21.A.101 Type-certification basis, operational suitability data certification basis and environmental protection requirements for a major change to a type-certificate

• Regulation (EU) 2022/201 found in: Initial Airworthiness and Environmental Protection (748/2012) Part-21 Part-21L (Jul 2024)
• Regulation (EU) 2024/1108 found in: Initial Airworthiness and Environmental Protection (748/2012) (Nov 2025)

21.A.101 Type-certification basis, operational suitability data certification basis and environmental protection requirements for a major change to a type-certificate Regulation (EU) 2022/201 (a)     A major change to a type-certificate and areas affected by the change shall comply with either the certification specifications applicable to the changed product on the date of the application for the change or certification specifications which became applicable after that date in accordance with point (f) below. The validity of the application shall be determined in accordance with point [21.A.93](#_DxCrossRefBm1649096851)(c). In addition, the changed product shall comply with the environmental protection requirements designated by the Agency in accordance with point [21.B.85](#_DxCrossRefBm1649096971). (b)     Except as provided in point (h), by derogation from point (a), an earlier amendment to a certification specification referred to in point (a) and to any other certification specification which is directly related may be used in any of the following situations, unless the earlier amendment became applicable before the date at which the corresponding certification specifications incorporated by reference in the type-certificate became applicable: 1.       a change that the Agency finds not to be significant. In determining whether a specific change is significant, the Agency shall consider the change in the context of all previous relevant design changes and all related revisions to the applicable certification specifications incorporated by reference in the type-certificate for the product. Changes meeting one of the following criteria shall automatically be considered significant: (i)      the general configuration or the principles of construction are not retained; (ii)     the assumptions used for certification of the product to be changed do not remain valid; 2.       each area, system, part or appliance that the Agency finds not affected by the change; 3.       each area, system, part or appliance that is affected by the change for which the Agency finds that compliance with the certification specifications referred to in point (a) does not contribute materially to the level of safety of the changed product or is impractical. (c)      By derogation from point (a), in the case of a change to an aircraft other than a rotorcraft of 2 722 kg (6 000 lb) or less maximum weight, or to a non-turbine rotorcraft of 1 361 kg (3 000 lb) or less maximum weight, the change and areas affected by the change shall comply with the type-certification basis incorporated by reference in the type-certificate. However, if the Agency finds that the change is significant in an area, the Agency may require that the change and areas affected by the change comply with an amendment to a certification specification of the type-certification basis incorporated by reference in the type-certificate and with any other certification specification which is directly related, unless the Agency also finds that compliance with that amendment does not contribute materially to the level of safety of the changed product or is impractical. (d)     If the Agency finds that the certification specifications applicable on the date of the application for the change do not provide adequate standards with respect to the proposed change, the change and areas affected by the change shall also comply with any special conditions, and amendments to those special conditions, prescribed by the Agency in accordance with point [21.B.75](#_DxCrossRefBm1649097063), to provide a level of safety equivalent to that established by the certification specifications applicable on the date of the application for the change. (e)     By derogation from points (a), (b) and (c), the change and areas affected by the change may comply with an alternative to a certification specification designated by the Agency if proposed by the applicant, provided that the Agency finds that the alternative provides a level of safety which is: 1.       in the case of a type-certificate: (i)      equivalent to that of the certification specifications designated by the Agency under (a), (b) or (c) above; or (ii)     compliant with the essential requirements of Annex II to [Regulation (EU) 2018/1139](https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX:32018R1139#:~:text=Regulation%20%28EU%29%202018%2F1139%20of%20the%20European%20Parliament%20and,No%20376%2F2014%20and%20Directives%202014%2F30%2FEU%20and%202014%2F53%2FEU%20); 2.       in the case of a restricted type-certificate, adequate with regard to the intended use. (f)      If an applicant chooses to comply with a certification specification set out in an amendment that becomes applicable after submitting the application for a change to a type-certificate, the change and areas affected by the change shall also comply with any other certification specification which is directly related. (g)     When the application for a change to a type-certificate for an aircraft includes, or is supplemented after the initial application to include, changes to the operational suitability data, the operational suitability data certification basis shall be established in accordance with points (a)‑(f). (h)     For large aeroplanes subject to point 26.300 of Annex I to [Commission Regulation (EU) 2015/640](https://eur-lex.europa.eu/eli/reg/2015/640#:~:text=COMMISSION%20REGULATION%20%28EU%29%202015%2F640%20of%2023%20April%202015,of%20operations%20and%20amending%20Regulation%20%28EU%29%20No%20965%2F2012)[[23]](#_ftn23), 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](https://eur-lex.europa.eu/eli/reg/2015/640#:~:text=COMMISSION%20REGULATION%20%28EU%29%202015%2F640%20of%2023%20April%202015,of%20operations%20and%20amending%20Regulation%20%28EU%29%20No%20965%2F2012), except for applicants for supplemental type-certificates who are not required to take into account point 26.303. --- [[23]](#_ftnref23) 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). #### 21.A.101 Type-certification basis, operational suitability data certification basis and environmental protection requirements for a major change to a type-certificate *Regulation (EU) 2024/1108* (a) A major change to a type-certificate and the areas affected by the change shall comply with either the certification specifications applicable to the changed product, UAS or CMU on the date of the application for the change or the certification specifications which became applicable after that date in accordance with point (f). The validity of the application shall be determined in accordance with point [21.A.93](#_DxCrossRefBm485230341)(c). In addition, the changed product or the changed UAS shall comply with the environmental protection requirements designated by the Agency in accordance with point [21.B.85](#_DxCrossRefBm485230462). (b) Except as provided for in point (h), by way of derogation from point (a), an earlier amendment to a certification specification referred to in point (a) and to any other certification specification which is directly related may be used in any of the following situations, unless the earlier amendment became applicable before the date on which the corresponding certification specifications incorporated by reference in the type-certificate became applicable: 1. a change that the Agency does not find to be significant; in determining whether a specific change is significant, the Agency shall consider the change in the context of all previous relevant design changes and all related revisions to the applicable certification specifications incorporated by reference in the type‑certificate for the product or the CMU; changes that meet one of the following criteria shall automatically be considered significant: (i) the general configuration or the principles of construction are not retained; (ii) the assumptions used for the certification of the product, the UAS or the CMU to be changed do not remain valid; 2. each area, system, part, appliance or CMU component that the Agency finds not to be affected by the change; 3. each area, system, part, appliance or CMU component that is affected by the change for which the Agency finds that compliance with the certification specifications referred to in point (a) does not contribute materially to the level of safety of the changed product, changed UAS or changed CMU, or is impractical. (c) By derogation from point (a), in the case of a change to an aircraft other than a rotorcraft of 2 722 kg (6 000 lb) or less maximum weight, or to a non-turbine rotorcraft of 1 361 kg (3 000 lb) or less maximum weight, the change and areas affected by the change shall comply with the type-certification basis incorporated by reference in the type-certificate. However, if the Agency finds that the change is significant in an area, the Agency may require that the change and areas affected by the change comply with an amendment to a certification specification of the type-certification basis incorporated by reference in the type-certificate and with any other certification specification which is directly related, unless the Agency also finds that compliance with that amendment does not contribute materially to the level of safety of the changed product or is impractical. (d) If the Agency finds that the certification specifications applicable on the date of the application for the change do not provide adequate standards with respect to the proposed change, the change and areas affected by the change shall also comply with any special conditions, and amendments to those special conditions, prescribed by the Agency in accordance with point [21.B.75](#_DxCrossRefBm485230554), to provide a level of safety equivalent to that established by the certification specifications applicable on the date of the application for the change. (e) By derogation from points (a), (b) and (c), the change and areas affected by the change may comply with an alternative to a certification specification designated by the Agency if proposed by the applicant, provided that the Agency finds that the alternative provides a level of safety which is: 1. in the case of a type-certificate: (i) equivalent to that of the certification specifications designated by the Agency under (a), (b) or (c) above; or (ii) compliant with the essential requirements of Annex II to [Regulation (EU) 2018/1139](https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX:32018R1139#:~:text=Regulation%20%28EU%29%202018%2F1139%20of%20the%20European%20Parliament%20and,No%20376%2F2014%20and%20Directives%202014%2F30%2FEU%20and%202014%2F53%2FEU%20); 2. in the case of a restricted type-certificate, adequate with regard to the intended use. (f) If an applicant chooses to comply with a certification specification set out in an amendment that becomes applicable after submitting the application for a change to a type-certificate, the change and areas affected by the change shall also comply with any other certification specification which is directly related. (g) When the application for a change to a type-certificate for an aircraft includes, or is supplemented after the initial application to include, changes to the operational suitability data, the operational suitability data certification basis shall be established in accordance with points (a)‑(f). (h) For large aeroplanes subject to point 26.300 of Annex I to [Commission Regulation (EU) 2015/640](https://eur-lex.europa.eu/eli/reg/2015/640#:~:text=COMMISSION%20REGULATION%20%28EU%29%202015%2F640%20of%2023%20April%202015,of%20operations%20and%20amending%20Regulation%20%28EU%29%20No%20965%2F2012)[[24]](#_ftn24), 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](https://eur-lex.europa.eu/eli/reg/2015/640#:~:text=COMMISSION%20REGULATION%20%28EU%29%202015%2F640%20of%2023%20April%202015,of%20operations%20and%20amending%20Regulation%20%28EU%29%20No%20965%2F2012), except for applicants for supplemental type-certificates who are not required to take into account point 26.303. --- [[24]](#_ftnref24) 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).