EUR-Lex Regulation 2022/0201

21.1

21.2

21.A.1

21.A.2

21.A.3A

21.A.3B

21.A.4

21.A.5

21.A.6

21.A.7

21.A.9

21.A.11

21.A.13

21.A.14

21.A.15

21.A.19

21.A.20

21.A.21

21.A.31

21.A.33

21.A.35

21.A.41

21.A.44

21.A.47

21.A.51

21.A.62

21.A.65

21.A.90A

21.A.90B

21.A.90C

21.A.91

21.A.92

21.A.93

21.A.95

21.A.97

21.A.101

21.A.108

21.A.109

21.A.111

21.A.112A

21.A.112B

21.A.113

21.A.115

21.A.116

21.A.117

21.A.118A

21.A.118B

21.A.120B

21.A.121

21.A.122

21.A.124

21.A.124A

21.A.125A

21.A.125B

21.A.125C

21.A.126

21.A.127

21.A.128

21.A.129

21.A.130

21.A.131

21.A.133

21.A.134

21.A.134A

21.A.135

21.A.139

21.A.143

21.A.145

21.A.147

21.A.148

21.A.149

21.A.151

21.A.153

21.A.158

21.A.159

21.A.163

21.A.165

21.A.171

21.A.172

21.A.173

21.A.174

21.A.175

21.A.177

21.A.179

21.A.181

21.A.182

21.A.201

21.A.203

21.A.204

21.A.207

21.A.209

21.A.211

21.A.231

21.A.233

21.A.234

21.A.235

21.A.239

21.A.243

21.A.245

21.A.247

21.A.249

21.A.251

21.A.253

21.A.258

21.A.259

21.A.263

21.A.265

21.A.301

21.A.303

21.A.305

21.A.307

21.A.431A

21.A.431B

21.A.432A

21.A.432B

21.A.432C

21.A.433

21.A.435

21.A.439

21.A.441

21.A.443

21.A.445

21.A.451

21.A.601

21.A.602A

21.A.602B

21.A.603

21.A.604

21.A.605

21.A.606

21.A.607

21.A.608

21.A.609

21.A.610

21.A.611

21.A.619

21.A.621

21.A.701

21.A.703

21.A.707

21.A.708

21.A.709

21.A.710

21.A.711

21.A.713

21.A.715

21.A.719

21.A.723

21.A.725

21.A.727

21.A.801

21.A.803

21.A.804

21.A.805

21.A.807

21.B.10

21.B.15

21.B.20

21.B.25

21.B.30

21.B.35

21.B.55

21.B.65

21.B.70

21.B.75

21.B.80

21.B.82

21.B.85

21.B.100

21.B.103

21.B.105

21.B.107

21.B.109

21.B.111

21.B.115

21.B.120

21.B.125

21.B.135

21.B.140

21.B.215

21.B.220

21.B.221

21.B.222

21.B.225

21.B.240

21.B.320

21.B.325

21.B.326

21.B.327

21.B.420

21.B.425

21.B.430

21.B.431

21.B.432

21.B.433

21.B.435

21.B.450

21.B.453

21.B.480

21.B.520

21.B.525

(a)

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

(b)

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

(c)

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

(d)

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

(e)

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

(f)

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

(a)

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

(b)

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

(c)

with regard to permits to fly:

(d)

retain records of the competence and qualifications, referred to in points 21.A.139(c), 21.A.145(b), 21.A.145(c), 21.A.239(c), 21.A.245(a) or 21.A.245(e)(1), of the personnel that are involved in the following functions:

(e)

retain records of the authorisation of personnel, when they employ personnel that:

(a)

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

(b)

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

‘(a)

undertake the obligations laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.9, 21.A.62 and 21.A.65, and, for this purpose, shall continue to meet the qualification requirements for eligibility under point 21.A.13;’;

‘(a)

undertake the obligations laid down in points 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.9 and 21.A.108;’;

‘1.

laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.9 and 21.A.120B;’;

(a)

An organisation may use any alternative means of compliance to establish compliance with this Regulation.

(b)

If an organisation wishes to use an alternative means of compliance, it shall, prior to using it, provide the competent authority with a full description. The description shall include any revisions to manuals or procedures that may be relevant, as well as an explanation indicating how compliance with this Regulation is achieved.

The organisation may use those alternative means of compliance subject to prior approval from the competent authority.’;

‘21.A.125A

(a)

After receipt of the notification of findings in accordance with point 21.B.125, the holder of a letter of agreement shall:

(b)

The actions referred to in point (a) shall be performed within the period agreed with that competent authority in accordance with point 21.B.125.

(c)

The observations received in accordance with point 21.B.125(e) shall be given due consideration by the holder of the letter of agreement. The organisation shall record the decisions taken in respect of those observations.’;

(a)

The letter of agreement shall be issued for a limited period of time that in any case shall not exceed 1 year. It shall remain valid subject to the organisation’s compliance with all the following conditions:

(b)

Upon surrender, revocation or expiry, the letter of agreement shall be returned to the competent authority.’;

(a)

point (5) is replaced by the following:

(b)

point (6) is deleted;

(a)

the title is replaced by the following:

(b)

point (e) is replaced by the following:

(c)

point (f) is deleted;

(a)

An organisation may use any alternative means of compliance to establish compliance with this Regulation.

(b)

If an organisation wishes to use an alternative means of compliance, it shall, prior to using it, provide the competent authority with a full description. The description shall include any revisions to manuals or procedures that may be relevant, as well as an explanation indicating how compliance with this Regulation is achieved.

The organisation may use those alternative means of compliance subject to prior approval from the competent authority..’;

‘21.A.135

(a)

The production organisation shall establish, implement and maintain a production management system that includes a safety management element and a quality management element, with clearly defined accountability and lines of responsibility throughout the organisation.

(b)

The production management system shall:

(c)

As part of the safety management element of the production management system, the production organisation shall:

(d)

As part of the quality management element of the production management system, the production organisation shall:

(e)

The production organisation shall establish, as part of the production management system, an independent monitoring function to verify compliance of the organisation with the relevant requirements of this Annex as well as compliance with and adequacy of the production management system. Monitoring shall include feedback to the person or group of persons referred to in point 21.A.145(c)(2) and to the manager referred to in point 21.A.145(c)(1) to ensure, where necessary, the implementation of corrective action.

(f)

If the production organisation holds one or more additional organisation certificates within the scope of Regulation (EU) 2018/1139, the production management system may be integrated with that required under the additional certificate(s) held.’;

(a)

the title is replaced by the following:

(b)

point (a) is amended as follows:

(c)

point (b) is replaced by the following:

(d)

the following point (c) is added:

(a)

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

(b)

with regard to all the necessary airworthiness and environmental protection data:

(c)

with regard to management and staff:

(d)

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

(a)

After receipt of the notification of findings in accordance with point 21.B.225, the holder of the production organisation approval certificate shall:

(b)

The actions referred to in point (a) shall be performed within the period agreed with that competent authority in accordance with point 21.B.225.

(c)

The observations received in accordance with 21.B.225(e) shall be given due consideration by the holder of the production organisation approval certificate. The organisation shall record the decisions taken in respect of those observations.’;

(a)

A production organisation approval certificate shall be issued for an unlimited period of time. It shall remain valid subject to the production organisation’s compliance with all the following conditions:

(b)

Upon surrender or revocation, the production organisation approval certificate shall be returned to the competent authority.’;

(a)

points (d) to (h) are replaced by the following:

(b)

points (i), (j) and (k) are deleted;

(a)

the introductory phrase is replaced by the following:

(b)

point (1) is replaced by the following:

(c)

point (4) is replaced by the following:

(a)

the introductory phrase is replaced by the following:

(b)

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

(c)

point (4) is replaced by the following:

(a)

The design organisation shall establish, implement and maintain a design management system that includes a safety management element and a design assurance element with clearly defined accountability and lines of responsibility throughout the organisation.

(b)

The design management system shall:

(c)

As part of the safety management element of the design management system, the design organisation shall:

(d)

As part of the design assurance element of the design management system, the design organisation shall:

(e)

The design organisation shall establish, as part of the design management system, an independent monitoring function to verify compliance of the organisation with the relevant requirements of this Annex as well as the compliance with and adequacy of the design management system. Monitoring shall include feedback to the person or the group of persons referred to in point 21.A.245(b) and to the manager referred to in point 21.A.245(a) to ensure, where necessary, the implementation of corrective action.

(f)

If the design organisation holds one or more additional organisation certificates within the scope of Regulation (EU) 2018/1139, the design management system may be integrated with that required under the additional certificate(s).’;

(a)

As part of the design management system, the design organisation shall create and furnish to the Agency a handbook that describes, directly or by cross reference, the organisation, its relevant policies, processes and procedures, the type of design work, and the categories of products, parts and appliances for which the design organisation holds a design organisation approval, as identified in the terms of approval issued in accordance with point 21.A.251 and, where relevant, the interfaces with and the control of its partners or subcontractors.

If flight tests are to be conducted, a flight test operations manual that defines the organisation’s policies and procedures in relation to flight tests shall also be created and furnished to the Agency. The flight test operations manual shall include:

(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 demonstrate, for all parts and appliances, the compliance in accordance with point 21.A.239(d)(2), and shall contain, directly or by cross reference, descriptions of and information on the design activities and the organisation of those partner organisations or subcontractors, as necessary to establish the statement.

(c)

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

(d)

The design organisation shall establish and maintain a statement of the qualifications and experience of the management staff and of other persons in the organisation that are responsible for making decisions that affect airworthiness, operational suitability data and environmental protection matters. It shall submit that statement to the competent authority’;

(a)

The organisation shall appoint a head of the design organisation with the authority to ensure that, within the organisation, all design activities are performed to the required standards and that the design organisation is continuously in compliance with the requirements of the design management system referred to in point 21.A.239 and the procedures specified in the handbook referred to in point 21.A.243.

(b)

The head of the design organisation shall nominate and specify the extent of authority of:

(c)

By way of derogation from point 21.A.245(b)(1), the airworthiness function referred to in point 21.A.239(d)(1)(i) may be performed under the direct supervision of the head of the design organisation in either of the following cases:

(d)

The person or group of persons nominated pursuant to point (b) shall:

(e)

The design organisation shall ensure that:

(a)

After the receipt of the notification of findings in accordance with point 21.B.433, the holder of the design organisation approval shall:

(b)

The actions referred to in point (a) shall be performed within the period agreed by the Agency in accordance with point 21.B.433.

(c)

The observations received in accordance with point 21.B.433(e) shall be given due consideration by the holder of the design organisation approval. The organisation shall record the decisions taken in respect of those observations.’;

(a)

A design organisation approval shall be issued for an unlimited period of time. It shall remain valid subject to the design organisation’s compliance with all the following conditions:

(b)

Upon surrender or revocation, the certificate shall be returned to the Agency.’;

‘(c)

The holder of a design organisation approval shall be entitled, within the scope of its terms of approval issued under point 21.A.251 and under the relevant procedures of the design management system:’;

(a)

point (c) is replaced by the following:

(b)

point (h) is replaced by the following:

(c)

the following point (i) is inserted:

(a)

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

(b)

point (b)(1) is replaced by the following:

‘(a)

by way of derogation from points 21.A.9, 21.A.603, 21.A.610 and 21.A.621, 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.A.47, 21.B.75 and 21.B.80. However, an ETSO authorisation shall be issued in accordance with point 21.A.606 instead of the type-certificate;’;

(a)

point (b) is replaced by the following:

(b)

point (f) is replaced by the following:

(a)

An ETSO authorisation shall be issued for an unlimited period of time. It shall remain valid subject to compliance with all the following conditions:

(b)

Upon surrender or revocation, the ETSO authorisation shall be returned to the Agency.’;

‘21.A.711

‘(a)

A permit to fly shall be issued for a maximum period of 12 months and shall remain valid subject to compliance with all the following conditions:

‘21.B.103

‘21.B.107

‘21.B.111

‘21.B.425

‘21.B.453

(a)

Upon receiving an application for the initial issue of a design organisation approval, the competent authority shall verify the applicant’s compliance with the applicable requirements,

(b)

A meeting with the head of the design organisation shall be convened at least once during the investigation for initial certification to ensure that this person understands their role and accountability.

(c)

The competent authority shall record all the findings issued, closure actions as well as recommendations for the issue of the design organisation approval.

(d)

The competent authority shall confirm to the applicant in writing all the findings raised during the verification. For initial certification, all findings must be corrected to the satisfaction of the competent authority before the design organisation approval can be issued.

(e)

When satisfied that the applicant complies with the applicable requirements, the competent authority shall issue the design organisation approval.

(f)

The certificate reference number shall be included in the design organisation approval in a manner specified by the Agency.

(g)

The certificate shall be issued for an unlimited period of time. The privileges and the scope of the activities that the design organisation is approved to perform, including any limitations as applicable, shall be specified in the terms of approval attached to the design organisation approval.

(a)

The verification shall:

(b)

The competent authority shall establish the scope of the oversight set out in point (a) taking into account the results of past oversight activities and the safety priorities.

(c)

The competent authority shall collect and process any information deemed necessary for performing oversight activities.

(a)

The competent authority shall establish and maintain an oversight programme covering the oversight activities required to comply with point 21.B.431(a).

(b)

The oversight programme shall take into account the specific nature of the organisation, the complexity of its activities, the results of past certification or oversight activities, or both, and it shall be based on the assessment of the associated risks. It shall include, within each oversight planning cycle:

(c)

The oversight planning cycle shall not exceed 24 months.

(d)

Notwithstanding point (c), the oversight planning cycle may be extended to 36 months if the competent authority has established that during the previous 24 months:

(e)

The oversight planning cycle may be reduced if there is evidence that the safety performance of the organisation has decreased.

(f)

The oversight programme shall include records of the dates when assessments, audits, inspections and meetings are due, and when assessments, audits, inspections and meetings have been effectively carried out.

(g)

At the completion of each oversight planning cycle, the competent authority shall issue a recommendation report on the continuation of the approval, reflecting the results of the oversight.

(a)

The competent authority shall have a system in place to analyse findings for their safety significance.

(b)

A level 1 finding shall be issued by the competent authority when a non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the design organisation’s certificate including the terms of approval, which may lead to uncontrolled non-compliances and to a potential unsafe condition.

The level 1 findings shall also include:

(c)

A level 2 finding shall be issued by the competent authority when any non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the certificate including the terms of approval, which is not classified as a level 1 finding.

(d)

When a finding is detected during oversight or by any other means, the competent authority shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and its delegated and implementing acts, communicate in writing the finding to the organisation and request corrective action to address the non-compliance(s) identified. Where a level 1 finding directly relates to a product, the competent authority shall inform the competent authority of the Member State in which the aircraft is registered.

(e)

The competent authority may issue observations for any of the following cases not requiring level 1 or level 2 findings:

(a)

Upon receiving an application for a significant change to the design management system, the competent authority shall verify the organisation’s compliance with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, before issuing the approval.

(b)

The competent authority shall establish the conditions under which the organisation may operate during the change unless the competent authority determines that the design organisation approval needs to be suspended.

(c)

When it is satisfied that the organisation complies with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, the competent authority shall approve the change.

(d)

Without prejudice to any additional enforcement measures, if the organisation implements a significant change to the design management system without having received the approval of the competent authority pursuant to point (c), the competent authority shall consider the need to suspend, limit or revoke the organisation’s certificate.

(e)

For non-significant changes to the design management system, the competent authority shall include the review of such changes in its continuing oversight in accordance with the principles set forth in point 21.B.431. If any non-compliance is found, the competent authority shall notify the organisation, request further changes and act in accordance with point 21.B.433.’;

‘21.B.453

‘21.B.480