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Document 02012R0748-20210518

Consolidated text: 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)Text with EEA relevance

ELI: http://data.europa.eu/eli/reg/2012/748/2021-05-18

02012R0748 — EN — 18.05.2021 — 010.001


This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

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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)

(OJ L 224 21.8.2012, p. 1)

Amended by:

 

 

Official Journal

  No

page

date

►M1

COMMISSION REGULATION (EU) No 7/2013 of 8 January 2013

  L 4

36

9.1.2013

►M2

COMMISSION REGULATION (EU) No 69/2014 of 27 January 2014

  L 23

12

28.1.2014

►M3

COMMISSION REGULATION (EU) 2015/1039 of 30 June 2015

  L 167

1

1.7.2015

 M4

COMMISSION REGULATION (EU) 2016/5 of 5 January 2016

  L 3

3

6.1.2016

►M5

COMMISSION DELEGATED REGULATION (EU) 2019/897 of 12 March 2019

  L 144

1

3.6.2019

►M6

COMMISSION DELEGATED REGULATION (EU) 2020/570 of 28 January 2020

  L 132

1

27.4.2020

►M7

COMMISSION DELEGATED REGULATION (EU) 2021/699 of 21 December 2020

  L 145

1

28.4.2021


Corrected by:

 C1

Corrigendum, OJ L 146, 5.6.2019, p.  116 (2019/897)




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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;

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(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:

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(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;

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(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

21.A.65

Continuing structural integrity for aeroplanes structures

(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;

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Appendix II —

EASA Form 15a and 15c — Airworthiness Review Certificate;

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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.

▼B

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 by, a certification programme for the demonstration of compliance in accordance with point 21.A.20, consisting of:

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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).

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

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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.

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21.A.44    Obligations of the holder

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

(a) 

undertake the obligations laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.55, 21.A.57, 21.A.61, 21.A.62 and 21.A.65; and, for this purpose, shall continue to meet the qualification requirements for eligibility under point 21.A.14; and

(b) 

specify the marking in accordance with Subpart Q.

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

▼B

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.

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21.A.65    Continuing structural integrity for aeroplanes structures

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

▼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.

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(b) 

An application shall include, or be supplemented after the initial application by, a certification programme for the demonstration of compliance in accordance with point 21.A.20, consisting of:

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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

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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 change to type-certificate or restricted type-certificate for a large aeroplane or a large rotorcraft, and by more than three years for an application for a change to any other type-certificate or restricted type certificate.

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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.

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(b) 

Except as provided in point (h), 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:

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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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(h) 

For large aeroplanes subject to point 26.300 of Annex I to Regulation (EU) 2015/640 ( 2 ), the applicant shall comply with certification specifications that provide at least an equivalent level of safety to points 26.300, 26.320 and 26.330 of Annex I to Regulation (EU) 2015/640, except for applicants for supplemental type-certificates who are not required to take into account point 26.303.

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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 to delivery, to maintain the aircraft in a condition for safe operation;

(xvii) 

issue of permit to fly and approval of associated flight conditions.

The control procedures need to include specific provisions for any critical parts.

2. 

An independent quality assurance function to monitor compliance with, and adequacy of, the documented procedures of the quality system. This monitoring shall include a feedback system to the person or group of persons referred to in point 21.A.145(c)(2) and ultimately to the manager referred to in point 21.A.145(c)(1) to ensure, as necessary, corrective action.

21.A.143    Exposition

(a) The organisation shall submit to the competent authority a production organisation exposition providing the following information:

1. 

a statement signed by the accountable manager confirming that the production organisation exposition and any associated manuals which define the approved organisation’s compliance with this Subpart will be complied with at all times;

2. 

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

3. 

the duties and responsibilities of the manager(s) as required by point 21.A.145(c)(2) including matters on which they may deal directly with the competent authority on behalf of the organisation;

4. 

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

5. 

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

6. 

a general description of man-power resources;

7. 

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

8. 

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

9. 

the procedure for the notification of organisational changes to the competent authority;

10. 

the amendment procedure for the production organisation exposition;

11. 

a description of the quality system and the procedures as required by point 21.A.139(b)(1);

12. 

a list of those outside parties referred to in point 21.A.139(a);

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13. 

if flight tests are to be conducted, a flight test operations manual defining the organisation's policies and procedures in relation to flight test. The flight test operations manual shall include:

(i) 

a description of the organisation's processes for flight test, including the flight test organisation involvement into the permit to fly issuance process;

(ii) 

crewing policy, including composition, competency, currency and flight time limitations, in accordance with Appendix XII to this Annex I (Part 21), where applicable;

(iii) 

procedures for the carriage of persons other than crew members and for flight test training, when applicable;

(iv) 

a policy for risk and safety management and associated methodologies;

(v) 

procedures to identify the instruments and equipment to be carried;

(vi) 

a list of documents that need to be produced for flight test.

▼B

(b) The production organisation exposition shall be amended as necessary to remain an up-to-date description of the organisation, and copies of any amendments shall be supplied to the competent authority.

21.A.145    Approval requirements

The production organisation shall demonstrate, on the basis of the information submitted in accordance with point 21.A.143 that:

(a) 

with regard to general approval requirements, facilities, working conditions, equipment and tools, processes and associated materials, number and competence of staff, and general organisation are adequate to discharge obligations under point 21.A.165;

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(b) 

with regard to all necessary airworthiness and environmental data:

1. 

the production organisation is in receipt of such data from the Agency, and from the holder of, or applicant for, the type-certificate, restricted type-certificate or design approval, including any exemption granted against the CO2 production cut-off requirements, to determine conformity with the applicable design data;

2. 

the production organisation has established a procedure to ensure that airworthiness and environmental data are correctly incorporated in its production data and,

3. 

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

(c) 

with regard to management and staff:

1. 

a manager has been nominated by the production organisation, and is accountable to the competent authority. His or her responsibilities within the organisation shall consist of ensuring that all production is performed to the required standards and that the production organisation is continuously in compliance with the data and procedures identified in the exposition referred to in point 21.A.143;

2. 

a person or group of persons have been nominated by the production organisation to ensure that the organisation is in compliance with the requirements of this Annex (Part 21), and are identified, together with the extent of their authority. Such person(s) shall act under the direct authority of the accountable manager referred to in point (1). The person(s) nominated shall be able to show the appropriate knowledge, background and experience to discharge their responsibilities;

3. 

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

▼B

(d) 

with regard to certifying staff, authorised by the production organisation to sign the documents issued under point 21.A.163 under the scope or terms of approval:

1. 

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

2. 

the production organisation maintains a record of all certifying staff which shall include details of the scope of their authorisation;

3. 

certifying staff are provided with evidence of the scope of their authorisation.

21.A.147    Changes to the approved production organisation

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(a) After the issue of a production organisation approval, each change to the approved production organisation that is significant to the showing of conformity or to the airworthiness and environmental characteristics of the product, part or appliance, particularly changes to the quality system, shall be approved by the competent authority. An application for approval shall be submitted in writing to the competent authority and the organisation shall demonstrate to the competent authority, before implementing the change, that it complies with this Subpart.

▼B

(b) The competent authority shall establish the conditions under which a production organisation approved under this Subpart may operate during such changes unless the competent authority determines that the approval should be suspended.

21.A.148    Changes of location

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

21.A.149    Transferability

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

21.A.151    Terms of approval

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

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

21.A.153    Changes to the terms of approval

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

21.A.157    Investigations

A production organisation shall make arrangements that allow the competent authority to make any investigations, including investigations of partners and subcontractors, necessary to determine compliance and continued compliance with the applicable requirements of this Subpart.

21.A.158    Findings

(a) When objective evidence is found showing non-compliance of the holder of a production organisation approval 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.225,

1. 

in case of a level one finding, the holder of the production organisation approval 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 production organisation approval.

(d) In case of level one or level two findings, the production organisation approval may be subject to a partial or full limitation, suspension or revocation under point 21.B.245. The holder of the production organisation approval shall provide confirmation of receipt of the notice of limitation, suspension or revocation of the production organisation approval in a timely manner.

21.A.159    Duration and continued validity

(a) A production organisation approval shall be issued for an unlimited duration. It shall remain valid unless:

1. 

the production organisation fails to demonstrate compliance with the applicable requirements of this Subpart; or

2. 

the competent authority is prevented by the holder or any of its partners or subcontractors to perform the investigations in accordance with point 21.A.157; or

3. 

there is evidence that the production organisation cannot maintain satisfactory control of the manufacture of products, parts or appliances under the approval; or

4. 

the production organisation no longer meets the requirements of point 21.A.133; or

5. 

the certificate has been surrendered or revoked under point 21.B.245.

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

21.A.163    Privileges

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

(a) 

perform production activities under this Annex I (Part 21);

(b) 

in the case of complete aircraft and upon presentation of a statement of conformity (EASA Form 52) under point 21.A.174, obtain an aircraft certificate of airworthiness and a noise certificate without further showing;

(c) 

in the case of other products, parts or appliances, issue authorised release certificates (EASA Form 1) without further showing;

(d) 

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

(e) 

under procedures agreed with its competent authority for production, for an aircraft it has produced and when the production organisation itself is controlling under its POA the configuration of the aircraft and is attesting conformity with the design conditions approved for the flight, to issue a permit to fly in accordance with point 21.A.711(c) including approval of the flight conditions in accordance with point 21.A.710(b).

21.A.165    Obligations of the holder

The holder of a production organisation approval shall:

(a) 

ensure that the production organisation exposition furnished in accordance with point 21.A.143 and the documents to which it refers, are used as basic working documents within the organisation;

(b) 

maintain the production organisation in conformity with the data and procedures approved for the production organisation approval;

(c) 
1. 

determine that each completed aircraft conforms to the type design and is in condition for safe operation prior to submitting statements of conformity to the competent authority; or

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2. 

determine that other products, parts or appliances are complete and conform to the approved design data and are in a condition for safe operation before issuing an EASA Form 1 to certify conformity to approved design data and condition for safe operation;

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3. 

additionally, in the case of environmental requirements determine that:

(i) 

the completed engine is in compliance with the applicable engine exhaust emissions requirements on the date of manufacture of the engine: and

(ii) 

the completed aeroplane is in compliance with the applicable CO2 emissions requirements on the date its first certificate of airworthiness is issued.

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4. 

determine that other products, parts or appliances conform to the applicable data before issuing an EASA Form 1 as a conformity certificate;

▼B

(d) 

record all details of work carried out;

(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 or design approval, all cases where products, parts or appliances have been released by the production organisation and subsequently identified to have possible deviations from the applicable design data, and investigate with the holder of the type-certificate or design approval in order 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 holder of the production organisation approval is acting as a 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;

(g) 

provide assistance to the holder of the 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;

(h) 

establish an archiving system incorporating requirements imposed on its partners, suppliers and subcontractors, ensuring conservation of the data used to justify conformity of the products, parts or appliances. Such data shall be held at the disposal of the competent authority and be retained in order to provide the information necessary to ensure the continuing airworthiness of the products, parts or appliances;

(i) 

where, under its terms of approval, the holder issues a certificate of release to service, determine that each completed aircraft has been subjected to necessary maintenance and is in condition for safe operation, prior to issuing the certificate;

(j) 

where applicable, under the privilege of point 21.A.163(e), determine the conditions under which a permit to fly can be issued;

(k) 

where applicable, under the privilege of point 21.A.163(e), establish compliance with points 21.A.711(c) and (e) before issuing a permit to fly to an aircraft.

SUBPART H —   CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS

21.A.171    Scope

This Subpart establishes the procedure for issuing airworthiness certificates.

21.A.172    Eligibility

Any natural or legal person under whose name an aircraft is registered or will be registered in a Member State (‘Member State of registry’), or its representative, shall be eligible as an applicant for an airworthiness certificate for that aircraft under this Subpart.

21.A.173    Classification

Airworthiness certificates shall be classified as follows:

(a) 

certificates of airworthiness shall be issued to aircraft which conform to a type-certificate that has been issued in accordance with this Annex I (Part 21);

(b) 

restricted certificates of airworthiness shall be issued to aircraft:

1. 

which conform to a restricted type-certificate that has been issued in accordance with this Annex I (Part 21); or

2. 

which have been shown to the Agency to comply with specific airworthiness specifications ensuring adequate safety.

21.A.174    Application

(a) Pursuant to point 21.A.172, an application for an airworthiness certificate shall be made in a form and manner established by the competent authority of the Member State of registry.

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

1. 

the class of airworthiness certificate applied for;

2. 

with regard to new aircraft:

(i) 

a statement of conformity:

— 
issued under point 21.A.163(b); or
— 
issued under point 21.A.130 and validated by the competent authority; or
— 
for an imported aircraft, a statement signed by the exporting authority that the aircraft conforms to a design approved by the Agency;
(ii) 

a weight and balance report with a loading schedule and;

(iii) 

the flight manual, when required by the applicable certification specifications for the particular aircraft.

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3. 

with regard to used aircraft originating from:

(i) 

a Member State, an airworthiness review certificate issued in accordance with Annex I (Part-M) or Annex Vb (Part-ML) to Commission Regulation (EU) No 1321/2014 ( 3 );

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(ii) 

a non-member State:

— 
a statement by the competent authority of the State where the aircraft is, or was, registered, reflecting the airworthiness status of the aircraft on its register at the time of transfer;
— 
a weight and balance report with a loading schedule;
— 
the flight manual when such a manual is required by the airworthiness code for the aircraft;
— 
historical records to establish the production, modification and maintenance standard of the aircraft, including all limitations associated with a restricted certificate of airworthiness issued in accordance with point 21.B.327;
— 
a recommendation for the issuance of a certificate of airworthiness or restricted certificate of airworthiness and for an airworthiness review certificate pursuant to an airworthiness review in accordance with Annex I (Part-M) to Regulation (EU) No 1321/2014 ( 4 ) or an airworthiness review certificate in accordance with Annex Vb (Part-ML) to Regulation (EU) No 1321/2014.
— 
the date on which the first certificate of airworthiness was issued and, if the standards of Volume III of Annex 16 to the Chicago Convetnion apply, the CO2 metric value data.;

▼B

(c) Unless otherwise agreed, the statements referred to in points (b)(2)(i) and (b)(3)(ii) shall be issued no more than 60 days before presentation of the aircraft to the competent authority of the Member State of registry.

21.A.175    Language

The manuals, placards, listings, and instrument markings and other necessary information required by applicable certification specifications shall be presented in one or more of the official language(s) of the European Union acceptable to the competent authority of the Member State of registry.

21.A.177    Amendment or modification

An airworthiness certificate may be amended or modified only by the competent authority of the Member State of registry.

21.A.179    Transferability and re-issuance within Member States

(a) Where ownership of an aircraft has changed:

1. 

if it remains on the same register, the certificate of airworthiness, or the restricted certificate of airworthiness conforming to a restricted type-certificate only, shall be transferred together with the aircraft;

2. 

if the aircraft is registered in another Member State, the certificate of airworthiness, or the restricted certificate of airworthiness conforming to a restricted type-certificate only, shall be issued:

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(i) 

upon presentation of the former certificate of airworthiness and of a valid airworthiness review certificate issued in accordance with Annex I (Part-M) or Annex Vb (Part-ML) of Regulation (EU) No 1321/2014;

▼B

(ii) 

when satisfying point 21.A.175.

(b) Where ownership of an aircraft has changed, and the aircraft has a restricted certificate of airworthiness not conforming to a restricted type-certificate, the airworthiness certificates shall be transferred together with the aircraft provided the aircraft remains on the same register, or issued only with the formal agreement of the competent authority of the Member State of registry to which it is transferred.

21.A.180    Inspections

The holder of the airworthiness certificate shall provide access to the aircraft for which that airworthiness certificate has been issued upon request by the competent authority of the Member State of registry.

21.A.181    Duration and continued validity

(a) An airworthiness certificate shall be issued for an unlimited duration. It shall remain valid subject to:

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1. 

compliance with the applicable type-design and continued airworthiness requirements; and

▼B

2. 

the aircraft remaining on the same register; and

3. 

the type-certificate or restricted type-certificate under which it is issued not being previously invalidated under point 21.A.51;

4. 

the certificate not being surrendered or revoked under point 21.B.330.

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

21.A.182    Aircraft identification

Each applicant for an airworthiness certificate under this Subpart shall demonstrate that its aircraft is identified in accordance with Subpart Q.

SUBPART I —   NOISE CERTIFICATES

21.A.201    Scope

This Subpart establishes the procedure for issuing noise certificates.

21.A.203    Eligibility

Any natural or legal person under whose name an aircraft is registered or will be registered in a Member State (Member State of registry), or its representative, shall be eligible as an applicant for a noise certificate for that aircraft under this Subpart.

21.A.204    Application

(a) Pursuant to point 21.A.203, an application for a noise certificate shall be made in a form and manner established by the competent authority of the Member State of registry.

(b) Each application shall include:

1. 

with regard to new aircraft:

(i) 

a statement of conformity:

— 
issued under point 21.A.163(b), or
— 
issued under point 21.A.130 and validated by the competent authority, or
— 
for an imported aircraft, a statement, signed by the exporting authority that the aircraft conforms to a design approved by the Agency; and
(ii) 

the noise information determined in accordance with the applicable noise requirements;

2. 

with regard to used aircraft:

(i) 

the noise information determined in accordance with the applicable noise requirements; and

(ii) 

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

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

21.A.207    Amendment or modification

A noise certificate may be amended or modified only by the competent authority of the Member State of registry.

21.A.209    Transferability and re-issuance within Member States

Where ownership of an aircraft has changed:

(a) 

if the aircraft remains on the same register, the noise certificate shall be transferred together with the aircraft; or

(b) 

if the aircraft moves to the register of another Member State, the noise certificate shall be issued upon presentation of the former noise certificate.

21.A.210    Inspections

The holder of the noise certificate shall provide access to the aircraft for which that noise certificate has been issued upon request by the competent authority of the Member State of registry or by the Agency for inspection.

21.A.211    Duration and continued validity

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

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1. 

compliance with the applicable type-design, environmental protection and continued airworthiness requirements; and

▼B

2. 

the aircraft remaining on the same register; and

3. 

the type-certificate or restricted type-certificate under which it is issued not being previously invalidated under point 21.A.51;

4. 

the certificate not being surrendered or revoked under point 21.B.430.

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

SUBPART J —   DESIGN ORGANISATION APPROVAL

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21.A.231    Scope

This Subpart establishes the procedure for the approval of design organisations and rules governing the rights and obligations of applicants for, and holders of, such approvals. In this Subpart, the references to type-certificates include type-certificates and restricted type-certificates.

▼B

21.A.233    Eligibility

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

(a) 

in accordance with points 21.A.14, 21.A.112B, 21.A.432B or 21.A.602B; or

(b) 

for approval of minor changes or minor repair design, when requested for the purpose of obtaining privileges under point 21.A.263.

21.A.234    Application

Each application for a design organisation approval shall be made in a form and manner established by the Agency and shall include an outline of the information required by point 21.A.243, and the terms of approval requested to be issued under point 21.A.251.

21.A.235    Issue of design organisation approval

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

21.A.239    Design assurance system

(a) The design organisation shall demonstrate that it has established and is able to maintain a design assurance system for the control and supervision of the design, and of design changes, of products, parts and appliances covered by the application. This design assurance system shall be such as to enable the organisation:

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1. 

to ensure that the design of the products, parts and appliances or the design change thereof, comply with the applicable type-certification basis, the applicable operational suitability data certification basis and environmental protection requirements; and

▼B

2. 

to ensure that its responsibilities are properly discharged in accordance with:

(i) 

the appropriate provisions of this Annex I (Part 21); and

(ii) 

the terms of approval issued under point 21.A.251;

3. 

to independently monitor the compliance with, and adequacy of, the documented procedures of the system. This monitoring shall include a feed-back system to a person or a group of persons having the responsibility to ensure corrective actions.

(b) The design assurance system shall include an independent checking function of the showings of compliance on the basis of which the organisation submits compliance statements and associated documentation to the Agency.

(c) The design organisation shall specify the manner in which the design assurance system accounts for the acceptability of the parts or appliances designed or the tasks performed by partners or subcontractors according to methods which are the subject of written procedures.

21.A.243    Data

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(a) The design organisation shall furnish a handbook to the Agency describing, directly or by cross-reference, the organisation, the relevant procedures and the products or changes to products to be designed. If flight tests are to be conducted, a flight test operations manual defining the organisation's policies and procedures in relation to flight test shall be furnished. The flight test operations manual shall include:

(i) 

a description of the organisation's processes for flight test, including the flight test organisation involvement into the permit to fly issuance process;

(ii) 

crewing policy, including composition, competency, currency and flight time limitations, in accordance with Appendix XII to this Annex I (Part 21), where applicable;

(iii) 

procedures for the carriage of persons other than crew members and for flight test training, when applicable;

(iv) 

a policy for risk and safety management and associated methodologies;

(v) 

procedures to identify the instruments and equipment to be carried;

(vi) 

a list of documents that need to be produced for flight test.

▼B

(b) Where any parts or appliances or any changes to the products are designed by partner organisations or subcontractors, the handbook shall include a statement of how the design organisation is able to give, for all parts and appliances, the assurance of compliance required by point 21.A.239(b), and shall contain, directly or by cross-reference, descriptions and information on the design activities and organisation of those partners or subcontractors, as necessary to establish this statement.

(c) The handbook shall be amended as necessary to remain an up-to-date description of the organisation, and copies of amendments shall be supplied to the Agency.

(d) The design organisation shall furnish a statement of the qualifications and experience of the management staff and other persons responsible for making decisions affecting airworthiness and environmental protection in the organisation.

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21.A.245    Approval requirements

The design organisation shall demonstrate, on the basis of the information submitted in accordance with point 21.A.243 that, in addition to complying with point 21.A.239:

(a) 

the staff in all technical departments are of sufficient numbers and experience and have been given appropriate authority to be able to discharge their allocated responsibilities and these, together with the accommodation, facilities and equipment are adequate to enable the staff to achieve the airworthiness, operational suitability and environmental protection objectives for the product;

(b) 

there is full and efficient coordination between departments and within departments in respect of airworthiness, operational suitability and environmental protection matters.

21.A.247    Changes in design assurance system

After the issue of a design organisation approval, each change to the design assurance system that is significant to the showing of compliance or to the airworthiness, operational suitability and environmental protection of the product, shall be approved by the Agency. An application for approval shall be submitted in writing to the Agency and the design organisation shall demonstrate to the Agency, on the basis of submission of proposed changes to the handbook, and before implementation of the change, that it will continue to comply with this Subpart after implementation.

▼B

21.A.249    Transferability

Except as a result of a change in ownership, which is deemed significant for the purposes of point 21.A.247, a design organisation approval is not transferable.

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21.A.251    Terms of approval

The terms of approval shall identify the types of design work, the categories of products, parts and appliances for which the design organisation holds a design organisation approval, and the functions and duties that the organisation is approved to perform with regard to the airworthiness, operational suitability and environmental characteristics of the products. For design organisation approvals covering type-certification or European Technical Standard Order (ETSO) authorisation for auxiliary power units (APUs), the terms of approval shall contain in addition the list of products or APUs. Those terms shall be issued as part of a design organisation approval.

▼B

21.A.253    Changes to the terms of approval

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

21.A.257    Investigations

(a) The design organisation shall make arrangements that allow the Agency to make any investigations, including investigations of partners and subcontractors, necessary to determine compliance and continued compliance with the applicable requirements of this Subpart.

(b) The design organisation shall allow the Agency to review any report and make any inspection and perform or witness any flight and ground test necessary to check the validity of the compliance statements submitted by the applicant under point 21.A.239(b).

21.A.258    Findings

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(a) When, during the investigations referred to in points 21.A.257 and 21.B.100, objective evidence is found demonstrating non-compliance of the holder of a design organisation approval with the applicable requirements of this Annex, the finding shall be classified as follows:

1. 

a ‘level 1’ finding is any non-compliance with the requirements of this Annex that may lead to uncontrolled non-compliances with applicable requirements and affect the safety of the aircraft;

2. 

a ‘level 2’ finding is any non-compliance with the requirements of this Annex that is not classified as a ‘level 1’ finding.

▼B

(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).

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(c) After receipt of notification of findings under the applicable administrative procedures established by the Agency:

1. 

in the case of a ‘level 1’ finding, the holder of a design organisation approval shall demonstrate to the satisfaction of the Agency that it has taken adequate corrective action within a period of no more than 21 working days after written confirmation of the finding;

2. 

in the case of a ‘level 2’ findings, the holder of a design organisation approval shall demonstrate to the satisfaction of the Agency that it has taken adequate corrective action within a time period set by the Agency which is appropriate to the nature of the finding and is initially no longer than three months. The Agency may extend that initial time period where it considers that the nature of the finding allows such extension and where the applicant has submitted a corrective action plan which the Agency finds satisfactory; and

3. 

a ‘level 3’ finding shall not require immediate action by the holder of a design organisation approval.

(d) In cases of ‘level 1’ or ‘level 2’ findings, the design organisation approval may be subject to a partial or full suspension or revocation under the applicable administrative procedures established by the Agency. In that case, the holder of a design organisation approval shall provide confirmation of receipt of the notice of suspension or revocation of the design organisation approval in a timely manner.

▼B

21.A.259    Duration and continued validity

(a) A design organisation approval shall be issued for an unlimited duration. It shall remain valid unless:

1. 

the design organisation fails to demonstrate compliance with the applicable requirements of this Subpart; or

2. 

the Agency is prevented by the holder or any of its partners or subcontractors to perform the investigations in accordance with point 21.A.257; or

3. 

there is evidence that the design assurance system cannot maintain satisfactory control and supervision of the design of products or changes thereof under the approval; or

4. 

the certificate has been surrendered or revoked under the applicable administrative procedures established by the Agency.

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

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21.A.263    Privileges

(a) 

(Reserved)

(b) 

(Reserved)

(c) 

A holder of a design organisation approval shall be entitled, within the scope of its terms of approval, as established by the Agency, and under the relevant procedures of the design assurance system:

1. 

to classify changes to a type-certificate or to a supplemental type-certificate and repair designs as ‘major’ or ‘minor’;

2. 

to approve minor changes to a type-certificate or to a supplemental type-certificate and minor repair designs;

3. 

(Reserved);

4. 

(Reserved);

5. 

to approve certain major repair designs under Subpart M to products or auxiliary power units (APUs);

6. 

to approve for certain aircraft the flight conditions under which a permit to fly can be issued in accordance with point 21.A.710(a)(2), except for permits to fly to be issued for the purpose of point 21.A.701(a)(15);

7. 

to issue a permit to fly in accordance with point 21.A.711(b) for an aircraft it has designed or modified, or for which it has approved, in accordance with point 21.A.263(c)(6), the flight conditions under which the permit to fly can be issued, and where the holder of a design organisation approval itself:

(i) 

controls the configuration of the aircraft, and

(ii) 

attests conformity with the design conditions approved for the flight;

8. 

to approve certain major changes to a type-certificate under Subpart D; and

9. 

to issue certain supplemental type-certificates under Subpart E and approve certain major changes to those certificates.

21.A.265    Obligations of the holder

The holder of a design organisation approval shall, within the scope of its terms of approval, as established by the Agency:

(a) 

maintain the handbook required under point 21.A.243 in conformity with the design assurance system;

(b) 

ensure that this handbook or the relevant procedures included by cross-reference are used as a basic working document within the organisation;

(c) 

determine that the design of products, or changes or repairs thereto comply with the applicable specifications and requirements and have no unsafe features;

(d) 

provide the Agency with statements and associated documentation confirming compliance with point (c), except for approval processes carried out in accordance with point 21.A.263(c);

(e) 

provide to the Agency data and information related to the actions required under point 21.A.3B;

(f) 

determine, in accordance with point 21.A.263(c)(6), the flight conditions under which a permit to fly can be issued;

(g) 

establish, in accordance with point 21.A.263(c)(7), compliance with points (b) and (e) of point 21.A.711 before issuing a permit to fly to an aircraft;

(h) 

designate data and information issued under the authority of the approved design organisation within the scope of its terms of approval as established by the Agency with the following statement: ‘The technical content of this document is approved under the authority of the DOA ref. EASA. 21J.[XXXX]’.

▼B

SUBPART K —   PARTS AND APPLIANCES

21.A.301    Scope

This Subpart establishes the procedure relating to the approval of parts and appliances.

21.A.303    Compliance with applicable requirements

The showing of compliance of parts and appliances to be installed in a type-certificated product shall be made:

(a) 

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

(b) 

where applicable, under the ETSO authorisation procedures of Subpart O; or

(c) 

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

21.A.305    Approval of parts and appliances

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

21.A.307    Release of parts and appliances for installation

A part or appliance shall be eligible for installation in a type-certificated product when it is in a condition for safe operation, and it is:

(a) 

accompanied by an authorised release certificate (EASA Form 1), certifying that the item was manufactured in conformity to approved design data and is marked in accordance with Subpart Q; or

(b) 

a standard part; or

(c) 

in the case of ELA1 or ELA2 aircraft, a part or appliance that is:

1. 

not life-limited, nor part of the primary structure, nor part of the flight controls;

2. 

manufactured in conformity to applicable design;

3. 

marked in accordance with Subpart Q;

4. 

identified for installation in the specific aircraft;

5. 

to be installed in an aircraft for which the owner has verified compliance with the conditions 1 through 4 and has accepted responsibility for this compliance.

(SUBPART L — NOT APPLICABLE)

SUBPART M —   REPAIRS

21.A.431 A    Scope

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(a) This Subpart establishes the procedure for the approval of a repair design of a product, part or appliance and establishes the rights and obligations of the applicants for, and holders of, those approvals.

▼B

(b) This Subpart defines standard repairs that are not subject to an approval process under this Subpart.

▼M5

(c) A ‘repair’ means the elimination of damage and/or restoration to an airworthy condition following the initial release to service by the manufacturer of any product, part or appliance.

(d) The elimination of damage by replacement of parts or appliances without the necessity for design activity shall be considered as a maintenance task and shall therefore require no approval under this Annex.

▼B

(e) A repair to an ETSO article other than an Auxiliary Power Unit (APU) shall be treated as a change to the ETSO design and shall be processed in accordance with point 21.A.611.

▼M5

(f) In this Subpart, the references to type-certificates include type-certificates and restricted type-certificates.

▼B

21.A.431B    Standard repairs

(a) Standard repairs are repairs:

(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 and powered sailplanes, balloons and airships as defined in ELA1 or ELA2.

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(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 repairs, including the associated instructions for continued airworthiness; and

▼B

(3) 

that are not in conflict with TC holders data.

(b) Points 21.A.432A to 21.A.451 are not applicable to standard repairs.

21.A.432A    Eligibility

(a) Any natural or legal person that has demonstrated, or is in the process of demonstrating, its capability under point 21.A.432B shall be eligible as an applicant for a major repair design approval under the conditions laid down in this Subpart.

(b) Any natural or legal person shall be eligible to apply for approval of a minor repair design.

21.A.432B    Demonstration of capability

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(a) An applicant for approval of a major repair design 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.

▼M5

(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.432C(b).

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21.A.432C    Application for a repair design approval

(a) 

An application for a repair design approval shall be made in a form and manner established by the Agency.

(b) 

▼M7

An application for a major repair design approval shall include, or be supplemented after the initial application by, a certification programme containing:

▼M5

1. 

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

2. 

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

3. 

an identification of any reinvestigations necessary to demonstrate compliance of the repair design and areas affected by the repair design with the type-certification basis incorporated by reference in, as applicable, either the type-certificate, the supplemental type-certificate or the APU ETSO authorisation;

4. 

any proposed amendments to the type-certification basis incorporated by reference in, as applicable, either the type-certificate, the supplemental type-certificate or the APU ETSO authorisation;

5. 

a proposal for a breakdown of the certification programme into meaningful groups of compliance demonstration activities and data, including the means and process proposed to be followed to demonstrate compliance with point 21.A.433(a)(1) and references to 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 and the potential impact of that non-compliance on product safety. 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

7. 

the specification whether the certification data is prepared completely by the applicant or on the basis of an arrangement with the owner of the type-certification data.

▼M5

21.A.433    Requirements for approval of a repair design

(a) 

A repair design shall only be approved:

1. 

when it has been demonstrated, following the certification programme referred to in point 21.A.432C(b), that the repair design complies with the type-certification basis incorporated by reference in, as applicable, either the type-certificate, the supplemental type-certificate or the APU ETSO authorisation, as well as with any amendments established and notified by the Agency in accordance with point 21.B.450;

2. 

when compliance with the type-certification basis that applies in accordance with point (a)(1) has been declared and the justifications of compliance have been recorded in the compliance documents;

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3. 

when no feature or characteristic has been identified that may make the product unsafe for the uses for which certification is requested;

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4. 

where 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.432C(b)(7):

(i) 

when the holder has indicated that it has no technical objection to the information submitted under point (a)(2); and

(ii) 

when the holder has agreed to collaborate with the repair design approval holder to ensure discharge of all obligations for continued airworthiness of the changed product through compliance with point 21.A.451;

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5. 

when, for a repair to an aeroplane subject to point 26.302 of Annex I to Regulation (EU) 2015/640, it has been demonstrated that the structural integrity of the repair and affected structure is at least equivalent to the level of structural integrity established for the baseline structure by point 26.302 of Annex I to Regulation (EU) 2015/640.

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(b) 

The applicant shall submit to the Agency the declaration referred to in point (a)(2) and, on request by the Agency, all necessary substantiation data.

21.A.435    Classification and approval of repair designs

(a) 

A repair design shall be classified as either ‘major’ or ‘minor’ in accordance with the criteria set out in point 21.A.91 for a change to the type-certificate.

(b) 

A repair design 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), (2) and (5) of point 21.A.263(c), as recorded in the terms of approval.

▼M5 —————

▼B

21.A.439    Production of repair parts

Parts and appliances to be used for the repair shall be manufactured in accordance with production data based upon all the necessary design data as provided by the repair design approval holder:

(a) 

under Subpart F; or

(b) 

by an organisation appropriately approved in accordance with Subpart G; or

(c) 

by an appropriately approved maintenance organisation.

21.A.441    Repair embodiment

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(a) The embodiment of a repair shall be made in accordance with Annex I (Part-M), Annex II (Part-145), Annex Vb (Part-ML) or Annex Vd (Part-CAO) of Regulation (EU) No 1321/2014, or by a production organisation approved in accordance with Subpart G of this Annex, in accordance with the privilege provided for in point 21.A.163(d).

▼B

(b) The design organisation shall transmit to the organisation performing the repair all the necessary installation instructions.

21.A.443    Limitations

A repair design may be approved subject to limitations, in which case the repair design approval shall include all necessary instructions and limitations. These instructions and limitations shall be transmitted by the repair design approval holder to the operator in accordance with a procedure agreed with the Agency.

21.A.445    Unrepaired damage

(a) When a damaged product, part or appliance, is left unrepaired, and is not covered by previously approved data, the evaluation of the damage for its airworthiness consequences may only be made:

1. 

by the Agency; or

2. 

by an appropriately approved design organisation under a procedure agreed with the Agency.

Any necessary limitations shall be processed in accordance with the procedures of point 21.A.443.

(b) Where the organisation evaluating the damage under point (a) is neither the Agency nor the type-certificate, supplemental type-certificate or APU ETSO authorisation holder, this organisation shall justify that the information on which the evaluation is based is adequate either from its organisation’s own resources or through an arrangement with the type-certificate, supplemental type-certificate or APU ETSO authorisation holder, or manufacturer, as applicable.

21.A.447    Record-keeping

For each repair, all relevant design information, drawings, test reports, instructions and limitations possibly issued in accordance with point 21.A.443, justification for classification and evidence of the design approval, shall:

(a) 

be held by the repair design approval holder at the disposal of the Agency; and

(b) 

be retained by the repair design approval holder in order to provide the information necessary to ensure the continued airworthiness of the repaired products, parts or appliances.

21.A.449    Instructions for continued airworthiness

(a) The holder of the repair design approval shall furnish at least one complete set of those changes to the instructions for continued airworthiness which result from the design of the repair, comprising descriptive data and accomplishment instructions prepared in accordance with the applicable requirements, to each operator of aircraft incorporating the repair. The repaired product, part or appliance may be released into service before the changes to those instructions have been completed, but this shall be for a limited service period, and in agreement with the Agency. Those changes to the instructions shall be made available on request to any other person required to comply with any of the terms of those changes to the instructions. The availability of some manual or portion of the changes 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) If updates to those changes to the instructions for continued airworthiness are issued by the holder of the repair design approval after the repair has been first approved, these updates shall be furnished to each operator and shall be made available on request to any other person required to comply with any of the terms of those changes to the instructions. A programme showing how updates to the changes to the instructions for continued airworthiness are distributed shall be submitted to the Agency.

21.A.451    Obligations and EPA marking

(a) Each holder of a major repair design approval shall:

1. 

undertake the obligations:

(i) 

laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.439, 21.A.441, 21.A.443, 21.A.447 and 21.A.449;

(ii) 

implicit in the collaboration with the type-certificate, supplemental type-certificate and with the APU ETSO authorisation holder under point 21.A.433 (b), as appropriate.

2. 

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

(b) Except for type-certificate holders or APU authorisation holders for which point 21.A.44 applies, the holder of a minor repair design approval shall:

1. 

undertake the obligations laid down in points 21.A.4, 21.A.447 and 21.A.449; and

2. 

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

(SUBPART N — NOT APPLICABLE)

SUBPART O —   EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS

21.A.601    Scope

This Subpart establishes the procedure for issuing ETSO authorisations and the rules governing the rights and obligations of applicants for, or holders of, such authorisations.

21.A.602A    Eligibility

Any natural or legal person that produces or is preparing to produce an ETSO article, and that has demonstrated, or is in the process of demonstrating, its capability under point 21.A.602B shall be eligible as an applicant for an ETSO authorisation.

21.A.602B    Demonstration of capability

Any applicant for an ETSO authorisation shall demonstrate its capability as follows:

(a) 

for production, by holding a production organisation approval, issued in accordance with Subpart G, or through compliance with Subpart F procedures; and

(b) 

for design:

1. 

for an Auxiliary Power Unit, by holding a design organisation approval, issued by the Agency in accordance with Subpart J;

2. 

for all other articles, by using procedures setting out the specific design practices, resources and sequence of activities necessary to comply with this Annex I (Part 21).

21.A.603    Application

(a) An application for an ETSO authorisation shall be made in a form and manner established by the Agency and shall include an outline of the information required by point 21.A.605.

(b) When a series of minor changes in accordance with point 21.A.611 is anticipated, the applicant shall set forth in its application the basic model number of the article and the associated part numbers with open brackets after it to denote that suffix change letters or numbers (or combinations of them) will be added from time to time.

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21.A.604    ETSO authorisation for an auxiliary power unit (APU)

With regard to an ETSO authorisation for an APU:

(a) 

by way of derogation from points 21.A.603, 21.A.610 and 21.A.615, the following points shall apply: points 21.A.15, 21.A.20, 21.A.21, 21.A.31, 21.A.33, 21.A.44, 21.B.75 and 21.B.80. However, an ETSO authorisation shall be issued in accordance with point 21.A.606 instead of a type-certificate;

▼M6

(b) 

by way of derogation from point 21.A.611, the requirements of Subpart D shall apply to the approval of design changes by the APU ETSO authorisation holder and design changes from other applicants classified as a minor change, and the requirements of Subpart E shall apply to the approval of design changes by other applicants classified as a major change. Where the requirements of Subpart E apply, a separate ETSO authorisation shall be issued instead of a supplemental type certificate; and

▼M5

(c) 

the requirements of Subpart M shall apply to the approval of repair designs.

21.A.605    Data requirements

(a) 

The applicant shall submit to the Agency the following documents:

1. 

a certification programme for the ETSO authorisation, setting out the means to demonstrate compliance with point 21.A.606(b);

2. 

a statement of compliance certifying that the applicant has met the requirements of this Subpart;

3. 

a declaration of design and performance (DDP), stating that the applicant has demonstrated that the article complies with the applicable ETSO in accordance with the certification programme;

4. 

a copy of the technical data required in the applicable ETSO;

5. 

the exposition, or a reference to the exposition, referred to in point 21.A.143 for the purpose of obtaining an appropriate production organisation approval under Subpart G or the manual, or a reference to the manual, referred to in point 21.A.125A(b) for the purpose of manufacturing under Subpart F without production organisation approval;

6. 

for an APU, the handbook, or a reference to the handbook, referred to in point 21.A.243 for the purpose of obtaining an appropriate design organisation approval under Subpart J;

7. 

for all other articles, the procedures, or a reference to the procedures, referred to in point 21.A.602B(b)(2);

(b) 

The applicant shall report to the Agency any difficulty or event encountered during the approval process that may significantly impact the ETSO authorisation.

21.A.606    Requirements for the issuance of an ETSO authorisation

In order to be issued an ETSO authorisation, the applicant shall:

(a) 

demonstrate its capability in accordance with point 21.A.602B;

(b) 

demonstrate that the article complies with the technical conditions of the applicable ETSO or with deviations therefrom approved in accordance with point 21.A.610, if any;

(c) 

comply with the requirements of this Subpart; and

(d) 

declare that no feature or characteristic has been identified that may make the article unsafe for the uses for which certification is requested.

▼B

21.A.607    ETSO authorisation privileges

The holder of an ETSO authorisation is entitled to produce and to mark the article with the appropriate ETSO marking.

21.A.608    Declaration of Design and Performance (DDP)

(a) The DDP shall contain at least the following information:

1. 

information corresponding to point 21.A.31(a) and (b), identifying the article and its design and testing standard;

2. 

the rated performance of the article, where appropriate, either directly or by reference to other supplementary documents;

3. 

a statement of compliance certifying that the article has met the appropriate ETSO;

4. 

reference to relevant test reports;

5. 

reference to the appropriate Maintenance, Overhaul and Repair Manuals;

6. 

the levels of compliance, where various levels of compliance are allowed by the ETSO;

7. 

list of deviations accepted in accordance with point 21.A.610.

(b) The DDP shall be endorsed with the date and signature of the holder of the ETSO authorisation, or its authorised representative.

21.A.609    Obligations of holders of ETSO authorisations

The holder of an ETSO authorisation under this Subpart shall:

(a) 

manufacture each article in accordance with Subpart G or Subpart F that ensures that each completed article conforms to its design data and is safe for installation;

(b) 

prepare and maintain, for each model of each article for which an ETSO authorisation has been issued, a current file of complete technical data and records in accordance with point 21.A.613;

(c) 

prepare, maintain and update master copies of all manuals required by the applicable airworthiness specifications for the article;

(d) 

make available to users of the article and to the Agency on request those maintenance, overhaul and repair manuals necessary for the usage and maintenance of the article, and changes to those manuals;

(e) 

mark each article in accordance with point 21.A.807;

(f) 

comply with points 21.A.3A, 21.A.3B and 21.A.4;

(g) 

continue to meet the qualification requirements of point 21.A.602B.

21.A.610    Approval for deviation

(a) Each manufacturer who requests approval to deviate from any performance standard of an ETSO shall demonstrate that the standards from which a deviation is requested are compensated for by factors or design features providing an equivalent level of safety.

(b) The request for approval to deviate, together with all pertinent data, shall be submitted to the Agency.

21.A.611    Design changes

(a) The holder of the ETSO authorisation may make minor design changes (any change other than a major change) without further authorisation by the Agency. In this case, the changed article keeps the original model number (part number changes or amendments shall be used to identify minor changes) and the holder shall forward to the Agency any revised data that are necessary for compliance with point 21.A.603(b).

(b) Any design change by the holder of the ETSO authorisation that is extensive enough to require a substantially complete investigation to determine compliance with an ETSO is a major change. Before making such a change, the holder shall assign a new type or model designation to the article and apply for a new authorisation under point 21.A.603.

(c) No design change by any natural or legal person other than the holder of the ETSO authorisation who submitted the statement of compliance for the article is eligible for approval under this Subpart O unless the person seeking the approval applies under point 21.A.603 for a separate ETSO authorisation.

21.A.613    Record-keeping

Further to the record-keeping requirements appropriate to or associated with the quality system, all relevant design information, drawings and test reports, including inspection records for the article tested, shall be held at the disposal of the Agency and shall be retained in order to provide the information necessary to ensure the continued airworthiness of the article and of the type-certificated product in which it is fitted.

21.A.615    Inspection by the Agency

Upon a request of the Agency, each applicant for, or holder of an ETSO authorisation for an article shall allow the Agency to:

(a) 

witness any tests;

(b) 

inspect the technical data files on that article.

21.A.619    Duration and continued validity

(a) An ETSO authorisation shall be issued for an unlimited duration. It shall remain valid unless:

1. 

the conditions required when ETSO authorisation was granted are no longer being observed; or

2. 

the obligations of the holder specified in point 21.A.609 are no longer being discharged; or

3. 

the article has proved to give rise to unacceptable hazards in service; or

4. 

the authorisation has been surrendered or revoked under the applicable administrative procedures established by the Agency.

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

21.A.621    Transferability

Except for a change in ownership of the holder, which shall be regarded as a change of significance, and shall therefore comply with points 21.A.147 and 21.A.247 as applicable, an ETSO authorisation issued under this Annex I (Part 21) is not transferable.

SUBPART P —   PERMIT TO FLY

21.A.701    Scope

(a) Permits to fly shall be issued in accordance with this Subpart to aircraft that do not meet, or have not been shown to meet, applicable airworthiness requirements but are capable of safe flight under defined conditions and for the following purposes:

1. 

development;

2. 

showing compliance with regulations or certification specifications;

3. 

design organisations or production organisations crew training;

4. 

production flight testing of new production aircraft;

5. 

flying aircraft under production between production facilities;

6. 

flying the aircraft for customer acceptance;

7. 

delivering or exporting the aircraft;

8. 

flying the aircraft for Authority acceptance;

9. 

market survey, including customer’s crew training;

10. 

exhibition and air show;

11. 

flying the aircraft to a location where maintenance or airworthiness review are to be performed, or to a place of storage;

12. 

flying an aircraft at a weight in excess of its maximum certificated takeoff weight for flight beyond the normal range over water, or over land areas where adequate landing facilities or appropriate fuel is not available;

13. 

record breaking, air racing or similar competition;

14. 

flying aircraft meeting the applicable airworthiness requirements before conformity to the environmental requirements has been found;

15. 

for non-commercial flying activity on individual non-complex aircraft or types for which a certificate of airworthiness or restricted certificate of airworthiness is not appropriate;

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16. 

flying an aircraft for troubleshooting purposes or to check the functioning of one or more systems, parts or appliances after maintenance.

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(b) This Subpart establishes the procedure for issuing permits to fly and approving associated flight conditions, and establishes the rights and obligations of the applicants for, and holders of, those permits and approvals of flight conditions.

21.A.703    Eligibility

(a) Any natural or legal person shall be eligible as an applicant for a permit to fly except for a permit to fly requested for the purpose of point 21.A.701(a)(15) where the applicant shall be the owner.

(b) Any natural or legal person shall be eligible for application for the approval of the flight conditions.

21.A.705    Competent authority

Notwithstanding point 21.1 of this Annex I (Part 21) for the purpose of this Subpart, the ‘competent authority’ shall be:

(a) 

the authority designated by the Member State of registry; or

(b) 

for unregistered aircraft, the authority designated by the Member State which prescribed the identification marks.

21.A.707    Application for permit to fly

(a) Pursuant to point 21.A.703 and when the applicant has not been granted the privilege to issue a permit to fly, an application for a permit to fly shall be made to the competent authority in a form and manner established by that authority.

(b) Each application for a permit to fly shall include:

1. 

the purpose(s) of the flight(s), in accordance with point 21.A.701;

2. 

the ways in which the aircraft does not comply with the applicable airworthiness requirements;

3. 

the flight conditions approved in accordance with point 21.A.710.

(c) Where the flight conditions are not approved at the time of application for a permit to fly, an application for approval of the flight conditions shall be made in accordance with point 21.A.709.

21.A.708    Flight conditions

Flight conditions include:

(a) 

the configuration(s) for which the permit to fly is requested;

(b) 

any condition or restriction necessary for safe operation of the aircraft, including:

1. 

the conditions or restrictions put on itineraries or airspace, or both, required for the flight(s);

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2. 

any conditions or restrictions put on the flight crew to fly the aircraft, in addition to those defined in Appendix XII to this Annex I (Part 21);

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3. 

the restrictions regarding carriage of persons other than flight crew;

4. 

the operating limitations, specific procedures or technical conditions to be met;

5. 

the specific flight test programme (if applicable);

6. 

the specific continuing airworthiness arrangements including maintenance instructions and regime under which they will be performed;

(c) 

the substantiation that the aircraft is capable of safe flight under the conditions or restrictions of point (b);

(d) 

the method used for the control of the aircraft configuration, in order to remain within the established conditions.

21.A.709    Application for approval of flight conditions

(a) Pursuant to point 21.A.707(c) and when the applicant has not been granted the privilege to approve the flight conditions, an application for approval of the flight conditions shall be made:

1. 

when approval of the flight conditions is related to the safety of the design, to the Agency in a form and manner established by the Agency; or

2. 

when approval of the flight conditions is not related to the safety of the design, to the competent authority in a form and manner established by that authority.

(b) Each application for approval of the flight conditions shall include:

1. 

the proposed flight conditions;

2. 

the documentation supporting these conditions; and

3. 

a declaration that the aircraft is capable of safe flight under the conditions or restrictions of point 21.A.708(b).

21.A.710    Approval of flight conditions

(a) When approval of the flight conditions is related to the safety of the design, the flight conditions shall be approved by:

1. 

the Agency; or

2. 

an appropriately approved design organisation, under the privilege of point 21.A.263(c)(6).

(b) When approval of the flight conditions is not related to the safety of the design, the flight conditions shall be approved by the competent authority, or the appropriately approved organisation that will also issue the permit to fly.

(c) Before approving the flight conditions, the Agency, the competent authority or the approved organisation must be satisfied that the aircraft is capable of safe flight under the specified conditions and restrictions. The Agency or the competent authority may make or require the applicant to make any necessary inspections or tests for that purpose.

21.A.711    Issue of a permit to fly

(a) A permit to fly (EASA Form 20a, see Appendix III) may be issued by the competent authority under the conditions specified in point 21.B.525.

(b) An appropriately approved design organisation may issue a permit to fly (EASA Form 20b, see Appendix IV) under the privilege granted under point 21.A.263(c)(7), when the flight conditions referred to in point 21.A.708 have been approved in accordance with point 21.A.710.

(c) An appropriately approved production organisation may issue a permit to fly (EASA Form 20b, see Appendix IV) under the privilege granted under point 21.A.163(e), when the flight conditions referred to in point 21.A.708 have been approved in accordance with point 21.A.710.

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(d) An approved organisation may issue a permit to fly (EASA Form 20b, see Appendix IV) under the privilege granted in accordance with point M.A.711 of Annex I (Part-M) of Regulation (EU) No 1321/2014 or point CAMO.A.125 of Annex Vc (Part-CAMO) of Regulation (EU) No 1321/2014 or point CAO.A.095 of Annex Vd (Part-CAO) of Regulation (EU) No 1321/2014, when the flight conditions referred to in point 21.A.708 of this Annex have been approved in accordance with point 21.A.710 of this Annex;

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(e) The permit to fly shall specify the purpose(s) and any conditions and restrictions which have been approved in accordance with point 21.A.710.

(f) For permits issued under points (b), (c) or (d), a copy of the permit to fly and associated flight conditions shall be submitted to the competent authority at the earliest opportunity but not later than 3 days.

(g) Upon evidence that any of the conditions specified in point 21.A.723(a) are not met for a permit to fly that an organisation has issued pursuant to points (b), (c) or (d), that organisation shall immediately revoke that permit to fly and inform without delay the competent authority.

21.A.713    Changes

(a) Any change that invalidates the flight conditions or associated substantiation established for the permit to fly shall be approved in accordance with point 21.A.710. When relevant an application shall be made in accordance with point 21.A.709.

(b) A change affecting the content of the permit to fly requires the issuance of a new permit to fly in accordance with point 21.A.711.

21.A.715    Language

The manuals, placards, listings, and instrument markings and other necessary information required by applicable certification specifications shall be presented in one or more of the official language(s) of the European Union acceptable to the competent authority.

21.A.719    Transferability

(a) A permit to fly is not transferable.

(b) Notwithstanding point (a) for a permit to fly issued for the purpose of point 21.A.701(a)(15), where ownership of an aircraft has changed, the permit to fly shall be transferred together with the aircraft provided the aircraft remains on the same register, or issued only with the agreement of the competent authority of the Member State of registry to which it is transferred.

21.A.721    Inspections

The holder of, or the applicant for, a permit to fly shall provide access to the aircraft concerned at the request of the competent authority.

21.A.723    Duration and continued validity

(a) A permit to fly shall be issued for a maximum of 12 months and shall remain valid subject to:

1. 

compliance with the conditions and restrictions of point 21.A.711(e) associated with the permit to fly;

2. 

the permit to fly not being surrendered or revoked;

3. 

the aircraft remaining on the same register.

(b) Notwithstanding point (a), a permit to fly issued for the purpose of point 21.A.701(a)(15) may be issued for unlimited duration.

(c) Upon surrender or revocation, the permit to fly shall be returned to the competent authority.

21.A.725    Renewal of permit to fly

Renewal of the permit to fly shall be processed as a change in accordance with point 21.A.713.

21.A.727    Obligations of the holder of a permit to fly

The holder of a permit to fly shall ensure that all the conditions and restrictions associated with the permit to fly are satisfied and maintained.

21.A.729    Record-keeping

(a) All documents produced to establish and justify the flight conditions shall be held by the holder of the approval of the flight conditions at the disposal of the Agency and competent authority and shall be retained in order to provide the information necessary to ensure the continued airworthiness of the aircraft.

(b) All documents associated with the issue of permits to fly under the privilege of approved organisations, including inspection records, documents supporting the approval of flight conditions and the permit to fly itself, shall be held by the related approved organisation at the disposal of the Agency or the competent authority and shall be retained in order to provide the information necessary to ensure the continued airworthiness of the aircraft.

SUBPART Q —   IDENTIFICATION OF PRODUCTS, PARTS AND APPLIANCES

21.A.801    Identification of products

(a) The identification of products shall include the following information:

1. 

manufacturer’s name;

2. 

product designation;

3. 

manufacturer’s Serial number;

4. 

any other information the Agency finds appropriate.

(b) Any natural or legal person that manufactures an aircraft or engine under Subpart G or Subpart F shall identify that aircraft or engine by means of a fireproof plate that has the information specified in point (a) marked on it by etching, stamping, engraving, or other approved method of fireproof marking. The identification plate shall be secured in such a manner that it is accessible and legible, and will not likely be defaced or removed during normal service, or lost or destroyed in an accident.

(c) Any natural or legal person that manufactures a propeller, propeller blade, or propeller hub under Subpart G or Subpart F shall identify it by means of a plate, stamping, engraving, etching or other approved method of fireproof identification that is placed on it on a non-critical surface, contains the information specified in point (a), and will not likely be defaced or removed during normal service or lost or destroyed in an accident.

(d) For manned balloons, the identification plate prescribed in point (b) shall be secured to the balloon envelope and shall be located, if practicable, where it is legible to the operator when the balloon is inflated. In addition, the basket, load frame assembly and any heater assembly shall be permanently and legibly marked with the manufacturer’s name, part number, or equivalent, and serial number, or equivalent.

21.A.803    Handling of identification data

(a) No person shall remove, change, or place identification information referred to in point 21.A.801(a) on any aircraft, engine, propeller, propeller blade, or propeller hub, or in point 21.A.807(a) on an APU, without the approval of the Agency.

(b) No person shall remove or install any identification plate referred to in point 21.A.801, or in point 21.A.807 for an APU, without the approval of the Agency.

(c) By way of derogation from points (a) and (b), any natural or legal person performing maintenance work under the applicable associated implementing rules may, in accordance with methods, techniques and practices established by the Agency:

1. 

remove, change, or place the identification information referred to in point 21.A.801(a) on any aircraft, engine, propeller, propeller blade, or propeller hub, or in point 21.A.807(a) on an APU; or

2. 

remove an identification plate referred to in point 21.A.801, or point 21.A.807 for an APU, when necessary during maintenance operations.

(d) No person shall install an identification plate removed in accordance with point (c)(2) on any aircraft, engine, propeller, propeller blade, or propeller hub other than the one from which it was removed.

21.A.804    Identification of parts and appliances

(a) Each part or appliance shall be marked permanently and legibly with:

1. 

a name, trademark, or symbol identifying the manufacturer in a manner identified by the applicable design data; and

2. 

the part number, as defined in the applicable design data; and

3. 

the letters EPA for parts or appliances produced in accordance with approved design data not belonging to the type-certificate holder of the related product, except for ETSO articles.

(b) By way of derogation from point (a), if the Agency agrees that a part or appliance is too small or that it is otherwise impractical to mark a part or appliance with any of the information required by point (a), the authorised release document accompanying the part or appliance or its container shall include the information that could not be marked on the part.

21.A.805    Identification of critical parts

In addition to the requirement of point 21.A.804, each manufacturer of a part to be fitted on a type-certificated product which has been identified as a critical part shall permanently and legibly mark that part with a part number and a serial number.

21.A.807    Identification of ETSO articles

(a) Each holder of an ETSO authorisation under Subpart O shall permanently and legibly mark each article with the following information:

1. 

the name and address of the manufacturer;

2. 

the name, type, part number or model designation of the article;

3. 

the serial number or the date of manufacture of the article or both; and

4. 

the applicable ETSO number.

(b) By way of derogation from point (a), if the Agency agrees that a part is too small or that it is otherwise impractical to mark a part with any of the information required by point (a), the authorised release document accompanying the part or its container shall include the information that could not be marked on the part.

(c) Each person who manufactures an APU under Subpart G or Subpart F shall identify that APU by means of a fireproof plate that has the information specified in point (a) marked on it by etching, stamping, engraving, or other approved method of fireproof marking. The identification plate shall be secured in such a manner that it is accessible and legible, and will not likely be defaced or removed during normal service, or lost or destroyed in an accident.

SECTION B

PROCEDURES FOR COMPETENT AUTHORITIES

SUBPART A —   GENERAL PROVISIONS

21.B.5    Scope

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(a) This Section establishes the procedure for the competent authority, when exercising its tasks and responsibilities concerned with the issuance, maintenance, amendment, suspension and revocation of certificates, approvals and authorisations referred to in this Annex I.

▼B

(b) The Agency shall develop in accordance with Article 19 of Regulation (EC) No 216/2008 certification specifications and guidance material to assist Member States in the implementation of this Section.

21.B.20    Obligations of the competent authority

Each competent authority of the Member State is responsible for the implementation of Section A, Subparts F, G, H, I and P only for applicants, or holders, whose principal place of business is in its territory.

21.B.25    Requirements for the organisation of the competent authority

(a) General:

The Member State shall designate a competent authority with allocated responsibilities for the implementation of Section A, Subparts F, G, H, I and P with documented procedures, organisation structure and staff.

(b) Resources:

1. 

the number of staff shall be sufficient to perform the allocated tasks;

2. 

the competent authority of the Member State shall appoint a manager, or managers, who are responsible for the execution of the related task(s) within the authority, including the communication with the Agency and the other national authorities as appropriate.

(c) Qualification and training:

All staff shall be appropriately qualified and have sufficient knowledge, experience and training to perform their allocated task.

21.B.30    Documented procedures

(a) The competent authority of the Member State shall establish documented procedures to describe its organisation, means and methods to fulfil the requirements of this Annex I (Part 21). The procedures shall be kept up to date and serve as the basic working documents within that authority for all related activities.

(b) A copy of the procedures and their amendments shall be available to the Agency.

21.B.35    Changes in organisation and procedures

(a) The competent authority of the Member State shall notify any significant change in its organisation and documented procedures to the Agency.

(b) The competent authority of the Member State shall update its documented procedures relating to any change to regulations in a timely manner to ensure effective implementation.

21.B.40    Resolution of disputes

(a) The competent authority of the Member State shall establish a process for the resolution of disputes within its organisation documented procedures.

(b) Where a dispute, which cannot be resolved, exists between the competent authorities of the Member States it is the responsibility of the managers as defined in point 21.B.25(b)(2) to raise the issue with the Agency for mediation.

21.B.45    Reporting/coordination

(a) The competent authority of the Member State shall ensure coordination as applicable with other related certification, investigation, approval or authorisation teams of that authority, other Member States and the Agency to ensure efficient exchange of information relevant for safety of the products, parts and appliances.

(b) The competent authority of the Member State shall notify any difficulty in the implementation of this Annex I (Part 21) to the Agency.

21.B.55    Record-keeping

The competent authority of the Member State shall keep, or maintain access to, the appropriate records related to the certificates, approvals and authorisations it has granted in accordance with the respective national regulations, and for which responsibility is transferred to the Agency, as long as these records have not been transferred to the Agency.

21.B.60    Airworthiness directives

When the competent authority of a Member State receives an airworthiness directive from the competent authority of a non-member State, that airworthiness directive shall be transferred to the Agency for dissemination in accordance with Article 20 of Regulation (EC) No 216/2008.

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SUBPART B —   TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES

21.B.70    Certification specifications

The Agency, in accordance with Article 76(3) of Regulation (EU) 2018/1139, shall issue certification specifications and other detailed specifications, including certification specifications for airworthiness, operational suitability data and environmental protection, that competent authorities, organisations and personnel may use to demonstrate compliance of products, parts and appliances with the relevant essential requirements set out in Annexes II, IV and V to that Regulation, as well as with those for environmental protection set out in Article 9(2) and Annex III of that Regulation. Such specifications shall be sufficiently detailed and specific to indicate to applicants the conditions under which certificates are to be issued, amended or supplemented.

21.B.75    Special conditions

(a) 

The Agency shall prescribe special detailed technical specifications, named ‘special conditions, for a product if the related certification specifications do not contain adequate or appropriate safety standards for the product because:

1. 

the product has novel or unusual design features relative to the design practices on which the applicable certification specifications are based;

2. 

the intended use of the product is unconventional; or

3. 

experience from other similar products in service or products having similar design features or newly identified hazards have shown that unsafe conditions may develop.

(b) 

Special conditions contain such safety standards as the Agency finds necessary in order to establish a level of safety equivalent to that of the applicable certification specifications.

21.B.80    Type-certification basis for a type-certificate or restricted type-certificate

The Agency shall establish the type certification basis and notify it to the applicant for a type-certificate or restricted type-certificate. The type certification basis shall consist of:

(a) 

the certification specifications for airworthiness designated by the Agency from those applicable to the product at the date of application for that certificate, unless:

1. 

the applicant chooses to comply, or is required to comply in accordance with point 21.A.15(f), with certification specifications which became applicable after the date of the application; If an applicant chooses to comply with a certification specification which became applicable after the date of the application, the Agency shall include in the type-certification basis any other certification specification that is directly related; or

2. 

the Agency accepts any alternative to a designated certification specification that cannot be complied with, for which compensating factors have been found that provide an equivalent level of safety; or

3. 

the Agency accepts or prescribes other means that:

(i) 

in the case of a type-certificate, demonstrate compliance with the essential requirements of Annex II to Regulation (EU) 2018/1139; or

(ii) 

in the case of a restricted type-certificate, provide a level of safety adequate with regard to the intended use; and

(b) 

any special condition prescribed by the Agency in accordance with point 21.B.75(a).

21.B.82    Operational suitability data certification basis for an aircraft type-certificate or restricted type-certificate

The Agency shall establish the operational suitability data certification basis and notify it to the applicant for an aircraft type-certificate or restricted type-certificate. The operational suitability data certification basis shall consist of:

(a) 

the certification specifications for operational suitability data designated by the Agency out of those applicable to the aircraft at the date of the application or at the date of the application supplement for operational suitability data, whichever date is later, unless:

1. 

the applicant chooses to comply, or in accordance with point 21.A.15(f) is required to comply with certification specifications which became applicable after the date of the application; If an applicant chooses to comply with a certification specification which became applicable after the date of the application, the Agency shall include in the type-certification basis any other certification specification that is directly related; or

2. 

the Agency accepts or prescribes alternative means to demonstrate compliance with the relevant essential requirements of Annexes II, IV and V to Regulation (EU) 2018/1139.

(b) 

any special condition prescribed by the Agency in accordance with point 21.B.75(a).

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21.B.85    Designation of applicable environmental protection requirements and certification specifications for a type-certificate or restricted type-certificate

(a) 

The Agency shall designate and notify to the applicant for a type-certificate or restricted type-certificate for an aircraft, for a supplemental type-certificate or for a major change to a type-certificate or to a supplemental type-certificate, the applicable noise requirements established in Annex 16 to the Chicago Convention, Volume I, Part II, Chapter 1 and:

1. 

for subsonic jet aeroplanes, in Chapters 2, 3, 4 and 14;

2. 

for propeller-driven aeroplanes in Chapters 3, 4, 5, 6, 10, and 14;

3. 

for helicopters, in Chapters 8 and 11;

4. 

for supersonic aeroplanes, in Chapter 12; and

5. 

for tilt rotors, in Chapter 13.

(b) 

The Agency shall designate and notify to the applicant referred to in point (a) the applicable emission requirements for preventions of intentional fuel venting for aircraft established in Annex 16 to the Chicago Convention, Volume II, Part II, Chapter 1 and 2.

(c) 

The Agency shall designate and notify to the applicant referred to in point (a) the applicable smoke, gaseous and particulate matter engine emission requirements established in Annex 16 to the Chicago Convention, Volume II, Part III, Chapter 1 and

1. 

for smoke and gaseous emissions of turbojet and turbofan engines intended for propulsion only at subsonic speeds, in Chapter 2;

2. 

for smoke and gaseous emissions of turbojet and turbofan engines intended for propulsion at supersonic speeds, in Chapter 3;and

3. 

for particulate matter emissions of turbojet and turbofan engines intended for propulsion only at subsonic speeds, in Chapter 4.

(d) 

The Agency shall designate and notify to the applicant referred to in point (a) the applicable aeroplane CO2 emission requirements established in Annex 16 to the Chicago Convention, Volume III, Part II, Chapter 1 and

1. 

for subsonic jet aeroplanes, in Chapter 2; and

2. 

for subsonic propeller-driven aeroplanes, in Chapter 2.

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21.B.100    Level of involvement

(a) 

The Agency shall determine its involvement in the verification of the compliance demonstration activities and data related to the application for a type-certificate, restricted type-certificate, major change approval, supplemental type certificate, major repair design approval or ETSO authorisation for APU. It shall do so on the basis of an assessment of meaningful groups of compliance demonstration activities and data of the certification programme. That assessment shall address:

— 
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,

and consider at least the following elements:

1. 

novel or unusual features of the certification project, including operational, organisational and knowledge management aspects;

2. 

complexity of the design and/or demonstration of compliance;

3. 

criticality of the design or technology and the related safety and environmental risks, including those identified on similar designs; and

4. 

performance and experience of the design organisation of the applicant in the domain concerned.

(b) 

For the approval of a minor repair design, minor change or ETSO authorisation other than for APU, the Agency shall determine its involvement at the level of the entire certification project, taking into account any novel or unusual features, complexity of the design and/or demonstration of compliance, criticality of the design or technology, as well as the performance and experience of the applicant's design organisation.

(c) 

The Agency shall notify its level of involvement to the applicant and it shall update its level of involvement when this is warranted by information which has an appreciable impact on the risk previously assessed pursuant to point (a) or (b). The Agency shall notify the applicant about the change in the level of involvement.

21.B.103    Issuance of a type-certificate or restricted type-certificate

(a) 

The Agency shall issue an aircraft, engine or propeller type-certificate or an aircraft restricted type-certificate, provided that:

1. 

the applicant has complied with point 21.A.21;

2. 

the Agency, through verifications of the demonstration of compliance in accordance with its involvement determined pursuant to point 21.B.100, has not found any non-compliance with the type-certification basis, the operational suitability data certification basis where applicable in accordance with point 21.B.82, and the environmental protection requirements; and

3. 

no feature or characteristic has been identified that may make the product unsafe for the uses for which the certification is requested.

(b) 

By derogation from point (a), at the applicant's request included in the declaration referred to in point 21.A.20(d), the Agency may issue an aircraft type-certificate 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 to be actually used.

▼B

(SUBPART C — NOT APPLICABLE)

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

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21.B.105    Type-certification basis, environmental protection requirements and operational suitability data certification basis for a major change to a type-certificate

The Agency shall establish the applicable type-certification basis, the environmental protection requirements, and in the case of a change affecting the operational suitability data, the operational suitability data certification basis established in accordance with point 21.A.101 and notify them to the applicant for a major change to a type certificate.

21.B.107    Issuance of an approval of a change to a type-certificate

(a) 

The Agency shall issue an approval of a change to a type-certificate provided that:

1. 

the applicant for an approval has complied with:

(i) 

point 21.A.95 for a minor change; or

(ii) 

point 21.A.97 for a major change;

2. 

the Agency, through its verification of the demonstration of compliance in accordance with the level of its involvement determined pursuant to point (a) or (b) of point 21.B.100 has not found any non-compliance with the type-certification basis, operational suitability data certification basis where applicable in accordance with point 21.B.82, and environmental protection requirements; and

3. 

no feature or characteristic has been identified that may make the product unsafe for the uses for which certification is requested.

(b) 

In the case of a change affecting the operational suitability data, by derogation from points (1) and (2) of point (a), at the applicant's request included in the declaration referred to in point 21.A.20(d), the Agency may approve a change to an aircraft type-certificate 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 to be actually used.

(c) 

The approval of the changes to the operational suitability data shall be included in the approval of the change to the type-certificate.

(d) 

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

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SUBPART E —   SUPPLEMENTAL TYPE-CERTIFICATES

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In this Subpart, references to type-certificates include type-certificates and restricted type-certificates.

21.B.109    Type-certification basis, environmental protection requirements and operational suitability data certification basis for a supplemental type-certificate

The Agency shall establish the applicable type-certification basis, the environmental protection requirements and, in the case of a change affecting the operational suitability data, the operational suitability data certification basis established in accordance with point 21.A.101 and notify them to the applicant for a supplemental type-certificate.

21.B.111    Issuance of a supplemental type-certificate

(a) 

The Agency shall issue a supplemental type-certificate, provided that:

1. 

the applicant has complied with point 21.A.115(b);

2. 

the Agency, through its verification of the demonstration of compliance in accordance with the level of involvement established pursuant to point 21.B.100(a), has not found any non-compliance with the type-certification basis, operational suitability data certification basis where applicable in accordance with point 21.B.82, and environmental protection requirements; and

3. 

no feature or characteristic has been identified that may make the product unsafe for the uses for which certification is requested.

(b) 

In the case of a supplemental type-certificate affecting the operational suitability data, by derogation from points (1) and (2) of point (a), at the applicant's request included in the declaration referred to in point 21.A.20(d), the Agency may issue a supplemental type-certificate 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 to be actually used.

(c) 

The approval of the changes to the operational suitability data shall be included in the supplemental type-certificate.

(d) 

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

▼B

SUBPART F —   PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL

21.B.120    Investigation

(a) The competent authority shall appoint an investigation team for each applicant for, or holder of, a letter of agreement to conduct all relevant tasks related to this letter of agreement, consisting of a team-leader to manage and lead the investigation team and, if required, one or more team members. The team-leader shall report to the manager responsible for the activity, as defined in point 21.B.25 (b)(2).

(b) The competent authority shall perform sufficient investigation activities for an applicant for, or holder of, a letter of agreement to justify recommendations for the issuance, maintenance, amendment, suspension or revocation of the letter of agreement.

(c) The competent authority shall prepare procedures for the investigation of applicants for, or holders of, a letter of agreement as part of the documented procedures covering at least the following elements:

1. 

evaluation of applications received;

2. 

determination of investigation team;

3. 

investigation preparation and planning;

4. 

evaluation of the documentation (manual, procedures, etc.);

5. 

auditing and inspection;

6. 

follow up of corrective actions; and

7. 

recommendation for issuance, amendment, suspension or revocation of the letter of agreement.

21.B.125    Findings

(a) When during audits or by other means objective evidence is found by the competent authority, showing non-compliance of the holder of a letter of agreement with the applicable requirements of Section A of this Annex, this finding shall be classified in accordance with point 21.A.125B(a).

(b) The competent authority shall take the following actions:

1. 

for level 1 findings, immediate action shall be taken by the competent authority to limit, suspend or revoke the letter of agreement in whole or in part, depending upon the extent of the finding, until successful corrective action has been completed by the organisation;

2. 

for level 2 findings, the competent authority shall grant a corrective action period appropriate to the nature of the finding that shall not be more than 3 months. In certain circumstances, at the end of this period and subject to the nature of the finding, the competent authority can extend the 3 months period subject to a satisfactory corrective action plan provided by the organisation.

(c) Action shall be taken by the competent authority to suspend the letter of agreement in whole or in part in case of failure to comply within the timescale granted by the competent authority.

21.B.130    Issue of letter of agreement

(a) When satisfied that the manufacturer is in compliance with the applicable requirements of Section A, Subpart F, the competent authority shall issue a letter of agreement to the showing of conformity of individual products, parts or appliances (EASA Form 65, see Appendix XI) without undue delay.

(b) The letter of agreement shall contain the scope of the agreement, a termination date and, where applicable, the appropriate limitations relating to the authorisation.

(c) The duration of the letter of agreement shall not exceed one year.

21.B.135    Maintenance of the letter of agreement

The competent authority shall maintain the letter of agreement as long as:

(a) 

the manufacturer is properly using the EASA Form 52 (see Appendix VIII) as a statement of conformity for complete aircraft, and the EASA Form 1 (see Appendix I) for products other than complete aircraft, parts and appliances; and

(b) 

inspections performed by the competent authority of the Member State before validation of the EASA Form 52 (see Appendix VIII) or the EASA Form 1 (see Appendix I), as per point 21.A.130(c) did not reveal any findings of non-compliance with the requirements or the procedures as contained in the manual provided by the manufacturer, or any non-conformity of the respective products, parts or appliances. These inspections shall check at least that:

1. 

the agreement covers the product, part or appliance being validated, and remains valid;

2. 

the manual described in point 21.A.125A(b) and its change status referred in the letter of agreement is used as basic working document by the manufacturer. Otherwise, the inspection shall not continue and therefore the release certificates shall not be validated;

3. 

production has been carried out under the conditions prescribed in the letter of agreement and satisfactorily performed;

4. 

inspections and tests (including flight tests, if appropriate), as per points 21.A.130(b)(2) and/or (b)(3), have been carried out under the condition prescribed in the letter of agreement and satisfactorily performed;

5. 

the inspections by the competent authority described or addressed in the letter of agreement have been performed and found acceptable;

6. 

the statement of conformity complies with point 21.A.130, and the information provided by it does not prevent its validation; and

(c) 

any termination date for the letter of agreement has not been reached.

21.B.140    Amendment of a letter of agreement

(a) The competent authority shall investigate, as appropriate, in accordance with point 21.B.120 any amendment of the letter of agreement.

(b) When the competent authority is satisfied that the requirements of Section A, Subpart F continue to be complied with, it shall amend the letter of agreement accordingly.

21.B.145    Limitation, suspension and revocation of a letter of agreement

(a) The limitation, suspension or revocation of the letter of agreement shall be communicated in writing to the holder of the letter of agreement. The competent authority shall state the reasons for the limitation, suspension or revocation and inform the holder of the letter of agreement on its right to appeal.

(b) When a letter of agreement has been suspended it shall only be reinstated after compliance with Section A Subpart F has been re-established.

21.B.150    Record-keeping

(a) The competent authority shall establish a system of record-keeping that allows adequate traceability of the process to issue, maintain, amend, suspend or revoke each individual letter of agreement.

(b) The records shall at least contain:

1. 

the documents provided by the applicant for, or holder of, a letter of agreement;

2. 

documents established during investigation and inspection, in which the activities and the final results of the elements defined in point 21.B.120 are stated;

3. 

the letter of agreement, including changes; and

4. 

minutes of the meetings with the manufacturer.

(c) The records shall be archived for a minimum retention period of six years after termination of the letter of agreement.

(d) The competent authority shall also maintain records of all Statements of Conformity (EASA Form 52, see Appendix VIII) and Authorised Release Certificates (EASA Form 1, see Appendix I) that it has validated.

SUBPART G —   PRODUCTION ORGANISATION APPROVAL

21.B.220    Investigation

(a) The competent authority shall appoint a production organisation approval team for each applicant, or holder of, a production organisation approval to conduct all relevant tasks related to this production organisation approval, consisting of a team leader to manage and lead the approval team and, if required, one or more team members. The team leader shall report to the manager responsible for the activity as defined in point 21.B.25(b)(2).

(b) The competent authority shall perform sufficient investigation activities for an applicant for, or holder of, a production organisation approval to justify recommendations for the issuance, maintenance, amendment, suspension or revocation of the approval.

(c) The competent authority shall prepare procedures for the investigation of a production organisation approval as part of the documented procedures covering at least the following elements:

1. 

evaluation of applications received;

2. 

determination of production organisation approval team;

3. 

investigation preparation and planning;

4. 

evaluation of the documentation (production organisation exposition, procedures, etc.);

5. 

auditing;

6. 

follow up of corrective actions;

7. 

recommendation for issuance, amendment, suspension or revocation of production organisation approval;

8. 

continued surveillance.

21.B.225    Findings

(a) When during audits or by other means objective evidence is found by the competent authority, showing non-compliance of the holder of a production organisation approval with the applicable requirements of Section A, this finding shall be classified in accordance with point 21.A.158(a).

(b) The competent authority shall take the following actions:

1. 

for level 1 findings, immediate action shall be taken by the competent authority to limit, suspend or revoke the production organisation approval, in whole or in part, depending upon the extent of the finding, until successful corrective action has been completed by the organisation;

2. 

for level 2 findings, the competent authority shall grant a corrective action period appropriate to the nature of the finding that shall not be more than 3 months. In certain circumstances, at the end of this period and subject to the nature of the finding, the competent authority can extend the 3 months period subject to a satisfactory corrective action plan provided by the organisation.

(c) Action shall be taken by the competent authority to suspend the approval in whole or in part in case of failure to comply within the timescale granted by the competent authority.

21.B.230    Issue of certificate

(a) When satisfied that the production organisation is in compliance with the applicable requirements of Section A, Subpart G, the competent authority shall issue a Production Organisation Approval (EASA Form 55, see Appendix X) without undue delay.

(b) The reference number shall be included on the EASA Form 55 in a manner specified by the Agency.

21.B.235    Continued surveillance

(a) In order to justify the maintenance of the production organisation approval the competent authority shall perform continued surveillance:

1. 

to verify that the production organisation approval holder’s quality system complies with Section A Subpart G;

2. 

to verify that the organisation of the production organisation approval holder operates in accordance with the production organisation exposition;

3. 

to verify the effectiveness of the production organisation exposition procedures; and

4. 

to monitor by sample the standards of the product, part or appliance.

(b) Continued surveillance shall be performed in accordance with point 21.B.220.

(c) The competent authority shall provide through planned continued surveillance that a production organisation approval is completely reviewed for compliance with this Annex I (Part 21) during a period of 24 months. The continued surveillance may be made up of several investigation activities during this period. The number of audits may vary depending upon the complexity of the organisation, the number of sites and the criticality of the production. As a minimum the holder of a production organisation approval shall be subject to continued surveillance activity by the competent authority at least once every year.

21.B.240    Amendment of a production organisation approval

(a) The competent authority shall monitor any minor change through the continued surveillance activities.

(b) The competent authority shall investigate as appropriate in accordance with point 21.B.220 any significant change of a production organisation approval or application by the holder of a production organisation approval for an amendment of the scope and terms of approval.

(c) When the competent authority is satisfied that the requirements of Section A, Subpart G continue to be complied with it shall amend the production organisation approval accordingly.

21.B.245    Suspension and revocation of a production organisation approval

(a) In case of a level one or level two finding, the competent authority shall partly or fully limit, suspend or revoke a production organisation approval as follows:

1. 

in case of a level one finding the production organisation approval shall be immediately limited or suspended. If the holder of the production organisation approval fails to comply with point 21.A.158(c)(1), the production organisation approval shall be revoked;

2. 

in case of a level two finding, the competent authority shall decide on any restriction to the scope of approval by temporary suspension of the production organisation approval or parts thereof. If the holder of a production organisation approval fails to comply with point 21.A.158(c)(2), the production organisation approval shall be revoked.

(b) The limitation, suspension or revocation of the production organisation approval shall be communicated in writing to the holder of the production organisation approval. The competent authority shall state the reasons for the suspension or revocation and inform the holder of the production organisation approval of its right to appeal.

(c) When a production organisation approval has been suspended it shall only be reinstated after compliance with Section A, Subpart G has been re-established.

21.B.260    Record-keeping

(a) The competent authority shall establish a system of record-keeping that allows adequate traceability of the process to issue, maintain, amend, suspend or revoke each individual production organisation approval.

(b) The records shall at least contain:

1. 

the documents provided by the applicant for, or holder of, a production organisation approval certificate;

2. 

documents established during the investigation, in which the activities and the final results of the elements defined in point 21.B.220 are stated, including findings established in accordance with point 21.B.225;

3. 

the continued surveillance programme, including records of investigations performed;

4. 

the production organisation approval certificate, including changes;

5. 

minutes of the meetings with the holder of the production organisation approval.

(c) The records shall be archived for a minimum retention period of six years.

SUBPART H —   CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS

21.B.320    Investigation

(a) The competent authority of the Member State of registry shall perform sufficient investigation activities for an applicant for, or holder of, an airworthiness certificate to justify the issuance, maintenance, amendment, suspension or revocation of the certificate or permit.

(b) The competent authority of the Member State of registry shall prepare evaluation procedures covering at least the following elements:

1. 

evaluation of eligibility of the applicant;

2. 

evaluation of the eligibility of the application;

3. 

classification of airworthiness certificates;

4. 

evaluation of the documentation received with the application;

5. 

inspection of aircraft;

6. 

determination of necessary conditions, restrictions or limitations to the airworthiness certificates.

21.B.325    Issue of airworthiness certificate

(a) The competent authority of the Member State of registry shall issue or change a certificate of airworthiness (EASA Form 25, see Appendix VI) without undue delay when it is satisfied that the requirements of point 21.B.326 and the applicable requirements of Section A of Subpart H of this Annex I (Part 21) are met.

(b) The competent authority of the Member State of registry shall issue or change a Restricted certificate of airworthiness (EASA Form 24, see Appendix V) without undue delay when it is satisfied that requirements of point 21.B.327 and the applicable requirements of Section A of Subpart H of this Annex I (Part 21) are met.

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(c) For aircraft originating from a non-member State, in addition to the appropriate airworthiness certificate referred to in point (a) or (b), the competent authority of the Member State of registry shall issue:

1. 

for new or used aircraft subject to Annex I (Part-M) to Commission Regulation (EU) No 1321/2014, an initial airworthiness review certificate (EASA Form 15a, Appendix II);

2. 

for new aircraft subject to Annex Vb (Part-ML) to Commission Regulation (EU) No 1321/2014, an initial airworthiness review certificate (EASA Form 15c, Appendix II);

3. 

for used aircraft subject to Annex Vb (Part-ML) to Commission Regulation (EU) No 1321/2014, an initial airworthiness review certificate (EASA Form 15c, Appendix II), when the competent authority has performed the airworthiness review.

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21.B.326    Certificate of airworthiness

The competent authority of the Member State of registry shall issue a certificate of airworthiness for:

(a) 

new aircraft:

1. 

upon presentation of the documentation required by point 21.A.174(b)(2);

2. 

where the competent authority of the Member State of registry is satisfied that the aircraft conforms to an approved design and is in a condition for safe operation; this may include inspections by the competent authority of the Member State of registry; and

3. 

where the competent authority of the Member State of registry is satisfied that the aircraft is in compliance with the applicable CO2 emissions requirements on the date on which the certificate of airworthiness is first issued.

(b) 

used aircraft:

1. 

upon presentation of the documentation required by point 21.A.174(b)(3) demonstrating that:

(i) 

the aircraft conforms to a type design approved under a type-certificate and any supplemental type-certificate, change or repair approved in accordance with this Annex I (Part 21) and;

(ii) 

the applicable airworthiness directives have been complied with and;

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(iii) 

the aircraft has been inspected in accordance with the provisions of Annex I (Part-M) or Annex Vb (Part-ML) of Regulation (EU) No 1321/2014, as appropriate.

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(iv) 

the aircraft was in compliance with the applicable CO2 emissions requirements on the date on which the certificate of airworthiness was first issued;

2. 

where the competent authority of the Member State of registry is satisfied that the aircraft conforms to an approved design and is in a condition for safe operation; this may include inspections by the competent authority of the Member State of registry and;

3. 

where the competent authority of the Member State of registry is satisfied that the aircraft was in compliance with the applicable CO2 emissions requirements on the date on which the certificate of airworthiness was first issued.

▼B

21.B.327    Restricted certificate of airworthiness

(a) The competent authority of the Member State of registry shall issue a restricted certificate of airworthiness for:

1. 

new aircraft:

(i) 

upon presentation of the documentation required by point 21.A.174(b)(2);

(ii) 

when the competent authority of the Member State of registry is satisfied that the aircraft conforms to a design approved by the Agency under a restricted type-certificate or in accordance with specific airworthiness specifications, and is in a condition for safe operation. This may include inspections by the competent authority of the Member State of registry;

2. 

used aircraft:

(i) 

upon presentation of the documentation required by point 21.A.174(b)(3) demonstrating that:

(A) 

the aircraft conforms to a design approved by the Agency under a restricted type-certificate or in accordance with specific airworthiness specifications and any supplemental type-certificate change or repair approved in accordance with this Annex I (Part 21); and

(B) 

the applicable airworthiness directives have been complied with; and

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(C) 

the aircraft has been inspected in accordance with the provisions of Annex I (Part-M) or Annex Vb (Part-ML) of Regulation (EU) No 1321/2014, as appropriate;

▼B

(ii) 

when the competent authority of the Member State of registry is satisfied that the aircraft conforms to the approved design and is in a condition for safe operation. This may include inspections by the competent authority of the Member State of registry.

(b) For an aircraft that cannot comply with the essential requirements referred to in Regulation (EC) No 216/2008 and which is not eligible for a restricted type-certificate, the Agency shall, as necessary to take account of deviations from these essential requirements:

1. 

issue and check compliance with specific airworthiness specifications ensuring adequate safety with regard to the intended use, and

2. 

specify limitations for use of this aircraft.

(c) Limitations for use will be associated with restricted certificates of airworthiness, including airspace restrictions, as necessary to take account of deviations from essential requirements for airworthiness laid down in Regulation (EC) No 216/2008.

21.B.330    Suspension and revocation of certificates of airworthiness and restricted certificates of airworthiness

(a) Upon evidence that any of the conditions specified in point 21.A.181(a) is not met, the competent authority of the Member State of registry shall suspend or revoke an airworthiness certificate.

(b) Upon issuance of the notice of suspension and revocation of a certificate of airworthiness or restricted certificate of airworthiness the competent authority of the Member State of registry shall state the reasons for the suspension or revocation and inform the holder of the certificate of its right to appeal.

21.B.345    Record-keeping

(a) The competent authority of the Member State of registry shall establish a system of record-keeping that allows adequate traceability of the process to issue, maintain, amend, suspend or revoke each individual airworthiness certificate.

(b) The records shall at least contain:

1. 

the documents provided by the applicant;

2. 

documents established during the investigation, in which the activities and the final results of the elements defined in point 21.B.320(b) are stated; and

3. 

a copy of the certificate or permit, including amendments.

(c) The records shall be archived for a minimum retention period of six years after leaving that national register.

SUBPART I —   NOISE CERTIFICATES

21.B.420    Investigation

(a) The competent authority of the Member State of registry shall perform sufficient investigation activities for an applicant for, or holder of, a noise certificate to justify the issuance, maintenance, amendment, suspension or revocation of the certificate.

(b) The competent authority of the Member State of registry shall prepare evaluation procedures as part of the documented procedures covering at least the following elements:

1. 

evaluation of eligibility;

2. 

evaluation of the documentation received with the application;

3. 

inspection of aircraft.

21.B.425    Issue of noise certificates

The competent authority of the Member State of registry shall, as applicable, issue, or amend noise certificates (EASA Form 45, see Appendix VII) without undue delay when it is satisfied that the applicable requirements of Section A, Subpart I are met.

21.B.430    Suspension and revocation of a noise certificate

(a) Upon evidence that some of the conditions specified in point 21.A.211(a) are not met, the competent authority of the Member State of registry shall suspend or revoke a noise certificate.

(b) Upon issuance of the notice of suspension and revocation of a noise certificate the competent authority of the Member State of registry shall state the reasons for the suspension and revocation and shall inform the holder of the certificate on its right to appeal.

21.B.445    Record-keeping

(a) The competent authority of the Member State of registry shall establish a system of record-keeping with minimum retention criteria that allows adequate traceability of the process to issue, maintain, amend, suspend or revoke each individual noise certificate.

(b) The records shall at least contain:

1. 

the documents provided by the applicant;

2. 

documents established during the investigation, in which the activities and the final results of the elements defined in point 21.B.420(b) are stated;

3. 

a copy of the certificate including amendments.

(c) The records shall be archived for a minimum retention period of six years after leaving that national register.

SUBPART J —   DESIGN ORGANISATION APPROVAL

Administrative procedures established by the Agency shall apply.

SUBPART K —   PARTS AND APPLIANCES

Administrative procedures established by the Agency shall apply.

(SUBPART L — NOT APPLICABLE)

SUBPART M —   REPAIRS

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21.B.450    Type-certification basis and environmental protection requirements for a repair design approval

The Agency shall designate any amendments to the type-certification basis incorporated by reference in, as applicable, either the type-certificate, the supplemental type-certificate or the APU ETSO authorisation, which the Agency considers necessary for maintaining a level of safety equal to that previously established and notify them to the applicant for a repair design.

21.B.453    Issuance of a repair design approval

(a) 

The Agency shall issue an approval of a major repair design, provided that:

1. 

the applicant has demonstrated its capability in accordance with point 21.A.432B;

2. 

the applicant has complied with point 21.A.433;

3. 

the Agency, through its verification of the demonstration of compliance in accordance with the level of involvement established pursuant to point 21.B.100(a), has not found any non-compliance with the type-certification basis and environmental protection requirements; and

4. 

no feature or characteristic has been identified that may make the product unsafe for the uses for which certification is requested.

(b) 

The Agency shall issue an approval of a minor repair design, provided that the applicant has complied with points (2) and (4) of point (a) and provided that the Agency, through its verifications of the demonstration of compliance in accordance with the level of involvement pursuant to point 21.B.100(b), has not found any non-compliance with the type-certification basis and environmental protection requirements.

▼B

(SUBPART N — NOT APPLICABLE)

SUBPART O —   EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS

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21.B.480    Issuance of an ETSO authorisation

The Agency shall issue an ETSO authorisation, provided that:

(a) 

the applicant has complied with point 21.A.606;

(b) 

the Agency, through its verifications of the demonstration of compliance in accordance with the level of involvement pursuant to point 21.B.100(b), has not found any non-compliance with the technical conditions of the applicable ETSO or with deviations therefrom approved in accordance with point 21.A.610, if any; and

(c) 

no feature or characteristic has been identified that may make the article unsafe for the uses for which certification is requested.

▼B

SUBPART P —   PERMIT TO FLY

21.B.520    Investigation

(a) The competent authority shall perform sufficient investigation activities to justify the issuance, or revocation of the permit to fly.

(b) The competent authority shall prepare evaluation procedures covering at least the following elements:

1. 

evaluation of the eligibility of the applicant;

2. 

evaluation of the eligibility of the application;

3. 

evaluation of the documentation received with the application;

4. 

inspection of the aircraft;

5. 

approval of the flight conditions in accordance with point 21.A.710(b).

21.B.525    Issue of permits to fly

The competent authority shall issue a permit to fly (EASA Form 20a, see Appendix III) without undue delay:

(a) 

upon presentation of the data required by point 21.A.707; and

(b) 

when the flight conditions referred to in point 21.A.708 have been approved in accordance with point 21.A.710; and

(c) 

when the competent authority, through its own investigations, which may include inspections, or through procedures agreed with the applicant, is satisfied that the aircraft conforms to the design defined under point 21.A.708 before flight.

21.B.530    Revocation of permits to fly

(a) Upon evidence that any of the conditions specified in point 21.A.723(a) are not met for a permit to fly it has issued, the competent authority shall revoke that permit to fly.

(b) Upon issuance of the notice of revocation of a permit to fly the competent authority shall state the reasons for the revocation and inform the holder of the permit to fly on the right to appeal.

21.B.545    Record-keeping

(a) The competent authority shall operate a system of record-keeping that provides adequate traceability of the process for the issue and revocation of each individual permit to fly.

(b) The records shall at least contain:

1. 

the documents provided by the applicant;

2. 

documents established during the investigation, in which the activities and the final results of the elements defined in point 21.B.520(b) are stated; and

3. 

a copy of the permit to fly.

(c) The records shall be kept for a minimum of six years after the permit ceases to be valid.

SUBPART Q —   IDENTIFICATION OF PRODUCTS, PARTS AND APPLIANCES

Administrative procedures established by the Agency shall apply.




Appendices

EASA FORMS

When the Forms of this Annex are issued in a language other than English they shall include an English translation.

The EASA (‘European Aviation Safety Agency’) Forms referred to in the appendices to this Part shall have the following obligatory features. Member States shall ensure that the EASA Forms they issue are recognisable and shall be responsible for having those Forms printed.

Appendix I — EASA Form 1 Authorised release Certificate

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Appendix II — EASA Form 15a and 15c – Airworthiness Review Certificate

▼B

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 qualifications 85




Appendix I

Authorised Release Certificate — EASA Form 1 referred to in Annex I (Part 21)