(40)

Subpart B of Section B is replaced by the following: ‘SUBPART B — TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES 21.B.70 Certification specifications The Agency, in accordance with Article 76(3) of Regulation (EU) 2018/1139, shall issue certification specifications and other detailed specifications, including certification specifications for airworthiness, operational suitability data and environmental protection, that competent authorities, organisations and personnel may use to demonstrate compliance of products, parts and appliances with the relevant essential requirements set out in Annexes II, IV and V to that Regulation, as well as with those for environmental protection set out in Article 9(2) and Annex III of that Regulation. Such specifications shall be sufficiently detailed and specific to indicate to applicants the conditions under which certificates are to be issued, amended or supplemented. 21.B.75 Special conditions (a) The Agency shall prescribe special detailed technical specifications, named ‘special conditions, for a product if the related certification specifications do not contain adequate or appropriate safety standards for the product because: 1. the product has novel or unusual design features relative to the design practices on which the applicable certification specifications are based; 2. the intended use of the product is unconventional; or 3. experience from other similar products in service or products having similar design features or newly identified hazards have shown that unsafe conditions may develop. (b) Special conditions contain such safety standards as the Agency finds necessary in order to establish a level of safety equivalent to that of the applicable certification specifications. 21.B.80 Type-certification basis for a type-certificate or restricted type-certificate The Agency shall establish the type certification basis and notify it to the applicant for a type-certificate or restricted type-certificate. The type certification basis shall consist of: (a) the certification specifications for airworthiness designated by the Agency from those applicable to the product at the date of application for that certificate, unless: 1. the applicant chooses to comply, or is required to comply in accordance with point 21.A.15(f), with certification specifications which became applicable after the date of the application; If an applicant chooses to comply with a certification specification which became applicable after the date of the application, the Agency shall include in the type-certification basis any other certification specification that is directly related; or 2. the Agency accepts any alternative to a designated certification specification that cannot be complied with, for which compensating factors have been found that provide an equivalent level of safety; or 3. the Agency accepts or prescribes other means that: (i) in the case of a type-certificate, demonstrate compliance with the essential requirements of Annex II to Regulation (EU) 2018/1139; or (ii) in the case of a restricted type-certificate, provide a level of safety adequate with regard to the intended use; and (b) any special condition prescribed by the Agency in accordance with point 21.B.75(a). 21.B.82 Operational suitability data certification basis for an aircraft type-certificate or restricted type-certificate The Agency shall establish the operational suitability data certification basis and notify it to the applicant for an aircraft type-certificate or restricted type-certificate. The operational suitability data certification basis shall consist of: (a) the certification specifications for operational suitability data designated by the Agency out of those applicable to the aircraft at the date of the application or at the date of the application supplement for operational suitability data, whichever date is later, unless: 1. the applicant chooses to comply, or in accordance with point 21.A.15(f) is required to comply with certification specifications which became applicable after the date of the application; If an applicant chooses to comply with a certification specification which became applicable after the date of the application, the Agency shall include in the type-certification basis any other certification specification that is directly related; or 2. the Agency accepts or prescribes alternative means to demonstrate compliance with the relevant essential requirements of Annexes II, IV and V to Regulation (EU) 2018/1139. (b) any special condition prescribed by the Agency in accordance with point 21.B.75(a). 21.B.85 Designation of applicable environmental protection requirements and certification specifications for a type-certificate or restricted type-certificate (a) The Agency shall designate and notify to the applicant for a type-certificate or restricted type-certificate for an aircraft, for a supplemental type-certificate or for a major change to a type-certificate or to a supplemental type-certificate, the applicable noise requirements established in Annex 16 to the Chicago Convention, Volume I, Part II, Chapter 1 and: 1. for subsonic jet aeroplanes, in Chapters 2, 3, 4 and 14; 2. for propeller-driven aeroplanes in Chapters 3, 4, 5, 6, 10, and 14; 3. for helicopters, in Chapters 8 and 11; 4. for supersonic aeroplanes, in Chapter 12; and 5. for tilt rotors, in Chapter 13. (b) The Agency shall designate and notify to the applicant referred to in point (a) the applicable emission requirements for preventions of intentional fuel venting for aircraft established in Annex 16 to the Chicago Convention, Volume II, Part II, Chapter 1 and 2. (c) The Agency shall designate and notify to the applicant referred to in point (a) the applicable smoke, gaseous and particulate matter engine emission requirements established in Annex 16 to the Chicago Convention, Volume II, Part III, Chapter 1 and 1. for smoke and gaseous emissions of turbojet and turbofan engines intended for propulsion only at subsonic speeds, in Chapter 2; 2. for smoke and gaseous emissions of turbojet and turbofan engines intended for propulsion at supersonic speeds, in Chapter 3;and 3. for particulate matter emissions of turbojet and turbofan engines intended for propulsion only at subsonic speeds, in Chapter 4. (d) The Agency shall designate and notify to the applicant referred to in point (a) the applicable aeroplane CO2 emission requirements established in Annex 16 to the Chicago Convention, Volume III, Part II, Chapter 1 and 1. for subsonic jet aeroplanes, in Chapter 2; and 2. for subsonic propeller-driven aeroplanes, in Chapter 2. 21.B.100 Level of involvement (a) The Agency shall determine its involvement in the verification of the compliance demonstration activities and data related to the application for a type-certificate, restricted type-certificate, major change approval, supplemental type certificate, major repair design approval or ETSO authorisation for APU. It shall do so on the basis of an assessment of meaningful groups of compliance demonstration activities and data of the certification programme. That assessment shall address: — the likelihood of an unidentified non-compliance with the type-certification basis, operational suitability data certification basis or environmental protection requirements; and — the potential impact of that non-compliance on product safety or environmental protection, and consider at least the following elements: 1. novel or unusual features of the certification project, including operational, organisational and knowledge management aspects; 2. complexity of the design and/or demonstration of compliance; 3. criticality of the design or technology and the related safety and environmental risks, including those identified on similar designs; and 4. performance and experience of the design organisation of the applicant in the domain concerned. (b) For the approval of a minor repair design, minor change or ETSO authorisation other than for APU, the Agency shall determine its involvement at the level of the entire certification project, taking into account any novel or unusual features, complexity of the design and/or demonstration of compliance, criticality of the design or technology, as well as the performance and experience of the applicant's design organisation. (c) The Agency shall notify its level of involvement to the applicant and it shall update its level of involvement when this is warranted by information which has an appreciable impact on the risk previously assessed pursuant to point (a) or (b). The Agency shall notify the applicant about the change in the level of involvement. 21.B.103 Issuance of a type-certificate or restricted type-certificate (a) The Agency shall issue an aircraft, engine or propeller type-certificate or an aircraft restricted type-certificate, provided that: 1. the applicant has complied with point 21.A.21; 2. the Agency, through verifications of the demonstration of compliance in accordance with its involvement determined pursuant to point 21.B.100, has not found any non-compliance with the type-certification basis, the operational suitability data certification basis where applicable in accordance with point 21.B.82, and the environmental protection requirements; and 3. no feature or characteristic has been identified that may make the product unsafe for the uses for which the certification is requested. (b) By derogation from point (a), at the applicant's request included in the declaration referred to in point 21.A.20(d), the Agency may issue an aircraft type-certificate before compliance with the operational suitability data certification basis has been demonstrated, provided that the applicant demonstrates such compliance before the date at which those data are to be actually used.’