21L.B.41 Certification specifications
Regulation (EU) 2022/1358
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, and environmental compatibility that competent authorities, organisations and personnel may use to demonstrate the compliance of products and parts 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) of and Annex III to 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.
21L.B.42 Initial investigation
Regulation (EU) 2022/1358
(a) Upon receiving an application for a type certificate under this Annex, the Agency shall verify whether the product is within the scope established in point 21L.A.21 and whether the applicant is eligible in accordance with point 21L.A.22 to apply for a type certificate for the product.
(b) When the conditions of point (a) are not fulfilled, the Agency shall reject the application.
21L.B.43 Type-certification basis for a type certificate
Regulation (EU) 2022/1358
(a) The Agency shall establish the type-certification basis and notify it to the applicant. The type‑certification basis shall consist of:
1. the certification specifications for airworthiness designated by the Agency from those applicable to the product at the date of application for that certificate, unless:
(i) the applicant chooses 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
(ii) 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
(iii) the Agency accepts or prescribes other means that demonstrate compliance with the essential requirements of Annex II to Regulation (EU) 2018/1139;
2. any special condition prescribed by the Agency in accordance with point 21L.B.44(a).
(b) The Agency may amend the type-certification basis at any point before the issuance of the type certificate if it has determined that experience from other similar products in service, or products that have similar design features, has shown that unsafe conditions may develop, and the type-certification basis that was established and notified to the applicant does not address this unsafe condition.
GM1 21L.B.43(a) Type-certification basis for a type certificate
ED Decision 2023/013/R
1. INTRODUCTION
This GM addresses the type-certification basis for a type certificate (TC).
2. APPLICABLE CERTIFICATION SPECIFICATIONS (CSs)
The type-certification basis for a TC consists of the airworthiness CSs that were effective on the date of application and were applicable for the particular certificate.
3. ELECT TO COMPLY (see point 21L.B.43(a)(1)(i))
It is also possible for an applicant to elect to comply with a CS that became applicable after the date on which the applicant has submitted the application.
The Agency should assess whether the proposed certification basis is appropriate to ensure that the ‘elect to comply’ proposal includes any other CSs that are ‘directly related’ to one or several of the CSs in it. Directly related CSs are those that are deemed to contribute to the same safety objective by building on each other’s requirements, addressing complementary aspects of the same safety concern, etc. Typically, they are adopted simultaneously with, or prior to, the CSs with which the applicant has elected to comply.
4. EQUIVALENT LEVEL OF SAFETY (see point 21L.B.43(a)(1)(ii))
In cases in which the applicable CSs cannot be literally complied with, either fully or in part, EASA may accept a suitable alternative which provides an equivalent level of safety through the use of appropriate compensating factors.
In cases in which the requirements contain not only objectives but also prescriptive parts, an equivalent level of safety may be accepted if:
— the objectives are met by designs or features other than those required in the CSs; or
— suitable compensating factors are proposed.
5. ALTERNATIVE MEANS OF COMPLIANCE (see point 21L.B.43(a)(1)(iii))
If the intent of the CSs defined in point 21L.B.43(a)(1) cannot be met, EASA may accept mitigating factors to the CSs, provided that the safety objective is met.
In the case of a TC, the alternative means should provide a demonstration of compliance with the essential requirements for airworthiness laid down in Annex II to Regulation (EU) 2018/1139.
Note: ‘Alternative means of compliance’ should not be confused with ‘AMC’.
6. SPECIAL CONDITIONS (see point 21L.B.43(a)(2))
The Agency may also prescribe special conditions in accordance with point 21L.B.44. Guidance on special conditions is provided in GM1 21L.B.44.
Regulation (EU) 2022/1358
(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.
GM1 21L.B.44 Special conditions
ED Decision 2023/013/R
GENERAL
The term ‘novel or unusual design features’ should be judged in view of the applicable certification basis for a particular product. A design feature, in particular, should be judged to be a ‘novel or unusual design feature’ when the certification basis does not sufficiently cover it.
The term ‘unsafe condition’ is used with the same meaning as described in AMC1 21L.B.23(b) ‘Airworthiness directives’.
The term ‘newly identified hazards’ is intended to address new risks that may be recognised in the design (e.g. questionable features) or its operational characteristics (e.g. volcanic ash) for which there is not yet enough in-service experience.
21L.B.45 Designation of the applicable environmental protection requirements for a type certificate
Regulation (EU) 2022/1358
The Agency shall designate and notify to the applicant for a type certificate for an aircraft or for an engine, the applicable environmental requirements in accordance with point 21.B.85 of Annex I (Part 21).
Regulation (EU) 2022/1358
Upon receiving an application for a type certificate under this Annex, the Agency shall:
(a) conduct a review of the initial compliance demonstration plan and any subsequent update provided by the applicant in order to establish the completeness of the plan and the appropriateness of the proposed means and methods of demonstrating compliance with the type-certification basis established in accordance with point 21L.B.43 and with the applicable environmental protection requirements designated in accordance with point 21L.B.45; if the compliance demonstration plan is incomplete or the means and methods are not appropriate to achieve compliance demonstration, the Agency shall inform the applicant and request an amendment of it;
(b) when satisfied that the compliance demonstration plan provided is appropriate so that the applicant can demonstrate compliance, approve the compliance demonstration plan and any subsequent updates of the compliance demonstration plan;
(c) after receiving the declaration of compliance in accordance with point (f) of point 21L.A.25, conduct a physical inspection and assessment of the first article of that product in the final configuration, taking into consideration the critical design review carried out in accordance with point (a) of point 21L.B.242, in order to verify the compliance of the product with the applicable type-certification basis and the applicable environmental protection requirements; the Agency shall verify the compliance of the product, considering the likelihood of an unidentified non-compliance with the type-certification basis or the applicable environmental protection requirements, and the potential impact of that non‑compliance on the safety or environmental compatibility of the product;
(d) if during the establishment of the type-certification basis, designation of the applicable environmental protection requirements or during the review of the compliance demonstration plan the Agency determines that the product design contains any element for which an unidentified non-compliance with the type-certification basis or the applicable environmental protection requirements may have an adverse impact on the safety or environmental compatibility of the product, the Agency shall determine which investigations are necessary in addition to those described in point (c) in order to verify the compliance demonstration; the Agency shall notify the applicant of any additional investigations and which elements of the design would be subject to those investigations.
AMC1 21L.B.46(c) Investigation
ED Decision 2023/013/R
PHYSICAL INSPECTION AND CRITICAL DESIGN REVIEW
Prior to the approval of the flight conditions to support the issuance of a permit to fly, a physical inspection and a critical design review is conducted with the applicant and the competent authority for conformity (production) under point 21L.B.242(a). The experience and outcome of this activity should be used by EASA to determine the scope and particular aspects of the design that should be the focus of the physical inspection and assessment of the first article of that product (first-article inspection) that is conducted under point 21L.B.46(c) prior to the issuance of the type certificate for a particular product.
AMC2 21L.B.46(c) Investigation
ED Decision 2023/013/R
PHYSICAL INSPECTION AND ASSESSMENT OF THE FIRST ARTICLE OF A PRODUCT (FIRST-ARTICLE INSPECTION)
The purposes of the first-article inspection (of the article that is in conformance with the proposed type design for certification) prior to the issuance of the type certificate for a particular aircraft, propeller or engine design are:
a. for EASA to verify the completion of the demonstration-of-compliance activities conducted by the applicant under point 21L.A.25 and in accordance with the approved compliance-demonstration plan;
b. for EASA to verify100The verification of compliance is limited to the scope of the activities that can be conducted under point 2 and the elements of the design that are selected for review based upon a risk-based approach to compliance. with a risk-based approach that the type design complies with the type-certification basis and the applicable environmental protection requirements;
c. in case the applicant is a declared design organisation, for EASA to conduct a further oversight visit in accordance with point 21L.B.183(b) of Subpart J in order to ensure that the applicant is able to discharge its obligations.
The first-article inspection should be conducted by EASA at an appropriate location(s) selected by the applicant for a type certificate. This (these) location(s) should include the physical location of the aircraft, engine or propeller for which the type certificate has been requested and should be in the principal place of business (which in accordance with Article 8(2) of Regulation (EU) No 748/2012 must be in an EU Member State).
The Agency should conduct a physical inspection of the aircraft, engine or propeller for which the type certificate has been requested. This inspection, along any other activity that is considered necessary should ensure that the objectives mentioned in point 1 are met. Evidence to support compliance will be gathered by EASA prior to and during the first-article inspection.
The physical inspection of the aircraft and, if applicable, of the engine and the propeller will provide substantial evidence that the design is in compliance with the type-certification basis and that the applicant (if a declared design organisation) is able to discharge its obligations.
Additional sources of evidence to support the determination of compliance of the design that are available to EASA prior to and during the first-article inspection include:
a. witnessing or participating in live testing (including flight testing) of the aircraft, engine, propeller, systems or components;
b. evaluation of the final compliance-demonstration plan produced by the applicant and how it relates to the final design;
c. evaluation of the completeness of the declaration of compliance submitted by the applicant;
d. evaluation of supporting compliance documentation and test reports;
e. discussions with key design and production personnel;
f. review of design processes and procedures (for non-approved organisations).
If the applicant selects to use flight testing to demonstrate compliance (see MC6 in Appendix A to AMC1 21L.A.24(b)), EASA may decide to conduct flight testing to verify compliance for applications for an aircraft type certificate. An appropriate flight-test plan should be developed and proposed by the applicant prior to the first-article inspection and agreed by EASA in order to ensure that there are no adverse flight characteristics.
Flight testing could be a combination of:
a. a predefined flight-test plan that is not specific to the particular aircraft type;
b. specific flight testing to focus on targeted aspects after a review of the applicant’s flight-testing data/reports.
The above list of additional sources of evidence is not exhaustive.
It is possible that during the first-article inspection EASA may discover evidence that:
a. the design is not in compliance with the type-certification basis or the applicable environmental protection requirements (this could be due to the applicant misinterpreting or misunderstanding the applicable design requirements);
b. the applicant has not fulfilled its design obligations as a declared design organisation;
c. there are shortfalls in the applicant’s design management system (in accordance with point 21.A.239 or 21L.A.174) that result in a non-compliance or a loss of control of the design.
If such evidence is discovered, EASA may require a more in-depth investigation into the compliance documentation and/or the design practices of the design organisation. The purpose of this in-depth investigation should be to determine whether or not compliance was demonstrated, the root cause(s) and to establish corrective actions. This investigation should also serve to prevent a reoccurrence of the issue.
3. Aircraft condition and configuration
The aircraft, engine or propeller presented to EASA should be in the final configuration for which a type certificate has been requested and the compliance demonstration has been declared.
The applicant could arrange visits with EASA prior to the declaration of compliance (in accordance with point 21L.A.25(f)) (for example, for noise testing).
Any differences between the configuration presented to EASA for the first-article inspection and the final configuration in the declaration of compliance (in accordance with point 21L.A.25(f)) should be justified by the applicant and should be subject to detailed scrutiny during the first-article inspection.
4. Availability of supporting documentation and key personnel
The supporting documentation and compliance data should be available at the time EASA visits the applicant’s facilities or at any other time upon request by EASA. Key design personnel will be made available to EASA in case of need. If this is not the case, EASA might not be in a position to issue the type certificate.
5. Findings and resolution
If a non-compliance is discovered by EASA in the process of the activities mentioned in point 2, an appropriate finding or observation should be raised against the aircraft, engine or propeller or declared design organisation in accordance with point 21L.B.21, which may result in the enforcement measures contained in point 21L.B.22. Findings of non-compliance should be resolved before the type certificate is issued. Depending upon their nature, findings against the declared design organisation may need to be resolved before the type certificate is issued.
21L.B.47 Issuance of a type certificate
Regulation (EU) 2022/1358
(a) The Agency shall issue without undue delay an aircraft, engine or propeller type certificate, provided that:
1. the applicant has complied with point 21L.A.27;
2. the Agency, through the investigation carried out pursuant to point 21L.B.46, has not found any non-compliance with the type-certification basis or with the applicable environmental protection requirements;
3. there are no unresolved issues from the investigation carried out pursuant to point (c) of point 21L.B.46 of that product in the final configuration;
4. no feature or characteristic has been identified that may make the product unsafe or environmentally incompatible for the uses for which the certification is requested.
(b) The type certificate shall include:
1. the type design;
2. the operating limitations;
3. the instructions for continued airworthiness;
4. the type certificate data sheet for airworthiness and, if applicable, the record of engine exhaust emissions compliance;
5. the applicable type-certification basis and the applicable environmental protection requirements with which the Agency records compliance;
6. if applicable, the type certificate data sheet for noise; and
7. any other conditions or limitations prescribed for the product in the applicable type‑certification basis and the applicable environmental protection requirements.
21L.B.48 Continuing airworthiness oversight of products for which a type certificate has been issued
Regulation (EU) 2022/1358
If the Agency, through its continuing airworthiness oversight, including through reports received in accordance with point 21L.A.3, or by any other means, detects a non-compliance with the type-certification basis or the applicable environmental protection requirements, the Agency shall raise a finding in accordance with point 21L.B.21, or issue an airworthiness directive under the conditions of point 21L.B.23.
21L.B.49 Transfer of a type certificate
Regulation (EU) 2022/1358
(a) When the Agency receives an application for verification of whether a type certificate can be transferred by its holder in accordance with point 21L.A.29 or when the Agency considers a request to adopt a type certificate in accordance with point 21L.A.29, the Agency shall verify corresponding to points 21L.B.42 and 21L.B.46 whether the transferee is eligible to be a type-certificate holder in accordance with point 21L.A.22 and is able to undertake the obligations of a type-certificate holder under point 21L.A.28.
(b) When the Agency concludes that the conditions referred to in point (a) are met by the transferee, it shall inform the type-certificate holder or the natural or legal person requesting to adopt a type certificate that a transfer of the type certificate to that natural or legal person is accepted by the Agency.