(2)

Section B is amended as follows: (a) the following Subpart A in inserted: ‘SUBPART A – GENERAL PROVISIONS 21L.B.11 Oversight documentation The competent authority shall provide all the legislative acts, standards, rules, technical publications, and related documents to the relevant personnel in order to allow them to perform their tasks and to discharge their responsibilities. 21L.B.12 Exchange of information (a) The competent authority of the Member State and the Agency shall share the information available to them through their investigation conducted and oversight performed in accordance with this Section, which is relevant for the other party when performing certification, oversight or enforcement tasks under this Section. (b) The competent authority of the Member State and the Agency shall coordinate a product-focused investigation and oversight of the design and production of products and parts under this Annex, including, where necessary, conducting joint oversight visits. 21L.B.13 Information to the Agency (a) The competent authority of the Member State shall notify the Agency in case of any significant problems with the implementation of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, within 30 days from the manifestation of such problems. (b) Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, the competent authority of the Member State shall provide the Agency as soon as possible with any safety-significant information stemming from the occurrence reports stored in the national database as specified in Article 6(6) of Regulation (EU) No 376/2014. 21L.B.14 Airworthiness directives received from non-Member States 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. 21L.B.15 Immediate reaction to a safety problem (a) Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, the competent authority of the Member State shall implement a system to appropriately collect, analyse, and disseminate safety information. (b) The Agency shall implement a system to appropriately analyse any relevant safety information received, and without undue delay, provide Member States and the Commission with any information, including recommendations or corrective actions to be taken, that is necessary for them to react in a timely manner to a safety problem involving products, parts, persons or organisations that are subject to Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof. (c) Upon receiving the information referred to in points (a) and (b), the competent authority of the Member State shall take adequate measures to address the safety problem. (d) Measures taken under point (c) of point 21L.B.15 shall immediately be notified to all persons or organisations that need to comply with them under Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof. The competent authority of the Member State shall also notify those measures to the Agency and, when combined action is required, to the other Member States concerned. 21L.B.16 Management system (a) The competent authority shall establish and maintain a management system, including as a minimum: 1. documented policies and procedures to describe its organisation, means and methods to achieve compliance with Regulation (EU) 2018/1139 and Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof. The procedures shall be kept up to date, and serve as the basic working documents within that competent authority for all related tasks; 2. a sufficient number of personnel to perform its tasks and discharge its responsibilities. A system shall be in place to plan the availability of personnel, in order to ensure the proper completion of all tasks; 3. personnel who are qualified to perform their allocated tasks and who have the necessary knowledge, experience, initial and recurrent training to ensure continuing competency; 4. adequate facilities and office accommodation to perform the allocated tasks; 5. a function to monitor the compliance of the management system with the relevant requirements, and the adequacy of the procedures, including the establishment of an internal audit process, and a safety risk management process. The compliance monitoring function shall include a system to provide feedback about audit findings to the senior management of the competent authority to ensure the implementation of corrective actions as necessary; 6. a person or group of persons having a responsibility to the senior management of the competent authority for the compliance monitoring function. (b) The competent authority shall, for each field of activity, including the management system, appoint one or more persons with the overall responsibility for the management of the relevant task(s). (c) The competent authority shall establish procedures for participation in a mutual exchange of all the necessary information with any other competent authorities concerned and provide them with assistance, whether from within the Member State or in other Member States, including on: 1. all the findings raised and any follow-up actions taken as a result of the oversight of persons and organisations that carry out activities in the territory of a Member State, but certified by the competent authority of another Member State, or by the Agency; 2. any information stemming from mandatory and voluntary occurrence reporting as required by point 21L.A.3. (d) A copy of the procedures related to the management system of the competent authority of the Member State and any amendments to those procedures shall be made available to the Agency for the purpose of standardisation. 21L.B.17 Allocation of tasks to qualified entities (a) A competent authority may allocate the tasks related to the initial certification or to the continuing oversight of products and parts, and of natural or legal persons subject to Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, to qualified entities. When allocating tasks, the competent authority shall ensure that it has: 1. put a system in place to initially and continuously assess whether the qualified entity complies with Annex VI “Essential requirements for qualified entities” to Regulation (EU) 2018/1139. This system and the results of the assessments shall be documented; 2. established a documented agreement with the qualified entity, approved by both parties at the appropriate management level, which defines: (i) the tasks to be performed; (ii) the declarations, reports, and records to be provided; (iii) the technical conditions to be met in performing such tasks; (iv) the related liability coverage; (v) the protection given to the information acquired in carrying out such tasks. (b) The competent authority shall ensure that the internal audit process and the safety risk management process required by point (a)(5) of point 21L.B.16 cover all the certification and continuing oversight tasks performed on its behalf by the qualified entity. 21L.B.18 Changes in the management system (a) The competent authority shall have a system in place to identify changes that affect its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU) 2018/1139 and Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof. This system shall enable it to take the action necessary to ensure that its management system remains adequate and effective. (b) The competent authority shall update its management system to reflect any change to Regulation (EU) 2018/1139 and Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof in a timely manner, so as to ensure its effective implementation. (c) The competent authority of the Member State shall notify the Agency of any changes affecting its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU) 2018/1139 and Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof. 21L.B.19 Resolution of disputes The competent authority of the Member State shall establish a process for the resolution of disputes within its documented procedures. 21L.B.20 Record-keeping (a) The competent authority shall establish a system of record-keeping that allows the adequate storage, accessibility, and reliable traceability of: 1. the management system’s documented policies and procedures; 2. the training, qualifications, and authorisation of its personnel; 3. the allocation of tasks covering the elements required by point 21L.B.17, as well as the details of the tasks allocated; 4. certification processes and the continuing oversight of certified and declared organisations, including: (i) applications for a certificate; (ii) declarations of capability; (iii) declarations of design compliance; (iv) the competent authority’s continuing oversight programme, including all assessments, audits and inspection records; (v) the certificates issued, including any changes to them; (vi) a copy of the oversight programme listing the dates when audits are due and when audits were carried out; (vii) copies of all formal correspondence; (viii) recommendations for the issue or continuation of a certificate or continuation of the registration of a declaration, details of findings, and actions taken by organisations to close these, including the date of closure of each item, enforcement actions, and observations; (ix) any assessment, audit or inspection report issued by another competent authority; (x) copies of all organisation handbooks, procedures and processes or manuals and amendments to them; (xi) copies of any other documents approved by the competent authority; 5. statements of conformity of aircraft (EASA Form 52B) or authorised release certificates (EASA Form 1) for engines, propellers or parts that it has inspected according to Subpart R of this Annex. (b) The competent authority of the Member State shall include in the record-keeping: 1. the evaluation and notification to the Agency of any alternative means of compliance proposed by organisations, and the assessment of any alternative means of compliance used by the competent authority itself; 2. safety information in accordance with point 21L.B.13 and follow-up measures; 3. the use of safeguard and flexibility provisions in accordance with Articles 71(1) and 76(4) of Regulation (EU) 2018/1139. (c) The competent authority shall maintain a list of all the certificates that it has issued and any declarations that it has registered. (d) All the records referred to in points (a), (b) and (c) shall be kept for a minimum period of 5 years, subject to the applicable data protection law. (e) All the records referred to in points (a), (b) and (c) shall be made available upon request to the competent authorities of another Member State or the Agency. 21L.B.21 Findings and observations (a) When the competent authority, during investigation or oversight or by any other means, detects a non-compliance with the applicable requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, of a procedure or manual required by those Regulations, or of a certificate or declaration issued in accordance with those Regulations, it shall, without prejudice to any additional action required by those Regulations, raise a finding. (b) The competent authority shall have a system to analyse findings for their safety significance. A level 1 finding shall be issued by the competent authority when any significant non-compliance is detected which lowers safety or seriously endangers flight safety, or in the case of design organisations may lead to an uncontrolled non-compliance and to a potential unsafe condition as per point 21L.B.23; level 1 findings shall also include but not be limited to the following: 1. any failure to grant the competent authority access to the organisation’s or natural or legal person’s facilities as defined in point 21L.A.10 during normal operating hours and after two written requests; 2. providing wrong information or falsification of documentary evidence; 3. any evidence of malpractice or of fraudulent use of a certificate, declaration or statement issued in accordance with this Annex; 4. the lack of an accountable manager or head of the design organisation, as applicable. 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 the delegated and implementing acts adopted on the basis thereof, of a procedure or manual required by those Regulations, or of a declaration issued in accordance with those Regulations, which is not classified as a level 1 finding. (c) The competent authority shall communicate the finding to the organisation or the natural or legal person in writing, and request corrective action to address the non-compliance(s) identified. (d) If there are any level 1 findings, the competent authority shall take immediate and appropriate action in accordance with point 21L.B.22, unless the finding is on a design organisation which has declared its design capabilities, in which case the Agency shall first grant the organisation a corrective action implementation period that is appropriate to the nature of the finding, which in any case shall not be more than 21 working days. The period shall commence from the date of the written communication of the finding to the organisation, requesting corrective action to address the non-compliance identified. If the level 1 finding directly relates to an aircraft, the competent authority shall inform the competent authority of the Member State in which the aircraft is registered. (e) For level 2 findings, the competent authority shall grant the organisation or the natural or legal person a corrective action implementation period that is appropriate to the nature of the finding. The period shall commence from the date of the written communication of the finding to the organisation or the natural or legal person, requesting corrective action to address the non-compliance identified. At the end of this period, and subject to the nature of the finding, the competent authority may extend the period, provided that a corrective action plan has been agreed by the competent authority. The competent authority shall assess the corrective action and the implementation plan proposed by the organisation or the natural or legal person, and if the assessment concludes that they are sufficient to address the non-compliance(s), accept these. If an organisation or natural or legal person fails to submit an acceptable corrective action plan, or to perform the corrective action within the time period accepted or extended by the competent authority, the finding shall be raised to a level 1 finding, and action shall be taken as laid down in point (d). (f) The competent authority may issue observations for those cases not requiring level 1 or level 2 findings: 1. for any item the performance of which has been assessed to be ineffective; 2. when it has been identified that an item has the potential to cause a non-compliance; or 3. when suggestions or improvements are of interest for the overall safety performance of the organisation. Observations issued under this point shall be communicated to the organisation or the natural or legal person in writing and recorded by the competent authority. 21L.B.22 Enforcement measures (a) The competent authority shall: 1. suspend a certificate if the competent authority considers that there are reasonable grounds that such action is necessary to prevent a credible threat to aircraft safety; 2. issue an airworthiness directive under the conditions of point 21L.B.23; 3. suspend, revoke or limit a certificate if such action is required pursuant to point (d) of point 21L.B.21; 4. suspend or revoke a certificate of airworthiness or a restricted certificate of airworthiness when the conditions specified in point (b) of point 21L.B.163 are met; 5. suspend or revoke a noise certificate or a restricted noise certificate when the conditions specified in point (b) of point 21L.B.173 are met; 6. take immediate and appropriate action necessary to limit or prohibit the activities of an organisation or natural or legal person if the competent authority considers that there are reasonable grounds that such action is necessary to prevent a credible threat to aircraft safety; 7. limit or prohibit the activities of an organisation or a natural or legal person that have declared their capabilities to design or produce products or parts in accordance with Section A or that issue statements of conformity (EASA Form 52B) or authorised release certificates (EASA Form 1) in accordance with Subpart R of Section A of this Annex pursuant to point (d) of point 21L.B.21; 8. not register a declaration of design compliance as long as there are unresolved findings from the initial oversight investigation; 9. temporarily or permanently de-register a declaration of design compliance or a declaration of capability pursuant to point (d) of point 21L.B.21; 10. take any further enforcement measures necessary in order to ensure the termination of a non-compliance with the essential requirements set out in Annex II to Regulation (EU) 2018/1139 and with this Annex, and, where necessary, remedy the consequences thereof. (b) Upon taking an enforcement measure in accordance with point (a), the competent authority shall notify it to the addressee, state the reasons for it, and inform the addressee of their right to appeal. 21L.B.23 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 or part installed on this aircraft; and 2. that condition is likely to exist or develop in other aircraft. (c) An airworthiness directive shall contain at least information identifying: 1. the unsafe condition; 2. the affected aircraft; 3. the action(s) required; 4. the compliance time for the required action(s); 5. the date of entry into force. 21L.B.24 Means of compliance (a) The Agency shall develop acceptable means of compliance (“AMC”) that may be used to establish compliance with Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof. (b) Alternative means of compliance may be used to establish compliance with this Regulation. (c) Competent authorities shall inform the Agency of any alternative means of compliance used by natural or legal persons under their oversight for establishing compliance with this Regulation.’; (b) the following Subparts G, H and I are inserted: ‘SUBPART G – DECLARED PRODUCTION ORGANISATIONS 21L.B.141 Initial oversight investigation (a) Upon receiving a declaration from an organisation declaring their production capability, the competent authority shall verify that: 1. the declarant is eligible to declare their production capability in accordance with point 21L.A.122; 2. the declaration contains all the information specified in point (c) of point 21L.A.123; and 3. the declaration does not contain information that indicates a non-compliance with the requirements of Subpart G of Section A of this Annex. (b) The competent authority shall acknowledge the receipt of the declaration, including the assignment of an individual declared production organisation reference number to the declarant. 21L.B.142 Registration of a declaration of production capability The competent authority shall register the declaration of production capability on a suitable database, including the declared scope of work, provided that: (a) the declarant has declared their capability in accordance with point 21L.A.123; (b) the declarant has made a commitment that the obligations in accordance with point 21L.A.127 will be undertaken; (c) there are no unresolved issues in accordance with point 21L.B.141. 21L.B.143 Oversight (a) The competent authority shall oversee the declared production organisation in order to verify the continuous compliance of the declared production organisation with the applicable requirements of Section A and the implementation of safety measures mandated according to points (c) and (d) of point 21L.B.15. (b) The oversight shall include a first article inspection of every new aircraft, engine, propeller or part design that is produced for the first time and, as determined by the oversight programme in accordance with point 21L.B.144, inspections of further produced aircraft, engines, propellers and parts that are produced by the declared production organisation. 21L.B.144 Oversight programme (a) The competent authority shall establish and maintain an oversight programme in order to ensure compliance with point 21L.B.143. This oversight programme shall take into account the specific nature of the organisation, the complexity of its activities and the results of past certification and/or oversight activities, and it shall be based on the assessment of the associated risks. It shall include, within each oversight planning cycle: 1. assessments, audits and inspections, including as appropriate: (i) management system assessments and process audits; (ii) product audits of a relevant sample of the products and parts that are under the scope of the organisation; (iii) sampling of the work performed; and (iv) unannounced inspections; 2. meetings convened between the accountable manager and the competent authority to ensure that they both remain informed of any significant issues. (b) 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. (c) An oversight planning cycle that does not exceed 24 months shall be applied. (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: 1. the organisation has demonstrated that it can effectively identify aviation safety hazards and manage the associated risks; 2. the organisation has continuously demonstrated compliance with point 21L.A.128 and that it has full control over all changes to the management system for production; 3. no level 1 findings have been issued; 4. all corrective actions have been implemented within the time period that was accepted or extended by the competent authority as defined in point 21L.B.21. (e) Notwithstanding point (c), the oversight planning cycle may be further extended to a maximum of 48 months if, in addition to the conditions provided in point (d), the organisation has established, and the competent authority has approved, an effective continuous system for reporting to the competent authority on the safety performance and regulatory compliance of the organisation itself. (f) The oversight planning cycle may be reduced if there is evidence that the safety performance of the organisation has decreased. (g) At the completion of each oversight planning cycle, the competent authority shall issue a recommendation report on the continuation of the activities conducted by the declared production organisation based on its declaration of production capability, reflecting the results of the oversight. 21L.B.145 Oversight activities (a) When the competent authority verifies the compliance of the declared production organisation in accordance with point 21L.B.143 and the oversight programme established in accordance with point 21L.B.144, it shall: 1. provide the personnel responsible for oversight with guidance to perform their functions; 2. conduct assessments, audits, inspections, and, if needed, unannounced inspections; 3. collect the evidence needed in case further action is required, including the measures provided for in points 21L.B.21 and 21L.B.22; 4. inform the declared production organisation about the results of the oversight activities. (b) If the facilities of the declared production organisation are located in more than one State, the competent authority identified in point 21L.2 may agree to have oversight tasks performed by the competent authority(ies) of the Member State(s) where other facilities are located, or by the Agency for facilities that are located in a non-Member State. Any declared production organisation that is subject to such an agreement shall be informed of its existence and of its scope. (c) For any oversight activities that are performed by the competent authority at facilities located in a Member State other than where the organisation has its principal place of business, the competent authority shall inform the competent authority of that Member State before performing any on-site audit or inspection of the facilities. (d) The competent authority shall collect and process any information deemed necessary for conducting oversight activities. (e) If the competent authority detects a non-compliance of the declared production organisation with the applicable requirements of Section A and the implementation of safety measures mandated according to points (c) and (d) of point 21L.B.15, the competent authority shall act in accordance with points 21L.B.21 and 21L.B.22. 21L.B.146 Changes to declarations (a) Upon receiving a notification of changes in accordance with point 21L.A.128, the competent authority shall verify the completeness of the notification in accordance with point 21L.B.141. (b) The competent authority shall update its oversight programme established according to point 21L.B.144 and investigate whether it is necessary to establish any conditions under which the organisation may operate during the change. (c) When the change affects any aspect of the declaration that is registered in accordance with point 21L.B.142, the competent authority shall update the register. (d) Upon completion of the activities required by points (a) to (c), the competent authority shall acknowledge the receipt of the notification to the declared production organisation. SUBPART H – CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS 21L.B.161 Investigation (a) The competent authority of the Member State of registry shall prepare procedures for its investigations, covering at least the following elements: 1. evaluation of the eligibility of the applicant; 2. evaluation of the conditions for the application; 3. classification of airworthiness certificates; 4. evaluation of the documentation received with the application; 5. inspections of aircraft; 6. determination of the necessary conditions, restrictions or limitations to the certificate. (b) Upon receiving an application for a certificate of airworthiness or a restricted certificate of airworthiness, the competent authority of the Member State of registry shall verify whether the aircraft is within the scope established in point 21L.A.141. (c) The competent authority of the Member State of registry shall perform sufficient investigation activities to justify the issuance, maintenance, amendment, suspension or revocation of the certificate of airworthiness or restricted certificate of airworthiness. When conducting investigations related to the issuance of a certificate of airworthiness or a restricted certificate of airworthiness for a newly produced aircraft, the competent authority of the Member State of registry shall evaluate the need to conduct a physical inspection of the aircraft to ensure the conformity and safety of flight of the aircraft prior to the issuance of a certificate of airworthiness or a restricted certificate of airworthiness. This evaluation shall take into account: 1. the results of the physical inspection of the first article of that product in the final configuration, conducted in accordance with point (b) of point 21L.B.143 or point (b) of point 21L.B.251 by the competent authority of the Member State of registry, or by the competent authority overseeing the organisation or the natural or legal person that produced this aircraft, if different; 2. the time period since the last physical inspection conducted by the competent authority of the Member State of registry of an aircraft produced by the organisation, or the natural or legal person that produced that aircraft; 3. the results of the oversight conducted under Subpart G of this Annex or under Subpart G of Section B of Annex I (Part 21) of the organisation issuing the statement of conformity for the aircraft, or the verification conducted under Subpart R of Section A of this Annex of other statements of conformity (EASA Form 52B) or authorised release certificates (EASA Form 1) that were issued by the same signatory; 4. the time period since the last oversight visit of the organisation in accordance with Subpart G of this Annex, or Subpart G of Section B of Annex I (Part 21), or since the last verification conducted under Subpart R of Section A of this Annex of a statement of conformity (EASA Form 52B) or authorised release certificate (EASA Form 1) issued by the same signatory. 21L.B.162 Issuance or amendment of a certificate of airworthiness or a restricted certificate of airworthiness (a) The competent authority of the Member State of registry shall issue or amend a certificate of airworthiness (EASA Form 25, see Appendix VI to Annex I (Part 21)) without undue delay when the applicant has provided the documentation required by point 21L.A.143 and complies with the obligations in point 21L.A.144, and when it is satisfied: 1. for new aircraft, that the aircraft, and its engine and propeller if applicable, conforms to a design approved in accordance with Subpart B of this Annex and is in a condition for safe operation; 2. for used aircraft, that: (i) the aircraft, and its engine and propeller if applicable, conforms to a type design approved in accordance with Subpart B of this Annex and any supplemental type certificate, change or repair approved in accordance with Subpart D, E or M of this Annex; (ii) the applicable airworthiness directives have been complied with; and (iii) the aircraft, and its engine and propeller if applicable, has been inspected in accordance with Annex I (Part-M) or Annex Vb (Part-ML) to Regulation (EU) No 1321/2014. (b) The competent authority of the Member State of registry shall issue or amend a restricted certificate of airworthiness (EASA Form 24B, see Appendix I) without undue delay when the applicant has provided the documentation required by point 21L.A.143 and complies with the obligations in point 21L.A.144, and when it is satisfied: 1. for new aircraft, that the aircraft, and its engine and propeller if applicable, conforms to an aircraft design for which design compliance has been declared in accordance with Subpart C of Section A of this Annex which is registered by the Agency in accordance with point 21L.B.63 at the time of application, and is in a condition for safe operation; 2. for used aircraft, that: (i) the aircraft, and its engine and propeller if applicable, conforms to an aircraft design for which design compliance has been declared in accordance with Subpart C of Section A of this Annex, and which is registered by the Agency in accordance with point 21L.B.63 at the time of application, along with any design changes or repair design changes for which design compliance has been declared in accordance with Subpart F or N of Section A of this Annex which are registered by the Agency in accordance with point 21L.B.122 or point 21L.B.222, or by the declarant in accordance with point (c) of point 21L.A.105; (ii) the applicable airworthiness directives have been complied with; and (iii) the aircraft has been inspected in accordance with Annex I (Part-M) or Annex Vb (Part-ML) to Regulation (EU) No 1321/2014. (c) By derogation from points (a) and (b) of point 21L.B.162, for a used aircraft originating from another Member State, the competent authority of the new Member State of registry shall issue the certificate of airworthiness or restricted certificate of airworthiness when the applicant has provided the documentation required by point (b) of point 21L.A.145 and when it is satisfied that the applicant complies with point (a) of point 21L.A.144. (d) For new aircraft, and used 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 aircraft subject to Annex I (Part-M) to 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 Regulation (EU) No 1321/2014, an initial airworthiness review certificate (EASA Form 15c, Appendix II); 3. for used aircraft originating from a non-Member State and subject to Annex Vb (Part-ML) to Regulation (EU) No 1321/2014, an initial airworthiness review certificate (EASA Form 15c, Appendix II), when the competent authority has performed the airworthiness review. (e) A certificate of airworthiness or a restricted certificate of airworthiness shall be issued for an unlimited duration. It may be amended only by the competent authority of the Member State of registry. 21L.B.163 Oversight (a) Upon evidence of a violation of any of the conditions under which the certificate of airworthiness or the restricted certificate of airworthiness was issued, or that the holder does not comply with the relevant requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof or with the applicable type design or with the applicable design data of an aircraft for which design compliance has been declared, or with the continuing airworthiness requirements, the competent authority of the Member State of registry shall issue a finding in accordance with point 21L.B.21. (b) When the type certificate under which the certificate of airworthiness was issued is suspended or revoked, or otherwise becomes invalid in accordance with point 21L.A.30, or the declaration of design compliance under which the restricted certificate of airworthiness was issued is not any longer registered in accordance with point 21L.B.63, the competent authority of the Member State of registry shall take action in accordance with point 21L.B.22. SUBPART I – NOISE CERTIFICATES 21L.B.171 Investigation (a) The competent authority of the Member State of registry shall prepare procedures for its investigations, covering at least the following elements: 1. evaluation of the eligibility of the applicant; 2. evaluation of the conditions for the application; 3. evaluation of the documentation received with the application; 4. inspections of aircraft. (b) Upon receiving an application for a noise certificate or a restricted noise certificate, the competent authority of the Member State of registry shall verify whether the aircraft is within the scope established in point 21L.A.161. (c) The competent authority of the Member State of registry shall perform sufficient investigation activities for an applicant for, or a holder of, a noise certificate or a restricted noise certificate to justify the issuance, maintenance, amendment, suspension or revocation of the certificate. 21L.B.172 Issuance or amendment of noise certificates (a) The competent authority of the Member State of registry shall issue or amend noise certificates (EASA Form 45, see Appendix VII to Annex I (Part 21)) and restricted noise certificates (EASA Form 45B, see Appendix II) without undue delay when the applicant has provided the documentation required by point 21L.A.163, and when it is satisfied that the aircraft is in conformity with the applicable noise information determined in accordance with the applicable noise requirements. (b) For used aircraft originating from another Member State, the noise certificate or restricted noise certificate shall be issued against the corresponding data that is provided by the Agency database on noise levels. (c) A noise certificate or a restricted noise certificate shall be issued for an unlimited duration. It may be amended only by the competent authority of the Member State of registry. 21L.B.173 Oversight (a) Upon evidence of a violation of any of the conditions under which the noise certificate or the restricted noise certificate was issued, or that the holder does not comply with the relevant requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof or with the applicable type design or with the applicable design data of an aircraft for which design compliance has been declared, the competent authority of the Member State of registry shall issue a finding in accordance with point 21L.B.21. (b) When the type certificate under which the noise certificate was issued is suspended or revoked, or otherwise becomes invalid in accordance with point 21L.A.30, or the declaration of design compliance under which the restricted noise certificate was issued is not any longer registered in accordance with point 21L.B.63, the competent authority of the Member State of registry shall take action in accordance with point 21L.B.22.’; (c) the following Subpart P in inserted: ‘SUBPART P – PERMIT TO FLY 21L.B.241 Investigation prior to the issuance of a permit to fly (a) Without prejudice to Subpart P of Section B of Annex I (Part 21), when investigating an application for the issuance of a permit to fly for an aircraft which is within the scope of this Annex, the competent authority of the Member State shall conduct a physical inspection of the aircraft and be satisfied that the aircraft conforms to the design defined under point 21.A.708 of that Annex I (Part 21) before flight when the application for a permit to fly relates to: 1. the demonstration of compliance activities in point 21L.A.25 for an aircraft which is, or is intended to be, type-certified; 2. the demonstration of compliance activities in point 21L.A.44 for an aircraft for which design compliance is, or is intended to be, declared. (b) For all other requests for the issuance of a permit to fly for activities and aircraft within the scope of this Annex, the competent authority shall assess, in accordance with point 21.B.520 of Annex I (Part 21), the need for a physical inspection. (c) If the competent authority finds evidence indicating that the aircraft does not conform to the design defined under point 21.A.708 of Annex I (Part 21), it shall raise a finding in accordance with point 21L.B.21. 21L.B.242 Investigation prior to issuance of the flight conditions (a) Without prejudice to Subpart P of Section B of Annex I (Part 21), when investigating an application for the approval of flight conditions for an aircraft which is within the scope of this Annex, the Agency shall: 1. if the application for flight conditions is related to the demonstration of compliance activities in point 21L.A.25 for an aircraft which is, or is intended to be, type-certified, conduct a critical design review of the design and a physical inspection and assessment of the aircraft in order to ensure that the aircraft is capable of safe flight, and that flight testing can be conducted safely; 2. if the application for flight conditions is related to the demonstration of compliance activities in point 21L.A.44 for an aircraft for which design compliance is, or is intended to be, declared, conduct a physical inspection and assessment of the aircraft in order to ensure that the aircraft is capable of safe flight, and that flight testing can be conducted safely; 3. if the application for flight conditions is related to the demonstration of compliance activities for a major change in point 21L.A.66, a supplemental type certificate in point 21L.A.85 or a major repair in point 21L.A.206, based upon the evaluation conducted in point 21L.B.83, point 21L.B.102 and point 21L.B.203, determine the need to conduct a physical inspection and assessment of the aircraft and a critical design review of the design in order to ensure that the aircraft is capable of safe flight, and that flight testing can be conducted safely; 4. if the application for flight conditions is related to the demonstration of compliance activities for a major change in point 21L.A.108 or a major repair in point 21L.A.227, based upon the evaluation conducted in point 21L.B.121 and point 21L.B.221, determine the need to conduct a physical inspection and assessment of the aircraft in order to ensure that the aircraft is capable of safe flight, and that flight testing can be conducted safely. (b) If the Agency finds evidence indicating that the aircraft could be incapable of conducting a safe flight, the Agency shall raise a finding in accordance with point 21L.B.21.’; (d) the following Subpart R is inserted: ‘SUBPART R – STATEMENT OF CONFORMITY FOR AIRCRAFT AND AUTHORISED RELEASE CERTIFICATES (EASA FORM 1) FOR ENGINES AND PROPELLERS, AND PARTS THEREOF, WHICH CONFORM TO A DECLARATION OF DESIGN COMPLIANCE 21L.B.251 Oversight (a) The competent authority shall oversee the natural or legal person issuing statements of conformity (EASA Form 52B) or authorised release certificates (EASA Form 1) under Subpart R of Section A of this Annex in order to verify the continuous compliance of the natural or legal person with the applicable requirements of Section A and the implementation of safety measures mandated according to points (c) and (d) of point 21L.B.15. (b) The oversight shall include a first article inspection of every new aircraft, engine, propeller or part that is produced for the first time for which the natural or legal person has issued a statement of conformity (EASA Form 52B) or authorised release certificates (EASA Form 1), and, as determined by the oversight programme in accordance with point 21L.B.252, inspections of further aircraft, engines, propellers and parts produced by that natural or legal person. 21L.B.252 Oversight programme (a) The competent authority shall establish and maintain an oversight programme in order to ensure compliance with point 21L.B.251. This oversight programme shall take into account the specific nature of the natural or legal person, the complexity of their activities and the results of past oversight activities, and it shall be based on the assessment of the associated risks. It shall include, within each oversight planning cycle: 1. assessments, audits and inspections, including as appropriate: (i) production control system assessments and process audits; (ii) product audits of a relevant sample of the products and parts that are under the scope of the natural or legal person; (iii) sampling of the work performed; and (iv) unannounced inspections; 2. meetings convened between the legal or natural person and the competent authority to ensure that they both remain informed of any significant issues. (b) 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. (c) An oversight planning cycle that does not exceed 24 months shall be applied. (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: 1. the natural or legal person has demonstrated that they can effectively identify aviation safety hazards and manage the associated risks; 2. the natural or legal person has continuously demonstrated compliance with point 21L.A.273 and that they have full control over all changes to the management system for production; 3. no level 1 findings have been issued; 4. all corrective actions have been implemented within the time period that was accepted or extended by the competent authority as defined in point 21L.B.21. (e) Notwithstanding point (c), the oversight planning cycle may be further extended to a maximum of 48 months if, in addition to the conditions provided in point (d), the natural or legal person has established, and the competent authority has approved, an effective continuous system for reporting to the competent authority on the safety performance and regulatory compliance of the natural or legal person themselves. (f) The oversight planning cycle may be reduced if there is evidence that the safety performance of the natural or legal person has decreased. (g) At the completion of each oversight planning cycle, the competent authority shall issue a recommendation report on the continuation of the activities conducted by the natural or legal person, reflecting the results of the oversight. 21L.B.253 Oversight activities (a) When the competent authority verifies the compliance of the natural or legal person in accordance with point 21L.B.251 and the oversight programme established in accordance with point 21L.B.252, it shall: 1. provide the personnel responsible for oversight with guidance to perform their functions; 2. conduct assessments, audits, inspections, and, if needed, unannounced inspections; 3. collect the evidence needed in case further action is required, including the measures provided for in point 21L.B.21 and 21L.B.22; 4. inform the natural or legal person about the results of the oversight activities. (b) If the facilities of the natural or legal person are located in more than one State, the competent authority identified in point 21L.2 may agree to have oversight tasks performed by the competent authority(ies) of the Member State(s) where other facilities are located, or by the Agency for facilities that are located in a non-Member State. Any natural or legal person who is subject to such an agreement shall be informed of its existence and of its scope. (c) For any oversight activities that are performed by the competent authority at facilities located in a Member State other than where the natural or legal person has its principal place of business, the competent authority shall inform the competent authority of that Member State before performing any on-site audit or inspection of the facilities. (d) The competent authority shall collect and process any information deemed necessary for conducting oversight activities. (e) If the competent authority detects a non-compliance of the natural or legal person issuing statements of conformity (EASA Form 52B) or authorised release certificates (EASA Form 1) with the applicable requirements of Section A and the implementation of safety measures mandated according to points (c) and (d) of point 21L.B.15, the competent authority shall act in accordance with points 21L.B.21 and 21L.B.22.’.