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Document 32022R0201
Commission Delegated Regulation (EU) 2022/201 of 10 December 2021 amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by design and production organisations, as well as procedures applied by the Agency, and correcting that Regulation
Commission Delegated Regulation (EU) 2022/201 of 10 December 2021 amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by design and production organisations, as well as procedures applied by the Agency, and correcting that Regulation
Commission Delegated Regulation (EU) 2022/201 of 10 December 2021 amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by design and production organisations, as well as procedures applied by the Agency, and correcting that Regulation
C/2021/8886
OJ L 33, 15.2.2022, p. 7–40
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
15.2.2022 |
EN |
Official Journal of the European Union |
L 33/7 |
COMMISSION DELEGATED REGULATION (EU) 2022/201
of 10 December 2021
amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by design and production organisations, as well as procedures applied by the Agency, and correcting that Regulation
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (1), and in particular Article 19(1) and Article 62(13) thereof,
Whereas:
(1) |
Commission Regulation (EU) No 748/2012 (2) lays down the requirements for the design and production of civil aircraft as well as engines, propellers and parts to be installed therein. |
(2) |
In accordance with point 3.1(b) of Annex II to Regulation (EU) 2018/1139, approved design and production organisations must, as appropriate for the type of activity undertaken and the size of the organisation, implement and maintain a management system, to ensure compliance with the essential requirements set out in that Annex, manage safety risks and aim for the continuous improvement of that system. |
(3) |
Pursuant to Annex 19 ‘Safety Management’ to the Convention on International Civil Aviation, signed in Chicago on 7 December 1944 (the ‘Chicago Convention’), competent authorities are to require approved organisations that design and produce civil aircraft, as well as engines, propellers and parts to be installed therein, to implement a safety management system. |
(4) |
Regulation (EU) No 748/2012 already requires approved design and production organisations to comply with some elements of the management system; however, this management system does not completely cover the Standards and Recommended Practices (SARPs) for such a safety management system established in Annex 19 to the Chicago Convention. Therefore, the missing elements of the management system should be added to the existing requirements. |
(5) |
In order to ensure a proportionate implementation and consistency with the approach used for continuing airworthiness organisations operating in the general aviation domain, design and production organisations, for which an approval is not mandatory under Regulation (EU) No 748/2012, should not be required to comply with all the elements of the management system. |
(6) |
All organisations, including those that have their principal place of business outside the Union, when they design and produce products and parts in accordance with Regulation (EU) No 748/2012, are already required to establish a mandatory and voluntary occurrence-reporting system. However, Regulation (EU) No 748/2012 should be amended to ensure that that occurrence-reporting system is aligned with the principles of Regulation (EU) No 376/2014 of the European Parliament and of the Council (3). |
(7) |
In addition, the requirements for the Agency with regard to the tasks related to design certification, oversight and enforcement should be amended. |
(8) |
A sufficient transition period should be provided for approved design organisations to ensure their compliance with the new rules and procedures introduced by this Regulation. |
(9) |
The measures provided for in this Regulation are based on Opinion No 04/2020 (4), issued by the Agency in accordance with Article 76(1) of Regulation (EU) 2018/1139. |
(10) |
Regulation (EU) No 748/2012 should therefore be amended accordingly. |
(11) |
Commission Delegated Regulation (EU) 2021/699 (5) introduced a requirement that any future holder of the type-certificate or restricted type-certificate for a large aeroplane is to ensure that the continuing structural integrity programme remains valid throughout the operational life of the aeroplane. In particular, point 21.A.101(h) was added in Annex I to Regulation (EU) No 748/2012 to the effect that certain future holders are to 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 Commission Regulation (EU) 2015/640 (6). An error occurred by referring to point 26.320, which does not exist. Regulation (EU) No 748/2012 should therefore be corrected accordingly, |
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EU) No 748/2012 is amended as follows:
(1) |
in Article 8, the following paragraph 4 is added: ‘4. By way of derogation from points 21.B.433(d)(1) and (2) of Annex I (Part 21), a design organisation that holds a valid approval certificate issued in accordance with Annex I (Part 21) may correct, until 7 March 2025, any findings of non-compliance related to the Annex I requirements introduced by Commission Delegated Regulation (EU) 2022/201 (*1). Where after 7 March 2025, the organisation has not closed such findings, the approval certificate shall be revoked, limited or suspended in whole or in part. (*1) Commission Delegated Regulation (EU) 2022/201 of 10 December 2021 amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by design and production organisations, as well as procedures applied by the Agency, and correcting that Regulation (OJ L 33, …, p. 7)’;" |
(2) |
Annex I (Part 21) is amended in accordance with Annex I to this Regulation. |
Article 2
Annex I (Part 21) to Regulation (EU) No 748/2012 is corrected in accordance with Annex II to this Regulation.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 7 March 2023, with the exception of Article 2 which shall apply from 7 March 2022.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 December 2021.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 212, 22.8.2018, p. 1.
(2) 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 (OJ L 224, 21.8.2012, p. 1).
(3) Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18).
(4) https://www.easa.europa.eu/document-library/opinions
(5) Commission Delegated Regulation (EU) 2021/699 of 21 December 2020 amending and correcting Regulation (EU) No 748/2012 as regards the instructions for continued airworthiness, the production of parts to be used during maintenance and the consideration of ageing aircraft aspects during certification (OJ L 145, 28.4.2021, p. 1).
(6) Commission Regulation (EU) 2015/640 of 23 April 2015 on additional airworthiness specifications for a given type of operations and amending Regulation (EU) No 965/2012 (OJ L 106, 24.4.2015, p. 18).
ANNEX I
Annex I (Part 21) is amended as follows:
(1) |
the table of contents is replaced by the following: ‘ Contents
SECTION A – TECHNICAL REQUIREMENTS SUBPART A – GENERAL PROVISIONS
SUBPART B – TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES
(SUBPART C – NOT APPLICABLE) SUBPART D – CHANGES TO TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES
SUBPART E – SUPPLEMENTAL TYPE-CERTIFICATES
SUBPART F – PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL
SUBPART G – PRODUCTION ORGANISATION APPROVAL
SUBPART H – CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS
SUBPART I – NOISE CERTIFICATES
SUBPART J – DESIGN ORGANISATION APPROVAL
SUBPART K – PARTS AND APPLIANCES
(SUBPART L – NOT APPLICABLE) SUBPART M – REPAIRS
(SUBPART N – NOT APPLICABLE) SUBPART O – EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS
SUBPART P – PERMIT TO FLY
SUBPART Q – IDENTIFICATION OF PRODUCTS, PARTS AND APPLIANCES
SECTION B – PROCEDURES FOR COMPETENT AUTHORITIES SUBPART A – GENERAL PROVISIONS
SUBPART B – TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES
(SUBPART C – NOT APPLICABLE) SUBPART D – CHANGES TO TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES
SUBPART E – SUPPLEMENTAL TYPE-CERTIFICATES
SUBPART F – PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL
SUBPART G – PRODUCTION ORGANISATION APPROVAL
SUBPART H – CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS
SUBPART I – NOISE CERTIFICATES
SUBPART J – DESIGN ORGANISATION APPROVAL
SUBPART K – PARTS AND APPLIANCES (SUBPART L – NOT APPLICABLE) SUBPART M – REPAIRS
(SUBPART N – NOT APPLICABLE) SUBPART O – EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS
SUBPART P – PERMIT TO FLY
SUBPART Q – IDENTIFICATION OF PRODUCTS, PARTS AND APPLIANCES Appendices Appendix I – EASA Form 1 – Authorised Release Certificate Appendix II – EASA Form 15a and 15c – Airworthiness Review Certificate Appendix III – EASA Form 20a – Permit to Fly Appendix IV – EASA Form 20b – Permit to Fly (issued by approved organisations) Appendix V – EASA Form 24 – Restricted Certificate of Airworthiness Appendix VI – EASA Form 25 – Certificate of Airworthiness Appendix VII – EASA Form 45 – Noise Certificate Appendix VIII – EASA Form 52 – Aircraft statement of conformity Appendix IX – EASA Form 53 – Certificate of Release to Service Appendix X – EASA Form 55 – Production organisation approval certificate Appendix XI – EASA Form 65 – Letter of Agreement for production without production organisation approval Appendix XII – Categories of flight tests and associated flight test crew qualification.’; |
(2) |
point 21.A.1 is replaced by the following: ‘21.A.1 Scope This Subpart establishes the general rights and obligations of the applicant for, and holder of, any certificate that has been issued or is to be issued in accordance with this Annex.’; |
(3) |
point 21.A.3A is replaced by the following: ‘21.A.3A Reporting system
(*1) Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18).’;" |
(4) |
point 21.A.5 is replaced by the following: ‘21.A.5 Record-keeping All natural or legal persons that hold or have applied for a type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, design or repair approval, permit to fly, production organisation approval certificate or letter of agreement under this Regulation shall:
|
(5) |
the following point 21.A.9 is inserted: ‘21.A.9 Access and investigation Any natural or legal person that holds or has applied for a type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, design change or repair approval, certificate of airworthiness, noise certificate, permit to fly, design organisation approval, production organisation approval certificate or letter of agreement under this Regulation, shall:
|
(6) |
in point 21.A.44, point (a) is replaced by the following:
|
(7) |
point 21.A.47 is replaced by the following: ‘21.A.47 Transferability The transfer of a type-certificate or a restricted type-certificate or an ETSO authorisation for an auxiliary power unit may only be made to a natural or legal person that is able to undertake the obligations laid down in point 21.A.44, and, for this purpose, has demonstrated its capability in accordance with point 21.A.14.’; |
(8) |
in point 21.A.109, point (a) is replaced by the following:
|
(9) |
in point 21.A.118A(a), point (1) is replaced by the following:
|
(10) |
the following point 21.A.124A is inserted: ‘21.A.124A Means of compliance
|
(11) |
in point 21.A.125A, the title is replaced by the following:
|
(12) |
point 21.A.125B is replaced by the following: ‘21.A.125B Findings and observations
|
(13) |
point 21.A.125C is replaced by the following: ‘21.A.125C Duration and continued validity
|
(14) |
point 21.A.126(b) is amended as follows:
|
(15) |
point 21.A.129 is amended as follows:
|
(16) |
the following point 21.A.134A is inserted: ‘21.A.134A Means of compliance
|
(17) |
in point 21.A.135, the title is replaced by the following:
|
(18) |
point 21.A.139 is replaced by the following: ‘21.A.139 Production management system
|
(19) |
point 21.A.143 is amended as follows:
|
(20) |
point 21.A.145 is replaced by the following: ‘21.A.145 Resources The production organisation shall demonstrate that:
|
(21) |
point 21.A.147 is replaced by the following: ‘21.A.147 Changes in the production management system After the issue of a production organisation approval certificate, each change in the production management system that is significant for the demonstration of conformity or the airworthiness and environmental protection characteristics of the product, part or appliance, shall be approved by the competent authority before being implemented. The production organisation shall submit an application for approval to the competent authority demonstrating that it will continue to comply with this Annex.’; |
(22) |
point 21.A.157 is deleted; |
(23) |
point 21.A.158 is replaced by the following: ‘21.A.158 Findings and observations
|
(24) |
point 21.A.159 is replaced by the following: ‘21.A.159 Duration and continued validity
|
(25) |
point 21.A.165 is amended as follows:
|
(26) |
point 21.A.180 is deleted; |
(27) |
point 21.A.181(a) is amended as follows:
|
(28) |
point 21.A.210 is deleted; |
(29) |
point 21.A.211(a) is amended as follows:
|
(30) |
point 21.A.239 is replaced by the following: ‘21.A.239 Design management system
|
(31) |
point 21.A.243 is replaced by the following: ‘21.A.243 Handbook
|
(32) |
point 21.A.245 is replaced by the following: ‘21.A.245 Resources
|
(33) |
point 21.A.247 is replaced by the following: ‘21.A.247 Changes in the design management system After the issue of a design organisation approval, each change to the design management system that is significant to the demonstration of compliance or to the airworthiness, operational suitability and environmental protection of the product, part or appliance shall be approved by the Agency before being implemented. The design organisation shall submit to the Agency an application for approval demonstrating, on the basis of the proposed changes to the handbook, that it will continue to comply with this Annex.’; |
(34) |
point 21.A.257 is deleted; |
(35) |
point 21.A.258 is replaced by the following: ‘21.A.258 Findings and observations
|
(36) |
point 21.A.259 is replaced by the following: ‘21.A.259 Duration and continued validity
|
(37) |
in point 21.A.263(c), the introductory phrase is replaced by the following:
|
(38) |
point 21.A.265 is amended as follows:
|
(39) |
point 21.A.451 is amended as follows:
|
(40) |
in point 21.A.604, point (a) is replaced by the following:
|
(41) |
point 21.A.609 is amended as follows:
|
(42) |
point 21.A.615 is deleted; |
(43) |
point 21.A.619 is replaced by the following: ‘21.A.619 Duration and continued validity
|
(44) |
point 21.A.705 is deleted; |
(45) |
in point 21.A.711, the title is replaced by the following:
|
(46) |
point 21.A.721 is deleted; |
(47) |
in point 21.A.723, point (a) is replaced by the following:
|
(48) |
point 21.A.729 is deleted; |
(49) |
in point 21.B.103, the title is replaced by the following:
|
(50) |
in point 21.B.107, the title is replaced by the following:
|
(51) |
in point 21.B.111, the title is replaced by the following:
|
(52) |
point 21.B.150 is deleted; |
(53) |
point 21.B.260 is deleted; |
(54) |
in point 21.B.425, the title is replaced by the following:
|
(55) |
in point 21.B.453, the title is replaced by the following:
|
(56) |
points 21.B.430 and 21.B.445 are deleted; |
(57) |
in Section B, Subpart J is replaced by the following:: ‘ SUBPART J – DESIGN ORGANISATION APPROVAL 21.B.430 Initial certification procedure
21.B.431 Oversight principles The competent authority shall verify whether certified organisations continue to comply with the applicable requirements
21.B.432 Oversight programme
21.B.433 Findings and corrective actions; observations
21.B.435 Changes in the design management system
|
(58) |
in point 21.B.453, the title is replaced by the following
|
(59) |
in point 21.B.480, the title is replace by the following:
|
(60) |
Appendix VIII is replaced by the following: ‘Appendix VIII Aircraft statement of conformity – EASA Form 52
Instructions for the use of the “Aircraft statement of conformity – EASA Form 52” 1. PURPOSE AND SCOPE
2. GENERAL
3. COMPLETION OF THE STATEMENT OF CONFORMITY BY THE ORIGINATOR
|
(61) |
Appendix X is replaced by the following: ‘Appendix X Production organisation approval certificate – EASA Form 55 Production organisation approval certificates referred to in Subpart G of Annex I (Part 21)
|
(62) |
Appendix XI is replaced by the following: ‘Appendix XI Letter of agreement for production without a production organisation approval – EASA Form 65 Letter of agreement referred to in Subpart F of Annex I (Part 21)
|
(*1) Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18).’;’
ANNEX II
In Annex I (Part 21), point 21.A.101, point (h) is replaced by the following:
‘(h) |
For large aeroplanes subject to point 26.300 of Annex I to Commission Regulation (EU) 2015/640 (*1), the applicant shall comply with certification specifications that provide at least an equivalent level of safety to points 26.300 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. |
(*1) Commission Regulation (EU) 2015/640 of 23 April 2015 on additional airworthiness specifications for a given type of operations and amending Regulation (EU) No 965/2012 (OJ L 106, 24.4.2015, p. 18).’.’