Commission Delegated Regulation (EU) 2019/897 of 12 March 2019 amending Regulation (EU) No 748/2012 as regards the inclusion of risk-based compliance verification in Annex I and the implementation of requirements for environmental protection (Text with EEA relevance.)

COMMISSION DELEGATED REGULATION (EU) 2019/897

of 12 March 2019

amending Regulation (EU) No 748/2012 as regards the inclusion of risk-based compliance verification in Annex I and the implementation of requirements for environmental protection

(Text with EEA relevance)

Article 1

(1)In Article 1(2), the following point (k) is added:

‘(k)“Operational Suitability Data (OSD)” means data, which are part of an aircraft type-certificate, restricted type-certificate or supplemental type-certificate, consisting of all of the following:

(i)the minimum syllabus of pilot type rating training, including determination of type rating;

(ii)the definition of scope of the aircraft validation source data to support the objective qualification of simulators or the provisional data to support their interim qualification;

(iii)the minimum syllabus of maintenance certifying staff type rating training, including determination of type rating;

(iv)determination of type or variant for cabin crew and type specific data for cabin crew;

(v)the master minimum equipment list;’

(2)In Article 9, the following paragraph 4 is added:

‘4.  By way of derogation from paragraph 1, the production organisation may apply to the competent authority for exemptions from the environmental requirements referred to in the first subparagraph of Article 9(2) of Regulation (EU) 2018/1139 (^*1).

(3)Annex I to Regulation (EU) No 748/2012 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 23 March 2020, with the exception of Article 1(2) and point 11, points 13 to 14, points 23 to 26, point 28, point 30, point 21.B.85 in point 40 and point 43 of Annex which shall apply from 23 June 2019.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX

Annex I (Part-21) to Regulation (EU) No 748/2012 is amended as follows:

(1)the table of contents is replaced by the following:

(2)point 21.A.14 is amended as follows:

(a)point (a) is replaced by the following:

‘(a)An applicant for a type-certificate or restricted type-certificate shall demonstrate its capability by holding a design organisation approval, issued by the Agency in accordance with Subpart J.’;

(b)point (c) is replaced by the following:

‘(c)By way of derogation from point (a), an applicant may demonstrate its capability by obtaining the Agency's acceptance of its certification programme established in accordance with point 21.A.15(b), where the product to be certified is:

1.an ELA1 aircraft; or

2.an engine or propeller installed in ELA1 aircraft.’;

(3)point 21.A.15 is amended as follows:

(a)points (b), (c) and (d) are replaced by the following:

‘(b)An application for a type-certificate or restricted type-certificate shall include, as a minimum, preliminary descriptive data of the product, the intended use of the product and the kind of operations for which certification is requested. In addition, it shall include, or be supplemented after the initial application, a certification programme for the demonstration of compliance in accordance with point 21.A.20, consisting of:

1.a detailed description of the type design, including all the configurations to be certified;

2.the proposed operating characteristics and limitations;

3.the intended use of the product and the kind of operations for which certification is requested;

4.a proposal for the initial type-certification basis, operational suitability data certification basis and environmental protection requirements, prepared in accordance with the requirements and options specified in points 21.B.80, 21.B.82 and 21.B.85;

5.a proposal for a breakdown of the certification programme into meaningful groups of compliance demonstration activities and data, including a proposal for the means of compliance and related compliance documents;

6.a proposal for the assessment of the meaningful groups of compliance demonstration activities and data, addressing 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. The proposed assessment shall take into account at least the elements set out in subpoints (1) to (4) of point 21.B.100(a). Based on this assessment, the application shall include a proposal for the Agency's involvement in the verification of the compliance demonstration activities and data; and

7.a project schedule including major milestones.

(c)After its initial submission to the Agency, the certification programme shall be updated by the applicant when there are changes to the certification project affecting any of the points 1 to 7 of point (b).

(d)An application for a type-certificate or restricted type-certificate for an aircraft shall include, or be supplemented after the initial application, an application supplement for approval of the operational suitability data.’;

(b)the following points (e) and (f) are added:

‘(e)An application for a type-certificate or restricted type-certificate for a large aeroplane or a large rotorcraft shall be valid for five years and an application for any other type-certificate or restricted type-certificate shall be valid for three years, unless the applicant demonstrates at the time of application that its product requires a longer time period to demonstrate and declare compliance and the Agency agrees to that longer time period.

(f)In the case where a type-certificate or restricted type-certificate has not been issued, or it is evident that it will not be issued, within the time limit provided for in point (e), the applicant may:

1.submit a new application and comply with the type-certification basis, operational suitability data certification basis and environmental protection requirements, as established and notified by the Agency in accordance with points 21.B.80, 21.B.82 and 21.B.85 for the date of the new application; or

2.apply for an extension of the time period provided for in point (e) and propose a new date for the issuance of the type-certificate or restricted type-certificate. In that case, the applicant shall comply with the type-certification basis, operational suitability data certification basis and environmental protection requirements, as established and notified by the Agency in accordance with points 21.B.80, 21.B.82 and 21.B.85 for a date to be selected by the applicant. However, that date shall not precede the new date proposed by the applicant for the issuance of the type-certificate or restricted type-certificate by more than five years for an application for a type-certificate or restricted type-certificate for a large aeroplane or a large rotorcraft, and by more than three years for an application for any other type-certificate or restricted type certificate.’;

(4)point 21.A.16A is deleted;

(5)point 21.A.16B is deleted;

(6)point 21.A.17A is deleted;

(7)point 21.A.17B is deleted;

(8)point 21.A.18 is deleted;

(9)points 21.A.20 and 21.A.21 are replaced by the following:

‘21.A.20   Demonstration of compliance with the type certification basis, operational suitability data certification basis and environmental protection requirements

(a)Following the acceptance of the certification programme by the Agency, the applicant shall demonstrate compliance with the type certification basis, operational suitability data certification basis and environmental protection requirements, as established and notified to the applicant by the Agency in accordance with points 21.B.80, 21.B.82, 21.B.85, and shall provide the Agency with the means by which such compliance has been demonstrated.

(b)The applicant shall report to the Agency any difficulty or event encountered during the process of demonstration of compliance that may have an appreciable effect on the risk assessment under point 21.A.15(b)(6) or on the certification programme, or may otherwise necessitate a change to the level of involvement of the Agency previously notified to the applicant in accordance with point 21.B.100(c).

(c)The applicant shall record justifications of compliance within the compliance documents as referred to in the certification programme.

(d)After completion of all demonstrations of compliance in accordance with the certification programme, including any inspections and tests in accordance with point 21.A.33, and after all flight tests in accordance with point 21.A.35, the applicant shall declare that:

1.it has demonstrated compliance with the type-certification basis, operational suitability data certification basis and environmental protection requirements, as established and notified by the Agency, following the certification programme as accepted by the Agency; and

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

(e)The applicant shall submit to the Agency the declaration of compliance provided for in point (d). Where the applicant holds an appropriate design organisation approval, the declaration of compliance shall be made in accordance with Subpart J and submitted to the Agency.

21.A.21   Requirements for the issuance of a type certificate or restricted type certificate

(a)In order to be issued a product type certificate or, when the aircraft does not meet the essential requirements of Annex II to Regulation (EU) 2018/1139 an aircraft restricted type certificate, the applicant shall:

1.demonstrate its capability in accordance with point 21.A.14;

2.comply with point 21.A.20;

3.demonstrate that the engine and propeller, if installed in the aircraft:

(A)have a type-certificate issued or determined in accordance with this Regulation; or

(B)have been demonstrated to be in compliance with the aircraft type-certification basis established and the environmental protection requirements designated and notified by the Agency as necessary to ensure the safe flight of the aircraft.

(b)By derogation from point (a)(2), at the applicant's request included in the declaration referred to in point 21.A.20(d), the applicant is entitled to have the aircraft type-certificate or restricted type-certificate issued before the applicant has demonstrated compliance with the operational suitability data certification basis, provided that the applicant demonstrates such compliance before the date at which those data are to be actually used.’;

(10)point 21.A.23 is deleted;

(11)in point 21.A.31(a), point 4 is replaced by the following:

‘4.any other data allowing by comparison the determination of the airworthiness and, if relevant, the environmental characteristics of later products of the same type.’;

(12)point 21.A.33 is replaced by the following:

‘21.A.33   Inspections and tests

(a)(Reserved)

(b)Before each test is undertaken during the demonstration of compliance required by point 21.A.20, the applicant shall have verified:

1.for the test specimen, that:

(i)the materials and processes adequately conform to the specifications for the proposed type design;

(ii)the parts of the products adequately conform to the drawings in the proposed type design; and

(iii)the manufacturing processes, construction and assembly adequately conform to those specified in the proposed type design; and

2.for the test and measuring equipment to be used for the test, that those are adequate for the test and appropriately calibrated.

(c)On the basis of the verifications carried out in accordance with point (b), the applicant shall issue a statement of conformity listing any potential non-conformity, together with a justification that this will not affect the test results, and shall allow the Agency to make an inspection it considers necessary to check the validity of that statement.

(d)The applicant shall allow the Agency to:

1.review any data and information related to the demonstration of compliance; and

2.witness or carry out any test or inspection conducted for the purpose of the demonstration of compliance.

(e)For all the tests and inspections witnessed or carried out by the Agency in accordance with point (d)(2):

1.the applicant shall submit to the Agency a statement of conformity provided for in point (c); and

2.no change that affects the validity of the statement of conformity shall be made to the test specimen, or the test and measuring equipment, between the time the statement of conformity provided for in point (c) was issued and the time the test specimen is presented to the Agency for test.’;

(13)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 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 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.’;

(14)point 21.A.91 is replaced by the following:

‘21.A.91   Classification of changes to a type-certificate

Changes to a type-certificate are classified as minor and major. A “minor change” has no appreciable effect on the mass, balance, structural strength, reliability, operational characteristics, operational suitability data, or other characteristics affecting the airworthiness of the product or its environmental characteristics. Without prejudice to point 21.A.19, all other changes are “major changes” under this Subpart. Major and minor changes shall be approved in accordance with points 21.A.95 or 21.A.97, as appropriate, and shall be adequately identified.’

(15)point 21.A.93 is replaced by the following:

‘21.A.93   Application

(a)An application for approval of a change to a type-certificate shall be made in a form and manner established by the Agency.

(b)An application shall include, or be supplemented after the initial application, a certification programme for the demonstration of compliance in accordance with point 21.A.20, consisting of:

1.a description of the change identifying:

(i)the configuration(s) of the product in the type certificate upon which the change is to be made;

(ii)all areas of the product in the type-certificate, including the approved manuals, that are changed or affected by the change; and

(iii)when the change affects the operational suitability data, any necessary changes to the operational suitability data;

2.an identification of any reinvestigations necessary to demonstrate compliance of the change and areas affected by the change with the type-certification basis, operational suitability data certification basis and environmental protection requirements; and

3.for a major change to a type-certificate:

(i)a proposal for the initial type-certification basis, operational suitability data certification basis and environmental protection requirements, prepared in accordance with the requirements and options specified in point 21.A.101;

(ii)a proposal for a breakdown of the certification programme into meaningful groups of compliance demonstration activities and data, including a proposal for the means of compliance and related compliance documents;

(iii)a proposal for the assessment of the meaningful groups of compliance demonstration activities and data, addressing 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. The proposed assessment shall take into account at least the elements set out in subpoints (1)–(4) of point 21.B.100(a). Based on this assessment, the application shall include a proposal for the Agency's involvement in the verification of the compliance demonstration activities and data; and

(iv)a project schedule including major milestones.

(c)An application for a change to a type-certificate of a large aeroplane or a large rotorcraft shall be valid for five years and an application for a change to any other type-certificate shall be valid for three years. In the case where the change has not been approved, or it is evident that it will not be approved, within the time limit provided for in this point, the applicant may:

1.submit a new application for a change to the type-certificate and comply with the type-certification basis, operational suitability data certification basis and environmental protection requirements, as established by the Agency in accordance with point 21.A.101 and notified in accordance with point 21.B.105 for the date of the new application; or

2.apply for an extension of the time period provided for in the first sentence of point (c) for the original application and propose a new date for the issuance of the approval. In that case, the applicant shall comply with the type-certification basis, operational suitability data certification basis and environmental protection requirements, as established by the Agency in accordance with point 21.A.101 and notified in accordance with point 21.B.105, for a date to be selected by the applicant. However, that date shall not precede the new date proposed by the applicant for the issuance of the approval by more than five years for an application for a type-certificate or restricted type-certificate for a large aeroplane or a large rotorcraft, and by more than three years for an application for any other type-certificate or restricted type certificate.’;

(16)points 21.A.95, 21.A.97 and 21.A.101 are replaced by the following:

‘21.A.95   Requirements for approval of a minor change

(a)Minor changes to a type-certificate shall be classified and approved by:

1.the Agency; or

2.an approved design organisation within the scope of its privileges provided for in points (1) and (2) of point 21.A.263(c), as recorded in the terms of approval.

(b)A minor change to a type-certificate shall only be approved:

1.when it has been demonstrated that the change and areas affected by the change comply with the type-certification basis and the environmental protection requirements incorporated by reference in the type-certificate;