Opinion 07-2019

Draft Annex to draft Commission Delegated Regulation (EU) …/… amending 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 1  ANNEX Amendments to Annex I (Part 21) to Commission Regulation (EU) No 748/2012 1. ‘Section A’ of the ‘Contents’ is replaced by the following: ‘Contents 21.1 General SECTION A — TECHNICAL REQUIREMENTS SUBPART A — GENERAL PROVISIONS 21.A.1 Scope 21.A.2 Undertaking by another person than the applicant for, or holder of, a certificate 21.A.3A Failures, malfunctions and defects 21.A.3B Airworthiness directives 21.A.4 Coordination between design and production 21.A.5 Record-keeping 21.A.6 Manuals 21.A.7 Instructions for continued airworthiness SUBPART B — TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES 21.A.11 Scope 21.A.13 Eligibility 21.A.14 Demonstration of capability 21.A.15 Application 21.A.19 Changes requiring a new type-certificate 21.A.20 Compliance with the type-certification basis and environmental protection requirements 21.A.21 Issue of a type-certificate 21.A.31 Type design 21.A.33 Inspection and tests 21.A.35 Flight tests 21.A.41 Type-certificate 21.A.44 Obligations of the holder 21.A.47 Transferability 21.A.51 Duration and continued validity (SUBPART C — NOT APPLICABLE) SUBPART D — CHANGES TO TYPE-CERTIFICATES AND RESTRICTED TYPE- CERTIFICATES 2 21.A.90A Scope 21A.90B Standard changes 21.A.90C Stand-alone changes to the Instructions for Continued Airworthiness 21.A.91 Classification of changes in type design 21.A.92 Eligibility 21.A.93 Application 21.A.95 Requirements for the approval of a minor change 21.A.97 Requirements for the approval of a major change 21.A.101 Type-certification basis, operational suitability data certification basis and environmental protection requirements for a major change to a type-certificate 21.A.108 Availability of operational suitability data 21.A.109 Obligations and EPA marking SUBPART E — SUPPLEMENTAL TYPE-CERTIFICATES 21.A.111 Scope 21.A.112A Eligibility 21.A.112B Demonstration of capability 21.A.113 Application for a supplemental type-certificate 21.A.115 Requirements for the approval of major changes in the form of a supplemental type-certificate 21.A.116 Transferability 21.A.117 Changes to that part of a product covered by a supplemental type-certificate 21.A.118A Obligations and EPA marking 21.A.118B Duration and continued validity 21.A.120B Availability of operational suitability data SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL 21.A.121 Scope 21.A.122 Eligibility 21.A.124 Application 21.A.125A Issue of a letter of agreement 21.A.125B Findings 21.A.125C Duration and continued validity 21.A.126 Production inspection system 21.A.127 Tests: aircraft 21.A.128 Tests: engines and propellers 21.A.129 Obligations of the manufacturer 3 21.A.130 Statement of conformity SUBPART G — PRODUCTION ORGANISATION APPROVAL 21.A.131 Scope 21.A.133 Eligibility 21.A.134 Application 21.A.135 Issue of a production organisation approval 21.A.139 Quality System 21.A.143 Exposition 21.A.145 Approval requirements 21.A.147 Changes to the approved production organisation 21.A.148 Change of location 21.A.149 Transferability 21.A.151 Terms of approval 21.A.153 Changes to the terms of approval 21.A.157 Investigations 21.A.158 Findings 21.A.159 Duration and continued validity 21.A.163 Privileges 21.A.165 Obligations of the holder SUBPART H — CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS 21.A.171 Scope 21.A.172 Eligibility 21.A.173 Classification 21.A.174 Application 21.A.175 Language 21.A.177 Amendment or modification 21.A.179 Transferability and reissuance within Member States 21.A.180 Inspections 21.A.181 Duration and continued validity 21.A.182 Aircraft identification SUBPART I — NOISE CERTIFICATES 21.A.201 Scope 21.A.203 Eligibility 4 21.A.204 Application 21.A.207 Amendment or modification 21.A.209 Transferability and reissuance within Member States 21.A.210 Inspections 21.A.211 Duration and continued validity SUBPART J — DESIGN ORGANISATION APPROVAL 21.A.231 Scope 21.A.233 Eligibility 21.A.234 Application 21.A.235 Issue of a design organisation approval 21.A.239 Design assurance system 21.A.243 Data 21.A.245 Approval requirements 21.A.247 Changes in the design assurance system 21.A.249 Transferability 21.A.251 Terms of approval 21.A.253 Changes to the terms of approval 21.A.257 Investigations 21.A.258 Findings 21.A.259 Duration and continued validity 21.A.263 Privileges 21.A.265 Obligations of the holder SUBPART K — PARTS AND APPLIANCES 21.A.301 Scope 21.A.303 Compliance with applicable requirements 21.A.305 Approval of parts and appliances 21.A.307 The eligibility of parts and appliances for installation (SUBPART L — NOT APPLICABLE) SUBPART M — REPAIRS 21.A.431A Scope 21A.431B Standard repairs 21.A.432A Eligibility 21.A.432B Demonstration of capability 21.A.432C Application for a repair design approval 21.A.433 Requirements for the approval of a repair design 5 21.A.435 Classification and approval of repair designs 21.A.439 Production of repair parts 21.A.441 Repair embodiment 21.A.443 Limitations 21.A.445 Unrepaired damage 21.A.451 Obligations and EPA marking (SUBPART N — NOT APPLICABLE) SUBPART O — EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS 21.A.601 Scope 21.A.602A Eligibility 21.A.602B Demonstration of capability 21.A.603 Application 21.A.604 ETSO Authorisation for an Auxiliary Power Unit (APU) 21.A.605 Data requirements 21.A.606 Requirements for the issuance of an ETSO authorisation 21.A.607 ETSO authorisation privileges 21.A.608 Declaration of design and performance (DDP) 21.A.609 Obligations of holders of ETSO authorisations 21.A.610 Approval for deviation 21.A.611 Design changes 21.A.615 Inspection by the Agency 21.A.619 Duration and continued validity 21.A.621 Transferability SUBPART P — PERMIT TO FLY 21.A.701 Scope 21.A.703 Eligibility 21.A.705 Competent authority 21.A.707 Application for a permit to fly 21.A.708 Flight conditions 21.A.709 Application for the approval of flight conditions 21.A.710 Approval of flight conditions 21.A.711 Issue of a permit to fly 21.A.713 Changes 21.A.715 Language 6 21.A.719 Transferability 21.A.721 Inspections 21.A.723 Duration and continued validity 21.A.725 Renewal of a permit to fly 21.A.727 Obligations of the holder of a permit to fly 21.A.729 Record-keeping SUBPART Q — IDENTIFICATION OF PRODUCTS, PARTS AND APPLIANCES 21.A.801 Identification of products 21.A.803 Handling of identification data 21.A.804 Identification of parts and appliances 21.A.805 Identification of critical parts 21.A.807 Identification of ETSO articles’ 2. The following points 21.A.5 to 21.A.7 are inserted: ‘21.A.5 Record-keeping All relevant design information, drawings and test reports, including inspection records for the product or article tested for the purpose of certification, shall be held by the holder of a type-certificate, restricted type-certificate, supplemental type-certificate, design change or repair design approval or of an ETSO authorisation at the disposal of the Agency and shall be retained in order to provide the information necessary to ensure the continued airworthiness, continued validity of the operational suitability data and continued compliance with the applicable environmental protection requirements of the product or the article. 21.A.6 Manuals The holder of a type-certificate, restricted type-certificate, or supplemental type- certificate shall produce, maintain and update master copies of all manuals or variations in the manuals required by the applicable type-certification basis, the applicable operational suitability data certification basis and the environmental protection requirements for the product or article, and provide copies, on request, to the Agency. 21.A.7 Instructions for continued airworthiness (a) The holder of a type-certificate, restricted type-certificate, supplemental type- certificate, design change or repair design approval shall develop or reference the instructions which are necessary for ensuring that the airworthiness standard related to the aircraft type and any associated part is maintained throughout the operational life of the aircraft, when demonstrating compliance with the applicable type-certification basis in accordance with point 21.B.80. 7  (b) At least one set of complete instructions for continued airworthiness shall be provided by the holder of: 1. a type-certificate or restricted type-certificate to each known owner of one or more products upon its delivery or upon the issuance of the first certificate of airworthiness or restricted certificate of airworthiness for the affected aircraft, whichever occurs later, 2. a supplemental type-certificate or design change approval to all known operators of the product affected by the change upon the release to service of the modified product, 3. a repair design approval to all known operators of the product affected by the repair upon the release to service of the product in which the repair design is embodied. The repaired product, part or appliance may be released into service before the related instructions for continued airworthiness have been completed, but this shall be for a limited service period, and in agreement with the Agency. Thereafter, those design approval holders shall make those instructions available on request to any other person required to comply with those instructions. (c) By way of derogation from paragraph (b), the type-certificate holder or restricted type-certificate holder may delay the availability of a part of the instructions for continued airworthiness, dealing with long lead accomplishment instructions of a scheduled nature, until after the product or modified product has entered into service, but shall make those instructions available before the use of this data is required for the product or modified product. (d) The design approval holder, who is required to provide instructions for continued airworthiness in accordance with paragraph (b), shall also make available changes to those instructions to all known operators of the product affected by the change and, on request, to any other person required to comply with those changes. That design approval holder shall demonstrate to the Agency, on request, the adequacy of the process of making changes to the instructions for continued airworthiness available in accordance with this paragraph.’ 3. Point 21.A.41 is replaced by the following: ‘21.A.41 Type-certificate The type-certificate and restricted type-certificate shall include the type design, the operating limitations, the instructions for continued airworthiness, the type-certificate data sheet for airworthiness and emissions, the applicable type-certification basis, and environmental protection requirements with which the Agency records compliance, and any other conditions or limitations prescribed for the product in the applicable certification specifications and environmental protection requirements. The aircraft type- certificate and restricted type-certificate shall include in addition the applicable operational suitability data certification basis, the operational suitability data and the 8  type-certificate data sheet for noise. The aircraft type-certificate and restricted type- certificate data sheet shall include the record of CO2 emissions compliance and the engine type-certificate data sheet shall include the record of exhaust emissions compliance.’ 4. In point 21.A.44, point (a) is replaced by the following: ‘(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 and 21.A.62; and, for this purpose, shall continue to meet the qualification requirements for eligibility under point 21.A.14; and’ 5. Points 21.A.55, 21.A.57 and 21.A.61 are deleted. 6. In point 21.A.90B, point 2 is replaced by the following: ‘2. that follow design data included in the certification specifications issued by the Agency, containing acceptable methods, techniques and practices for carrying out and identifying standard changes, including the associated instructions for continued airworthiness; and’ 7. The following point 21.A.90C is inserted: ‘21.A.90C Stand-alone changes to the Instructions for Continued Airworthiness (a) Stand-alone changes to the instructions for continued airworthiness are changes that are not directly prepared as a result of a change to the type design or repair design. (b) Stand-alone changes to the instructions for continued airworthiness can only be made by the holder of the design approval for which those instructions have been established. (c) Points 21.A.91 to 21.A.109 shall not apply to stand-alone changes to the instructions for continued airworthiness that: 1. do not affect the airworthiness limitations section of the instructions for continued airworthiness, and 2. do not require the design approval holder to perform any additional demonstration of compliance with the certification basis. (d) Stand-alone changes to the instructions for continued airworthiness referred to in paragraph (c) shall be approved by the design approval holder under procedures agreed with the Agency.’ 8. Points 21.A.105 and 21.A.107 are deleted. 9. In point 21.A.109, point (a) is replaced by the following: ‘(a) undertake the obligations laid down in points 21.A.4, 21.A.5, 21.A.7 and 21.A.108; and’ 10. In point 21.A.118A, point (a)(1) is replaced by the following: 9  ‘1. laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.5, 21.A.6, 21.A.7, and 21.A.120B;’ 11. Points 21.A.119 and 21.A.120A are deleted. 12. Point 21.A.307 is replaced by the following: ‘21.A.307 The eligibility of parts and appliances for installation (a) A part or appliance is eligible for installation in a type-certified product when it is in a condition for safe operation, marked in accordance with Subpart Q and accompanied by an authorised release certificate (EASA Form 1), certifying that the item was manufactured in conformity with approved design data. (b) By way of derogation from paragraph (a), the following parts or appliances do not need to be accompanied by an EASA Form 1 in order to be eligible for installation in a type-certified product, provided that the conditions in paragraph (c) are met: (1) a standard part; (2) in the case of ELA1 or ELA2 aircraft, a part or appliance that is: (i) not life limited, nor part of the primary structure, nor part of the flight controls; (ii) identified for installation in the specific aircraft; and (iii) to be installed in an aircraft for which the owner has verified compliance with the applicable conditions in (i) and (ii), and has accepted responsibility for this compliance; (3) a part or appliance for which the consequences of a non-conformity with its approved design data has a negligible safety effect on the product and which is identified as such by the holder of the design approval in the instructions for continued airworthiness. In order to determine the safety effects of a non- conforming part or appliance, the design approval holder may establish in the instructions for continued airworthiness specific verification activities to be conducted by the installer of the part or appliance on the product; (4) in the case of the embodiment of a standard change in accordance with point 21.A.90B or a standard repair in accordance with point 21.A.431B, a part or appliance, for which the consequences of a non-conformity with its design data have a negligible safety effect on the product, and the part or appliance is identified as such in the Certification Specifications for Standard Changes and Standard Repairs. In order to determine the safety effects of a non- conforming part or appliance, specific verification activities to be conducted by the person that installs the part or appliance on the product may be established in the Certification Specifications referred to above; (5) a part or appliance that is exempted from an airworthiness approval in accordance with Commission Regulation (EU) No 965/2012; and 10  (6) a part or appliance that is an item of a higher assembly identified in paragraphs (b)(1) to (b)(5). (c) Parts and appliances listed in paragraph (b) are eligible for installation in a type- certified product without being accompanied by an EASA Form 1, provided that the installer holds a document issued by the person or organisation that manufactured the part or appliance, which declares the name of the part or appliance, the part number, and the conformity of the part or appliance with its design data, and which contains the date of issue. 13. Points 21.A.447 and 21.A.449 are deleted. 14. Point 21.A.451 is amended as follows: (a) paragraph (a)(1)(i) is replaced by the following: ‘(i) laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.5, 21.A.7, 21.A.439, 21.A.441, and 21.A.443;’; (b) paragraph (b)(1) is replaced by the following: ‘1. undertake the obligations laid down in points 21.A.4, 21.A.5 and 21.A.7; and’ 15. In point 21.A.609, point (b) is replaced by the following: ‘(b) prepare and maintain, for each model of each article for which an ETSO authorisation has been issued, a current file of complete technical data and records in accordance with point 21.A.5;’ 16. Point 21.A.613 is deleted. 17. Point 21.A.804 is replaced by the following: ‘21.A.804 Identification of parts and appliances (a) Each part or appliance which is eligible for installation in a type-certified product shall be marked permanently and legibly with: 1. a name, trademark, or symbol identifying the manufacturer in a manner identified by the applicable design data; 2. the part number, as defined in the applicable design data; and 3. the letters EPA for parts or appliances produced in accordance with approved design data not belonging to the type-certificate holder of the related product, except for ETSO articles and for parts and appliances covered under paragraph (b) of point 21.A.307. (b) By way of derogation from paragraph (a), if EASA agrees that a part or appliance is too small or that it is otherwise impractical to mark a part or appliance with any of the information required by paragraph (a), the authorised release document accompanying the part or appliance or its container shall include the information that could not be marked on the part or appliance.’ 11 Draft Annex to draft Commission Implementing Regulation (EU) …/… amending Commission Regulation (EU) No 1321/2014 of 26 November 2014 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks Page 1 of 6  ANNEX I Amendments to Annex I (Part-M) to Commission Regulation (EU) No 1321/2014 (1) In point M.A.305, point (e)(3)(iii) is replaced by the following: ‘(iii) the CRS and owner’s acceptance statement for any component that is fitted to an ELA2 aircraft without an EASA Form 1 in accordance with point 21.A.307(b)(2) of Annex I (Part 21) to Commission Regulation (EU) No 748/2012 but covering a period not shorter than 36 months.’ (2) Point M.A.401(b) is replaced by the following: ‘(b) For the purposes of this Annex, applicable maintenance data is: 1. any applicable requirement, procedure, standard or information issued by the competent authority or the Agency; 2. any applicable airworthiness directive; 3. the applicable instructions for continuing airworthiness and other maintenance instructions, issued by the type-certificate holder, supplementary type-certificate holder and any other organisation that publishes such data in accordance with Annex I (Part 21) to Commission Regulation (EU) No 748/2012; 4. for components approved for installation by the design approval holder, the applicable maintenance instructions published by the component manufacturers and acceptable to the design approval holder; 5. any applicable data issued in accordance with point 145.A.45(d).’ (3) In point M.A.501, point (a)(1) is replaced by the following: ‘(1) Components which are in a satisfactory condition, released on an EASA Form 1 or equivalent and marked in accordance with Subpart Q of Annex I (Part 21) to Commission Regulation (EU) No 748/2012, unless otherwise specified in point 21.A.307 of Annex I (Part 21) to Commission Regulation (EU) No 748/2012, or in this Annex (Part-M), or in Annex Vd (Part-CAO).’ (4) Point M.A.502 is replaced by the following: ‘M.A.502 Component maintenance (a) The maintenance of components other than the components referred to in points (b)(2) to (b)(6) of point 21.A.307 of Annex I (Part 21) to Commission Regulation (EU) No 748/2012 shall be performed by maintenance organisations approved in accordance with Subpart F of this Annex or with Annex II (Part-145) or with Annex Vd (Part-CAO), as applicable. (b) By way of derogation from point (a), where a component is fitted to the aircraft, the maintenance of such a component may be performed by an aircraft maintenance organisation approved in accordance with Subpart F of this Annex or with Annex II (Part-145) or with Annex Vd (Part-CAO) or by the certifying staff referred to in point (b)(2) of point M.A.801. Such maintenance shall be performed in accordance with the aircraft maintenance data or in accordance with the component maintenance data if agreed by the competent authority. Such an aircraft maintenance organisation or the certifying staff may temporarily remove the Page 2 of 6  component for maintenance if this is necessary to improve access to the component, except where additional maintenance is required due to the removal. Component maintenance performed in accordance with this point shall not be eligible for the issuance of an EASA Form 1 and shall be subject to the aircraft release requirements provided for in point M.A.801. (c) By way of derogation from point (a), where a component is fitted to the engine or the auxiliary power unit (APU), the maintenance of such component may be performed by an engine maintenance organisation approved in accordance with Subpart F of this Annex, or with Annex II (Part-145), or with Annex Vd (Part-CAO). Such maintenance shall be performed in accordance with the engine or the APU maintenance data or in accordance with the component maintenance data if agreed by the competent authority. Such B-rated organisation may temporarily remove the component for maintenance if this is necessary to improve access to the component, except where additional maintenance is required due to the removal. (d) The maintenance of components referred to in point (b)(2) of point 21.A.307 of Annex I (Part 21) to Commission Regulation (EU) No 748/2012, where the component is fitted to the aircraft or is temporarily removed to improve access, shall be performed by an aircraft maintenance organisation approved in accordance with Subpart F of this Annex or with Annex II (Part-145) or with Annex Vd (Part-CAO), as applicable, by the certifying staff referred to in point (b)(2) of point M.A.801 or by the pilot-owner referred to in point (b)(3) of point M.A.801. Component maintenance performed in accordance with this point shall not be eligible for the issuance of an EASA Form 1 and shall be subject to the aircraft release requirements provided for in point M.A.801. (e) The maintenance of components referred to in points (b)(3) to (b)(6) of point 21.A.307 of Annex I (Part 21) to Commission Regulation (EU) No 748/2012 shall be performed by the organisation referred to in point (a), or performed by any person or organisation and released with a ‘declaration of maintenance accomplished’ issued by the person or organisation that performed the maintenance. The ‘declaration of maintenance accomplished’ shall contain at least basic details of the maintenance carried out, the date on which the maintenance was completed, and the identification of the organisation or person that issues it. It shall be considered a maintenance record and equivalent to an EASA Form 1 in respect of the affected component.’ (5) In point M.A.802, point (a) is replaced by the following: ‘(a) Except for components released to service by a maintenance organisation that is approved in accordance with Annex II (Part-145) and for the cases covered by point (e) of point M.A.502, a CRS shall be issued at the completion of any maintenance work carried out on an aircraft component in accordance with point M.A.502.’ Page 3 of 6  ANNEX II Amendments to Annex II (Part-145) to Commission Regulation (EU) No 1321/2014 (6) In point 145.A.42, point (a)(i) is replaced by the following: ‘(i) Components which are in a satisfactory condition, released on an EASA Form 1 or equivalent and marked in accordance with Subpart Q of Annex I (Part 21) to Commission Regulation (EU) No 748/2012, unless otherwise specified in point 21.A.307 of Annex I (Part 21) to Commission Regulation (EU) No 748/2012, in point M.A.502 of Annex I (Part-M), in point ML.A.502 of Annex III (Part-ML), or in this Annex (Part-145).’ (7) In point 145.A.42, point (b)(iv) is replaced by the following: ‘(iv) Components which are referred to in point (b)(2) of point 21.A.307 of Annex I (Part 21) to Commission Regulation (EU) No 748/2012 shall only be installed if considered eligible for installation by the aircraft owner on their own aircraft.’ (8) Point 145.A.45(b) is replaced by the following: ‘(b) For the purposes of this Annex, applicable maintenance data shall be any of the following: 1. any applicable requirement, procedure, operational directive or information issued by the authority responsible for the oversight of the aircraft or component; 2. any applicable airworthiness directive issued by the authority responsible for the oversight of the aircraft or component; 3. the instructions for continuing airworthiness and other maintenance instructions, issued by the type-certificate holder, supplementary type-certificate holder and any other organisation that publishes such data in accordance with Annex I (Part 21) to Commission Regulation (EU) No 748/2012, and in the case of aircraft or components from third countries the airworthiness data mandated by the authority responsible for the oversight of the aircraft or component; 4. for components approved for installation by the design approval holder, the applicable maintenance instructions published by the component manufacturers and acceptable to the design approval holder; 5. any applicable standard such as but not limited to maintenance standard practices recognised by the Agency as good standards for maintenance; 6. any applicable data issued in accordance with point (d).’ Page 4 of 6  ANNEX III Amendments to Annex Vb (Part-ML) to Commission Regulation (EU) No 1321/2014 (9) Point ML.A.401(b) is replaced by the following: ‘(b) For the purposes of this Annex, ‘applicable maintenance data’ means: 1. any applicable requirement, procedure, standard or information issued by the competent authority or the Agency; 2. any applicable AD; 3. the applicable ICA and other maintenance instructions, issued by the type-certificate holder, supplementary type-certificate holder and any other organisation that publishes such data in accordance with Annex I (Part 21) to Commission Regulation (EU) No 748/2012; 4. for components approved for installation by the design approval holder, the applicable maintenance instructions published by the component manufacturers and acceptable to the design approval holder; 5. any applicable data issued in accordance with point 145.A.45(d).’ (10) In point ML.A.501, point (a) is replaced by the following: ‘(a) Unless otherwise specified in Subpart F of Annex I (Part-M), in Annex II (Part-145), in Annex Vd (Part-CAO) to this Regulation or in point 21.A.307 of Annex I (Part 21) to Commission Regulation (EU) No 748/2012, a component may be fitted only if all of the following conditions are met: (i) it is in a satisfactory condition; (ii) it has been appropriately released to service using an EASA Form 1 as set out in Appendix II to Annex I (Part-M), or equivalent; and (iii) it has been marked in accordance with Subpart Q of Annex I (Part 21) to Commission Regulation (EU) No 748/2012.’ (11) In point ML.A.502, point (a) is replaced by the following: ‘(a) Components which are accepted by the owner in accordance with point (b)(2) of point 21.A.307 of Annex I (Part 21) to Commission Regulation (EU) No 748/2012 shall be maintained by any person or organisation, subject to reacceptance by the owner under the conditions of point (b)(2) of point 21.A.307 of that Annex. This maintenance is not eligible for the issuance of an EASA Form 1, as set out in Appendix II to Annex I (Part-M), and shall be subject to the aircraft release requirements.’ (12) In point ML.A.502, a new point (c) is added as follows: ‘(c) Components which are referred to in points (b)(3) to (b)(6) of point 21.A.307 of Annex I (Part 21) to Commission Regulation (EU) No 748/2012 may be maintained by any person or organisation. In such cases, by way of derogation from point (b), the maintenance of these components shall be released with a ‘declaration of maintenance accomplished’ issued by the person or organisation that performed the maintenance. The ‘declaration of maintenance accomplished’ shall contain at least basic details of the maintenance carried out, the date on which the maintenance was completed, and the identification of the organisation or person Page 5 of 6  that issues it. It shall be considered a maintenance record and equivalent to an EASA Form 1 in respect of the affected component.’ (13) In point ML.A.802, point (a) is replaced by the following: ‘(a) Except for the cases covered by point (c) of point ML.A.502, a component CRS shall be issued after the required maintenance work has been properly carried out on an aircraft component in accordance with point ML.A.502.’ Page 6 of 6 EUROPEAN COMMISSION Brussels, XXX […](2019) XXX draft ANNEX I TO EASA OPINION No 07/2019 COMMISSION DELEGATED REGULATION (EU) …/... of XXX amending Commission Regulation (EU) No 748/2012 as regards the clarification of the status of the instructions for continued airworthiness and the introduction of alleviations that permit the production of certain parts and appliances to be used during maintenance without the need to be accompanied by an authorised release certificate (EASA Form 1) EN EN  EXPLANATORY MEMORANDUM 1. CONTEXT OF THE DELEGATED ACT In accordance with Regulation (EU) 2018/1139 (the EASA Basic Regulation), the Commission is empowered to adopt delegated acts with regard to the airworthiness of aircraft. Instructions for continued airworthiness (ICA) have to be produced by design approval holders (DAHs) as part of the product/part certification. If properly implemented, they should ensure that the product/part remains airworthy during its intended life. Experience has shown that the current rules and standards are open to interpretation, leading to differences as regards what qualifies as ICA as well as how they are distributed to organisations which are required to apply them, and therefore may lead to possible safety risks. Furthermore, parts that are manufactured for installation in an aircraft shall be accompanied by an EASA Form 1, certifying that the part was manufactured in conformity to approved design data. This Form can be issued by an approved production organisation (POA), or by other production organisations, but in the latter case it needs to be validated and countersigned by the competent authority. For parts that have a negligible safety impact, an EASA Form 1 does not provide for additional safety to the aircraft and creates a burden to the aviation industry. Maintenance companies, operators, continued airworthiness management organisations (CAMOs) and aircraft owners have in some cases difficulties in obtaining certain parts (spare parts or parts that belong to a design change/repair) accompanied with an EASA Form 1, as required. In other cases, an EASA Form 1 is issued ‘artificially’ (that is, by an organisation that did not manufacture the part but has only inspected it, because the part manufacturer does not hold the privilege to issue such form). This is compliant with the airworthiness requirements, but does not meet the regulatory intent that the manufacturer of the part certifies that the part has been manufactured in conformity with the approved design data. Therefore, it is proposed to amend Commission Regulation (EU) No 748/2012 (the initial airworthiness Regulation) and Commission Regulation (EU) No 1321/2014 (the continuing airworthiness Regulation) in order to: — establish ICA as part of the type certificate (TC) in order to strengthen the control of the ICA by the DAH, including the amendments to the ICA, and — legally permit that parts that have a negligible safety impact on the aircraft operation can be manufactured without a production organisation approval (POA) and can be released without an EASA Form 1 and installed on airworthy aircraft. 2. CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT In accordance with Article 128(4) of Regulation (EU) 2018/1139, before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law- Making. The draft delegated act was presented to the Air Safety experts group, which includes representatives from the Member States, at its meeting on […]. The draft delegated act is based on EASA Opinion No 07/2019 whose contents had been publicly consulted through Notice of Proposed Amendment (NPA) 2017-19 ‘Installation of parts and appliances that are released without an EASA Form 1 or equivalent’ (RMT.0018) and NPA 2018-01 ‘Instructions for continued airworthiness’ (RMT.0252 (MDM.056)) published by EASA on 14 December 2017 and 29 January 2018 respectively, and also with the affected stakeholders. EN 1 EN  3. LEGAL ELEMENTS OF THE DELEGATED ACT The Commission is empowered to adopt delegated acts, in accordance with Article 128 of Regulation (EU) 2018/1139, laying down detailed rules with regard to the necessary features and functionalities related to the initial and continuing airworthiness of aircraft. EN 2 EN  COMMISSION DELEGATED REGULATION (EU) …/... of XXX amending Commission Regulation (EU) No 748/2012 as regards the clarification of the status of the instructions for continued airworthiness and the introduction of alleviations that permit the production of certain parts and appliances to be used during maintenance without the need to be accompanied by an authorised release certificate (EASA Form 1) 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) thereof, Whereas: (1) Commission Regulation (EU) No 748/2012 (2) lays down the requirements for the production and availability of instructions for continued airworthiness as well as for the production of parts and appliances to be installed in civil aircraft. (2) Instructions for continued airworthiness have to be produced by design approval holders as part of the product/part certification which, if properly implemented, should ensure that the product/part remains airworthy during its intended life. As there is too much room for interpretation in the current rules and standards, different type-certificate holders have different interpretations of what is a complete set of instructions for continued airworthiness and to what level they are required to control the data that constitutes the instructions for continued airworthiness. (3) Therefore, Commission Regulation (EU) No 748/2012 should be amended to include a definition for ‘instructions for continued airworthiness’ and to establish instructions for continued airworthiness as part of the type certificate in order to strengthen the control of the instructions for continued airworthiness by the design approval holder, including the amendments to the instructions for continued airworthiness. (4) The requirements for record keeping, manuals and instructions for continued airworthiness are spread among the various subparts of Annex I (Part 21), leading to duplication of similar requirements. ( 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). EN 3 EN  (5) Therefore, Commission Regulation (EU) No 748/2012 should be amended to merge the requirements related to record keeping, manuals and instructions for continued airworthiness in the various subparts of Annex I (Part 21) into a single requirement. (6) An EASA Form 1 is issued in accordance with point 21.A.307(a) of Annex I (Part 21) to Commission Regulation (EU) No 748/2012 for a part or appliance to certify that the item was manufactured in conformity to approved design data. (7) An EASA Form 1 can only be issued by a production organisation which is approved in accordance with Subpart G of Annex I (Part 21) to Commission Regulation (EU) No 748/2012, or which demonstrates the conformity of parts and appliances with the applicable design data in accordance with the procedures established in Subpart F of Annex I (Part 21) to Commission Regulation (EU) No 748/2012. In the latter case, the EASA Form 1 issued by the production organisation also has to be validated by the competent authority. (8) For parts and appliances for which their effect on the safety of the operation of aircraft is negligible in case of non-conformity with their design, a high production standard, as certified with an EASA Form 1, does not provide additional safety for air operations, and the issuance of an EASA Form 1 is therefore an administrative burden. (9) Commission Regulation (EU) No 748/2012 should therefore be amended to permit the production of certain parts and appliances without the need to certify their conformity with the design data through the issuance of an EASA Form 1 as well as to permit the installation of such parts and appliances in type-certified products. (10) The measures provided for in this Regulation are based on Opinion No 07/2019 (3) of the European Union Aviation Safety Agency (EASA) in accordance with Articles 75(2)(b) and 76(1) of Regulation (EU) 2018/1139. (11) The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 127 of Regulation (EU) 2018/1139, HAS ADOPTED THIS REGULATION: Article 1 Commission Regulation (EU) No 748/2012 is amended as follows: (1) In Article 9, paragraph 1 is replaced by the following: ‘1. An organisation responsible for the manufacture of products, parts and appliances shall demonstrate its capability in accordance with the provisions of Annex I (Part 21). This demonstration of capability is not required for the parts or appliances that an organisation manufactures which, in accordance with the provisions of Annex I (Part 21), are eligible for installation in a type-certified product without the need to be accompanied by an authorised release certificate (i.e. EASA Form 1).’; (2) Annex I (Part 21) is amended in accordance with Annex I to this Regulation. ( 3) https://www.easa.europa.eu/document-library/opinions EN 4 EN  Article 2 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. This Regulation shall apply [please insert the date 1 year after its entry into force]. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, For the Commission The President […] EN 5 EN EUROPEAN COMMISSION Brussels, XXX […](2019) XXX draft ANNEX II TO EASA OPINION No 07/2019 COMMISSION IMPLEMENTING REGULATION (EU) …/... of XXX amending Commission Regulation (EU) No 1321/2014 as regards the applicable maintenance data and the introduction of requirements for the maintenance and the installation of certain aircraft components during maintenance EN EN  COMMISSION IMPLEMENTING REGULATION (EU) …/... of XXX amending Commission Regulation (EU) No 1321/2014 as regards the applicable maintenance data and the introduction of requirements for the maintenance and the installation of certain aircraft components during maintenance 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 Articles 23 and 27 thereof, Whereas: (1) Commission Regulation (EU) No 1321/2014 (2) lays down the requirements for the continuing airworthiness of aircraft, including the requirements for the installation of components on/in them. (2) An EASA Form 1 is also issued in accordance with Commission Regulation (EU) No 1321/2014 to a component that has undergone maintenance to attest that the identified maintenance work on the component has been conducted in accordance with the applicable requirements. (3) Commission Regulation (EU) No 1321/2014 should therefore be amended to allow the installation during maintenance of components that have been produced without being eligible for an EASA Form 1. (4) Commission Regulation (EU) No 1321/2014 should therefore be amended to establish some alleviations as regards the maintenance of these components. (5) Commission Regulation (EU) No 1321/2014 should therefore be amended to clarify the applicable maintenance data. (6) The measures provided for in this Regulation are based on Opinion No 07/2019 (3) of the European Union Aviation Safety Agency (EASA) in accordance with Articles 75(2)(b) and 76(1) of Regulation (EU) 2018/1139. (7) The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 127 of Regulation (EU) 2018/1139, ( 1) OJ L 212, 22.8.2018, p. 1. ( 2) Commission Regulation (EU) No 1321/2014 of 26 November 2014 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks (OJ L 362, 17.12.2014, p. 1). ( 3) https://www.easa.europa.eu/document-library/opinions EN 1 EN  HAS ADOPTED THIS REGULATION: Article 1 Commission Regulation (EU) No 1321/2014 is amended as follows: 1. Annex I (Part-M) is amended in accordance with Annex I to this Regulation. 2. Annex II (Part-145) is amended in accordance with Annex II to this Regulation. 3. Annex VI (Part-ML) is amended in accordance with Annex III to this Regulation. Article 2 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. This Regulation shall apply [please insert the date 1 year after its entry into force]. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, For the Commission The President […] EN 2 EN European Union Aviation Safety Agency Opinion No 07/2019 Instructions for continued airworthiness RMT.0252 (MDM.056) Installation of parts and appliances that are released without an EASA Form 1 or equivalent RMT.0018 EXECUTIVE SUMMARY The objective of this Opinion is to mitigate the risks linked to the uncertainty of the status of the instructions for continued airworthiness (ICA) and, therefore, to avoid leaving room for interpretation in the rules, leading to differences in the use of ICA and causing possible safety risks. In order to achieve this, this Opinion proposes to amend Annex I (Part 21) to Commission Regulation (EU) No 748/2012 to clarify that the ICA are part of the type certificate (TC). It also proposes to merge the requirements related to record keeping, manuals and ICA in the various subparts into a single requirement for each of these aspects in Subpart A (new points 21.A.5, 21.A.6 and 21.A.7). The proposed amendments are expected to improve the harmonisation of the ICA among the design approval holders (DAHs) in relation to the identification, approval, formatting and availability of the ICA to the end users. Another objective of this Opinion is to propose more proportionate and efficient requirements by introducing commensurate manufacturing requirements for new spare parts. The need to require a European Union Aviation Safety Agency (EASA) Form 1 to attest manufacturing in accordance with the approved design data is considered disproportionate for certain parts. In order to achieve this, this Opinion proposes to relax the requirement that all parts installed on an aircraft have to be issued with an EASA Form 1 or equivalent when they are installed during maintenance work. Instead, it is proposed that certain parts that do not impact safety could be manufactured outside the Part 21 production environment and do not require an EASA Form 1 to be installed in a product. Similarly, it is proposed that these parts should be exempted from the requirement to be maintained in a maintenance organisation approved in accordance with Commission Regulation (EU) No 1321/2014. The proposed amendments are expected to reduce the regulatory burden on maintenance organisations that use these parts during their maintenance work, so they would be able to easily obtain the parts, without decreasing the level of safety. Action area: Maintenance organisations and manufacturers Affected rules: Commission Regulation (EU) No 748/2012 (Annex I (Part 21)); Commission Regulation (EU) No 1321/2014 (Annex I (Part-M), Annex II (Part-145) and Annex VI (Part-ML) Affected stakeholders: DAHs and manufacturers; production organisation approval (POA) holders; aircraft operators; continuing airworthiness management organisations (CAMOs); approved maintenance organisation (AMOs) (Part-145 and Part-M Subpart F) and maintenance personnel Drivers: Efficiency/proportionality(RMT.0018); level playing field(RMT.0252 (MDM.056)) Rulemaking group: Yes Impact assessment: Light (RMT.0018/RMT.0252 (MDM.056)) Rulemaking Procedure: Standard RMT.0252 (MDM.056) 15.5.2013 (Issue 1) 29.1.2018 (NPA 2018-01) 20.6.2016 (Issue 5) 17.12.2019 2021/Q3 2021/Q3 RMT.0018 14.12.2017 (NPA 2017-19) 6.11.2012 TE.RPRO.00036-009 © European Union Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 1 of 10 An agency of the European Union  European Union Aviation Safety Agency Opinion No 07/2019 Table of contents Table of contents 1. About this Opinion ............................................................................................................... 3 1.1. How this Opinion was developed ..................................................................................................... 3 1.1.1. Instructions for Continued Airworthiness (ICA) (RMT.0252 (MDM.056)) ..................................... 3 1.1.2. Installation of parts and appliances that are released without an EASA Form 1 or equivalent (RMT.0018) .................................................................................................................................................... 3 1.2. The next steps ................................................................................................................................... 4 2. In summary — why and what................................................................................................ 5 2.1. Why we need to change the rules — issue/rationale ....................................................................... 5 2.1.1. Instructions for continued airworthiness (ICA) (RMT.0252 (MDM.056)) ...................................... 5 2.1.2. Installation of parts and appliances that are released without an EASA Form 1 or equivalent (RMT.0018) .................................................................................................................................................... 5 2.2. What we want to achieve — objectives ........................................................................................... 5 2.2.1. Instructions for continued airworthiness (ICA) (RMT.0252 (MDM.056)) ...................................... 5 2.2.2. Installation of parts and appliances that are released without an EASA Form 1 or equivalent (RMT.0018) .................................................................................................................................................... 6 2.3. How we want to achieve it — overview of the proposals ................................................................ 6 2.3.1. Instructions for continued airworthiness (ICA) (RMT.0252 (MDM.056)) ...................................... 6 2.3.2. Installation of parts and appliances that are released without an EASA Form 1 or equivalent (RMT.0018) .................................................................................................................................................... 6 2.4. What are the stakeholders’ views — outcome of the consultation ................................................. 7 2.4.1. Instructions for continued airworthiness (ICA) (RMT.0252 (MDM.056)) ...................................... 7 2.4.2. Installation of parts and appliances that are released without an EASA Form 1 or equivalent (RMT.0018) .................................................................................................................................................... 7 2.5. What are the expected benefits and drawbacks of the proposals ................................................... 8 2.5.1. Instructions for continued airworthiness (ICA) (RMT.0252 (MDM.056)) ...................................... 8 2.5.2. Installation of parts and appliances that are released without an EASA Form 1 or equivalent (RMT.0018) .................................................................................................................................................... 8 2.6. How we monitor and evaluate the rules .......................................................................................... 9 2.6.1. Instructions for continued airworthiness (ICA) (RMT.0252 (MDM.056)) ...................................... 9 2.6.2. Installation of parts and appliances that are released without an EASA Form 1 or equivalent (RMT.0018) .................................................................................................................................................... 9 3. References ......................................................................................................................... 10 3.1. Affected regulations ....................................................................................................................... 10 3.2. Related decisions ............................................................................................................................ 10 3.3. Other reference documents ........................................................................................................... 10 TE.RPRO.00036-009 © European Union Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 2 of 10 An agency of the European Union  European Union Aviation Safety Agency Opinion No 07/2019 1. About this Opinion 1. About this Opinion 1.1. How this Opinion was developed The European Union Aviation Safety Agency (EASA) developed this Opinion in line with Regulation (EU) 2018/11391 (the ‘Basic Regulation’) and the Rulemaking Procedure2. 1.1.1. Instructions for Continued Airworthiness (ICA) (RMT.0252 (MDM.056)) This rulemaking activity is included in the European Plan for Aviation Safety (EPAS) for 2019-20233 under rulemaking task RMT.0252 (MDM.056). The scope and timescales of the task were defined in the related terms of reference (ToR)4. All the interested parties were consulted through NPA 2018-01 ‘Instructions for continued airworthiness’5. 502 comments were received from the interested parties, including industry and national aviation authorities (NAAs). EASA reviewed the comments received during the public consultation with the support of Review Group (RG) RMT.0252. The comments received and EASA’s responses to them are presented in Comment-Response Document (CRD) 2018-016; the comments are summarised in Section 2.4. The draft text of this Opinion has been developed by EASA based in consideration of the recommendations of the RG RMT.0252. 1.1.2. Installation of parts and appliances that are released without an EASA Form 1 or equivalent (RMT.0018) This rulemaking activity is included in EPAS for 2019-20237 under rulemaking task RMT.0018. The scope and timescales of the task were defined in the related ToR8. All the interested parties were consulted through NPA 2017-19 ‘Installation of parts and appliances that are released without an EASA Form 1 or equivalent’9. 465 comments were received from the interested parties, including industry and NAAs. 1 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 (OJ L 212, 22.8.2018, p. 1) (https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1535612134845&uri=CELEX:32018R1139). 2 EASA is bound to follow a structured rulemaking process as required by Article 115(1) of Regulation (EU) 2018/1139. Such a process has been adopted by the EASA Management Board (MB) and is referred to as the ‘Rulemaking Procedure’. See MB Decision No 18-2015 of 15 December 2015 replacing Decision 01/2012 concerning the procedure to be applied by EASA for the issuing of opinions, certification specifications and guidance material (http://www.easa.europa.eu/the-agency/management-board/decisions/easa-mb-decision-18-2015- rulemaking-procedure). 3 https://www.easa.europa.eu/document-library/general-publications/european-plan-aviation-safety-2019-2023 4 https://www.easa.europa.eu/document-library/terms-of-reference-and-group-compositions/tor-mdm056-rmt0252 5 https://www.easa.europa.eu/document-library/notices-of-proposed-amendment/npa-2018-01 6 http://easa.europa.eu/document-library/comment-response-documents 7 https://www.easa.europa.eu/document-library/general-publications/european-plan-aviation-safety-2019-2023 8 https://www.easa.europa.eu/document-library/terms-of-reference-and-group-compositions/tor-21026-rmt0018-and-rmt0571 9 https://www.easa.europa.eu/document-library/notices-of-proposed-amendment/npa-2017-19 TE.RPRO.00036-009 © European Union Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 3 of 10 An agency of the European Union  European Union Aviation Safety Agency Opinion No 07/2019 1. About this Opinion EASA reviewed the comments received during the public consultation with the support of RG RMT.0018. The comments received and EASA’s responses to clustered comments are presented in CRD 2017-1910; the comments are summarised in Section 2.4. The draft text of this Opinion has been developed by EASA based in consideration of the recommendations of the RG RMT.0018. The major milestones of these rulemaking activities are presented on the title page. 1.2. The next steps This Opinion contains the proposed amendments to Commission Regulation (EU) No 748/201211 and Commission Regulation (EU) No 1321/201412. It is submitted to the European Commission, which will use it as a technical basis in order to prepare EU regulations. The Decision that contains the related acceptable means of compliance (AMC) and guidance material (GM) will be published by EASA when the related regulations are adopted by the European Commission. 10 http://easa.europa.eu/document-library/comment-response-documents 11 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) (https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1574352506031&uri=CELEX:32012R0748). 12 Commission Regulation (EU) No 1321/2014 of 26 November 2014 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks (OJ L 362, 17.12.2014, p. 1) (https://eur- lex.europa.eu/legal-content/EN/TXT/?qid=1574352663938&uri=CELEX:32014R1321). TE.RPRO.00036-009 © European Union Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 4 of 10 An agency of the European Union  European Union Aviation Safety Agency Opinion No 07/2019 2. In summary — why and what 2. In summary — why and what 2.1. Why we need to change the rules — issue/rationale 2.1.1. Instructions for continued airworthiness (ICA) (RMT.0252 (MDM.056)) ICA have to be produced by design approval holders (DAHs) as part of the product/part certification which, if properly implemented, should ensure that the product/part remains airworthy during its intended life. Experience has shown that there is too much room for interpretation in the current rules and standards, leading to differences and possible safety risks. It appears that different type certificate (TC) holders have different interpretations of what is a complete set of ICA and to what level they are required to control the data that constitutes the ICA. The consequence is that maintenance organisations may not have all the necessary data to perform the maintenance in the correct way, which can lead to the use of unapproved methods. The aim of this proposal is to clarify the status of the ICA in order to improve the continuing airworthiness of all aircraft that are within the scope of the Basic Regulation and, therefore, to improve safety. 2.1.2. Installation of parts and appliances that are released without an EASA Form 1 or equivalent (RMT.0018) To guarantee that new parts to be used during aircraft (or component) maintenance conform to the intended design (including the related manufacturing requirements), the current airworthiness rules stipulate that these parts need to be produced in accordance with the approved design data by following certain requirements (‘Production without production organisation approval’) or by being produced by an approved organisation (‘Production organisation approval’), and need to be released with an EASA Form 1. However, requiring an EASA Form 1 for all aircraft parts (e.g. parts not designed exclusively for aviation) might be too onerous and unnecessary13. 2.2. What we want to achieve — objectives The overall objectives of the EASA system are defined in Article 1 of the Basic Regulation. This proposal will contribute to the achievement of the overall objectives by addressing the issues outlined in Section 2.1. 2.2.1. Instructions for continued airworthiness (ICA) (RMT.0252 (MDM.056)) The specific objective of this proposal is to establish clear requirements and responsibilities for all applicants that have to comply with Part 21, and that are involved in the production of ICA, their approval and their implementation. 13 Current rules already permit certain alleviations to this concept for European light aircraft (ELA) ELA1, ELA2, and gliders. TE.RPRO.00036-009 © European Union Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 5 of 10 An agency of the European Union  European Union Aviation Safety Agency Opinion No 07/2019 2. In summary — why and what 2.2.2. Installation of parts and appliances that are released without an EASA Form 1 or equivalent (RMT.0018) The specific objective of this proposal is to provide industry with flexibility for the acceptance of parts and appliances with different production background for installation during maintenance, without decreasing the level of safety. 2.3. How we want to achieve it — overview of the proposals 2.3.1. Instructions for continued airworthiness (ICA) (RMT.0252 (MDM.056)) It is proposed to include a definition of ‘ICA’ and to establish ICA as part of the TC (amended point 21.A.41) in order to strengthen the control of the ICA by the DAH, including the amendments of ICA (new point 21.A.90(c)). The definition was agreed with the FAA and the TCCA. Furthermore, it is proposed to consolidate the ICA requirements in one single point (new point 21.A.7). In addition, in the current Part 21 there is a duplication also of the requirements for manuals and record keeping for each category of certificates or approvals. It is, therefore, proposed to create also for those requirements a single requirement for each of these aspects (new points 21.A.5 and 21.A.6). As current point M.401 only considers ICA as applicable maintenance data, it is proposed to amend point M.401(b) to clarify which maintenance data is applicable, including the component maintenance manuals (CMM) which are not ICA: most of these documents are used by the maintenance industry and this proposal clarifies that they must be acceptable to the DAH. 2.3.2. Installation of parts and appliances that are released without an EASA Form 1 or equivalent (RMT.0018) The proposal will allow that certain parts that are used during aircraft/component maintenance are manufactured by organisations not holding a POA, or by organisations not working under Part 21 Subpart F provisions. These parts, consequently, will not be accompanied with an EASA Form 1. In practice, this proposal will allow the DAH (for instance, TC holder) to identify in the ICA parts with a negligible safety effect on the aircraft whenever the installed part does not conform to its approved design. In this respect, the DAH can specify in the ICA certain verification activities that the installer of the part will have to conduct. The proposal will also allow that, in the case of point 21.A.90B ‘Standard changes’ or point 21.A.431B ‘Standard repairs’, parts whose potential non-conformance would have a negligible safety effect can be installed on an aircraft without an EASA Form 1, when they are identified as such in the Certification Specifications for Standard Changes and Standard Repairs (CS-STAN). The possibility provided in the related NPA that EASA would establish alleviation from the obligation that parts would need to be accompanied with an EASA Form 1 in particular cases has not been retained based on the comments to the NPA as well as RG and internal discussions. The proposal, contrary to the proposal of the NPA, permits that the parts that, as per the ICA or CS-STAN, are not required to be issued with as EASA Form 1 when manufactured, are also not required to be issued with an EASA Form 1 after the part undergoes maintenance. This possibility is now considered in the Opinion since the parts affected by this Opinion are only those with a negligible safety effect on the aircraft. TE.RPRO.00036-009 © European Union Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 6 of 10 An agency of the European Union  European Union Aviation Safety Agency Opinion No 07/2019 2. In summary — why and what Commission Regulation (EU) No 965/201214 (the Air Operations Regulation), in point CAT.IDE.A.100 ‘Instruments and equipment — general’ of Annex IV (Part-CAT), alleviates the need for an airworthiness certificate for certain equipment on board an aircraft. With the proposal of this Opinion, these parts and appliances are explicitly identified in Part 21 as not requiring an EASA Form 1. 2.4. What are the stakeholders’ views — outcome of the consultation 2.4.1. Instructions for continued airworthiness (ICA) (RMT.0252 (MDM.056)) 502 comments were received during the consultation of NPA 2018-01. The more relevant comments are summarised as follows: — The NPA is missing the necessary period to implement the control of changes to the ICA in accordance with Subpart D of Part 21. — The NPA proposes to merge all the requirements for the ICA, manuals and record keeping: the specificities, like for repair design, should not be missed with the grouping. — The NPA is missing the impact that the proposed amendments will have on Part-M. — Several commentators are concerned with the strengthening of the control of changes to the ICA under the DAH, considering that it will limit their ability to amend the ICA. — The NPA proposes to introduce a statement indicating that a document is part of the ICA which could be challenging for documents referred to by several ICA. — The NPA proposes to add the ICA to the TC, which creates disharmonisation with the FAA. The comments received on the NPA have been duly considered by EASA in the preparation of this Opinion. In consideration of these comments, a delayed applicability of 1 year has been added to the draft cover regulation, the delay for repair design ICA has been added to point 21.A.7(b), point M.A.401(b) has been amended, and the proposed amendment of point 21.A.265(h) has been removed. In view of the comments received on the potential disharmonisation with the FAA, EASA considers that the addition of the ICA to the TC will improve the control of the ICA in the European system and should not impact the validation of products between EASA and the FAA. For a detailed list of the comments received and a summary of the comments and responses to them, see CRD 2018-0115. 2.4.2. Installation of parts and appliances that are released without an EASA Form 1 or equivalent (RMT.0018) 465 comments were received during the consultation of NPA 2017-19. The more relevant comments are be summarised as follows: — The NPA-proposed classification of the parts into four categories is too complex and will be difficult for stakeholders to use. 14 Commission Regulation (EU) No 965/2012 of 5 October 2012 laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 296, 25.10.2012, p. 1) (https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1575282835595&uri=CELEX:32012R0965). 15 https://www.easa.europa.eu/document-library/comment-response-documents TE.RPRO.00036-009 © European Union Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 7 of 10 An agency of the European Union  European Union Aviation Safety Agency Opinion No 07/2019 2. In summary — why and what — In the proposal of the NPA, except for the cases where parts still require an EASA Form 1, it cannot be assumed that a relationship exists between the design and production organisations if the latter are not subject to aviation rules. The same applies for the existing reporting obligations to aviation authorities. — The NPA relied only on industry standards for the control of production processes. This does not guarantee enforcement action by an aviation authority in case of manufacturing flaws. — The NPA did not relax the requirements for the maintenance of parts. An approved maintenance organisation should not be required to perform the maintenance of parts that did not require an EASA Form 1 for their production. — The NPA proposed that design approval holders (DAH) could publish a list with the classification of the parts. Some commentators requested that DAHs should be required by law to publish the classification of the parts. — Commentators requested that the new system should not be rejected by foreign authorities, so potential future amendments to bilateral agreements could recognise the parts produced under the new system. The comments received on the NPA have been duly considered by EASA in the preparation of this Opinion. In this respect, EASA abandons the classification of the parts that was proposed in the NPA and which stakeholders considered it to be complex and difficult to implement. Instead, EASA proposes with this Opinion a criterion that can be used to determine parts with a negligible safety effect on the aircraft operation and for which, consequently, less stringent requirements for the production and maintenance need to be imposed by the corresponding rules. For a detailed list of the comments received and a summary of the comments and responses to them, see CRD 2017-1916. 2.5. What are the expected benefits and drawbacks of the proposals 2.5.1. Instructions for continued airworthiness (ICA) (RMT.0252 (MDM.056)) This proposal reinforces the status of the ICA, making them part of the TC. The clearer identification of the ICA by the DAH will improve their availability to end users. Being part of the TC, the amendments to the ICA will have to be dealt with in accordance with Part 21 Subpart D, strengthening their control by the DAH. Furthermore, the revised applicable maintenance data in Part-M will be clarified for the end users. The main drawbacks of this proposal are the need for manufacturers to update the development processes of some ICA; in addition, this proposal will potentially create disharmonisation with the FAA, which does not consider the ICA as part of the TC. 2.5.2. Installation of parts and appliances that are released without an EASA Form 1 or equivalent (RMT.0018) The proposal will achieve the establishment of balanced requirements that are proportionate to the safety effects of the parts on the operation of the aircraft. Persons and organisations conducting 16 https://www.easa.europa.eu/document-library/comment-response-documents TE.RPRO.00036-009 © European Union Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 8 of 10 An agency of the European Union  European Union Aviation Safety Agency Opinion No 07/2019 2. In summary — why and what maintenance will benefit from a less stringent system that eliminates the systematic need for an EASA Form 1 or equivalent for the acceptance of all parts to be installed on aircraft during maintenance, while permitting the DAH to retain the application of the criterion that discriminates which parts need to be manufactured under the requirements of Subparts F or G of Annex I (Part 21) to Commission Regulation (EU) No 748/2012 or that can be manufactured beyond these requirements. 2.6. How we monitor and evaluate the rules 2.6.1. Instructions for continued airworthiness (ICA) (RMT.0252 (MDM.056)) EASA continuously monitors the implementation of Part 21 through feedback from stakeholders and via its Advisory Bodies. Various tools will be used to further monitor the present proposal, e.g. surveys to collect data on the level of consistency and coherence of the ICA requirements. In addition, Part 21 will be subject to an evaluation, which is already planned in EASA’s European Plan for Aviation Safety (EPAS). The evaluation should assess the production of ICA by DAHs if the above- mentioned monitoring results show a need to do so. 2.6.2. Installation of parts and appliances that are released without an EASA Form 1 or equivalent (RMT.0018) The implementation of the proposed amendments to Commission Regulation (EU) No 748/2012 and Commission Regulation (EU) No 1321/2014, aiming to alleviate the requirement for an EASA Form 1 for certain parts to be used during maintenance, will be monitored and evaluated through the continued exchange of information between EASA and the Member States during EASA Advisory Body meetings as well as during standardisation inspections and assessing feedback from industry stakeholders. Based on the monitoring results, EASA may undertake an evaluation of the impact of the adopted rules. This evaluation shall assess the impact of the amendments versus the expected consequences, and shall conclude on the overall relevance, effectiveness and efficiency of the rules. In addition to the expected gains in efficiency for the overall aviation system thanks to the proposed amendments, EASA will be alert in case a part that did not require an EASA Form 1 contributes to an increase in the number of reported events in a fleet. Cologne, 17 December 2019 Patrick KY Executive Director TE.RPRO.00036-009 © European Union Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 9 of 10 An agency of the European Union  European Union Aviation Safety Agency Opinion No 07/2019 3. References 3. References 3.1. Affected regulations — 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) — Commission Regulation (EU) No 1321/2014 of 26 November 2014 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks (OJ L 362, 17.12.2014, p. 1) 3.2. Related decisions — ED Decision N° 2012/020/R of the Executive Director of the Agency of 30 October 2012 on acceptable means of compliance and guidance material 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 (‘AMC and GM to Part 21’) repealing Decision No 2003/01/RM of the Executive Director of the Agency of 17 October 2003 — ED Decision 2015/029/R of 17 December 2015 issuing acceptable means of compliance and guidance material to Part-M, Part-145, Part-66, and Part-147 of Regulation (EU) No 1321/2014 and repealing Decision 2003/19/RM of the Executive Director of the Agency of 28 November 2003 ‘AMC and GM to the Annexes to Regulation (EU) No 1321/2014 — Issue 2’ 3.3. Other reference documents — CRD to NPA 2017-19 ‘Installation of parts and appliances that are released without an EASA Form 1 or equivalent’ (RMT.0018) — CRD to NPA 2018-01 ‘Instructions for continued airworthiness’ (RMT.0252 (MDM.056)) TE.RPRO.00036-009 © European Union Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 10 of 10 An agency of the European Union