State and valid on 28 September 2003 shall be deemed to have been issued in accordance with this Regulation.

2. With regard to parts and appliances for which an approval or authorisation process was being carried out by a Member State on 28 September 2003, the following shall apply:

(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.

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Article 7a

Operational suitability data

1. The holder of an aircraft type-certificate issued before 17 February 2014 intending to deliver a new aircraft to an EU operator on or after 17 February 2014 shall obtain approval in accordance with point 21.A.21(e) of Annex I (Part 21) except for the minimum syllabus of maintenance certifying staff type rating training and except for aircraft validation source data to support the objective qualification of simulator(s). The approval shall be obtained not later than 18 December 2015 or before the aircraft is operated by an EU operator, whichever is the latest. The operational suitability data may be limited to the model which is delivered.

2. The applicant for an aircraft type-certificate for which the application was filed before 17 February 2014 and for which a type-certificate is not issued before 17 February 2014 shall obtain approval in accordance with point 21.A.21(e) of Annex I (Part 21) except for the minimum syllabus of maintenance certifying staff type rating training and for aircraft validation source data to support the objective qualification of simulator(s). The approval shall be obtained not later than 18 December 2015 or before the aircraft is operated by an EU operator, whichever is the latest. Compliance findings made by the authorities in Operational Evaluation Board processes conducted under the responsibility of the JAA or the Agency before the entry into force of this Regulation shall be accepted by the Agency without further verification.

3. Operational Evaluation Board reports and master minimum equipment lists issued in accordance with JAA procedures or by the Agency before the entry into force of this Regulation shall be deemed to constitute the operational suitability data approved in accordance with point 21.A.21(e) of Annex I (Part 21) and shall be included in the relevant type-certificate. Before 18 June 2014 the relevant type-certificate holders shall propose the Agency a division of the operational suitability data in mandatory data and non-mandatory data.

4. Holders of a type-certificate including operational suitability data shall be required to obtain approval of an extension of the scope of their design organisation approval or procedures alternative to design organisation approval, as applicable, to include operational suitability aspects before 18 December 2015.

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Article 8

Design organisations

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

2. By way of derogation from point 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 and appliance for which it applies, provided:

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

(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.

3. Design organisation approvals issued or recognised by a Member State in accordance with the JAA requirements and procedures and valid before 28 September 2003 shall be deemed to comply with this Regulation.

Article 9

Production organisations

1. An organisation responsible for the manufacture of products, parts and appliances shall demonstrate its capability in accordance with the provisions of Annex I (Part 21).

2. By way of derogation from point 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 and appliance for which it applies, provided:

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

(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.

3. Production organisation approvals issued or recognised by a Member State in accordance with the JAA requirements and procedures and valid before 28 September 2003 shall be deemed to comply with this Regulation.

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4. By way of derogation from paragraph 1, the production organisation may apply to the competent authority for exemptions from the environmental requirements referred to in the first subparagraph of Article 9(2) of Regulation (EU) 2018/1139 ( 1 ).

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Article 10

Agency measures

1. The Agency shall develop acceptable means of compliance (hereinafter called ‘AMC’) that competent authorities, organisations and personnel may use to demonstrate compliance with the provisions of the Annex I (Part 21) to this Regulation.

2. The AMC issued by the Agency shall neither introduce new requirements nor alleviate the requirements of the Annex I (Part 21) to this Regulation.

3. Without prejudice to Articles 54 and 55 of Regulation (EC) No 216/2008, when the acceptable means of compliance issued by the Agency are used, the related requirements of the Annex I (Part 21) to this Regulation shall be considered as met without further demonstration.

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 and appliances, and of design and production organisations

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Contents 21.1 General SECTION A — TECHNICAL REQUIREMENTS SUBPART A — GENERAL PROVISIONS 21.A.1 Scope 21.A.2 Undertaking by another person than the applicant for, or holder of, a certificate 21.A.3A Failures, malfunctions and defects 21.A.3B Airworthiness directives 21.A.4 Coordination between design and production 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.55 Record-keeping 21.A.57 Manuals 21.A.61 Instructions for continued airworthiness 21.A.62 Availability of operational suitability data (SUBPART C — NOT APPLICABLE) SUBPART D — CHANGES TO TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES 21.A.90A Scope 21.A.90B Standard changes 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.105 Record-keeping 21.A.107 Instructions for continued airworthiness 21.A.108 Availability of operational suitability data 21.A.109 Obligations and EPA marking 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 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.119 Manuals 21.A.120A Instructions for continued airworthiness 21.A.120B Availabiity of operational suitability data SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL 21.A.121 Scope 21.A.122 Eligibility 21.A.124 Application 21.A.125A Issue of a letter of agreement 21.A.125B Findings 21.A.125C Duration and continued validity 21.A.126 Production inspection system 21.A.127 Tests: aircraft 21.A.128 Tests: engines and propellers 21.A.129 Obligations of the manufacturer 21.A.130 Statement of conformity SUBPART G — PRODUCTION ORGANISATION APPROVAL 21.A.131 Scope 21.A.133 Eligibility 21.A.134 Application 21.A.135 Issue of production organisation approval 21.A.139 Quality System 21.A.143 Exposition 21.A.145 Approval requirements 21.A.147 Changes to the approved production organisation 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.157 Investigations 21.A.158 Findings 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 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 and reissuance within Member States 21.A.180 Inspections 21.A.181 Duration and continued validity 21.A.182 Aircraft identification 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 reissuance within Member States 21.A.210 Inspections 21.A.211 Duration and continued validity 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 assurance system 21.A.243 Data 21.A.245 Approval requirements 21.A.247 Changes in design assurance system 21.A.249 Transferability 21.A.251 Terms of approval 21.A.253 Changes to the terms of approval 21.A.257 Investigations 21.A.258 Findings 21.A.259 Duration and continued validity 21.A.263 Privileges 21.A.265 Obligations of the holder SUBPART K — PARTS AND APPLIANCES 21.A.301 Scope 21.A.303 Compliance with applicable requirements 21.A.305 Approval of parts and appliances 21.A.307 Release of parts and appliances for installation (SUBPART L — NOT APPLICABLE) 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.447 Record-keeping 21.A.449 Instructions for continued airworthiness 21.A.451 Obligations and EPA marking (SUBPART N — NOT APPLICABLE) 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.613 Record-keeping 21.A.615 Inspection by the Agency 21.A.619 Duration and continued validity 21.A.621 Transferability SUBPART P — PERMIT TO FLY 21.A.701 Scope 21.A.703 Eligibility 21.A.705 Competent authority 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 Issue of a permit to fly 21.A.713 Changes 21.A.715 Language 21.A.719 Transferability 21.A.721 Inspections 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 21.A.729 Record-keeping SUBPART Q — IDENTIFICATION OF PRODUCTS, PARTS AND APPLIANCES 21.A.801 Identification of products 21.A.803 Handling of identification data 21.A.804 Identification of parts and appliances 21.A.805 Identification of critical parts 21.A.807 Identification of ETSO articles SECTION B — PROCEDURES FOR COMPETENT AUTHORITIES SUBPART A — GENERAL PROVISIONS 21.B.5 Scope 21.B.20 Obligations of the competent authority 21.B.25 Requirements for the organisation of the competent authority 21.B.30 Documented procedures 21.B.35 Changes in organisation and procedures 21.B.40 Resolution of disputes 21.B.45 Reporting/coordination 21.B.55 Record-keeping 21.B.60 Airworthiness directives 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 restricted type-certificate 21.B.82 Operational suitability data certification basis for an aircraft type certificate or restricted type-certificate 21.B.85 Designation of applicable environmental protection requirements and certification specifications for a type-certificate or restricted type-certificate 21.B.100 Level of involvement 21.B.103 Issuance of a type-certificate or restricted type-certificate (SUBPART C — NOT APPLICABLE) 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 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 21.B.120 Investigation 21.B.125 Findings 21.B.130 Issue of letter of agreement 21.B.135 Maintenance of the letter of agreement 21.B.140 Amendment of a letter of agreement 21.B.145 Limitation, suspension and revocation of a letter of agreement 21.B.150 Record-keeping SUBPART G — PRODUCTION ORGANISATION APPROVAL 21.B.220 Investigation 21.B.225 Findings 21.B.230 Issue of certificate 21.B.235 Continued surveillance 21.B.240 Amendment of a production organisation approval 21.B.245 Suspension and revocation of a production organisation approval 21.B.260 Record-keeping SUBPART H — CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS 21.B.320 Investigation 21.B.325 Issue of airworthiness certificate 21.B.326 Certificate of airworthiness 21.B.327 Restricted certificate of airworthiness 21.B.330 Suspension and revocation of certificates of airworthiness and restricted certificates of airworthiness 21.B.345 Record-keeping SUBPART I — NOISE CERTIFICATES 21.B.420 Investigation 21.B.425 Issue of noise certificates 21.B.430 Suspension and revocation of a noise certificate 21.B.445 Record-keeping SUBPART J — DESIGN ORGANISATION APPROVAL SUBPART K — PARTS AND APPLIANCES (SUBPART L — NOT APPLICABLE) SUBPART M — REPAIRS 21.B.450 Type-certification basis and environmental protection requirements for a major repair design approval 21.B.453 Issuance of a repair design approval (SUBPART N — NOT APPLICABLE) SUBPART O — EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS 21.B.480 Issuance of an ETSO authorisation SUBPART P — PERMIT TO FLY 21.B.520 Investigation 21.B.525 Issue of permits to fly 21.B.530 Revocation of permits to fly 21.B.545 Record-keeping SUBPART Q — IDENTIFICATION OF PRODUCTS, PARTS AND APPLIANCES Appendices Appendix I — EASA Form 1 — Authorised Release Certificate; Appendix II — EASA Form 15a — Airworthiness Review Certificate; 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 85.

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21.1 General

For the purpose of this Annex I (Part 21), ‘competent authority’ shall be:

(a) for organisations having their principal place of business in a Member State, the authority designated by that Member State; or the Agency if so requested by that Member State; or

(b) for organisations having their principal place of business in a non-member State, the Agency.

SECTION A

TECHNICAL REQUIREMENTS

SUBPART A — GENERAL PROVISIONS

21.A.1 Scope

This Section establishes general provisions governing the rights and obligations of the applicant for, and holder of, any certificate issued or to be issued in accordance with this Section.

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

The actions and obligations required to be undertaken by the holder of, or applicant for, a certificate for a product, part or appliance under this Section may be undertaken on its behalf by any other natural or legal person, provided the holder of, or applicant for, that certificate can show that it has made an agreement with the other person such as to ensure that the holder’s obligations are and will be properly discharged.

21.A.3A Failures, malfunctions and defects

(a) System for Collection, Investigation and Analysis of Data

The holder of 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 have a system for collecting, investigating and analysing 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 or appliance covered by the type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation. Information about this system shall be made available to all known operators of the product, part or appliance and, on request, to any person authorised under other associated implementing Regulations.

(b) Reporting to the Agency

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

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

(c) Investigation of Reported Occurrences

1. When an occurrence reported under point (b), or under points 21.A.129(f)(2) or 21.A.165(f)(2) results from a deficiency in the design, or a manufacturing deficiency, the holder of the type-certificate, restricted type-certificate, supplemental type-certificate, major repair design approval, ETSO authorisation, or any other relevant approval deemed to have been issued under this Regulation, or the manufacturer as appropriate, shall investigate the reason for the deficiency and report to the Agency the results of its investigation and any action it is taking or proposes to take to correct that deficiency.

2. If the Agency finds that an action is required to correct the deficiency, the holder of the type-certificate, restricted type-certificate, supplemental type-certificate, major repair design approval, ETSO authorisation, or any other relevant approval deemed to have been issued under this Regulation, or the manufacturer as appropriate, shall submit the relevant data to the Agency.

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 to restore an acceptable level of safety, when evidence shows that the safety level of this aircraft 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, as a result of a deficiency in the aircraft, or an engine, propeller, part or appliance installed on this aircraft; and

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

(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;

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

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

1. an identification of the unsafe condition;

2. an identification of the affected aircraft;

3. the action(s) required;

4. the compliance time for the required action(s);

5. the date of entry into force.

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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 or appliance.

▼B

SUBPART B — TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES

21.A.11 Scope

This Subpart establishes the procedure for issuing type-certificates for products 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

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(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

(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;

2. an engine or propeller installed in ELA2 aircraft;

3. a piston engine;

4. a fixed or adjustable pitch propeller.

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(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

2. an engine or propeller installed in ELA1 aircraft.

▼B

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.

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(b) An application for a type-certificate or restricted type-certificate shall include, as a minimum, preliminary descriptive data of the product, the intended use of the product and the kind of operations for which certification is requested. In addition, it shall include, or be supplemented after the initial application, a certification programme for the demonstration of compliance in accordance with point 21.A.20, consisting of:

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

2. the proposed operating characteristics and limitations;

3. the intended use of the product and the kind of operations for which certification is requested;

4. 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;

5. 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;

6. 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 safety or environmental protection. The proposed assessment shall take into account at least the elements set out in subpoints (1) to (4) of point 21.B.100(a). Based on this assessment, the application shall include a proposal for the Agency's involvement in the verification of the compliance demonstration activities and data; and

7. 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, an application supplement for approval of the operational suitability data.

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

(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

2. 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.

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▼B

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

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

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

(a) Following the acceptance of the certification programme by the Agency, the applicant shall demonstrate compliance with the type certification basis, operational suitability data certification basis and environmental protection requirements, as established and notified to the applicant by the Agency in accordance with points 21.B.80, 21.B.82, 21.B.85, and shall provide the Agency with the means by which such compliance has been demonstrated.

(b) The applicant shall report to the Agency any difficulty or event encountered during the process of demonstration of compliance that may have an appreciable effect on the risk assessment under point 21.A.15(b)(6) or on the certification programme, or may otherwise necessitate a change to the level of involvement of the Agency previously notified to the applicant in accordance with point 21.B.100(c).

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

(d) After completion of all demonstrations of compliance in accordance with the certification programme, including any inspections and tests in accordance with point 21.A.33, and after all flight tests in accordance with point 21.A.35, the applicant shall declare that: 1. it has demonstrated compliance with the type-certification basis, operational suitability data certification basis and environmental protection requirements, as established and notified by the Agency, following the certification programme as accepted by the Agency; and 2. no feature or characteristic has been identified that may make the product unsafe for the uses for which certification is requested.

(e) The applicant shall submit to the Agency the declaration of compliance provided for in point (d). Where the applicant holds an appropriate design organisation approval, the declaration of compliance shall be made in accordance with Subpart J and submitted to the Agency.

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

(a) In order to be issued a product type certificate or, when the aircraft does not meet the essential requirements of Annex II to Regulation (EU) 2018/1139 an aircraft restricted type certificate, the applicant shall: 1. demonstrate its capability in accordance with point 21.A.14; 2. comply with point 21.A.20; 3. demonstrate that the engine and propeller, if installed in the aircraft: (A) have a type-certificate issued or determined in accordance with this Regulation; or (B) have been demonstrated to be in compliance with the aircraft type-certification basis established and the environmental protection requirements designated and notified by the Agency as necessary to ensure the safe flight of the aircraft.

(b) By 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 operational suitability data certification basis, provided that the applicant demonstrates such compliance before the date at which those data are to be actually used.

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▼B

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 shown to comply with the applicable type-certification basis and environmental protection requirements;

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

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3. an approved airworthiness limitations section of the instructions for continued airworthiness as defined by the applicable certification specifications; and

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4. any other data allowing by comparison the determination of the airworthiness and, if relevant, the environmental characteristics of later products of the same type.

▼B

(b) Each type design shall be adequately identified.

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21.A.33 Inspections and tests

(a) (Reserved)

(b) Before each test is undertaken during the demonstration of compliance required by point 21.A.20, the applicant shall have verified: 1. for the test specimen, that: (i) the materials and processes adequately conform to the specifications for the proposed type design; (ii) the parts of the products adequately conform to the drawings in the proposed type design; and (iii) the manufacturing processes, construction and assembly adequately conform to those specified in the proposed type design; and 2. for the test and measuring equipment to be used for the test, that those are adequate for the test and appropriately calibrated.

(c) On the basis of the verifications carried out in accordance with point (b), the applicant shall issue a statement of conformity listing any potential non-conformity, together with a justification that this will not affect the test results, and shall allow the Agency to make an inspection it considers necessary to check the validity of that statement.

(d) The applicant shall allow the Agency to: 1. review any data and information related to the demonstration of compliance; and 2. witness or carry out any test or inspection conducted for the purpose of the demonstration of compliance.

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

▼B

21.A.35 Flight Tests

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

(b) The applicant shall make all flight tests that the Agency finds necessary:

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

2. to determine whether there is reasonable assurance that the aircraft, its parts and appliances are reliable and function properly for aircraft to be certificated under this Annex I (Part 21), except for, (i) sailplanes and powered sailplanes; (ii) balloons and airships defined in ELA1 or ELA2; (iii) aeroplanes of 2 722 kg or less maximum take-off mass (MTOM).

(c) (Reserved)

(d) (Reserved)

(e) (Reserved)

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

1. for aircraft incorporating turbine engines of a type not previously used in a type-certificated aircraft, at least 300 hours of operation with a full complement of engines that conform to a type-certificate; and

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

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21.A.41 Type-certificate

The type-certificate and restricted type-certificate shall include the type design, the operating limitations, 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 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.

▼B

21.A.44 Obligations of the holder

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

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(a) undertake the obligations laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.55, 21.A.57, 21.A.61 and 21.A.62; and, for this purpose, shall continue to meet the qualification requirements for eligibility under point 21.A.14; and

▼B

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

21.A.47 Transferability

Transfer of a type-certificate or restricted type-certificate may only be made to a natural or legal person that is able to undertake the obligations under point 21.A.44, and, for this purpose, has demonstrated its ability to qualify under the criteria of point 21.A.14.

21.A.51 Duration and continued validity

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

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

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

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

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21.A.55 Record-keeping

All relevant design information, drawings and test reports, including inspection records for the product tested, shall be held by the type-certificate or restricted type-certificate holder at the disposal of the Agency and shall be retained in order to provide the information necessary to ensure the continued airworthiness, continued validity of the operational suitability data and compliance with applicable environmental protection requirements of the product.

21.A.57 Manuals

The holder of a type-certificate or restricted type-certificate shall produce, maintain and update master copies of all manuals required by the applicable type-certification basis, the applicable operational suitability data certification basis and environmental protection requirements for the product, and provide copies, on request, to the Agency.

▼B

21.A.61 Instructions for continued airworthiness

(a) The holder of the type-certificate or restricted type-certificate shall furnish at least one set of complete instructions for continued airworthiness, comprising descriptive data and accomplishment instructions prepared in accordance with the applicable type-certification basis, to each known owner of one or more aircraft, engine or propeller upon its delivery or upon issue of the first certificate of airworthiness for the affected aircraft, whichever occurs later and thereafter make those instructions available on request to any other person required to comply with any of the terms of those instructions. The availability of some manual or portion of the instructions for continued airworthiness, dealing with overhaul or other forms of heavy maintenance, may be delayed until after the product has entered into service, but shall be available before any of the products reaches the relevant age or flight-hours/cycles.

(b) In addition, changes to the instructions for continued airworthiness shall be made available to all known operators of the product and shall be made available on request to any person required to comply with any of those instructions. A programme showing how changes to the instructions for continued airworthiness are distributed shall be submitted to the Agency.

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21.A.62 Availability of operational suitability data

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

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

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

(c) on request, the relevant data referred to in points (a) and (b) above, to: 1. the competent authority responsible for verifying conformity with one or more elements of this set of operational suitability data; and 2. any person required to comply with one or more elements of this set of operational suitability data.

▼B

(SUBPART C — NOT APPLICABLE)

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

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21.A.90A Scope

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

▼B

21.A.90B Standard changes

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

1. in relation to: (i) aeroplanes of 5 700 kg Maximum Take-Off Mass (MTOM) or less; (ii) rotorcraft of 3 175 kg MTOM or less; (iii) sailplanes, powered sailplanes, balloons and airships, as defined in ELA1 or ELA2,

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

3. that are not in conflict with TC holders data.

▼B

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

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

Changes to a type-certificate are 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 its environmental characteristics. Without prejudice to point 21.A.19, all other changes are ‘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.

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21.A.92 Eligibility

(a) Only the type-certificate holder may apply for approval of a major change to a type-certificate under this Subpart; all other applicants for a major change to a type-certificate shall apply under Subpart E.

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

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21.A.93 Application

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

(b) An application shall include, or be supplemented after the initial application, 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 in the type certificate upon which the change is to be made; (ii) all areas of the product in the type-certificate, including the approved manuals, that 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; 2. an identification of any reinvestigations necessary to demonstrate compliance of the change and areas affected by the change with the type-certification basis, operational suitability data certification basis and environmental protection requirements; and 3. 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 type-certification basis, operational suitability data certification basis or environmental protection requirements and the potential impact of that non-compliance on product safety or environmental protection. The proposed assessment shall take into account at least the elements set out in subpoints (1)–(4) of point 21.B.100(a). Based on this assessment, the application shall include a proposal for the Agency's involvement in the verification of the compliance demonstration activities and data; and (iv) a project schedule including major milestones.

(c) An application for a change to a type-certificate of a large aeroplane or a large rotorcraft shall be valid for five years and an application for a change to any other type-certificate shall be valid for three years. In the case where the change has not been approved, or it is evident that it will not be approved, within the time limit provided for in this point, the applicant may: 1. submit a new application for a change to the type-certificate and comply with the type-certification basis, operational suitability data certification basis and environmental protection requirements, as established by the Agency in accordance with point 21.A.101 and notified in accordance with point 21.B.105 for the date of the new application; or 2. apply for an extension of the time period provided for in the first sentence of point (c) for the original application and propose a new date for the issuance of the approval. In that case, the applicant shall comply with the type-certification basis, operational suitability data certification basis and environmental protection requirements, as established by the Agency in accordance with point 21.A.101 and notified in accordance with point 21.B.105, for a date to be selected by the applicant. However, that date shall not precede the new date proposed by the applicant for the issuance of the approval by more than five years for an application for a 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.95 Requirements for approval of a minor change

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

(b) A minor change to a type-certificate shall only be approved: 1. when it has been demonstrated that the change and areas affected by the change comply with the type-certification basis and the environmental protection requirements incorporated by reference in the type-certificate; 2. in the case of a change affecting the operational suitability data, when it has been demonstrated that the necessary changes to the operational suitability data comply with the operational suitability data certification basis incorporated by reference in the type-certificate; 3. when compliance with the type-certification basis that applies in accordance with point (1) has been declared and the justifications of compliance have been recorded in the compliance documents; and 4. when no feature or characteristic has been identified that may make the product unsafe for the uses for which certification is requested.

(c) By derogation from point (1) in point (b), certification specifications which became applicable after those incorporated by reference in the type-certificate can be used for approval of a minor change, provided they do not affect the demonstration of compliance.

(d) By 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 operational suitability data certification basis has been demonstrated, provided that the applicant demonstrates such compliance before the date at which those data are actually used.

(e) The applicant shall submit to the Agency the substantiation data for the change and a statement that compliance has been demonstrated in accordance with point (b).

(f) An approval of a minor change to a type-certificate shall be limited to the specific configuration(s) in the type-certificate to which the change relates.

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

(a) Major changes to a type-certificate shall be classified and approved by: 1. the Agency; or 2. an approved design organisation within the scope of its privileges provided for in points (1) and (8) of point 21.A.263(c), as recorded in the terms of approval.

(b) A major change to a type-certificate shall only be approved: 1. when it has been demonstrated that the change and areas affected by the change comply with the type-certification basis and environmental protection requirements, as established by the Agency in accordance with point 21.A.101; 2. in the case of a change affecting the operational suitability data, when it has been demonstrated that the necessary changes to the operational suitability data meet the operational suitability data certification basis, as established by the Agency in accordance with point 21.A.101; and 3. when compliance with points (1) and (2) has been demonstrated in accordance with point 21.A.20, as applicable to the change.

(c) By 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 operational suitability data certification basis has been demonstrated, provided that the applicant demonstrates such compliance before the date at which those data are actually used.

(d) An approval of a major change to a type-certificate shall be limited to the specific configuration(s) in the type-certificate to which the change relates.

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

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

(b) By 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 at which the corresponding certification specifications incorporated by reference in the type-certificate became applicable: 1. a change that the Agency finds not 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. Changes meeting 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 certification of the product to be changed do not remain valid; 2. each area, system, part or appliance that the Agency finds not affected by the change; 3. each area, system, part or appliance that is affected by the change for which the Agency finds that compliance with the certification specifications referred to in point (a) does not contribute materially to the level of safety of the changed product or is impractical.

(c) By derogation from point (a), in the case of a change to an aircraft other than a rotorcraft of 2 722 kg (6 000 lb) or less maximum weight, or to a non-turbine rotorcraft of 1 361 kg (3 000 lb) or less maximum weight, the change and areas affected by the change shall comply with the type-certification basis incorporated by reference in the type-certificate. However, if the Agency finds that the change is significant in an area, the Agency may require that the change and areas affected by the change comply with an amendment to a certification specification of the type-certification basis incorporated by reference in the type-certificate and with any other certification specification which is directly related, unless the Agency also finds that compliance with that amendment does not contribute materially to the level of safety of the changed product or is impractical.

(d) If the Agency finds that the certification specifications applicable on the date of the application for the change do not provide adequate standards with respect to the proposed change, the change and areas affected by the change shall also comply with any special conditions, and amendments to those special conditions, prescribed by the Agency in accordance with point 21.B.75, to provide a level of safety equivalent to that established by the certification specifications applicable on the date of the application for the change.

(e) By derogation from points (a), (b) and (c), the change and areas affected by the change may comply with an alternative to a certification specification designated by the Agency if proposed by the applicant, provided that the Agency finds that the alternative provides a level of safety which is: 1. in the case of a type-certificate: (i) equivalent to that of the certification specifications designated by the Agency under (a), (b) or (c) above; or (ii) compliant with the essential requirements of Annex II to Regulation (EU) 2018/1139; 2. in the case of a restricted type-certificate, adequate with regard to the intended use.

(f) If an applicant chooses to comply with a certification specification set out in an amendment that becomes applicable after submitting the application for a change to a type-certificate, the change and areas affected by the change shall also comply with any other certification specification which is directly related.

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

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21.A.105 Record-keeping

For each change, all relevant design information, drawings and test reports, including inspection records for the changed product tested, shall be held by the applicant at the disposal of the Agency and shall be retained in order to provide the information necessary to ensure the continued airworthiness, continued validity of the operational suitability data and compliance with applicable environmental protection requirements of the changed product.

▼B

21.A.107 Instructions for continued airworthiness

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(a) The holder of a minor change approval to a type-certificate shall furnish at least one set of the associated variations, if any, to the instructions for continued airworthiness of the product on which the minor change is to be installed, prepared in accordance with the applicable type-certification basis, to each known owner of one or more aircraft, engine, or propeller incorporating the minor change, upon its delivery, or upon issuance of the first certificate of airworthiness for the affected aircraft, whichever occurs later, and thereafter make those variations in instructions available, on request, to any other person required to comply with any of the terms of those instructions.

▼B

(b) In addition, changes to those variations of the instructions for continued airworthiness shall be made available to all known operators of a product incorporating the minor change and shall be made available, on request, to any person required to comply with any of those instructions.

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21.A.108 Availability of operational suitability data

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

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

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

(c) on request, the relevant parts of the changes in points (a) and (b) above, to: 1. the competent authority responsible for verifying conformity with one or more elements of the affected operational suitability data; and 2. any person required to comply with one or more elements of this set of operational suitability data.

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21.A.109 Obligations and EPA marking

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

(a) undertake the obligations laid down in points 21.A.4, 21.A.105, 21.A.107 and 21.A.108; and

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

▼B

SUBPART E — SUPPLEMENTAL TYPE-CERTIFICATES

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21.A.111 Scope

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

21.A.112A Eligibility

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

▼B

21.A.112B Demonstration of capability

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

▼B

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

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

▼B

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

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

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

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

(ii) specify whether the certification data has been or will be prepared completely by the applicant or on the basis of an arrangement with the owner of the type-certification data.

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

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

(a) Supplemental type certificates shall be issued by: 1. the Agency; or 2. an approved design organisation within the scope of its privileges provided for in points (1) and (9) of point 21.A.263(c), as recorded in the terms of approval.

(b) A supplemental type-certificate shall only be issued when: 1. the applicant has demonstrated its capability in accordance with point 21.A.112B; 2. it has been demonstrated that the change to a type-certificate and areas affected by the change comply with the type-certification basis and the environmental protection requirements, as established by the Agency in accordance with point 21.A.101; 3. in the case of a supplemental type-certificate affecting the operational suitability data, it has been demonstrated that the necessary changes to the operational suitability data meet the operational suitability data certification basis, as established by the Agency in accordance with point 21.A.101; 4. compliance with points (2) and (3) has been demonstrated in accordance with point 21.A.20, as applicable to the change; and 5. in case the applicant has specified that it provided certification data on the basis of an arrangement with the owner of the type-certification data in accordance with point 21.A.113(b): (i) the type-certificate holder has indicated that it has no technical objection to the information submitted under point 21.A.93; and (ii) the type-certificate holder has agreed to collaborate with the supplemental type-certificate holder to ensure discharge of all obligations for continued airworthiness of the changed product through compliance with points 21.A.44 and 21.A.118A.

(c) By 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 operational suitability data certification basis, provided that the applicant demonstrates such compliance before the date at which those data are to be actually used.

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

▼B

21.A.116 Transferability

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

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

(a) Minor changes to that part of a product 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 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 covered by a supplemental type-certificate submitted by the supplemental type-certificate holder itself may be approved as a change to the existing supplemental type-certificate.

21.A.118A Obligations and EPA marking

Each holder of a supplemental type-certificate shall:

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(a) undertake the obligations: 1. laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.105, 21.A.119, 21.A.120A and 21.A.120B; 2. implicit in the collaboration with the type-certificate holder under point 21.A.115(d)(2); and for this purpose continue to meet the criteria of point 21.A.112B;

▼B

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

21.A.118B Duration and continued validity

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

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

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

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

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21.A.119 Manuals

The holder of a supplemental type-certificate shall produce, maintain, and update master copies of variations in the manuals required by the applicable type-certification basis, the applicable operational suitability data certification basis and environmental protection requirements for the product, necessary to cover the changes introduced under the supplemental type-certificate, and furnish copies of those manuals to the Agency on request.

21.A.120A Instructions for continued airworthiness

▼B

(a) The holder of the supplemental type-certificate for an aircraft, engine, or propeller, shall furnish at least one set of the associated variations to the instructions for continued airworthiness, prepared in accordance with the applicable type-certification basis, to each known owner of one or more aircraft, engine, or propeller incorporating the features of the supplemental type-certificate, upon its delivery, or upon issuance of the first certificate of airworthiness for the affected aircraft, whichever occurs later, and thereafter make those variations in instructions available, on request, to any other person required to comply with any of the terms of those instructions. Availability of some manual or portion of the variations to the instructions for continued airworthiness, dealing with overhaul or other forms of heavy maintenance, may be delayed until after the product has entered into service, but shall be available before any of the products reaches the relevant age or flight-hours/cycles.

(b) In addition, changes to those variations of the instructions for continued airworthiness shall be made available to all known operators of a product incorporating the supplemental type-certificate and shall be made available, on request, to any person required to comply with any of those instructions. A programme showing how changes to the variations to the instructions for continued airworthiness are distributed shall be submitted to the Agency.

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21.A.120B Availability of operational suitability data

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

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

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

(c) on request, the relevant parts of the changes in points (a) and (b) above, to: 1. the competent authority responsible for verifying conformity with one or more elements of the affected operational suitability data; and 2. any person required to comply with one or more elements of this set of operational suitability data.

▼B

SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL

21.A.121 Scope

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

(b) This Subpart establishes the rules governing the obligations of the manufacturer of a product, part, or appliance being manufactured under this Subpart.

21.A.122 Eligibility

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

(a) it holds or has applied for an approval covering the design of that product, part or appliance; or

(b) it has ensured satisfactory coordination between production and design, through an appropriate arrangement with the applicant for, or holder of, an approval of such a design.

21.A.124 Application

(a) Each application for an agreement to the showing of conformity of individual products, parts and appliances 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 or appliance under this Subpart is needed pending the issuance of a production organisation approval under Subpart G;

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

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

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

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

(b) having provided a manual that contains: 1. a description of the production inspection system required under point (a); 2. a description of the means for making the determination of the production inspection system; 3. a description of the tests required in points 21.A.127 and 21.A.128, and the names of persons authorised for the purpose of point 21.A.130(a);

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

21.A.125B Findings

(a) When objective evidence is found showing non-compliance of the holder of a letter of agreement with the applicable requirements of this Annex I (Part 21), the finding shall be classified as follows:

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

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

(b) A level three finding is any item where it has been identified, by objective evidence, to contain potential problems that could lead to a non-compliance under point (a).

(c) After receipt of notification of findings according to point 21.B.125:

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

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

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

(d) In case of level one or level two findings, the letter of agreement may be subject to a partial or full limitation, suspension and revocation under point 21.B.145. The holder of the letter of agreement shall provide confirmation of receipt of the notice of limitation, suspension or revocation of the letter of agreement in a timely manner.

21.A.125C Duration and continued validity

(a) The letter of agreement shall be issued for a limited duration not exceeding one year. It shall remain valid unless:

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

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

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

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

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

21.A.126 Production inspection system

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

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

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

3. processes, manufacturing techniques and methods of assembly affecting the quality and safety of the finished product are accomplished in accordance with specifications accepted by the competent authority;

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

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

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

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

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

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

5. materials and parts that are withheld because of departures from design data or specifications, and that are to be considered for installation in the finished product, are subjected to an approved engineering and manufacturing review procedure. Those materials and parts determined by this procedure to be serviceable shall be properly identified and reinspected if rework or repair is necessary. Materials and parts rejected by this procedure shall be marked and disposed of to ensure that they are not incorporated in the final product;

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

21.A.127 Tests: aircraft

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

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

1. a check on handling qualities;

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

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

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

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

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

21.A.128 Tests: engines and propellers

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

21.A.129 Obligations of the manufacturer

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

(a) make each product, part or appliance 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 conforms to the applicable design data;

(c) maintain the production inspection system that ensures that each product conforms to the applicable design data and is in 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 or appliances that have been produced;

(e) establish and maintain an internal occurrence reporting system in the interest of safety, to enable the collection and assessment of occurrence reports in order to identify adverse trends or to address deficiencies, and to extract reportable occurrences. This system shall include evaluation of relevant information relating to occurrences and the promulgation of related information;

(f) 1. report to the holder of the type-certificate, restricted type-certificate or design approval, all cases where products, parts or appliances have been released by the manufacturer and subsequently identified to have deviations from the applicable design data, and investigate with the holder of the type-certificate, restricted type-certificate or design approval to identify those deviations which could lead to an unsafe condition; 2. report to the Agency and the competent authority of the Member State the deviations which could lead to an unsafe condition identified according to point (1). Such reports shall be made in a form and manner established by the Agency under point 21.A.3A(b)(2) or accepted by the competent authority of the Member State; 3. where the manufacturer acts as supplier to another production organisation, report also to that other organisation all cases where it has released products, parts or appliances to that organisation and subsequently identified them to have possible deviations from the applicable design data.

21.A.130 Statement of conformity

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

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(b) A statement of conformity shall include all of the below:

1. for each product, part or appliance, a statement that the product, part or appliance conforms to the approved design data and is in condition for safe operation;

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

3. for each engine, or variable pitch propeller, a statement that the engine or variable pitch propeller has been subjected by the manufacturer to a final functional test in accordance with point 21.A.128;

4. additionally, in the case of environmental 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.

▼B

(c) Each manufacturer of such a product, part or appliance shall:

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

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

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

present a current statement of conformity, for validation by the competent authority.

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

SUBPART G — PRODUCTION ORGANISATION APPROVAL

21.A.131 Scope

This Subpart establishes:

(a) the procedure for the issuance of a production organisation approval for a production organisation showing conformity of products, parts and appliances with the applicable design data;

(b) the rules governing the rights and obligations of the applicant for, and holders of, such approvals.

21.A.133 Eligibility

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

(a) justify that, for a defined scope of work, an approval under this Subpart is appropriate for the purpose of showing conformity with a specific design; and

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

(c) have ensured, through an appropriate arrangement with the applicant for, or holder of, an approval of that specific design, satisfactory coordination between production and design.

21.A.134 Application

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

21.A.135 Issue of production organisation approval

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

21.A.139 Quality System

(a) The production organisation shall demonstrate that it has established and is able to maintain a quality system. The quality system shall be documented. This quality system shall be such as to enable the organisation to ensure that each product, part or appliance 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 condition for safe operation, and thus exercise the privileges set forth in point 21.A.163.

(b) The quality system shall contain:

1. as applicable within the scope of approval, control procedures for: (i) document issue, approval, or change; (ii) vendor and subcontractor assessment audit and control; (iii) verification that incoming products, parts, materials, and equipment, including items supplied new or used by buyers of products, are as specified in the applicable design data; (iv) identification and traceability; (v) manufacturing processes; (vi) inspection and testing, including production flight tests; (vii) calibration of tools, jigs, and test equipment; (viii) non-conforming item control; (ix) airworthiness coordination with the applicant for, or holder of, the design approval; (x) records completion and retention; (xi) personnel competence and qualification; (xii) issue of airworthiness release documents; (xiii) handling, storage and packing; (xiv) internal quality audits and resulting corrective actions; (xv) work within the terms of approval performed at any location other than the approved facilities; (xvi) work carried out after completion of production but prior