21.B.105  Type-certification basis, environmental protection requirements and operational suitability data certification basis for a major change to a type-certificate

Regulation (EU) 2019/897

The Agency shall establish the applicable type-certification basis, the environmental protection requirements, and in the case of a change affecting the operational suitability data, the operational suitability data certification basis established in accordance with point 21.A.101 and notify them to the applicant for a major change to a type certificate.

21.B.107 Issuance of an approval of a change to a type-certificate

Regulation (EU) 2022/201

(a) The Agency shall issue an approval of a change to a type-certificate provided that:

1. the applicant for an approval has complied with:

(i)  point 21.A.95 for a minor change; or

(ii)  point 21.A.97 for a major change;

2. the Agency, through its verification of the demonstration of compliance in accordance with the level of its involvement determined pursuant to point (a) or (b) of point 21.B.100 has not found any non-compliance with the type-certification basis, operational suitability data certification basis where applicable in accordance with point 21.B.82, and environmental protection requirements; and

3. no feature or characteristic has been identified that may make the product unsafe for the uses for which certification is requested.

(b) In the case of a change affecting the operational suitability data, by derogation from points (1) and (2) of point (a), at the applicant's request included in the declaration referred to in point 21.A.20(d), the Agency may approve a change to 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.

(c) The approval of the changes to the operational suitability data shall be included in the approval of the change to the type-certificate.

(d) The approval of a change to a type-certificate shall be limited to the specific configuration(s) in the type-certificate to which the change relates.

GM 21.B.107 and 21.B.111  Operational suitability data (OSD) considerations for the approval of changes to type certificates (TCs) or supplemental type certificates (STCs)

ED Decision 2019/018/R

The requirement for EASA in points 21.B.107(c) or 21.B.111(c) are applicable to necessary changes to the OSD as foreseen by 21.A.95(b) Section 2 for minor changes, 21.A.97(b) Section 2 for major changes, and 21.A.115(b) Section 3 for STCs. By analogy, these requirements should also be considered by design organisation approval (DOA) holders that approve changes or issue supplemental type certificates (STCs) under their privileges (without EASA’s involvement), as stated in the GM to A.21.A.90A.

Changes to TCs can comprise several interrelated changes to the TC. For example, a change to the cockpit design may trigger a necessary change to the flight crew data, which is part of the OSD, and is, therefore, included in the TC.

Interrelated changes (e.g. type design changes and necessary changes to the MMEL and/or flight crew data) should be approved together under a single approval.

GM 21.A.21(b), 21.A.95(c), 21.A.97(c), 21.A.115(c), 21.B.103(b), 21.B.107(b) and 21.B.111(b) Approval of operational suitability data (OSD)

ED Decision 2019/018/R

It is acknowledged that it may not always be possible to have the OSD available on the date of the issue of the (restricted) type certificate ((R)TC), change approval or supplemental type certificate (STC). The derogation provided by 21.A.21(b), 21.A.95(c), 21.A.97(c), 21.A.115(c), 21.B.103(b), 21.B.107(b) and 21.B.111(b) is intended for that case. The (R)TC, change approval or STC can be issued before compliance with the OSD certification basis has been demonstrated.

However, the OSD needs to be approved before the data is used by a training organisation for the purpose of obtaining a European Union (EU) licence, rating or attestation, or by an EU operator. This is normally done before the entry into service of the first aircraft by an EU operator but it could also be done later for some of the OSD constituents, such as the definition of the scope of validation source data to support the objective qualification of a simulator, which should only be available when a simulator has to be qualified.

The derogation provided in points 21.A.97(c), 21.A.115(c), 21.B.103(b), 21.B.107(b), and 21.B.111(b) is applicable to all major changes to a TC, so it is also applicable to minor design changes when triggering a major master minimum equipment list (MMEL) change, as well as to changes in which at least one of the OSD constituent changes is major.