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Document 32022R1358

    Commission Delegated Regulation (EU) 2022/1358 of 2 June 2022 amending Regulation (EU) No 748/2012 as regards the implementation of more proportionate requirements for aircraft used for sport and recreational aviation

    C/2022/3234

    OJ L 205, 5.8.2022, p. 7–98 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    Legal status of the document In force

    ELI: http://data.europa.eu/eli/reg_del/2022/1358/oj

    5.8.2022   

    EN

    Official Journal of the European Union

    L 205/7

    COMMISSION DELEGATED REGULATION (EU) 2022/1358

    of 2 June 2022

    amending Regulation (EU) No 748/2012 as regards the implementation of more proportionate requirements for aircraft used for sport and recreational aviation

    THE EUROPEAN COMMISSION,

    Having regard to the Treaty on the Functioning of the European Union,

    Having regard to Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (1), and in particular Articles 19(1) and 62(13) thereof,

    Whereas:

    (1)

    Commission Regulation (EU) No 748/2012 (2) lays down the requirements for the airworthiness and environmental certification of products, parts and appliances of civil aircraft, such as engines, propellers and parts to be installed therein.

    (2)

    Pursuant to Article 140(3) of Regulation (EU) 2018/1139, sport and recreational aviation is to be subject to simple and proportionate rules to avoid putting unnecessary administrative and financial burdens for the organisations involved in the design and production of such aircraft. Those rules are to be proportionate, cost-effective and flexible, while ensuring the necessary level of safety.

    (3)

    Organisations involved in the design and production of certain categories of products used in sport and recreational aviation should be provided with the possibility, as an alternative to design certification, to declare the compliance of the design of an aircraft, and if applicable of the engine and propeller, with the relevant industry standards, where it is considered that this will ensure an acceptable level of safety.

    (4)

    Organisations involved in the design and production of products used in sport and recreational aviation should also be provided with the possibility to utilise a more proportionate process for the certification of such products.

    (5)

    Organisations involved in the design and production of products used in sport and recreational aviation should be provided with the possibility, as an alternative to an organisational approval, to declare their capability to design and produce products and parts. Those organisations should be able to use existing approvals as a means to demonstrate their capability in conducting design and production activities.

    (6)

    Environmental protection requirements should be also laid down for the products the design of which is subject to a declaration of design compliance. Such environmental protection requirements should be based on requirements contained in Volumes I, II and III of Annex 16 to the Convention on International Civil Aviation (3) in order to ensure the same, uniform level of environmental protection irrespective of whether a product is subject to type certification or a declaration of design compliance.

    (7)

    Regulation (EU) No 748/2012 should therefore be amended accordingly.

    (8)

    A sufficient transitional period should be provided for organisations involved in the design and production of aircraft primarily used in sport and recreational aviation to ensure their compliance with the new rules and procedures introduced by this Regulation.

    (9)

    The measures provided for in this Regulation are in accordance with Opinion No 05/2021 (4), issued by the European Union Aviation Safety Agency in accordance with Article 76(1) of Regulation (EU) 2018/1139,

    HAS ADOPTED THIS REGULATION:

    Article 1

    Regulation (EU) No 748/2012 is amended as follows:

    (1)

    the title is replaced by the following:

    ‘ COMMISSION REGULATION (EU) No 748/2012

    of 3 August 2012

    laying down implementing rules for the airworthiness and environmental certification or declaration of compliance of aircraft and related products, parts and appliances, as well as for the capability requirements of design and production organisations

    (recast) ’;

    (2)

    Article 1 is replaced by the following:

    ‘Article 1

    Scope and definitions

    1.   This Regulation lays down, in accordance with Articles 19 and 62 of Regulation (EU) 2018/1139, common technical requirements and administrative procedures for the airworthiness and environmental certification of products, parts and appliances specifying:

    (a)

    the issue of type certificates, restricted type certificates, supplemental type certificates and changes to those certificates;

    (b)

    the issue of certificates of airworthiness, restricted certificates of airworthiness, permits to fly and authorised release certificates;

    (c)

    the issue of repair design approvals;

    (d)

    the showing of compliance with environmental protection requirements;

    (e)

    the issue of noise certificates and restricted noise certificates;

    (f)

    the identification of products, parts and appliances;

    (g)

    the certification of certain parts and appliances;

    (h)

    the certification of design and production organisations;

    (i)

    the issue of airworthiness directives;

    (j)

    the making of declarations of design compliance and changes to those declarations;

    (k)

    the making of declarations of design and production capability.

    2.   For the purpose of this Regulation, the following definitions shall apply:

    (a)

    “JAA” means the “Joint Aviation Authorities”;

    (b)

    “JAR” means “Joint Aviation Requirements”;

    (c)

    “Part 21” means the requirements and procedures for the certification of aircraft and related products, parts and appliances, and of design and production organisations laid down in Annex I (Part 21) to this Regulation;

    (d)

    “Part 21 Light” means the requirements and procedures for the certification or declaration of design compliance of aircraft intended primarily for sports and recreational use and related products and parts, and declaration of design and production capability of organisations laid down in Annex Ib (Part 21 Light) to this Regulation;

    (e)

    “principal place of business” means the head office or registered office of the undertaking within which the principal financial functions and operational control of the activities referred to in this Regulation are exercised;

    (f)

    “article” means any part and appliance to be used on civil aircraft;

    (g)

    “ETSO” means European Technical Standard Order. The European Technical Standard Order is a detailed airworthiness specification issued by the European Union Aviation Safety Agency (the “Agency”) to ensure compliance with the requirements of this Regulation as a minimum performance standard for specified articles;

    (h)

    “EPA” means European Part Approval. European Part Approval of an article means that the article has been produced in accordance with approved design data not belonging to the type-certificate holder of the related product, except for ETSO articles;

    (i)

    “ELA1 aircraft” means the following manned European Light Aircraft:

    (i)

    an aeroplane with a maximum take-off mass (MTOM) of 1 200 kg or less that is not classified as complex motor-powered aircraft;

    (ii)

    a sailplane or powered sailplane of 1 200 kg MTOM or less;

    (iii)

    a balloon with a maximum design lifting gas or hot air volume of not more than 3 400 m3 for hot air balloons, 1 050 m3 for gas balloons, 300 m3 for tethered gas balloons;

    (iv)

    an airship designed for not more than four occupants and a maximum design lifting gas or hot air volume of not more than 3 400 m3 for hot air airships and 1 000 m3 for gas airships;

    (j)

    “ELA2 aircraft” means the following manned European Light Aircraft:

    (i)

    an aeroplane with a maximum take-off mass (MTOM) of 2 000 kg or less that is not classified as complex motor-powered aircraft;

    (ii)

    a sailplane or powered sailplane of 2 000 kg MTOM or less;

    (iii)

    a balloon;

    (iv)

    a hot air airship;

    (v)

    a gas airship complying with all of the following characteristics:

    —

    3 % maximum static heaviness,

    —

    non-vectored thrust (except reverse thrust),

    —

    conventional and simple design of structure, control system and ballonet system,

    —

    non-power assisted controls;

    (vi)

    a rotorcraft with an MTOM not exceeding 600 kg which is of a simple design, designed to carry not more than two occupants, not powered by turbine and/or rocket engines; restricted to VFR day operations;

    (k)

    “operational suitability data (OSD)” means data, which is 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.’;

    (3)

    Article 2 is replaced by the following:

    ‘Article 2

    Certification of products, parts and appliances

    1.   Products, parts and appliances shall be issued certificates as specified in Annex I (Part 21).

    2.   By way of derogation from paragraph 1 of this Article, certificates may be alternatively issued as specified in Annex Ib (Part 21 Light) for the following products:

    (a)

    an aeroplane with a maximum take-off mass (MTOM) of 2 000 kg or less and a maximum operational seating configuration of four persons;

    (b)

    a sailplane or powered sailplane of 2 000 kg MTOM or less;

    (c)

    a balloon;

    (d)

    a hot air airship;

    (e)

    a passenger gas airship designed for not more than four persons;

    (f)

    a rotorcraft of 1 200 kg MTOM or less and a maximum operational seating configuration of four persons;

    (g)

    a piston engine or fixed pitch propeller that is intended to be installed on an aircraft referred to in points (a) to (f); or

    (h)

    a gyroplane.

    3.   By way of derogation from paragraphs 1 and 2 of this Article, a declaration of design compliance may alternatively be made, as specified in Annex Ib (Part 21 Light), for the following products:

    (a)

    an aeroplane of 1 200 kg MTOM or less that is not jet-powered and with a maximum operational seating configuration of two persons;

    (b)

    a sailplane or a powered sailplane of 1 200 kg MTOM or less;

    (c)

    a balloon designed for not more than four persons;

    (d)

    a hot air airship designed for not more than four persons.

    4.   By way of derogation from paragraphs 1 to 3 of this Article, aircraft, including any installed product, part and appliance, which are not registered in a Member State shall be exempted from the provisions of Subparts H and I of Section A of Annex I (Part 21) and Subparts H and I of Section A of Annex Ib (Part 21 Light). They shall also be exempted from the provisions of Subpart P of Section A of Annex I (Part 21) and Subpart P of Section A of Annex Ib (Part 21 Light), except where aircraft identification marks are prescribed by a Member State.’;

    (4)

    the following Article 2a is inserted:

    ‘Article 2a

    Transitional arrangements for certificates previously issued under Annex I (Part 21)

    1.   A holder of a valid type certificate or a supplemental type certificate issued, or deemed to have been issued, by the Agency under Annex I (Part 21) may, until 25 August 2025 request to the Agency to maintain, from a given date, the type design approved under that certificate in accordance with Annex Ib (Part 21 Light), provided that the product covered by that certificate is within the scope of Article 2(2).

    2.   Where a request is made pursuant to paragraph 1, that type certificate or supplemental type certificate shall be governed, as of the given date referred to in paragraph 1, by the provisions of Annex Ib (Part 21 Light) regarding the type certificates or supplemental type certificates, as applicable. The Agency shall amend the type certificate data sheet or supplemental type certificate data sheet accordingly.’;

    (5)

    in Article 3, paragraphs 3 and 4 are replaced by the following:

    ‘3.   With regard to products for which a type-certification process was proceeding through the JAA or a Member State on 28 September 2003, the following shall apply:

    (a)

    if a product is under certification by several Member States, the most advanced project shall be used as the reference;

    (b)

    points 21.A.15(a), (b) and (c) of Annex I (Part 21) shall not apply;

    (c)

    by way of derogation from point 21.B.80 of Annex I (Part 21), the type-certification basis shall be that established by the JAA or, where applicable, the Member State at the date of application for the approval;

    (d)

    compliance findings made under JAA or Member State procedures shall be deemed to have been made by the Agency for the purposes of compliance with points 21.A.20(a) and (d) of Annex I (Part 21).

    4.   With regard to products that have a national type certificate, or equivalent, and for which the approval process of a change carried out by a Member State was not finalised at the time when the type certificate had to be approved in accordance with this Regulation, the following conditions shall apply:

    (a)

    if an approval process is being carried out by several Member States, the most advanced project shall be used as the reference;

    (b)

    point 21.A.93 of Annex I (Part 21) shall not apply;

    (c)

    the applicable type-certification basis shall be that established by the JAA or, where applicable, the Member State at the date of application for the approval of change;

    (d)

    compliance findings made under JAA or Member State procedures shall be deemed to have been made by the Agency for the purposes of compliance with point 21.B.107 of Annex I (Part 21).’;

    (6)

    in Article 8, paragraphs 2 and 3 are replaced by the following:

    ‘2.   By way of derogation from paragraph 1 of this Article, a natural or legal person responsible for the design of products whose principal place of business is in a Member State and who applies for or holds a certificate for the design of products, or changes or repairs thereto, in accordance with Article 2(2) may, alternatively, demonstrate their capability in accordance with Annex Ib (Part 21 Light).

    3.   Natural or legal persons involved in the design of aircraft subject to a declaration of design compliance referred to in Article 2(3) need not demonstrate their capability.’;

    (7)

    in Article 8, the following paragraph 5 is added:

    ‘5.   By way of derogation from paragraph 1 of this Article, an organisation whose principal place of business is in a non-Member State may demonstrate its capability by holding a certificate issued by that State for the product, part and appliance for which it applies in accordance with Annex I (Part 21), provided that:

    (a)

    that State is the State of design;

    (b)

    the Agency has determined that the system of that State includes the same independent level of checking of compliance as provided by this Regulation, either through an equivalent system of approvals of organisations or through direct involvement of the competent authority of that State.’;

    (8)

    in Article 9, paragraphs 2 and 3 are replaced by the following:

    ‘2.   By way of derogation from paragraph 1 of this Article, a natural or legal person whose principal place of business is in a Member State and who is responsible for the manufacture of products and their parts and appliances in accordance with Article 2(2) may alternatively demonstrate their capability in accordance with Annex Ib (Part 21 Light).

    3.   The demonstration of capability pursuant to paragraphs 1 or 2 shall not be required where the production organisation or natural or legal person are involved in the following manufacturing activities:

    (a)

    the manufacture of parts or appliances that are eligible, in accordance with Annex I (Part 21), for installation in a type-certified product without the need to be accompanied by an authorised release certificate (that is to say EASA Form 1);

    (b)

    the manufacture of parts that are eligible, in accordance with Annex Ib (Part 21 Light), for installation in an aircraft that has been subject to a declaration of design compliance without the need to be accompanied by an authorised release certificate (that is to say EASA Form 1);

    (c)

    the manufacture of an aircraft that has been subject to a declaration of design compliance referred to in Article 2(3), and of parts that are eligible for installation on such aircraft. In such case, the manufacturing activities shall be conducted in accordance with Subpart R of Section A of Annex Ib (Part 21 Light).’;

    (9)

    Article 10 is replaced by the following:

    ‘Article 10

    Agency measures

    1.   The Agency shall develop acceptable means of compliance (“AMC”) which competent authorities, organisations and personnel may use to demonstrate compliance with the provisions of Annex I (Part 21) and Annex Ib (Part 21 Light).

    2.   The AMC issued by the Agency shall neither introduce new requirements nor alleviate the requirements of Annex I (Part 21) and Annex Ib (Part 21 Light).’;

    (10)

    Annex I (Part 21) is amended in accordance with Annex I to this Regulation;

    (11)

    Annex Ib (Part 21 Light) is added as set out in Annex II 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 25 August 2023.

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

    Done at Brussels, 2 June 2022.

    For the Commission

    The President

    Ursula VON DER LEYEN

    (1)   OJ L 212, 22.8.2018, p. 1.

    (2)  Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations (OJ L 224, 21.8.2012, p. 1).

    (3)  Convention on International Civil Aviation, signed at Chicago on 7 December 1944 (the ‘Chicago Convention’).

    (4)  Opinion 05/2021 of 22 October 2021 of the European Union Aviation Safety Agency, Part 21 Light – Certification and declaration of design compliance of aircraft used for sport and recreational aviation and related products and parts, and declaration of design and production capability of organisations, https://www.easa.europa.eu/document-library/opinions/opinion-052021

    ANNEX I

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

    (1)

    in Section A, Subpart G is amended as follows:

    (a)

    point 21.A.133 is replaced by the following:

    “21.A.133   Eligibility

    Any natural or legal person (‘organisation’) shall be eligible as an applicant for an approval under this Subpart. The applicant shall:

    (a)

    justify that, for a defined scope of work, an approval under this Subpart is appropriate for the purpose of showing conformity with a specific design; and

    (b)

    hold or have applied for an approval of that specific design; or

    (c)

    have declared or intends to declare compliance of that specific design in accordance with Subpart C of Section A of Annex Ib (Part 21 Light); or

    (d)

    have ensured satisfactory coordination between production and design, through an appropriate arrangement with:

    (1)

    the applicant for, or holder of, an approval of that specific design issued in accordance with this Regulation; or

    (2)

    the natural or legal person who made a declaration of compliance of that specific design in accordance with Subpart C of Section A of Annex Ib (Part 21 Light).”;

    (b)

    in point 21.A.139, point (d) is replaced by the following:

    “(d)

    as part of the quality management element of the production management system, the production organisation shall:

    1.

    ensure that each product, part or appliance produced by the organisation or by its partners, or supplied from or subcontracted to outside parties, conforms to the applicable design data and is in a condition for safe operation, and thus exercise the privileges as defined in point 21.A.163;

    2.

    establish, implement and maintain, as appropriate, within the scope of the approval, control procedures for:

    (i)

    document issue, approval or change;

    (ii)

    vendor and subcontractor assessment audit and control;

    (iii)

    the verification that incoming products, parts, materials and equipment, including items supplied new or used by buyers of products, are as specified in the applicable design data;

    (iv)

    identification and traceability;

    (v)

    manufacturing processes;

    (vi)

    inspection and testing, including production flight tests;

    (vii)

    the calibration of tools, jigs, and test equipment;

    (viii)

    non-conforming item control;

    (ix)

    airworthiness coordination with:

    (A)

    the applicant for, or holder of, the design approval;

    (B)

    the natural or legal person who made a declaration of design compliance in accordance with Subpart C of Section A of Annex Ib (Part 21 Light);

    (x)

    the completion and retention of records;

    (xi)

    the competence and qualifications of personnel;

    (xii)

    the issue of airworthiness release documents;

    (xiii)

    handling, storage and packing;

    (xiv)

    internal quality audits and the resulting corrective actions;

    (xv)

    work within the terms of approval performed at any location other than the approved facilities;

    (xvi)

    work performed after the completion of production but prior to delivery, to maintain the aircraft in a condition for safe operation;

    (xvii)

    the issue of a permit to fly and approval of the associated flight conditions.

    3.

    include specific provisions in the control procedures for any critical parts.”;

    (c)

    in point 21.A.145, point (b) is replaced by the following:

    “(b)

    with regard to all the necessary airworthiness and environmental protection data:

    1.

    the production organisation is in receipt of such data from the Agency and from the holder of, or applicant for, the type certificate, restricted type certificate or design approval issued in accordance with this Regulation or a natural or legal person who made a declaration of design compliance under Subpart C of Section A of Annex Ib (Part 21 Light), including any exemption granted against the environmental protection requirements, to determine conformity with the applicable design data;

    2.

    the production organisation has established a procedure to ensure that the airworthiness and environmental protection data are correctly incorporated in its production data;

    3.

    such data is kept up to date and made available to all personnel that need access to such data to perform their duties.”;

    (d)

    point 21.A.163 is replaced by the following:

    “21.A.163   Privileges

    Pursuant to the terms of approval issued under point 21.A.135, the holder of a production organisation approval may:

    (a)

    perform production activities under this Annex or Annex Ib (Part 21 Light);

    (b)

    in the case of complete type-certified aircraft and upon presentation of a statement of conformity (EASA Form 52) issued under points 21.A.174 and 21.A.204 of this Annex or under points 21L.A.143(c) and 21L.A.163 of Annex Ib (Part 21 Light), obtain an aircraft certificate of airworthiness and a noise certificate without further showing;

    (c)

    in the case of other products, parts or appliances, issue authorised release certificates (EASA Form 1) under this Annex (Part 21) or under Annex Ib (Part 21 Light) without further showing;

    (d)

    in the case of an aircraft that is subject to a declaration of design compliance under point 21L.A.43 of Annex Ib (Part 21 Light) and upon presentation of a statement of conformity (EASA Form 52B) issued under points 21L.A.143(d) and 21L.A.163 of Annex Ib (Part 21 Light), obtain an aircraft restricted certificate of airworthiness and a restricted noise certificate without further showing;

    (e)

    in the case of products or parts to be installed on an aircraft that is subject to a declaration of design compliance under point 21L.A.43 of Annex Ib (Part 21 Light), issue authorised release certificates (EASA Form 1) under Annex Ib (Part 21 Light) without further showing;

    (f)

    maintain a new aircraft that it has produced and issue a certificate of release to service (EASA Form 53) in respect of that maintenance;

    (g)

    under procedures agreed with its competent authority for production, for an aircraft it has produced and when the production organisation itself is controlling under its Production Organisation Approval the configuration of the aircraft and is attesting conformity with the design conditions approved for the flight, to issue a permit to fly in accordance with point 21.A.711(c) including approval of the flight conditions in accordance with point 21.A.710(b).”;

    (e)

    point 21.A.165 is replaced by the following:

    “21.A.165   Obligations of the holder

    Pursuant to the terms of approval issued under point 21.A.135, the holder of a production organisation approval shall:

    (a)

    ensure that the production organisation exposition furnished in accordance with point 21.A.143 and the documents to which it refers, are used as basic working documents within the organisation;

    (b)

    maintain the production organisation in conformity with the data and procedures approved for the production organisation approval;

    (c)

    1.

    determine that each completed aircraft conforms to the type design and is in condition for safe operation prior to submitting statements of conformity to the competent authority; or

    2.

    determine that other products, parts or appliances are complete and conform to the approved design data or declared design data and are in a condition for safe operation before issuing an EASA Form 1 to certify conformity to approved or declared design data and condition for safe operation;

    3.

    additionally, in the case of environmental requirements determine that:

    (i)

    the completed engine is in compliance with the applicable engine exhaust emissions requirements on the date of manufacture of the engine; and

    (ii)

    the completed aeroplane is in compliance with the applicable CO2 emissions requirements on the date its first certificate of airworthiness is issued.

    4.

    determine that other products, parts or appliances conform to the applicable data before issuing an EASA Form 1 as a conformity certificate;

    (d)

    provide assistance to the holder of the type certificate or other design approval or a natural or legal person who made a declaration of design compliance under Subpart C of Section A of Annex Ib (Part 21 Light) in dealing with any continuing airworthiness actions that are related to the products, parts or appliances that have been produced;

    (e)

    where, under its terms of approval, the holder intends to issue a certificate of release to service, determine that each completed aircraft has been subjected to the necessary maintenance and is in a condition for safe operation, prior to issuing the certificate;

    (f)

    where applicable, under the privilege of point 21.A.163(e), determine the conditions under which a permit to fly can be issued;

    (g)

    where applicable, under the privilege of point 21.A.163(e), establish compliance with points 21.A.711(c) and (e) before issuing an aircraft with a permit to fly;

    (h)

    comply with Subpart A of this Section.”;

    (2)

    in Section A, Subpart H is amended as follows:

    (a)

    point 21.A.171 is replaced by the following:

    “21.A.171   Scope

    This Subpart establishes the procedure for issuing airworthiness certificates to aircraft which conform to a type certificate that has been issued in accordance with this Annex.”;

    (b)

    in point 21.A.174, point (b) is replaced by the following:

    “(b)

    each application for a certificate of airworthiness or restricted certificate of airworthiness shall include:

    1.

    the class of airworthiness certificate applied for;

    2.

    with regard to new aircraft:

    (i)

    a statement of conformity:

    —

    issued under point 21.A.163(b); or

    —

    issued under point 21.A.130 and validated by the competent authority; or

    —

    for an imported aircraft, a statement of conformity issued under point 21.A.163(b) or, in the case of an aircraft imported in accordance with Article 9(4) of this Regulation, a statement signed by the exporting authority that the aircraft conforms to a design approved by the Agency;

    (ii)

    a weight and balance report with a loading schedule and;

    (iii)

    the flight manual, when required by the applicable certification specifications for the particular aircraft.

    3.

    with regard to used aircraft originating from:

    (i)

    a Member State, an airworthiness review certificate issued in accordance with Annex I (Part-M) or Annex Vb (Part-ML) to Commission Regulation (EU) No 1321/2014 (1);

    (ii)

    a non-Member State:

    —

    a statement by the competent authority of the State where the aircraft is, or was, registered, reflecting the airworthiness status of the aircraft on its register at the time of transfer;

    —

    a weight and balance report with a loading schedule;

    —

    the flight manual when such a manual is required by the airworthiness code for the aircraft;

    —

    historical records to establish the production, modification and maintenance standard of the aircraft, including all limitations associated with a restricted certificate of airworthiness issued in accordance with point 21.B.327;

    —

    a recommendation for the issuance of a certificate of airworthiness or restricted certificate of airworthiness and for an airworthiness review certificate pursuant to an airworthiness review in accordance with Annex I (Part-M) or Annex Vb (Part-ML) to Regulation (EU) No 1321/2014;

    —

    the date on which the first certificate of airworthiness was issued and, if the standards of Volume III of Annex 16 to the Convention on International Civil Aviation apply, the CO2 metric value data.”;

    (3)

    in Section A, Subpart I is amended as follows:

    (a)

    point 21.A.201 is replaced by the following:

    “21.A.201   Scope

    This Subpart establishes the procedure for issuing noise certificates to aircraft which conform to a type certificate that has been issued in accordance with this Annex.”;

    (b)

    in point 21.A.204, point (b) is replaced by the following:

    “(b)

    each application shall include:

    1.

    with regard to new aircraft:

    (i)

    a statement of conformity:

    —

    issued under point 21.A.163(b); or

    —

    issued under point 21.A.130 and validated by the competent authority; or

    —

    for an imported aircraft, a statement of conformity issued under point 21.A.163(b) or, in the case of an aircraft imported in accordance with Article 9(4) of this Regulation, a statement signed by the exporting authority that the aircraft conforms to a design approved by the Agency; and

    (ii)

    the noise information determined in accordance with the applicable noise requirements;

    2.

    with regard to used aircraft:

    (i)

    the noise information determined in accordance with the applicable noise requirements; and

    (ii)

    historical records to establish the production, modification, and maintenance standard of the aircraft.”;

    (4)

    in Section A, Subpart J is amended as follows:

    (a)

    point 21.A.233 is replaced by the following:

    “21.A.233   Eligibility

    Any natural or legal person (‘organisation’) shall be eligible as an applicant for an approval under this Subpart:

    (a)

    in order to demonstrate compliance with points 21.A.14, 21.A.112B, 21.A.432B or 21.A.602Bof this Annex; or

    (b)

    in order to demonstrate compliance with points 21L.A.23, 21L.A.83 or 21L.A.204 of Annex Ib (Part 21 Light); or

    (c)

    for the purpose of obtaining privileges under point 21.A.263 regarding approval of minor changes or minor repair design, or issuing declarations of compliance regarding minor changes or minor repair design of aircraft for which design compliance has been declared in accordance with Subpart C of Section A of Annex Ib (Part 21 Light).”;

    (b)

    in point 21.A.239, point (d) is replaced by the following]:

    “(d)

    as part of the design assurance element of the design management system, the design organisation shall:

    1.

    establish, implement and maintain a system for the control and supervision of the design, and of design changes and repairs, of products, parts and appliances covered by the terms of approval; this system shall:

    (i)

    include an airworthiness function responsible for managing that the design of products, parts and appliances, or the design changes and repairs, comply with the applicable type-certification basis, technical specifications concerning the making of declarations, the applicable operational suitability data certification basis and the environmental protection requirements;

    (ii)

    ensure that it properly discharges its responsibilities in accordance with this Annex and with the terms of approval issued under point 21.A.251;

    2.

    establish, implement and maintain an independent verification function of the demonstration of compliance on the basis of which the organisation declares compliance with the applicable airworthiness, operational suitability data and environmental protection requirements; and

    3.

    specify the manner in which the design assurance system accounts for the acceptability of the parts or appliances that are designed or the tasks that are performed by its partners or subcontractors according to the methods which are the subjects of written procedures.”;

    (c)

    point 21.A.263 is replaced by the following:

    “21.A.263   Privileges

    (a)

    (Reserved)

    (b)

    (Reserved)

    (c)

    The holder of a design organisation approval shall be entitled, within the scope of its terms of approval issued under point 21.A.251 and under the relevant procedures of the design management system:

    1.

    to classify changes to a type certificate or to a supplemental type certificate and repair designs as ‘major’ or ‘minor’;

    2.

    to approve minor changes to a type certificate or to a supplemental type certificate and minor repair designs under this Annex (Part 21) or under Annex Ib (Part 21 Light);

    3.

    to declare the compliance of a minor change or minor repair to the design of an aircraft for which design compliance has been declared by the declarant under point 21L.A.43 of Subpart C of Section A of Annex Ib (Part 21 Light);

    4.

    to declare compliance of a changed aircraft design, in accordance with point 21L.A.43 of Annex Ib (Part 21 Light), in the event that the natural or legal person who originally made a declaration of design compliance with respect to that aircraft under point 21L.A.43 of Annex Ib (Part 21 Light) is no longer active or is unresponsive to requests for the declaration of compliance of design changes;

    5.

    to approve certain major repair designs under Subpart M of this Annex to products or auxiliary power units (APUs);

    6.

    to approve for certain aircraft the flight conditions under which a permit to fly can be issued in accordance with point 21.A.710(a)(2), except for permits to fly to be issued for the purpose of point 21.A.701(a)(15);

    7.

    to issue a permit to fly in accordance with point 21.A.711(b) for an aircraft it has designed or modified, or for which it has approved, in accordance with point 21.A.263(c)(6), the flight conditions under which the permit to fly can be issued, and where the holder of a design organisation approval itself:

    (i)

    controls the configuration of the aircraft, and

    (ii)

    attests conformity with the design conditions approved for the flight;

    8.

    to approve certain major changes to a type certificate under Subpart D of this Annex or under Subpart D of Section A of Annex Ib (Part 21 Light); and

    9.

    to issue certain supplemental type certificates under Subpart E of this Annex or under Subpart E of Section A of Annex Ib (Part 21 Light) and approve certain major changes to those certificates.”;

    (d)

    in point 21.A.265, point (c) is replaced by the following:

    “(c)

    determine that the design of the products, or of the changes or repairs to them, complies with the applicable type-certification basis, technical specifications concerning the making of declarations, operational suitability data certification basis, and the environmental protection requirements and have no unsafe features;”;

    (5)

    in Section A, in Subpart K, in point 21.A.307, the following point (b)(7) is inserted:

    “7.

    a part or appliance manufactured by a person or organisation referred to in Article 9(4) of this Regulation;”;

    (6)

    In Appendix I, the text in title ‘Instructions for the use of EASA Form 1’ is replaced by the following:

    “These instructions relate only to the use of EASA Form 1 for production purposes. Attention is drawn to Appendix II to Annex I (Part-M) of Regulation (EU) No 1321/2014 which covers the use of EASA Form 1 for maintenance purposes.

    1.   PURPOSE AND USE

    1.1.

    		 A primary purpose of the certificate is to declare the airworthiness of new aviation products, parts and appliances (‘the item(s)’).

    1.2.

    		 Correlation must be established between the certificate and the item(s). The originator must retain a certificate in a form that allows verification of the original data.

    1.3.

    		 The certificate is acceptable to many airworthiness authorities, but this may be dependent on bilateral agreements and/or the policy of the airworthiness authority.

    1.4.

    		 The certificate is not a delivery or shipping note.

    1.5.

    		 Aircraft are not to be released using the certificate.

    1.6.

    		 The certificate does not constitute approval to install the item on a particular aircraft, engine, or propeller but helps the end user determine its airworthiness approval status.

    1.7.

    		 A mixture of production released and maintenance released items is not permitted on the same certificate.

    1.8.

    		 A mixture of items certified in conformity with ‘approved data’ and to ‘non-approved data’ is not permitted on the same certificate.

    2.   GENERAL FORMAT

    2.1.

    		 The certificate must comply with the format attached including block numbers and the location of each block. The size of each block may however be varied to suit the individual application, but not to the extent that would make the certificate unrecognisable.

    2.2.

    		 The certificate must be in ‘landscape’ format, but the overall size may be significantly increased or decreased so long as the certificate remains recognisable and legible. If in doubt, consult the competent authority.

    2.3.

    		 The user/installer responsibility statement can be placed on either side of the form.

    2.4.

    		 All printing must be clear and legible to permit easy reading.

    2.5.

    		 The certificate may either be pre-printed or computer generated but in either case the printing of lines and characters must be clear and legible and in accordance with the defined format.

    2.6.

    		 The certificate should be in English, and if appropriate, in one or more other languages.

    2.7.

    		 The details to be entered on the certificate may be either machine/computer printed or hand-written using block letters and must permit easy reading.

    2.8.

    		 Limit the use of abbreviations to a minimum, to aid clarity.

    2.9.

    		 The space remaining on the reverse side of the certificate may be used by the originator for any additional information but must not include any certification statement. Any use of the reverse side of the certificate must be referenced in the appropriate block on the front side of the certificate.

    3.   COPIES

    3.1.

    		 There is no restriction in the number of copies of the certificate sent to the customer or retained by the originator.

    4.   ERROR(S) ON A CERTIFICATE

    4.1.

    		 If an end user finds an error(s) on a certificate, they must identify it (them) in writing to the originator. The originator may issue a new certificate if they can verify and correct the error(s).

    4.2.

    		 The new certificate must have a new tracking number, signature and date.

    4.3.

    		 The request for a new certificate may be honoured without re-verification of the item(s) condition. The new certificate is not a statement of current condition and should refer to the previous certificate in block 12 by the following statement: ‘This certificate corrects the error(s) in block(s) [enter block(s) corrected] of the certificate [enter original tracking number] dated [enter original issuance date] and does not cover conformity/condition/release to service’. Both certificates should be retained according to the retention period associated with the first.

    5.   COMPLETION OF THE CERTIFICATE BY THE ORIGINATOR

    Block 1

    Approving competent authority/Country

    State the name and country of the competent authority under whose jurisdiction this certificate is issued. When the competent authority is the Agency, only ‘EASA’ must be stated.

    Block 2

    EASA Form 1 header

    ‘AUTHORISED RELEASE CERTIFICATE EASA FORM 1’

    Block 3

    Form Tracking Number

    Enter the unique number established by the numbering system/procedure of the organisation identified in block 4; this may include alpha/numeric characters.

    Block 4

    Organisation Name and Address

    Enter the full name and address of the production organisation (refer to EASA Form 55 Sheet A) or natural or legal persons releasing the item(s) covered by this certificate. Logos, etc. of the organisation are permitted if they can be contained within the block.

    Block 5

    Work Order/Contract/Invoice

    To facilitate customer traceability of the item(s), enter the work order number, contract number, invoice number, or similar reference number.

    Block 6

    Item

    Enter line item numbers when there is more than one line item. This block permits easy cross-referencing to the Remarks in block 12.

    Block 7

    Description

    Enter the name or description of the item. Preference should be given to the term used in the instructions for continued airworthiness or maintenance data (e.g. Illustrated Parts Catalogue, Aircraft Maintenance Manual, Service Bulletin, Component Maintenance Manual).

    Block 8

    Part Number

    Enter the part number as it appears on the item or tag/packaging. In the case of an engine or propeller, the type designation may be used.

    Block 9

    Quantity

    State the quantity of items.

    Block 10

    Serial Number

    If the item is required by regulation to be identified with a serial number, enter it here. Additionally, any other serial number not required by regulation may also be entered. If there is no serial number identified on the item, enter ‘N/A’.

    Block 11

    Status/Work

    Enter either ‘PROTOTYPE’ or ‘NEW’.

    Enter ‘PROTOTYPE’ for:

    (i)

    the production of a new item in conformity with non-approved design data;

    (ii)

    the production of a new item in conformity with design data that has not yet been declared by a declarant in accordance with Subpart C, F or N of Section A of Annex Ib (Part 21 Light);

    (iii)

    re-certification by the organisation identified in block 4 of the previous certificate after alteration or rectification work on an item, prior to entry into service, (e.g. after incorporation of a design change, correction of a defect, inspection or test, or renewal of shelf life). Details of the original release and the alteration or rectification work are to be entered in block 12;

    Enter ‘NEW’ for:

    (i)

    the production of a new item in conformity with the approved design data;

    (ii)

    the production of a new item in conformity with design data declared by the declarant in accordance with Subpart C, F or N of Section A of Annex Ib (Part 21 Light);

    (iii)

    re-certification by the organisation identified in block 4 of the previous certificate after alteration or rectification work on an item, prior to entry into service, (e.g. after incorporation of a design change, correction of a defect, inspection or test, or renewal of shelf-life). Details of the original release and the alteration or rectification work are to be entered in block 12;

    (iv)

    re-certification by the product manufacturer or the organisation identified in block 4 of the previous certificate of items from ‘prototype’ (conformity only to non-approved data) to ‘new’ (conformity to approved data and in a condition for safe operation), subsequent to approval of the applicable design data, provided that the design data has not changed.

    For certified products, the following statement must be entered in block 12:

    ‘RE-CERTIFICATION OF ITEMS FROM ‘PROTOTYPE’ TO ‘NEW’: THIS DOCUMENT CERTIFIES THE APPROVAL OF THE DESIGN DATA [INSERT TC/STC NUMBER, REVISION LEVEL], DATED [INSERT DATE IF NECESSARY FOR IDENTIFICATION OF REVISION STATUS], TO WHICH THIS ITEM (THESE ITEMS) WAS (WERE) MANUFACTURED.’

    The box ‘approved design data and are in a condition for safe operation’ should be marked in block 13a;

    For aircraft subject to a declaration of design compliance in accordance with Subpart C of Section A of Annex Ib (Part 21 Light), the following statement must be entered in block 12:

    ‘RE-CERTIFICATION OF ITEMS FROM ‘PROTOTYPE’ TO ‘NEW’: THIS DOCUMENT CERTIFIES THE DECLARATION OF THE DESIGN DATA [INSERT DECLARATION REFERENCE, REVISION LEVEL], DATED [INSERT DATE IF NECESSARY FOR IDENTIFICATION OF REVISION STATUS], TO WHICH THIS ITEM (THESE ITEMS) WAS (WERE) MANUFACTURED.’

    (v)

    the examination of a previously released new item prior to entry into service in accordance with a customer-specified standard or specification (details of which and of the original release are to be entered in block 12) or to establish airworthiness (an explanation of the basis of release and details of the original release are to be entered in block 12).

    Block 12

    Remarks

    Describe the work identified in block 11, either directly or by reference to supporting documentation, necessary for the user or installer to determine the airworthiness of item(s) in relation to the work being certified. If necessary, a separate sheet may be used and referenced from EASA Form 1. Each statement must clearly identify which item(s) in block 6 it relates to. If there is no statement, state ‘None’.

    Enter the justification for release to non-approved design data in block 12 (e.g. pending type certificate, for test only, pending approved data).

    If the item has been produced in accordance with design data that has not yet been declared by the declarant in accordance with Subpart C, F or N of Section A of Annex Ib (Part 21 Light), then the following statement shall be included in Block 12:

    ‘PENDING DECLARATION OF DESIGN COMPLIANCE IN ACCORDANCE WITH SUBPART C, F OR N of Section A of Annex Ib (Part 21 Light)’

    If the item has been produced in accordance with design data that has been declared by the declarant in accordance with Subpart C, F or N of Section A of Annex Ib (Part 21 Light), then the following statement shall be included in Block 12:

    ‘PRODUCED IN CONFORMITY WITH THE DESIGN DATA OF A DECLARATION OF DESIGN COMPLIANCE IN ACCORDANCE WITH SUBPART C, F OR N of Section A of Annex Ib (Part 21 Light)’

    If printing the data from an electronic EASA Form 1, any data not appropriate in other blocks should be entered in this block.

    Block 13a

    Mark only one of the two boxes:

    1.

    Mark the ‘approved design data and are in a condition for safe operation’ box if the item(s) was (were) manufactured using approved design data and found to be in a condition for safe operation.

    2.

    Mark the ‘non-approved design data specified in block 12’ box if the item(s) was (were) manufactured using applicable non-approved design data.

    This box shall also be marked when the item has been produced in conformity with design data that has been declared in accordance with Subpart C, F and N of Section A of Annex Ib (Part 21 Light).

    Identify the data in block 12 (e.g. pending type certificate, for test only, pending approved data, conformity to design data from a declaration of design compliance in accordance with Subpart C, F or N of Section A of Annex Ib (Part 21 Light).

    Mixtures of items released against approved and non-approved design data are not permitted on the same certificate.

    Block 13b

    Authorised Signature

    This space shall be completed with the signature of the authorised person. Only persons specifically authorised under the rules and policies of the competent authority are permitted to sign this block. To aid recognition, a unique number identifying the authorised person may be added.

    Block 13c

    Approval/Authorisation Number

    Enter the approval/authorisation number/reference. This number or reference is issued by the competent authority for approved or declared production organisations (for parts produced under Annex Ib (Part 21 Light). If the organisation has produced a part that conforms to design data declared by a declarant in accordance with Subpart C, F or N of Section A of Annex Ib (Part 21 Light) and the organisation is not an approved or a declared production organisation, then they should enter the following statement:

    ‘PRODUCED UNDER SUBPART R of Section A of Annex Ib (Part 21 Light)’

    Block 13d

    Name

    Enter the name of the person signing block 13b in a legible form.

    Block 13e

    Date

    Enter the date on which block 13b is signed, the date must be in the format dd = 2 digit day, mmm = first 3 letters of the month, yyyy = 4 digit year.

    Block 14a-14e

    General Requirements for blocks 14a-14e:

    Not used for production release. Shade, darken, or otherwise mark to preclude inadvertent or unauthorised use.

    User/Installer Responsibilities

    Place the following statement on the certificate to notify end users that they are not relieved of their responsibilities concerning installation and use of any item accompanied by the form:

    ‘THIS CERTIFICATE DOES NOT AUTOMATICALLY CONSTITUTE AUTHORITY TO INSTALL.

    WHERE THE USER/INSTALLER PERFORMS WORK IN ACCORDANCE WITH REGULATIONS OF AN AIRWORTHINESS AUTHORITY DIFFERENT THAN THE AIRWORTHINESS AUTHORITY SPECIFIED IN BLOCK 1, IT IS ESSENTIAL THAT THE USER/INSTALLER ENSURES THAT HIS/HER AIRWORTHINESS AUTHORITY ACCEPTS ITEMS FROM THE AIRWORTHINESS AUTHORITY SPECIFIED IN BLOCK 1.

    STATEMENTS IN BLOCKS 13A AND 14A DO NOT CONSTITUTE INSTALLATION CERTIFICATION. IN ALL CASES AIRCRAFT MAINTENANCE RECORDS MUST CONTAIN AN INSTALLATION CERTIFICATION ISSUED IN ACCORDANCE WITH THE NATIONAL REGULATIONS BY THE USER/INSTALLER BEFORE THE AIRCRAFT MAY BE FLOWN.’ ”

    (1)  Commission Regulation (EU) No 1321/2014 of 26 November 2014 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks (OJ L 362, 17.12.2014, p. 1).

    ANNEX II

    The following Annex Ib (Part 21 Light) is inserted:

    “Contents

    21L.1

    		 Scope

    21L.2

    		 Competent authority

    SECTION A –

    		TECHNICAL REQUIREMENTS

    SUBPART A –

    		 GENERAL PROVISIONS

    21L.A.1

    		 Scope

    21L.A.2

    		 Obligations and actions performed by a person other than the applicant for, or holder of, a certificate or the declarant of a declaration of design compliance

    21L.A.3

    		 Reporting system

    21L.A.4

    		 Airworthiness directives

    21L.A.5

    		 Collaboration between design and production

    21L.A.6

    		 Marking

    21L.A.7

    		 Record-keeping

    21L.A.8

    		 Manuals

    21L.A.9

    		 Instructions for continued airworthiness

    21L.A.10

    		 Access and investigation

    21L.A.11

    		 Findings and observations

    21L.A.12

    		 Means of compliance

    SUBPART B –

    		 TYPE CERTIFICATES

    21L.A.21

    		 Scope

    21L.A.22

    		 Eligibility

    21L.A.23

    		 Demonstration of design capability

    21L.A.24

    		 Application for a type certificate

    21L.A.25

    		 Demonstration of compliance

    21L.A.26

    		 Type design

    21L.A.27

    		 Requirements for the issuance of a type certificate

    21L.A.28

    		 Obligations of a type-certificate holder

    21L.A.29

    		 Transferability of a type certificate

    21L.A.30

    		 Continued validity of a type certificate

    SUBPART C –

    		 DECLARATIONS OF AIRCRAFT DESIGN COMPLIANCE

    21L.A.41

    		 Scope

    21L.A.42

    		 Eligibility

    21L.A.43

    		 Declaration of design compliance

    21L.A.44

    		 Compliance activities for a declaration of design compliance

    21L.A.45

    		 Detailed technical specifications and environmental protection requirements that are applicable to aircraft subject to declarations of design compliance

    21L.A.46

    		 Aircraft design data

    21L.A.47

    		 Obligations of the declarant of a declaration of design compliance

    21L.A.48

    		 Non-transferability of a declaration of aircraft design compliance

    SUBPART D –

    		 CHANGES TO TYPE CERTIFICATES

    21L.A.61

    		 Scope

    21L.A.62

    		 Standard changes

    21L.A.63

    		 Classification of changes to a type certificate

    21L.A.64

    		 Eligibility

    21L.A.65

    		 Application for a change to a type certificate

    21L.A.66

    		 Demonstration of compliance

    21L.A.67

    		 Requirements for the approval of a minor change to a type certificate

    21L.A.68

    		 Requirements for the approval of a major change to a type certificate

    21L.A.69

    		 Approval of a change to a type certificate under a privilege

    21L.A.70

    		 Obligations for minor changes to a type certificate

    SUBPART E –

    		 SUPPLEMENTAL TYPE CERTIFICATES

    21L.A.81

    		 Scope

    21L.A.82

    		 Eligibility

    21L.A.83

    		 Demonstration of design capability

    21L.A.84

    		 Application for a supplemental type certificate

    21L.A.85

    		 Demonstration of compliance

    21L.A.86

    		 Requirements for approval of a supplemental type certificate

    21L.A.87

    		 Approval of a supplemental type certificate under a privilege

    21L.A.88

    		 Obligations of a holder of a supplemental type certificate

    21L.A.89

    		 Transferability of a supplemental type certificate

    21L.A.90

    		 Continued validity of a supplemental type certificate

    21L.A.91

    		 Changes to a part of a product covered by a supplemental type certificate

    SUBPART F –

    		 CHANGES TO AIRCRAFT FOR WHICH DESIGN COMPLIANCE HAS BEEN DECLARED

    21L.A.101

    		 Scope

    21L.A.102

    		 Standard changes

    21L.A.103

    		 Classification of changes to the design of an aircraft for which design compliance has been declared

    21L.A.104

    		 Eligibility

    21L.A.105

    		 Declaration of design compliance for minor changes

    21L.A.106

    		 Obligations of the person making a declaration of compliance of the design of a minor change

    21L.A.107

    		 Declaration of design compliance for a major change

    21L.A.108

    		 Compliance activities for declaring compliance of a major change

    SUBPART G –

    		 DECLARED PRODUCTION ORGANISATIONS

    21L.A.121

    		 Scope

    21L.A.122

    		 Eligibility

    21L.A.123

    		 Declaration of production capability

    21L.A.124

    		 Management system for production

    21L.A.125

    		 Resources of the declared production organisation

    21L.A.126

    		 Scope of work

    21L.A.127

    		 Obligations of the declared production organisation

    21L.A.128

    		 Notification of changes and cessation of activities

    SUBPART H –

    		 CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS

    21L.A.141

    		 Scope

    21L.A.142

    		 Eligibility

    21L.A.143

    		 Application for a certificate of airworthiness or a restricted certificate of airworthiness

    21L.A.144

    		 Obligations of the applicant for a certificate of airworthiness or a restricted certificate of airworthiness

    21L.A.145

    		 Transferability and re-issuance of a certificate of airworthiness and of a restricted certificate of airworthiness within Member States

    21L.A.146

    		 Continued validity of a certificate of airworthiness and of a restricted certificate of airworthiness

    SUBPART I –

    		 NOISE CERTIFICATES AND RESTRICTED NOISE CERTIFICATES

    21L.A.161

    		 Scope

    21L.A.162

    		 Eligibility

    21L.A.163

    		 Application

    21L.A.164

    		 Transferability and re-issuance of noise certificates and restricted noise certificates within Member States

    21L.A.165

    		 Continued validity of a noise certificate and of a restricted noise certificate

    SUBPART J –

    		 DECLARED DESIGN ORGANISATIONS

    21L.A.171

    		 Scope

    21L.A.172

    		 Eligibility

    21L.A.173

    		 Declaration of design capability

    21L.A.174

    		 Management system for design

    21L.A.175

    		 Resources of the declared design organisation

    21L.A.176

    		 Scope of work

    21L.A.177

    		 Obligations of the declared design organisation

    21L.A.178

    		 Notification of changes and cessation of activities

    SUBPART K –

    		 PARTS

    21L.A.191

    		 Scope

    21L.A.192

    		 Showing of compliance

    21L.A.193

    		 Release of parts for installation

    SUBPART M –

    		 DESIGN OF REPAIRS TO TYPE-CERTIFIED PRODUCTS

    21L.A.201

    		 Scope

    21L.A.202

    		 Standard repairs

    21L.A.203

    		 Classification of repair designs to a type-certified product

    21L.A.204

    		 Eligibility

    21L.A.205

    		 Application for the approval of a repair design to a type-certified product

    21L.A.206

    		 Demonstration of compliance

    21L.A.207

    		 Requirements for the approval of a minor repair design

    21L.A.208

    		 Requirements for the approval of a major repair design

    21L.A.209

    		 Approval of a repair design under a privilege

    21L.A.210

    		 Obligations of a holder of a repair design approval

    21L.A.211

    		 Unrepaired damage

    SUBPART N –

    		 DESIGN OF REPAIRS TO AIRCRAFT FOR WHICH DESIGN COMPLIANCE HAS BEEN DECLARED

    21L.A.221

    		 Scope

    21L.A.222

    		 Standard repairs

    21L.A.223

    		 Classification of repair designs to an aircraft for which design compliance has been declared

    21L.A.224

    		 Eligibility

    21L.A.225

    		 Declaration of design compliance for minor repair designs

    21L.A.226

    		 Declaration of design compliance of major repair designs

    21L.A.227

    		 Compliance activities for declaring compliance of a major repair design

    21L.A.228

    		 Obligations of the declarant of a declaration of design compliance of a repair design

    21L.A.229

    		 Unrepaired damage

    SUBPART O –

    		 EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS

    SUBPART P –

    		 PERMIT TO FLY

    21L.A.241

    		 Permit to fly and flight conditions

    SUBPART Q –

    		 IDENTIFICATION OF PRODUCTS AND PARTS

    21L.A.251

    		 Scope

    21L.A.252

    		 Design of markings

    21L.A.253

    		 Identification of products

    21L.A.254

    		 Handling of identification data

    21L.A.255

    		 Identification of parts

    SUBPART R –

    		 STATEMENT OF CONFORMITY FOR AIRCRAFT AND AUTHORISED RELEASE CERTIFICATE (EASA FORM 1) FOR ENGINES AND PROPELLERS, OR PARTS THEREOF, THAT CONFORM TO A DECLARATION OF DESIGN COMPLIANCE

    21L.A.271

    		 Scope

    21L.A.272

    		 Eligibility

    21L.A.273

    		 Production control system

    21L.A.274

    		 Issuance of a statement of conformity (EASA Form 52B) or an authorised release certificate (EASA Form 1)

    21L.A.275

    		 Obligations of a natural or legal person issuing a statement of conformity (EASA Form 52B) or an authorised release certificate (EASA Form 1)

    SECTION B –

    		PROCEDURES FOR COMPETENT AUTHORITIES

    SUBPART A –

    		 GENERAL PROVISIONS

    21L.B.11

    		 Oversight documentation

    21L.B.12

    		 Exchange of information

    21L.B.13

    		 Information to the Agency

    21L.B.14

    		 Airworthiness directives received from non-Member States

    21L.B.15

    		 Immediate reaction to a safety problem

    21L.B.16

    		 Management system

    21L.B.17

    		 Allocation of tasks to qualified entities

    21L.B.18

    		 Changes in the management system

    21L.B.19

    		 Resolution of disputes

    21L.B.20

    		 Record-keeping

    21L.B.21

    		 Findings and observations

    21L.B.22

    		 Enforcement measures

    21L.B.23

    		 Airworthiness directives

    21L.B.24

    		 Means of compliance

    SUBPART B –

    		 TYPE CERTIFICATES

    21L.B.41

    		 Certification specifications

    21L.B.42

    		 Initial investigation

    21L.B.43

    		 Type-certification basis for a type certificate

    21L.B.44

    		 Special conditions

    21L.B.45

    		 Designation of the applicable environmental protection requirements for a type certificate

    21L.B.46

    		 Investigation

    21L.B.47

    		 Issuance of a type certificate

    21L.B.48

    		 Continuing airworthiness oversight of products for which a type certificate has been issued

    21L.B.49

    		 Transfer of a type certificate

    SUBPART C –

    		 DECLARATIONS OF DESIGN COMPLIANCE

    21L.B.61

    		 Detailed technical specifications and applicable environmental protection requirements for declarations of product design compliance

    21L.B.62

    		 Initial oversight investigation

    21L.B.63

    		 Registration of a declaration of design compliance

    21L.B.64

    		 Continuing airworthiness oversight of aircraft for which design compliance has been declared

    SUBPART D –

    		 CHANGES TO TYPE CERTIFICATES

    21L.B.81

    		 Type-certification basis and applicable environmental protection requirements for a major change to a type certificate

    21L.B.82

    		 Investigation and issuance of an approval of a minor change to a type certificate

    21L.B.83

    		 Investigation of a major change to a type certificate

    21L.B.84

    		 Issuance of an approval of a major change to a type certificate

    21L.B.85

    		 Continuing airworthiness oversight of changed products for which a type certificate has been issued

    SUBPART E –

    		 SUPPLEMENTAL TYPE CERTIFICATES

    21L.B.101

    		 Type-certification basis and applicable environmental protection requirements for a supplemental type certificate

    21L.B.102

    		 Investigation

    21L.B.103

    		 Issuance of a supplemental type certificate

    21L.B.104

    		 Continuing airworthiness oversight of products for which a supplemental type certificate has been issued

    SUBPART F –

    		 CHANGES TO AIRCRAFT FOR WHICH DESIGN COMPLIANCE HAS BEEN DECLARED

    21L.B.121

    		 Initial oversight investigation of a declaration of design compliance of a major change to the design of an aircraft for which design compliance has been declared

    21L.B.122

    		 Registration of a declaration of design compliance for a major change to an aircraft design

    21L.B.123

    		 Continuing airworthiness oversight of a changed aircraft for which design compliance has been declared

    SUBPART G –

    		 DECLARED PRODUCTION ORGANISATIONS

    21L.B.141

    		 Initial oversight investigation

    21L.B.142

    		 Registration of a declaration of production capability

    21L.B.143

    		 Oversight

    21L.B.144

    		 Oversight programme

    21L.B.145

    		 Oversight activities

    21L.B.146

    		 Changes to declarations

    SUBPART H –

    		 CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS

    21L.B.161

    		 Investigation

    21L.B.162

    		 Issuance or amendment of a certificate of airworthiness or a restricted certificate of airworthiness

    21L.B.163

    		 Oversight

    SUBPART I –

    		 NOISE CERTIFICATES

    21L.B.171

    		 Investigation

    21L.B.172

    		 Issuance or amendment of noise certificates

    21L.B.173

    		 Oversight

    SUBPART J –

    		 DECLARED DESIGN ORGANISATIONS

    21L.B.181

    		 Initial oversight investigation

    21L.B.182

    		 Registration of a declaration of design capability

    21L.B.183

    		 Oversight

    21L.B.184

    		 Oversight programme

    21L.B.185

    		 Oversight activities

    21L.B.186

    		 Changes to declarations

    SUBPART K –

    		 PARTS

    SUBPART M –

    		 DESIGN OF REPAIRS TO TYPE-CERTIFIED PRODUCTS

    21L.B.201

    		 Type-certification basis and applicable environmental protection requirements for a repair design approval

    21L.B.202

    		 Investigation and issuance of an approval for a minor repair design

    21L.B.203

    		 Investigation of an application for the approval of a major repair design

    21L.B.204

    		 Issuance of an approval of a major repair design

    21L.B.205

    		 Continuing airworthiness oversight of products for which a repair design has been approved

    21L.B.206

    		 Unrepaired damage

    SUBPART N –

    		 DESIGN OF REPAIRS TO AIRCRAFT FOR WHICH DESIGN COMPLIANCE HAS BEEN DECLARED

    21L.B.221

    		 Initial oversight investigation of a declaration of design compliance of a major repair design to an aircraft for which design compliance has been declared

    21L.B.222

    		 Registration of a declaration of a major repair design to an aircraft for which design compliance has been declared

    21L.B.223

    		 Continuing airworthiness oversight of a repair design for which design compliance has been declared

    SUBPART O –

    		 EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS

    SUBPART P –

    		 PERMIT TO FLY

    21L.B.241

    		 Investigation prior to the issuance of a permit to fly

    21L.B.242

    		 Investigation prior to issuance of the flight conditions

    SUBPART Q –

    		 IDENTIFICATION OF PRODUCTS AND PARTS

    SUBPART R –

    		 STATEMENT OF CONFORMITY FOR AIRCRAFT AND AUTHORISED RELEASE CERTIFICATES (EASA FORM 1) FOR ENGINES AND PROPELLERS, AND PARTS THEREOF, THAT CONFORM TO A DECLARATION OF DESIGN COMPLIANCE

    21L.B.251

    		 Oversight

    21L.B.252

    		 Oversight programme

    21L.B.253

    		 Oversight activities

    Appendices to Annex Ib

    21L.1   Scope

    (reserved)

    21L.2   Competent authority

    (reserved)

    SECTION A

    TECHNICAL REQUIREMENTS

    SUBPART A –   GENERAL PROVISIONS

    21L.A.1   Scope

    This Section establishes general rights and obligations that are applicable to:

    (a)

    the applicant for, and holder of, any certificate issued or to be issued in accordance with this Annex;

    (b)

    any declarant of design or production capability or of design compliance; and

    (c)

    any natural or legal person issuing a statement of conformity for an aircraft, or an authorised release certificate (EASA Form 1) for an engine, propeller or part produced.

    21L.A.2   Obligations and actions performed by a person other than the applicant for, or holder of, a certificate or the declarant of a declaration of design compliance

    The actions and obligations required to be undertaken by the applicant for, or holder of, a certificate for a product or part or by the declarant of a declaration of design compliance under this Section may be undertaken on its behalf by any other natural or legal person, provided that the applicant’s, holder’s or declarant’s obligations are and will be properly discharged.

    21L.A.3   Reporting system

    (a)

    Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council (1) and its delegated and implementing acts, any natural or legal person who holds or has applied for a type certificate, supplemental type certificate, major repair design approval, or any other relevant certificate deemed to have been issued under this Annex, or who has declared the compliance of an aircraft design, or a design change or repair design to it under this Annex shall:

    1.

    establish and maintain a system for collecting, investigating and analysing occurrence reports in order to identify adverse trends or to address deficiencies, and to extract occurrences, whose reporting is mandatory in accordance with point (3) and those which are reported voluntarily. The reporting system shall include:

    (i)

    reports of and information related to failures, malfunctions, defects or other events which cause or might cause adverse effects on the continuing airworthiness of the product or part covered by the type certificate, supplemental type certificate, major repair design approval, or any other relevant certificate deemed to have been issued under this Annex, or by the declaration of design compliance issued under this Annex;

    (ii)

    reports of errors, near misses, and hazards that do not fall under point (i);

    2.

    make available to known operators of the product or part, and, on request, to any person authorised under other associated implementing acts or delegated acts, the information about the system established in accordance with point (a)(1), and on how to provide such reports of and information related to failures, malfunctions, defects or other events referred to in point (a)(1)(i);

    3.

    report to the Agency any failure, malfunction, defect or other event of which they are aware related to a product or part, covered by the type certificate, supplemental type certificate, major repair design approval, or any other relevant certificate deemed to have been issued under this Annex, or by a declaration of design compliance issued under this Annex, and which has resulted in or may result in an unsafe condition.

    (b)

    Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, any natural or legal person who has declared their production capability under Subpart G of this Annex, or who produces a product or part under Subpart R of this Annex, shall:

    1.

    establish and maintain a system for collecting and assessing internal occurrence reports, including reports on internal errors, near misses, and hazards, in order to identify adverse trends or to address deficiencies, and extract occurrences, whose reporting is mandatory in accordance with points (2) and (3) and those which are reported voluntarily;

    2.

    report, to the responsible design approval holder or declarant of a declaration of design compliance, all cases in which products or parts have been released by them and subsequently identified to have possible deviations from the applicable design data, and investigate with the design approval holder or the declarant of a declaration of design compliance, to identify those deviations which could lead to an unsafe condition;

    3.

    report to the Agency and the competent authority of the Member State responsible in accordance with point 21L.2, if any, the deviations which could lead to an unsafe condition that were identified according to point (2) of point 21L.A.3(b);

    4.

    if acting as a supplier to another production organisation, report to that other organisation all the cases in which it has released products or parts to that organisation and subsequently identified them to have possible deviations from the applicable design data.

    The reporting obligations of point 21.A.3A(b) of Annex I of natural and legal persons who hold or have applied for a production organisation approval shall include occurrences related to products and parts produced in conformity with design data approved or declared in accordance with this Annex, and, where the design compliance was declared, reports shall be made to the declarant of design compliance.

    (c)

    Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, any natural or legal person referred to in points (a) and (b) when reporting in accordance with points (a)(3), (b)(2), (b)(3) and (b)(4), shall appropriately safeguard the confidentiality of the reporter and of the persons mentioned in the report.

    (d)

    Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, any natural or legal person referred to in points (a) and (b) shall make the reports defined in points (a)(3) and (b)(3) in a form and manner established by the competent authority as soon as practicable, and in any case, dispatch the reports not later than 72 hours after the natural or legal person referred to in points (a) and (b) has identified the possible unsafe condition, unless exceptional circumstances prevent this.

    (e)

    Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, if an occurrence reported under point (a)(3) or under point (b)(3) results from a deficiency in the design, or a production deficiency, the holder of the type certificate, supplemental type certificate, major repair design approval, or any other relevant certificate deemed to have been issued under this Annex, the declarant of a declaration of design compliance or the production organisation referred to in point (b) as appropriate, shall investigate the reason for the deficiency and report to the Agency and to the competent authority of the Member State responsible in accordance with point 21L.2, if any, the results of its investigation and any action it is taking or proposes to take to correct that deficiency.

    (f)

    If the competent authority finds that an action is required to correct the deficiency, the holder of the type certificate, supplemental type certificate, major repair design approval, or any other relevant certificate deemed to have been issued under this Annex, the declarant of a declaration of design compliance, or the production organisation referred to in point (b) as appropriate, shall submit the relevant data to the competent authority upon its request.

    21L.A.4   Airworthiness directives

    When an airworthiness directive has to be issued by the Agency in accordance with point 21L.B.23 to correct an unsafe condition, or to require the performance of an inspection, the holder of the type certificate, supplemental type certificate, major repair design approval, or any other relevant certificate deemed to have been issued under this Annex, as well as the declarant of a declaration of design compliance, as applicable, shall:

    (a)

    propose the appropriate corrective action or required inspections, or both, and submit details of these proposals to the Agency for approval;

    (b)

    following the approval by the Agency of the proposals referred to under point (a), make available to all known operators or owners of the product or part, and, on request, to any person required to comply with the airworthiness directive, appropriate descriptive data and accomplishment instructions.

    21L.A.5   Collaboration between design and production

    The holder of a type certificate, supplemental type certificate, approval of a change to type certificate or approval of a repair design, the declarant of a declaration of design compliance, and the organisation or the natural or legal person producing products or parts of that specific design shall collaborate so as to ensure that the product or part are in conformity to that design and to ensure the continued airworthiness of the product or part.

    21L.A.6   Marking

    (a)

    The holder of a type certificate, supplemental type certificate, approval of a change to type certificate or approval of a repair design, or the declarant of a declaration of design compliance shall specify the marking for products or parts in accordance with Subpart Q of this Annex.

    (b)

    The organisation or the natural or legal person producing products or parts shall mark these products and parts in accordance with Subpart Q of this Annex.

    21L.A.7   Record-keeping

    All natural or legal persons who hold or who have applied for a type certificate, supplemental type certificate, repair design approval, or permit to fly, who have declared design compliance, who have issued a declaration of design or production capability, or who produce products or parts under this Regulation shall:

    (a)

    when designing a product or part or changes or repairs thereto, establish a record-keeping system that incorporates the requirements imposed on its partners and subcontractors and maintain the relevant design information/data and hold it at the disposal of the Agency in order to provide the information necessary to ensure their continued airworthiness and compliance with the applicable environmental protection requirements;

    (b)

    when producing a product or part, establish a record-keeping system and record the details of the work relevant to the conformity of the products or parts, and the requirements imposed on its partners and suppliers, and hold them at the disposal of the competent authority in order to provide the information necessary to ensure the continuing airworthiness of the product and part;

    (c)

    with regard to permits to fly, in addition to the record-keeping requirements established in point 21.A.5(c) of Annex I, record any documents produced to demonstrate compliance with the additional requirements established in point 21L.A.241(b), and hold them at the disposal of the Agency and the competent authority;

    (d)

    retain records of competence and the qualifications of personnel who are involved in design or production and in the independent function to monitor the compliance, if required by points 21L.A.125(c), 21L.A.175(b) or 21L.A.175(e).

    21L.A.8   Manuals

    The holder of a type certificate or supplemental type certificate or the declarant of a declaration of design compliance shall produce, maintain and update master copies of all the manuals or variations in the manuals required by the applicable type-certification basis, the applicable detailed technical specifications and the applicable environmental protection requirements for the product or part, and provide copies, on request, to the Agency.

    21L.A.9   Instructions for continued airworthiness

    (a)

    The holder of a type certificate, supplemental type certificate, design change or repair design approval or the declarant of a declaration of design compliance shall establish the information which is necessary for ensuring that the airworthiness of the aircraft type and any associated part, conforming to that design, is maintained throughout the operational life.

    (b)

    The holder of a type certificate, supplemental type certificate, design change or repair design approval or the declarant of a declaration of design compliance shall provide the information established in (a) before that design is released to service.

    (c)

    The instructions for continued airworthiness shall be provided by:

    1.

    the holder of a type certificate or by the declarant of a declaration of design compliance to each known owner of one or more products upon its delivery or upon the issuance of the first certificate of airworthiness or restricted certificate of airworthiness, as applicable, for the affected aircraft, whichever occurs later;

    2.

    the holder of a type certificate, supplemental type certificate or minor change approval or by the declarant of a declaration of design compliance for a design change to all known operators of the product affected by the change upon the release to service of the modified product;

    3.

    the holder of a repair design approval or by the declarant of a declaration of design compliance for a repair design to all known operators of the product affected by the repair upon the release to service of the product in which the repair design is embodied. The repaired product or part may be released into service before the related instructions for continued airworthiness have been completed, but this shall be for a limited service period, and in agreement with the Agency.

    Thereafter, these certificate holders or declarants shall make this information available on request to any other person required to comply with those instructions for continued airworthiness.

    (d)

    By way of derogation from point (b), the type-certificate holder or declarant of a declaration of design compliance may delay the availability of a part of the instructions for continued airworthiness, dealing with long lead accomplishment instructions of a scheduled nature, until after the product or modified product has entered into service, but shall make those instructions available before the use of this data is required for the product or modified product.

    (e)

    The design approval holder or declarant of a declaration of design compliance who is required to provide instructions for continued airworthiness in accordance with point (b) shall also make available all the changes to those instructions to all the known operators of the product affected by the change, and, on request, to any other person required to comply with those changes.

    21L.A.10   Access and investigation

    All natural or legal persons who hold or who have applied for a type certificate, supplemental type certificate, major repair design approval, permit to fly, certificate of airworthiness, restricted certificate of airworthiness, noise certificate or restricted noise certificate, who have declared design compliance, who have declared their design or production capability or who produce aircraft, engines, propellers or parts under Subpart R of this Annex, shall:

    (a)

    grant the competent authority access to any facility, product, part, document, record, data, processes, procedures or any other material, and permit the review of any report and make any inspection and perform or witness any test that is necessary to verify the compliance and the continued compliance with the applicable requirements of this Section;

    (b)

    if the natural or legal person uses partners, suppliers or subcontractors, make arrangements with them to ensure that the competent authority has access and can investigate as described in point (a).

    21L.A.11   Findings and observations

    (a)

    After the receipt of the notification of findings, the natural or legal person who holds or who has applied for a type certificate, supplemental type certificate, major repair design approval, permit to fly, certificate of airworthiness, restricted certificate of airworthiness, noise certificate or restricted noise certificate, who has declared design compliance, who has declared their design or production capability or who produces aircraft, engines, propellers or parts under Subpart R of this Annex, shall take the following steps within the time period determined by the competent authority in accordance with point (d) or (e) of point 21L.B.21:

    1.

    identify the root cause(s) of, and contributing factor(s) to, the non-compliance;

    2.

    define a corrective action plan and propose it to the competent authority;

    3.

    demonstrate the implementation of the corrective action(s) to the satisfaction of the competent authority.

    (b)

    An observation notified by the competent authority in accordance with point (f) of point 21L.B.21 shall be given due consideration. The natural or legal person shall record the decision taken in respect of those observations.

    21L.A.12   Means of compliance

    (a)

    A legal or natural person may use any alternative means of compliance to the acceptable means of compliance (AMC) to establish compliance with this Regulation.

    (b)

    If a natural or legal person wishes to use an alternative means of compliance, they shall, prior to using it, provide the competent authority with a full description. The description shall include any revisions to manuals or procedures that may be relevant, as well as an explanation indicating how compliance with this Regulation is achieved.

    (c)

    The natural or legal person may use those alternative means of compliance subject to prior approval from the competent authority.

    SUBPART B –   TYPE CERTIFICATES

    21L.A.21   Scope

    This Subpart establishes the procedure for applying for type certificates, and establishes the rights and obligations of the applicants for, and holders of, those certificates for products, when the product is one of the following:

    (a)

    an aeroplane with a maximum take-off mass (MTOM) of 2 000 kg or less with a seating configuration of maximum four persons;

    (b)

    a sailplane or powered sailplane with an MTOM of 2 000 kg or less;

    (c)

    a balloon;

    (d)

    a hot air airship;

    (e)

    a passenger gas airship designed for not more than four persons;

    (f)

    a rotorcraft with an MTOM of 1 200 kg or less with a seating configuration of maximum four persons;

    (g)

    a piston engine and fixed pitch propeller that are intended to be installed on an aircraft referred to in points (a) to (f). In such cases, the type certificate data sheet shall be appropriately annotated to only permit installation of the engine or propeller on such aircraft;

    (h)

    gyroplanes.

    21L.A.22   Eligibility

    Any natural or legal person who has demonstrated, or is in the process of demonstrating, their design capability in accordance with point 21L.A.23, may apply for a type certificate under the conditions laid down in this Subpart.

    21L.A.23   Demonstration of design capability

    An applicant for a type certificate shall demonstrate their design capability by:

    (a)

    holding a design organisation approval with terms of approval that cover the respective category of the product, issued by the Agency in accordance with Subpart J of Section A of Annex I (Part 21); or

    (b)

    declaring their design capability for the type of design work and the category of the product in accordance with Subpart J of this Annex.

    21L.A.24   Application for a type certificate

    (a)

    An application for a type certificate shall be made in a form and manner established by the Agency.

    (b)

    An application for a type certificate shall include as a minimum:

    1.

    a justification that the application is within the scope as established in point 21L.A.21;

    2.

    preliminary descriptive data of the product, the intended use, and the kind of operation of the product for which certification is requested;

    3.

    a proposal for the type-certification basis and the applicable environmental protection requirements, prepared in accordance with the requirements and options specified in points 21L.B.43 and 21L.B.45;

    4.

    a compliance demonstration plan detailing the means and methods of compliance that shall be updated by the applicant when there are changes to the certification project that affect points (1) to (3) or any changes to the means and methods of compliance.

    (c)

    An application for a type certificate shall remain valid for 3 years. In case a type certificate has not been issued within this period, a new application shall be made in accordance with points (a) and (b).

    21L.A.25   Demonstration of compliance

    (a)

    The applicant for a type certificate shall, following the acceptance of the compliance demonstration plan by the Agency and in accordance with its contents, then:

    1.

    demonstrate compliance with the applicable type-certification basis as established and notified to the applicant by the Agency in accordance with point 21L.B.43;

    2.

    demonstrate compliance with the applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with point 21L.B.45; and

    3.

    provide the Agency with the means by which such compliance has been demonstrated.

    (b)

    The applicant for a type certificate shall provide the Agency with a recorded justification of the means of compliance within compliance documents according to the compliance demonstration plan.

    (c)

    When carrying out testing and inspections to demonstrate compliance in accordance with point (a), the applicant shall have verified and documented this verification prior to carrying out any test:

    1.

    for each test specimen, that:

    (i)

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

    (ii)

    the constituent parts of the products adequately conform to the drawings in the proposed type design;

    (iii)

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

    2.

    that the test and measuring equipment used for the test were adequate for the test and appropriately calibrated.

    (d)

    The flight testing for the purpose of obtaining a type certificate shall be conducted in accordance with the methods for such flight testing specified by the Agency. The applicant for a type certificate shall make all the flight tests necessary to determine compliance with the applicable type-certification basis. The flight tests shall include a period of operation in a final configuration of a sufficient duration to ensure that there will be no safety issues when the aircraft first enters service.

    (e)

    An applicant for a type certificate shall allow the Agency to:

    1.

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

    2.

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

    3.

    conduct a physical inspection of the first article of that product in the final configuration to verify the compliance of the design with the type-certification basis and the applicable environmental protection requirements and any other investigation determined in accordance with point 21L.B.46.

    (f)

    Upon the completion of the compliance demonstration, the applicant shall declare to the Agency that:

    1.

    they have demonstrated compliance with the type-certification basis and the applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with points 21L.B.43 and 21L.B.45, according to the compliance demonstration plan; and

    2.

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

    21L.A.26   Type design

    The applicant for a type certificate shall define the product type design to enable its unique and unambiguous identification, consisting of:

    (a)

    drawings and specifications and a listing of those drawings and specifications that are necessary to define the configuration and the design features of the product;

    (b)

    information on the materials and processes used;

    (c)

    information on the methods of manufacture and assembly;

    (d)

    any airworthiness limitations;

    (e)

    the environmental compatibility requirements; and

    (f)

    any other data allowing by comparison the determination of the airworthiness, and, if relevant, the environmental compatibility of later products of the same type.

    21L.A.27   Requirements for the issuance of a type certificate

    In order to be issued with a type certificate, the applicant shall:

    (a)

    demonstrate their design capability in accordance with point 21L.A.23;

    (b)

    demonstrate the compliance of the design in accordance with point 21L.A.25;

    (c)

    demonstrate, for aircraft type certificates, that the engine or propeller, or both, if installed on the aircraft, have either:

    1.

    a type certificate issued or determined in accordance with Annex I (Part 21) or issued in accordance with this Annex; or

    2.

    been included within the application for the aircraft type certificate and the applicant has ensured the compliance of the engine and propeller during the compliance demonstration in point 21L.A.25;

    (d)

    demonstrate that there are no unresolved issues from the physical inspection of the first article of that product in the final configuration or any other investigation carried out by the Agency in accordance with points (c) and (d) of point 21L.B.46.

    21L.A.28   Obligations of a type-certificate holder

    The holder of a type certificate shall undertake the obligations of a type-certificate holder set forth in Subpart A of this Annex and shall continue to comply with the eligibility requirement under point 21L.A.22.

    21L.A.29   Transferability of a type certificate

    A type certificate may be transferred to a new holder, provided that the Agency has verified, in accordance with point 21L.B.49, that the natural or legal person to whom the type certificate is intended to be transferred is eligible in accordance with point 21L.A.22 to hold a type certificate and is able to undertake the obligations of a type-certificate holder under point 21L.A.28. The holder of the type certificate or the natural or legal person who wishes to adopt the certificate shall apply to the Agency to verify whether these conditions are complied with, in a form and manner established by the Agency.

    21L.A.30   Continued validity of a type certificate

    (a)

    A type certificate shall remain valid as long as:

    1.

    the type certificate is not surrendered by the holder;

    2.

    the holder of the type certificate remains in compliance with the relevant requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, taking into account the provisions related to the handling of findings as specified under point 21L.B.21;

    3.

    the type certificate is not revoked by the Agency in accordance with point 21L.B.22.

    (b)

    Upon surrender or revocation, the type certificate shall be returned to the Agency.

    SUBPART C –   DECLARATIONS OF AIRCRAFT DESIGN COMPLIANCE

    21L.A.41   Scope

    (a)

    This Subpart establishes the procedure for declaring the design compliance of aircraft, and establishes the rights and obligations of the persons making such declarations.

    (b)

    This Subpart applies to the following categories of aircraft, provided that the design of the aircraft does not include novel or unusual design features:

    1.

    an aeroplane with a maximum take-off mass (MTOM) of 1 200 kg or less that is not jet-powered, and has a seating configuration of maximum two persons;

    2.

    a sailplane or powered sailplane with an MTOM of 1 200 kg or less;

    3.

    a balloon designed for not more than four persons;

    4.

    a hot air airship designed for not more than four persons.

    (c)

    For the purpose of this Subpart, a design feature shall be considered to be novel or unusual if at the time that the declaration of design compliance is made, that design feature is not covered by the detailed technical specifications established and made available by the Agency in accordance with point 21L.B.61.

    21L.A.42   Eligibility

    Any natural or legal person may declare the compliance of an aircraft design under the conditions laid down in this Subpart.

    21L.A.43   Declaration of design compliance

    (a)

    Prior to producing an aircraft or agreeing with a production organisation to produce an aircraft, a natural or legal person who designs that aircraft shall declare that its design complies with the applicable detailed technical specifications and the applicable environmental protection requirements referred to in point 21L.A.45.

    (b)

    The declaration shall be made in a form and manner established by the Agency and shall contain at least the following information:

    1.

    the name of the person submitting the declaration, and their address/place of business;

    2.

    a unique reference for identifying the aircraft;

    3.

    indication of the applicable detailed technical specifications and the applicable environmental protection requirements according to point 21L.A.45 with which the declarant declares compliance;

    4.

    a signed statement made under the sole responsibility of the person making the declaration that the design of the aircraft, and if applicable the engine or propeller, is in compliance with the applicable detailed technical specifications and the applicable environmental protection requirements referred to in point 3, according to the compliance demonstration plan referred to in point (c)(3);

    5.

    a signed statement made under the sole responsibility of the person making the declaration that no features or characteristics have been identified by that person that may make the aircraft unsafe or environmentally incompatible for the intended use;

    6.

    a signed commitment that the person making the declaration will undertake the obligations referred to in point 21L.A.47;

    7.

    if the aircraft design covered by the declaration includes an engine or propeller:

    (i)

    a reference to the engine or propeller type certificate issued or determined in accordance with Annex I (Part 21) or issued in accordance with this Annex; or

    (ii)

    in the case of piston engines and fixed pitch propellers, a statement that the declaration of design compliance of the aircraft covers the compliance of the engine or propeller with the applicable engine or propeller technical specifications;

    8.

    the instructions for continued airworthiness;

    9.

    the operating limitations;

    10.

    the data sheet for airworthiness and, if applicable, emissions;

    11.

    the data sheet for noise, if applicable;

    12.

    any other conditions or limitations prescribed for the aircraft, and if applicable the engine or propeller, in the applicable detailed technical specifications and the applicable environmental protection requirements with which the declarant declares compliance.

    (c)

    The declarant shall submit the declaration of design compliance referred to in point (b) to the Agency. Together with this declaration, the declarant shall provide to the Agency:

    1.

    a drawing of the aircraft;

    2.

    a detailed description of the aircraft design, including all the configurations covered by the declaration, the operating characteristics, design features and any limitations;

    3.

    a compliance demonstration plan detailing the means by which compliance with the applicable detailed technical specifications and the applicable environmental protection requirements has been demonstrated during compliance demonstration;

    4.

    recorded justifications of compliance obtained from the compliance activities that have been conducted according to the compliance demonstration plan;

    5.

    where compliance is demonstrated by carrying out tests, recorded justification of the conformity of the test articles and equipment, demonstrating:

    (i)

    for the test specimen, that:

    (A)

    the materials and processes adequately conformed to the specifications for the design;

    (B)

    the constituent parts of the products adequately conformed to the drawings in the design; and

    (C)

    the manufacturing processes, construction and assembly adequately conformed to those specified in the design;

    (ii)

    that the test and measuring equipment used for the test were adequate for the test and appropriately calibrated;

    6.

    reports, results of inspections or tests that the declarant found necessary to determine that the aircraft, and if applicable the engine or propeller, complies with the applicable detailed technical specifications and the applicable environmental protection requirements.

    21L.A.44   Compliance activities for a declaration of design compliance

    Prior to making a declaration of design compliance in accordance with point 21L.A.43, the declarant responsible for design of that aircraft shall, for that specific aircraft design:

    (a)

    establish a compliance demonstration plan detailing the means for compliance demonstration that shall be followed during the compliance demonstration. This document shall be updated as necessary;

    (b)

    record the justification of compliance within compliance documents according to the compliance demonstration plan;

    (c)

    perform testing and inspections as necessary in accordance with the compliance demonstration plan;

    (d)

    ensure and record the conformity of the test articles and equipment and ensure that the test specimen conforms to the specifications, drawings, manufacturing processes, construction and assembly means in the design;

    (e)

    ensure that the test and measuring equipment to be used for testing are adequate for testing and appropriately calibrated;

    (f)

    allow the Agency to conduct or participate in any inspections or tests of aircraft in the final or suitably mature design and production configuration that are necessary to determine that the product has no feature or characteristic that makes the aircraft unsafe or environmentally incompatible for the intended use;

    (g)

    carry out flight testing, in accordance with the methods for such flight testing specified by the Agency, to determine whether the aircraft complies with the applicable detailed technical specifications and the applicable environmental protection requirements. The flight testing shall include a period of operation in the final configuration of a sufficient duration to ensure that there will be no safety issues when the aircraft first enters service.

    21L.A.45   Detailed technical specifications and environmental protection requirements that are applicable to aircraft subject to declarations of design compliance

    The declarant shall demonstrate the compliance of the aircraft design with the detailed technical specifications and the applicable environmental protection requirements referred to in point 21L.B.61, which are applicable to that aircraft and which are effective on the date on which the declaration of design compliance is made to the Agency.

    21L.A.46   Aircraft design data

    (a)

    The declarant shall clearly define the aircraft design to enable its unique and unambiguous identification.

    (b)

    The aircraft design data that is used by the declarant to uniquely define the aircraft design shall include:

    1.

    the drawings and specifications and a listing of those drawings and specifications that are necessary to define the configuration and the design features of the product;

    2.

    information on the materials and processes used;

    3.

    information on the methods of manufacture and assembly;

    4.

    any airworthiness limitations;

    5.

    any environmental compatibility requirements; and

    6.

    any other data allowing by comparison the determination of the airworthiness and, if relevant, the environmental compatibility of later products of the same type.

    21L.A.47   Obligations of the declarant of a declaration of design compliance

    The declarant who made a declaration of aircraft design compliance to the Agency in accordance with point 21L.A.43 shall:

    (a)

    upon submission of the declaration, arrange for the Agency to conduct a physical inspection and flight tests of the first article of that aircraft in the final or a suitably mature configuration to ensure that the aircraft can achieve an acceptable level of safety and is environmentally compatible;

    (b)

    retain all the supporting documents for the declaration of design compliance, and make them available to the Agency upon request;

    (c)

    comply with all other obligations applicable to a declarant of a declaration of design compliance set forth in Subpart A of this Annex.

    21L.A.48   Non-transferability of a declaration of aircraft design compliance

    (a)

    A declaration of aircraft design compliance cannot be transferred.

    (b)

    A natural or legal person who is taking over the design of an aircraft for which compliance of the design has been previously declared shall:

    1.

    submit a new declaration of aircraft design compliance in accordance with this Subpart;

    2.

    demonstrate that the declarant who previously made a declaration of aircraft design compliance is no longer active or has agreed to the transfer of the aircraft design data;

    3.

    commit to comply with all the obligations applicable to persons making a declaration of aircraft design compliance set forth in this Subpart as per point 21L.A.47.

    SUBPART D –   CHANGES TO TYPE CERTIFICATES

    21L.A.61   Scope

    This Subpart establishes:

    (a)

    the procedure for applying for the approval of changes to type certificates for products certified in accordance with this Annex, provided that the changed product is still within the scope of point 21L.A.21;

    (b)

    the rights and obligations of the applicants for, and holders of, those approvals referred to in point (a);

    (c)

    provisions regarding the standard changes that do not require an approval.

    21L.A.62   Standard changes

    (a)

    Standard changes are those changes to a type certificate of a product approved in accordance with Subpart B of Section B of this Annex:

    1.

    that follow the design data included in the certification specifications issued by the Agency, containing the acceptable methods, techniques and practices for carrying out and identifying standard changes, including the associated instructions for continued airworthiness; and

    2.

    that are not in conflict with the data of the holder of that type certificate.

    (b)

    Points 21L.A.63 to 21L.A.70 are not applicable to standard changes.

    21L.A.63   Classification of changes to a type certificate

    (a)

    Changes to a type certificate shall be classified as minor or major.

    (b)

    A ‘minor change’ is a change that has no appreciable effect on the mass, balance, structural strength, reliability, certified noise or emissions levels, operational characteristics, or other characteristics affecting the airworthiness or the environmental compatibility of the product.

    (c)

    All other changes are ‘major changes’, unless the change in design, power, thrust, or mass is so extensive that a substantially complete investigation of compliance with the applicable type-certification basis or with the applicable environmental protection requirements or with the applicable detailed technical specifications is required, in which case the design shall be certified in accordance with Subpart B of this Annex.

    (d)

    The requirements for the approval of minor changes are those established in point 21L.A.67.

    (e)

    The requirements for the approval of major changes are those established in point 21L.A.68.

    21L.A.64   Eligibility

    (a)

    Only the type-certificate holder may apply for the approval of a major change to a type certificate under this Subpart; all other applicants for a major change to a type certificate shall apply under Subpart E of this Annex.

    (b)

    Any natural or legal person may apply for the approval of a minor change to a type certificate under this Subpart.

    21L.A.65   Application for a change to a type certificate

    (a)

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

    (b)

    For a major change to a type certificate, the applicant shall include in the application a compliance demonstration plan for the demonstration of compliance in accordance with point 21L.A.66, along with a proposal for the type-certification basis and the applicable environmental protection requirements, prepared in accordance with the requirements and options specified in point 21L.B.81.

    21L.A.66   Demonstration of compliance

    (a)

    The applicant for a major change to a type certificate shall demonstrate compliance with the applicable type-certification basis and the applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with point 21L.B.81, and shall provide the Agency with the means by which such compliance has been demonstrated.

    (b)

    The applicant for a major change to a type certificate shall provide the Agency with a recorded justification of the means of compliance according to the compliance demonstration plan.

    (c)

    When carrying out testing and inspections to demonstrate compliance in accordance with point (a), the applicant shall have verified and documented this verification prior to carrying out any test:

    1.

    for the test specimen, that:

    (i)

    the materials and processes adequately conform to the specifications for the proposed changed type design;

    (ii)

    the constituent parts of the products adequately conform to the drawings in the proposed changed type design;

    (iii)

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

    2.

    that the test and measuring equipment used for the test were adequate for the test and appropriately calibrated.

    (d)

    The flight testing for the purpose of obtaining an approval of a major change to a type certificate shall be conducted in accordance with the methods for such flight testing specified by the Agency. The applicant for a major change to a type certificate shall make all the flight tests necessary to determine compliance with the applicable type-certification basis and the applicable environmental protection requirements.

    (e)

    An applicant for a major change to a type certificate shall allow the Agency to:

    1.

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

    2.

    witness or carry out any test or inspection conducted for the purpose of the demonstration of compliance; and

    3.

    if it is considered necessary, conduct a physical inspection of the first article of that product in the final changed configuration to verify the compliance of the design with the type-certification basis and the applicable environmental protection requirements.

    (f)

    Upon completion of the compliance demonstration, the applicant shall declare to the Agency that:

    1.

    they have demonstrated compliance with the type-certification basis and the applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with point 21L.B.81, according to the compliance demonstration plan; and

    2.

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

    21L.A.67   Requirements for the approval of a minor change to a type certificate

    In order to be issued with an approval of a minor change to a type certificate, the applicant shall:

    (a)

    demonstrate that the change and the areas affected by the change comply:

    1.

    with the type-certification basis and the applicable environmental protection requirements incorporated by reference in the type certificate; or

    2.

    if the applicant chooses to, with the certification specifications that are applicable to the product on the date of the application for the change;

    (b)

    declare compliance with the type-certification basis and the applicable environmental protection requirements that apply in accordance with point (a)(1), or with the certification specifications chosen in accordance with point (a)(2), record the justifications of compliance in the compliance documents, and record that no feature or characteristic has been identified that may make the changed product unsafe for the uses for which certification is requested;

    (c)

    submit to the Agency the justification of compliance for the change and the declaration of compliance.

    21L.A.68   Requirements for the approval of a major change to a type certificate

    In order to be issued with an approval of a major change to a type certificate, the applicant shall:

    (a)

    demonstrate that the change and the areas affected by the change comply with the type-certification basis and the applicable environmental protection requirements, as established and notified to the applicant by the Agency in accordance with point 21L.B.81;

    (b)

    demonstrate compliance in accordance with point 21L.A.66;

    (c)

    demonstrate that there are no unresolved issues from the physical inspection of the first article of that product in the final changed configuration carried out by the Agency in accordance with point 21L.A.66(e)(3).

    21L.A.69   Approval of a change to a type certificate under a privilege

    (a)

    The approval of a change to a type certificate that it has designed may be issued by an approved design organisation without an application according to point 21L.A.65 in accordance with the scope of its privileges provided for in points (2) and (8) of point 21.A.263(c) of Annex I (Part 21) instead of the Agency, as recorded in the terms of approval.

    (b)

    When issuing an approval of a change to type certificate in accordance with point (a), the design organisation shall:

    1.

    ensure that all the substantiation data and justifications are available;

    2.

    ensure that the compliance of the change with the type-certification basis and the applicable environmental protection requirements according to point (a)(1) of point 21L.A.67 or point (a) of point 21L.A.68 has been demonstrated and declared in accordance with point 21L.A.66;

    3.

    confirm that it has not found:

    (i)

    any non-compliances with the type-certification basis or, where applicable, with the applicable environmental protection requirements, or with the certification specifications chosen;

    (ii)

    any feature or characteristic of the change that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested;

    4.

    limit the approval of a change to a type certificate to the specific configuration(s) in the type certificate to which the change relates.

    21L.A.70   Obligations for minor changes to a type certificate

    The holder of an approval of a minor change to a type certificate shall ensure that the obligations for holders of minor change approvals of Subpart A of this Annex are undertaken.

    SUBPART E –   SUPPLEMENTAL TYPE CERTIFICATES

    21L.A.81   Scope

    This Subpart establishes the procedure for natural or legal persons other than the holder of that type certificate for applying for the approval of major changes to type certificates, issued under Annex I (Part 21) or this Annex, of products within the scope of point 21L.A.21, provided that the changed product is still within the scope of that point, and establishes the rights and obligations of the applicants for, and holders of, those certificates.

    21L.A.82   Eligibility

    Any natural or legal person who has demonstrated, or is in the process of demonstrating, or have declared, their design capability in accordance with point 21L.A.83 may apply for a supplemental type certificate under the conditions laid down in this Subpart.

    21L.A.83   Demonstration of design capability

    An applicant for a supplemental type certificate shall demonstrate their design capability by:

    (a)

    holding a design organisation approval with terms of approval that cover the respective category of product, issued by the Agency in accordance with Subpart J of Section A of Annex I (Part 21); or

    (b)

    declaring their design capability for the scope of the product in accordance with Subpart J of this Annex.

    21L.A.84   Application for a supplemental type certificate

    (a)

    An application for a supplemental type certificate shall be made in a form and manner established by the Agency.

    (b)

    When applying for a supplemental type certificate, the applicant shall:

    1.

    include in the application the information required by point 21L.A.65(b);

    2.

    specify whether the certification data has been or will be prepared completely by the applicant or on the basis of an arrangement with the owner of the type-certification data.

    21L.A.85   Demonstration of compliance

    (a)

    The applicant for a supplemental type certificate shall demonstrate compliance with the applicable type-certification basis and the applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with point 21L.B.101 and shall provide the Agency with the means by which such compliance has been demonstrated.

    (b)

    The applicant for a supplemental type certificate shall provide the Agency with a recorded justification of the means of compliance within compliance documents according to the compliance demonstration plan.

    (c)

    When carrying out testing and inspections to demonstrate compliance in accordance with point (a), the applicant shall have verified and documented this verification prior to carrying out any test:

    1.

    for the test specimen, that:

    (i)

    the materials and processes adequately conform to the specifications for the proposed changed type design;

    (ii)

    the constituent parts of the products adequately conform to the drawings in the proposed changed type design;

    (iii)

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

    2.

    that the test and measuring equipment used for the test were adequate for the test and appropriately calibrated.

    (d)

    The flight testing for the purpose of obtaining a supplemental type certificate shall be conducted in accordance with the methods for such flight testing specified by the Agency. The applicant for a supplemental type certificate shall make all the flight tests necessary to determine compliance with the applicable type-certification basis.

    (e)

    An applicant for a supplemental type certificate shall allow the Agency to:

    1.

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

    2.

    witness or carry out any test or inspection conducted for the purpose of the demonstration of compliance; and

    3.

    conduct a physical inspection of the first article of that product in the final changed configuration to verify the compliance of the design with the type-certification basis and the applicable environmental protection requirements.

    (f)

    Upon completion of the compliance demonstration, the applicant for a supplemental type certificate shall declare to the Agency that:

    1.

    it has demonstrated compliance with the type-certification basis and the applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with points 21L.B.101, according to the compliance demonstration plan; and

    2.

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

    21L.A.86   Requirements for approval of a supplemental type certificate

    (a)

    In order to be issued with a supplemental type certificate, the applicant shall:

    1.

    demonstrate their design capability in accordance with point 21L.A.83;

    2.

    demonstrate that the change to a type certificate and the areas affected by the change comply with the type-certification basis and the applicable environmental protection requirements, as established by the Agency in accordance with point 21L.B.101;

    3.

    demonstrate compliance in accordance with point 21L.A.85;

    4.

    if the applicant has specified that they provided certification data on the basis of an arrangement with the owner of the type-certification data in accordance with point 21L.A.84(b), demonstrate that the type-certificate holder:

    (i)

    has no technical objection to the information submitted under point 21L.A.65; and

    (ii)

    has agreed to collaborate with the applicant to ensure the discharge of all the obligations for continued airworthiness of the changed product through compliance with points 21L.A.28 and 21L.A.88;

    5.

    demonstrate that there are no unresolved issues from the physical inspection of the first article of that product in the final changed configuration carried out by the Agency in accordance with point 21L.A.85(e)(3).

    (b)

    A supplemental type certificate shall be limited to the specific configuration(s) in the type certificate to which the related major change relates.

    21L.A.87   Approval of a supplemental type certificate under a privilege

    (a)

    The approval of a supplemental type certificate for a major change it has designed may be issued by an approved design organisation without an application according to point 21L.A.84 in accordance with the scope of its privileges provided for in point (9) of point 21.A.263(c) of Annex I (Part 21) instead of the Agency, as recorded in the terms of approval.

    (b)

    When issuing a supplemental type certificate in accordance with point (a), the design organisation shall:

    1.

    ensure that all the substantiation data and justifications are available;

    2.

    ensure that the compliance of the change with the type-certification basis and the applicable environmental protection requirements has been demonstrated and declared;

    3.

    confirm that it has not found:

    (i)

    any non-compliances with the type-certification basis or, where applicable, with the applicable environmental protection requirements, or with the certification specifications chosen;

    (ii)

    any feature or characteristic of the change that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested;

    4.

    limit the approval of the supplemental type certificate to the specific configuration(s) in the type certificate to which the change relates.

    21L.A.88   Obligations of a holder of a supplemental type certificate

    Each holder of a supplemental type certificate shall undertake the obligations of a supplemental type-certificate holder set forth in Subpart A of this Annex and shall continue to comply with the eligibility requirement under point 21L.A.82.

    21L.A.89   Transferability of a supplemental type certificate

    A supplemental type certificate may be transferred to a new holder, provided that the Agency has verified that the natural or legal person to whom the certificate is intended to be transferred is eligible in accordance with point 21L.A.83 to hold a supplemental type certificate and is able to undertake the obligations of a supplemental type-certificate holder under point 21L.A.88.

    21L.A.90   Continued validity of a supplemental type certificate

    (a)

    A supplemental type certificate shall remain valid as long as:

    1.

    the supplemental type certificate is not surrendered by the holder;

    2.

    the holder of the supplemental type certificate remains in compliance with the relevant requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, taking into account the provisions related to the handling of findings as specified under point 21L.B.21;

    3.

    the supplemental type certificate is not revoked by the Agency in accordance with point 21L.B.22.

    (b)

    Upon surrender or revocation, the type certificate shall be returned to the Agency.

    21L.A.91   Changes to a part of a product covered by a supplemental type certificate

    (a)

    A minor change to a part of a product covered by a supplemental type certificate shall be approved in accordance with Subpart D of this Annex.

    (b)

    A major change to that part of a product covered by a supplemental type certificate shall be approved as a separate supplemental type certificate in accordance with this Subpart.

    (c)

    By way of derogation from point (b), a major change to that part of a product covered by a supplemental type certificate submitted by the supplemental type-certificate holder may be approved as a change to the existing supplemental type certificate in accordance with points 21L.A.63 to 21L.A.69.

    SUBPART F –   CHANGES TO AIRCRAFT FOR WHICH DESIGN COMPLIANCE HAS BEEN DECLARED

    21L.A.101   Scope

    This Subpart establishes:

    (a)

    the procedure for declaring the compliance of a change to the design of an aircraft which was subject to a declaration made in accordance with Subpart C of this Annex;

    (b)

    the rights and obligations of the declarant making a declaration of compliance of the change referred to in point (a); and

    (c)

    provisions regarding the standard changes that do not require a declaration of design compliance.

    21L.A.102   Standard changes

    (a)

    Standard changes are changes to the design of an aircraft which was subject to a declaration made in accordance with Subpart C of this Annex and which:

    1.

    follow the design data included in the certification specifications issued by the Agency, containing the acceptable methods, techniques and practices for carrying out and identifying standard changes, including the associated instructions for continued airworthiness; and

    2.

    are not in conflict with the design data covered by the declaration of aircraft design compliance made in accordance with Subpart C of this Annex.

    (b)

    Points 21L.A.103 to 21L.A.108 are not applicable to standard changes.

    21L.A.103   Classification of changes to the design of an aircraft for which design compliance has been declared

    (a)

    Changes to the design of an aircraft which was subject to a declaration made in accordance with Subpart C of this Annex shall be classified as minor or major, using the criteria laid down in points 21L.A.63 (b) and (c).

    (b)

    The design compliance of a minor change shall be declared in accordance with point 21L.A.105.

    (c)

    The design compliance of a major change shall be declared in accordance with point 21L.A.107.

    21L.A.104   Eligibility

    (a)

    A declarant who made a declaration of aircraft design compliance in accordance with Subpart C of this Annex may declare compliance of a minor change to the design of that aircraft under the conditions laid down in this Subpart. In addition, such a declaration of compliance may also be made, under the conditions laid down in this Subpart, by a design organisation approved in accordance with point (c)(3) of point 21.A.263 of Annex I (Part 21).

    (b)

    Only the declarant who made a declaration of aircraft design compliance in accordance with Subpart C of this Annex may declare the compliance of a major change to the design of an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex, under the conditions laid down in this Subpart.

    (c)

    By derogation from point (b) of point 21.L.A.104, if the declarant who made a declaration of aircraft design compliance in accordance with Subpart C of this Annex is no longer active or is unresponsive to requests for design changes, the compliance of a changed aircraft design may also be declared in accordance with Subpart C of this Annex by a design organisation approved in accordance with point (c)(4) of point 21.A.263 of Annex I (Part 21) within the scope of their terms of approval, or by any other natural or legal person who is able to undertake the obligations laid down in point 21L.A.47 with respect to that changed aircraft.

    21L.A.105   Declaration of design compliance for minor changes

    (a)

    Prior to installing or incorporating or agreeing with a production organisation to install or incorporate a minor change to the design of an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex the organisation that has designed that minor change shall declare that the design of that minor change complies with:

    1.

    either the detailed technical specifications incorporated by reference in the declaration of design compliance of the aircraft, unless those detailed technical specifications or parts of them are no longer applicable in accordance with point 21L.B.61 because the Agency 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 detailed technical specifications that were referenced in the declaration of design compliance of the aircraft do not address this unsafe condition, or

    2.

    the detailed technical specifications applicable, on the date on which the declaration is made in accordance with point 21L.B.61, if chosen by the declarant; and

    3.

    the applicable environmental protection requirements referred to in point 21L.B.61 which are applicable on the date on which the declaration is made.

    (b)

    The declaration of design compliance shall be made in a form and manner established by the Agency.

    (c)

    The declarant or the organisation that has designed the minor change shall maintain a register of minor changes to the design of aircraft for which design compliance has been declared, and make any declaration made in accordance with point (a) available to the Agency upon request.

    21L.A.106   Obligations of the person making a declaration of compliance of the design of a minor change

    Any person that has made a declaration of compliance of a minor change to an aircraft design in accordance with point 21L.A.105 shall:

    (a)

    maintain a register of those declarations and shall make those declarations available to the Agency upon request;

    (b)

    retain all supporting documents for a declaration of design compliance, and make them available to the Agency upon request;

    (c)

    undertake all other obligations of a declarant of a declaration of design compliance set forth in Subpart A of this Annex.

    21L.A.107   Declaration of design compliance for a major change

    (a)

    Prior to installing or incorporating or agreeing with a production organisation to install or incorporate a major change to the design of an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex, the organisation that has designed that major change shall declare that the design of that major change and the areas affected by that change comply with:

    1.

    either the detailed technical specifications incorporated by reference in the declaration of design compliance of the aircraft, unless those detailed technical specifications or parts of them are no longer applicable in accordance with point 21L.B.61 because the Agency 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 detailed technical specifications that were referenced in the declaration of design compliance of the aircraft do not address this unsafe condition, or

    2.

    the detailed technical specifications applicable on the date on which the declaration is made in accordance with point 21L.B.61, if chosen by the declarant; and

    3.

    the applicable environmental protection requirements referred to in point 21L.B.61 which are applicable on the date on which the declaration is made.

    (b)

    The declaration of design compliance shall be made in a form and manner established by the Agency.

    (c)

    The declaration shall contain at least the following information:

    1.

    the name of the person submitting the declaration, and their address/place of business;

    2.

    the declaration reference number of the aircraft to which the major change relates;

    3.

    a unique reference for identifying the major change;

    4.

    indication of the detailed technical specifications and the applicable environmental protection requirements with which the declarant declares compliance;

    5.

    a signed statement made under the sole responsibility of the person making the declaration that the design of the major change is in compliance with the detailed technical specifications and the applicable environmental protection requirements referred to in point (4), according to the compliance demonstration plan referred to in point (d)(3);

    6.

    a signed statement made under the sole responsibility of the person making the declaration that no features or characteristics have been identified by that person that may make the aircraft unsafe or environmentally incompatible for the intended use;

    7.

    a signed commitment that the person making the declaration will undertake the obligations referred to in point 21L.A.47 in respect of the changed aircraft design;

    8.

    the instructions for continued airworthiness;

    9.

    the operating limitations, if changed;

    10.

    the data sheet for airworthiness and, if applicable, the record of emissions compliance;

    11.

    the data sheet for noise, if applicable;

    12.

    any other conditions or limitations prescribed for the aircraft in the applicable detailed technical specifications and the applicable environmental protection requirements with which the declarant declares compliance.

    (d)

    The declarant that designs a major change shall submit the declaration referred to in point (c) to the Agency. Together with this declaration, the declarant shall provide to the Agency:

    1.

    a description of the major change;

    2.

    basic data about the major change, including the operating characteristics, design features and any limitations;

    3.

    a compliance demonstration plan detailing the means for compliance demonstration that was followed during the compliance demonstration;

    4.

    recorded justifications of compliance within the compliance data obtained from the compliance activities that have been conducted according to the compliance demonstration plan;

    5.

    the means by which such compliance with the applicable detailed technical specifications and applicable environmental protection requirements in point 21L.B.61 has been demonstrated;

    6.

    where compliance is demonstrated by carrying out tests, recorded justification of the conformity of the test articles and equipment, demonstrating:

    (i)

    for the test specimen, that:

    (A)

    the materials and processes adequately conformed to the specifications for the design;

    (B)

    the constituent parts of the products adequately conformed to the drawings in the design; and

    (C)

    the manufacturing processes, construction and assembly adequately conformed to those specified in the design;

    (ii)

    that the test and measuring equipment used for the test were adequate for the test and appropriately calibrated;

    7.

    reports, results of inspections or tests that the declarant found necessary to determine that the aircraft complies with the applicable detailed technical specifications and applicable environmental protection requirements.

    (e)

    The declaration of a major change to a declaration of design compliance shall be limited to the specific configuration(s) in the declaration of design compliance to which the change relates.

    21L.A.108   Compliance activities for declaring compliance of a major change

    Prior to making a declaration of compliance in accordance with point 21L.A.107, the declarant shall, for that specific design:

    (a)

    establish a compliance demonstration plan detailing the means for compliance demonstration that shall be followed during the compliance demonstration. This document shall be updated as necessary;

    (b)

    record the justification of compliance within compliance documents according to the compliance demonstration plan;

    (c)

    perform testing and inspections as necessary in accordance with the compliance demonstration plan;

    (d)

    ensure and record the conformity of the test articles and equipment and ensure that the test specimen conforms to the specifications, drawings, manufacturing processes, construction and assembly means in the design;

    (e)

    ensure that the test and measuring equipment to be used for testing are adequate for testing and appropriately calibrated;

    (f)

    allow the Agency to conduct or participate in any inspections or tests of aircraft in the final or suitably mature design and production configuration that are necessary to determine that the changed product has no feature or characteristic that makes the aircraft unsafe or environmentally incompatible for the intended use;

    (g)

    carry out flight testing, in accordance with the methods for such flight testing specified by the Agency, as necessary to determine that the aircraft complies with the applicable detailed technical specifications and the applicable environmental protection requirements.

    SUBPART G –   DECLARED PRODUCTION ORGANISATIONS

    21L.A.121   Scope

    (a)

    This Subpart establishes:

    1.

    the procedures for declaring the production capability of natural and legal persons showing the conformity of products and parts with the applicable design data;

    2.

    the rights and obligations of the natural and legal persons making a declaration of production capability referred to in point (1).

    (b)

    The following categories of products and parts may be produced by organisations which have made a declaration of production capability in accordance with this Subpart:

    1.

    products and parts the design of which has been certified in accordance with this Annex;

    2.

    aircraft the design of which is covered by a declaration made in accordance with this Annex, and their engines, propellers and parts.

    21L.A.122   Eligibility

    Any natural or legal person (‘organisation’) may declare their production capability under this Subpart, if that person:

    (a)

    has applied or intends to apply for the approval of the design of the product or part in accordance with this Annex; or

    (b)

    has declared or intends to declare the compliance of an aircraft design in accordance with this Annex; or

    (c)

    is collaborating with the applicant for, or holder of, an approval of the design of the product to be issued or issued in accordance with this Annex, or with the organisation that has declared or intends to declare the compliance of that aircraft design in accordance with this Annex, in order to ensure that the manufactured product or part is in conformity to that design, and to ensure the continued airworthiness of the product or part.

    21L.A.123   Declaration of production capability

    (a)

    Prior to producing any products or parts, an organisation intending to show the conformity of those products or parts with the applicable design data shall declare its production capability.

    (b)

    The declaration, and any subsequent changes thereto, shall be made in a form and manner established by the competent authority.

    (c)

    The declaration shall include the information necessary for the competent authority to become familiar with the organisation and the intended scope of work, and shall include at least the following:

    1.

    the registered name of the organisation;

    2.

    the contact details of the organisation’s registered address of their principal place of business and, where applicable, the contact and the operating sites of the organisation;

    3.

    the names and contact details of the accountable manager of the organisation nominated in accordance with point (c)(1) of point 21L.A.125;

    4.

    the intended scope of work;

    5.

    the date of the intended commencement of production;

    6.

    a statement confirming that the organisation:

    (i)

    has a management system for production in accordance with point (a) of point 21L.A.124; and

    (ii)

    will maintain the management system for production in compliance with this Subpart;

    7.

    a statement confirming that the organisation will adhere to the processes and procedures established in accordance with point (d) of point 21L.A.124;

    8.

    a statement that the organisation agrees to undertake the obligations of a declared production organisation in accordance with point 21L.A.127.

    (d)

    The declaration of production capability shall be submitted to the competent authority.

    21L.A.124   Management system for production

    (a)

    The declared production organisation shall establish, implement, and maintain a management system for production with clear accountability and lines of responsibility throughout the organisation that:

    1.

    corresponds to the nature and complexity of its activities and the size of the organisation, and takes into account the hazards and associated risks inherent in these activities;

    2.

    is established under the accountability of an accountable manager nominated according to point (c)(1) of point 21L.A.125.

    (b)

    The management system for production shall include a means to manage quality by maintaining a quality system that shall:

    1.

    ensure that each product or part produced by the declared production organisation or by its partners, or supplied from or subcontracted to outside parties, conforms to the applicable design data and is in a condition for safe operation;

    2.

    establish, implement, and maintain, as appropriate, within the scope of their activities, control procedures for:

    (i)

    document issue, approval, or change;

    (ii)

    vendor and subcontractor assessment, audit and control;

    (iii)

    verification that incoming products, parts, materials, and equipment, including items supplied new or used by buyers of products, are as specified in the applicable design data;

    (iv)

    identification and traceability;

    (v)

    manufacturing processes;

    (vi)

    inspection and testing, including production flight tests;

    (vii)

    calibration of tools, jigs, and test equipment;

    (viii)

    non-conforming item control;

    (ix)

    the collaboration with the applicant for, or holder of, the design approval or the declarant of a declaration of design compliance;

    (x)

    the completion and retention of records;

    (xi)

    ensuring the competence and qualifications of personnel;

    (xii)

    the issue of airworthiness release documents;

    (xiii)

    handling, storage and packing;

    (xiv)

    internal quality audits and the resulting corrective actions;

    (xv)

    work performed at any location other than the operating sites included in the declaration;

    (xvi)

    work carried out after the completion of production but prior to delivery, to maintain the aircraft in a condition for safe operation;

    (xvii)

    the request for the issuance of permits to fly and the approval of associated flight conditions;

    3.

    include specific provisions in the control procedures for any critical parts.

    (c)

    The declared production organisation shall establish, as part of their management system for production, an independent function to monitor the compliance of the organisation with the relevant requirements, and compliance with, and the adequacy of, the production management system. This monitoring shall include a system to provide feedback to the person or group of persons referred to in points (c)(1) and (2) of point 21L.A.125 to ensure, as necessary, corrective action.

    (d)

    The declared production organisation shall establish, maintain and keep updated, as part of their management system for production, processes and procedures that ensure the compliance of products that are produced with the applicable design data. The declared production organisation shall make documentary evidence of these processes and procedures available to the competent authority upon request.

    (e)

    The declared production organisation shall have procedures in place to ensure that newly manufactured aircraft are maintained in accordance with the applicable maintenance instructions and are kept in an airworthy condition and, if applicable, that a certificate of release to service is issued for any maintenance that has been completed.

    (f)

    If the declared production organisation holds (an)other organisation certificate(s) issued on the basis of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, the production organisation may integrate the production management system with the management system that is required for the issuance of the other certificate(s).

    21L.A.125   Resources of the declared production organisation

    The declared production organisation shall ensure that:

    (a)

    the facilities, working conditions, equipment and tools, processes and associated materials, the number and competence of staff, and the general organisation are adequate to discharge its obligations under point 21L.A.127;

    (b)

    with regard to all necessary airworthiness and environmental protection data:

    1.

    it is in receipt of such data from the Agency, and from the declarant of design compliance or the holder of, or the applicant for, the type certificate, or design approval, to determine its conformity with the applicable design data;

    2.

    it has established a procedure to ensure that airworthiness and environmental compatibility data is correctly incorporated into its production data;

    3.

    such data is kept up to date and made available to all personnel who need access to such data to perform their duties;

    (c)

    with regard to management and staff:

    1.

    an accountable manager has been nominated by the declared production organisation with authority to ensure that, within the organisation, all production is performed to the required standards and that the declared production organisation is continuously in compliance with the requirements of the management system for production referred to in point (a) of point 21L.A.124, and the processes and the procedures identified in point (d) of point 21L.A.124;

    2.

    a person or group of persons has or have been nominated by the accountable manager to ensure that the organisation is in compliance with the requirements of this Subpart, and is (are) identified, together with the extent of their authority. Such a person or group of persons shall be responsible to the accountable manager and have direct access to them. They shall have the appropriate knowledge, background and experience to discharge their responsibilities;

    3.

    staff at all levels have been given appropriate authority to be able to discharge their allocated responsibilities and that there is full and effective coordination within the declared production organisation in respect of airworthiness and environmental compatibility data matters;

    4.

    the organisational structure of the organisation along with the key personnel who are responsible for ensuring that the organisation is in compliance with this Subpart is documented and kept updated;

    (d)

    with regard to certifying staff, authorised by the declared production organisation to sign the documents issued under point 21L.A.126 within the scope of declared production activities:

    1.

    the knowledge, background (including other functions in the organisation), and experience of the certifying staff are appropriate to discharge their allocated responsibilities;

    2.

    certifying staff are provided with evidence of the scope of their authorisation. A list of certifying staff shall be maintained by the declared production organisation.

    21L.A.126   Scope of work

    (a)

    A declared production organisation is entitled to show the conformity of the products and parts that are within the scope of this Section and that it has produced within the declared scope of work, with the applicable design data.

    (b)

    A declared production organisation is entitled, for a complete aircraft, after presentation of an aircraft statement of conformity (EASA Form 52B), to apply:

    1.

    for an aircraft that conforms to a type design approved in accordance with Subpart B of Section B of this Annex, for a certificate of airworthiness and a noise certificate;

    2.

    for an aircraft that conforms to a design for which compliance has been declared in accordance with Subpart C of this Annex, for a restricted certificate of airworthiness and a restricted noise certificate.

    (c)

    A declared production organisation is entitled to issue authorised release certificates (EASA Form 1) for engines, propellers and parts that either conform to:

    1.

    approved design data issued in accordance with Subparts B, D, E or M of Section B of this Annex;

    2.

    declared design data for which design compliance has been declared in accordance with Subparts C, F or N of this Annex;

    3.

    production data based upon all the necessary approved design data as provided by a repair design approval holder.

    (d)

    A declared production organisation is entitled to recommend the conditions for an aircraft that it has produced and for which it has attested conformity with the applicable design data, under which a permit to fly can be issued by the competent authority under Subpart P of Annex I (Part 21).

    (e)

    A declared production organisation is entitled to maintain a new aircraft that it has produced, as necessary to keep it in an airworthy condition, unless Regulation (EU) No 1321/2014 requires the maintenance to be performed under such rules, and to issue a certificate of release to service (EASA Form 53B) in respect of that maintenance.

    21L.A.127   Obligations of the declared production organisation

    (a)

    The declared production organisation shall work in accordance with clearly defined procedures, practices and processes.

    (b)

    If the declared production organisation intends to conduct flight tests, then it shall prepare, maintain and keep updated an operations manual that includes a description of the organisation’s policies and processes for flight testing. The declared production organisation shall make this manual available to the competent authority upon request.

    (c)

    For completed aircraft, prior to submitting an aircraft statement of conformity (EASA Form 52B) to the competent authority, the declared production organisation shall ensure that the aircraft is in a condition for safe operation and conforms to:

    1.

    the approved type design of a type-certified product issued in accordance with Subpart B of Section B of this Annex, or

    2.

    the design data of an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex.

    (d)

    For products (other than complete aircraft) and parts, the declared production organisation shall ensure prior to issuing an authorised release certificate (EASA Form 1) that the product or part is in a condition for safe operation and conforms to the approved type design of a type-certified product issued in accordance with Subpart B, D, E or M of Section B of this Annex or conforms to the design data of an aircraft for which design compliance has been declared in accordance with Subpart C, F or M of this Annex.

    (e)

    For engines, the declared production organisation shall ensure that the completed engine is in compliance with the applicable engine exhaust emissions requirements applicable on the date of production of the engine.

    (f)

    The declared production organisation shall include, in any authorised release certificates (EASA Form 1) that are issued by it, the reference number issued by the competent authority in accordance with point 21L.B.142 for this declared production organisation.

    (g)

    The declared production organisation shall ensure that the organisation records the details of any work that is completed.

    (h)

    The declared production organisation shall provide, to the design holder or the declarant of a declaration of design compliance, continuing airworthiness support for any products or parts that they have produced.

    (i)

    The declared production organisation shall have an archiving system that records the requirements that have been placed on other organisations, such as suppliers and subcontractors. The declared production organisation shall make the archived data available to the competent authority for continuing airworthiness purposes.

    (j)

    For the production of new aircraft, the declared production organisation shall ensure that the aircraft is kept in an airworthy condition and that maintenance is performed, including any necessary repairs in accordance with the applicable design data, prior to the issuance of an aircraft statement of conformity (EASA Form 52B).

    (k)

    Where the declared production organisation issues a certificate of release to service after such maintenance, it shall determine that each completed aircraft has been subjected to the necessary maintenance and is in a condition for safe operation, prior to issuing that certificate.

    (l)

    The declared production organisation shall comply with the requirements in Subpart A of this Annex applicable to a declared production organisation.

    21L.A.128   Notification of changes and cessation of activities

    The declared production organisation shall notify the competent authority without undue delay of the following:

    (a)

    any changes to the information that has been declared in accordance with point (c) of point 21L.A.123;

    (b)

    any changes to the management system for production that are significant to the showing of conformity or to the airworthiness and environmental compatibility characteristics of the product or part;

    (c)

    the cessation of some of or all the activities covered by the declaration.

    SUBPART H –   CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS

    21L.A.141   Scope

    This Subpart establishes the procedure for applying for a certificate of airworthiness or a restricted certificate of airworthiness for an aircraft whose design has been certified or declared in accordance with this Annex, and establishes the rights and obligations of the applicants for, and holders of, those certificates.

    21L.A.142   Eligibility

    Any natural or legal person under whose name an aircraft is registered or will be registered in a Member State (‘Member State of registry’) may apply for a certificate of airworthiness or for a restricted certificate of airworthiness for that aircraft under the conditions laid down in this Subpart.

    21L.A.143   Application for a certificate of airworthiness or a restricted certificate of airworthiness

    (a)

    A natural or legal person shall apply for a certificate of airworthiness or a restricted certificate of airworthiness in a form and manner established by the competent authority of the Member State of registry.

    (b)

    A natural or legal person may apply for:

    1.

    a certificate of airworthiness for aircraft which conform to a type certificate that has been issued by the Agency in accordance with Subpart B of Section B of this Annex; or

    2.

    a restricted certificate of airworthiness for aircraft which conform to a declaration of design compliance in accordance with Subpart C of this Annex which is registered by the Agency in accordance with point 21L.B.63 at the time of application.

    (c)

    For a new aircraft that conforms to a type certificate issued by the Agency, the applicant shall include in the application:

    1.

    an aircraft statement of conformity (EASA Form 52 or EASA Form 52B) that is either issued or signed by:

    (i)

    a production organisation that has declared their production capability under Subpart G of this Annex and has been registered by the competent authority in accordance with point 21L.B.142; or

    (ii)

    a production organisation approval holder under the privileges of point (b) of point 21.A.163 of Annex I (Part 21);

    2.

    a weight and balance report with a loading schedule;

    3.

    the flight manual if required by the applicable type-certification basis.

    (d)

    For a new aircraft that conforms to a declaration of design compliance which is registered by the Agency, the applicant shall include in the application:

    1.

    an aircraft statement of conformity (EASA Form 52B) that is either issued or signed by:

    (i)

    a natural or legal person in accordance with Subpart R of this Annex;

    (ii)

    a production organisation that has declared their production capability under Subpart G of this Annex and has been registered by the competent authority in accordance with point 21L.B.142; or

    (iii)

    a production organisation approval holder under the privileges of point (d) of point 21.A.163 of Annex I (Part 21);

    2.

    a weight and balance report with a loading schedule;

    3.

    the flight manual if required by the applicable detailed technical specifications for the declaration of design compliance.

    (e)

    For a used aircraft originating from a Member State, the applicant shall include in the application an airworthiness review certificate issued in accordance with Annex I (Part-M) or Annex Vb (Part-ML) to Regulation (EU) No 1321/2014.

    (f)

    For a used aircraft originating from a non-Member State, the applicant shall include in the application:

    1.

    a statement from the competent authority of the State where the aircraft is, or was, registered, reflecting the airworthiness status of the aircraft at the time of transfer;

    2.

    the historical records to establish the production, modification, and maintenance standard of the aircraft;

    3.

    a weight and balance report with a loading schedule;

    4.

    the flight manual;

    5.

    a recommendation for the issuance of a certificate of airworthiness or restricted certificate of airworthiness and for an airworthiness review certificate pursuant to an airworthiness review in accordance with Annex I (Part-M) to Regulation (EU) No 1321/2014 or an airworthiness review certificate in accordance with Annex Vb (Part-ML) to Regulation (EU) No 1321/2014.

    (g)

    Unless otherwise agreed, the statements referred to in points (c)(1), (d)(1) and (f)(1) shall be issued no more than 60 days before the presentation of the aircraft to the competent authority of the Member State of registry.

    21L.A.144   Obligations of the applicant for a certificate of airworthiness or a restricted certificate of airworthiness

    The applicant for a certificate of airworthiness or for a restricted certificate of airworthiness shall:

    (a)

    present the manuals, placards, listings, and instrument markings and other necessary information required by the applicable type-certification basis or by the applicable detailed technical specifications for declarations of design compliance in one or more of the official language(s) of the European Union acceptable to the competent authority of the Member State of registry;

    (b)

    demonstrate that their aircraft is identified in accordance with Subpart Q of this Annex;

    (c)

    arrange for inspections of the competent authority of the Member State of registry to assess whether the aircraft has any non-conformities that could affect the safety of the aircraft.

    21L.A.145   Transferability and re-issuance of a certificate of airworthiness and of a restricted certificate of airworthiness within Member States

    Where the ownership of an aircraft has changed:

    (a)

    if it remains on the same register, the certificate of airworthiness, or the restricted certificate of airworthiness issued in accordance with Subpart H of Section B of this Annex, shall be transferred together with the aircraft;

    (b)

    if the aircraft is intended to be registered in another Member State, the natural or legal person under whose name the aircraft will be registered shall apply to the competent authority of the new Member State of registry for a new certificate of airworthiness or a restricted certificate of airworthiness and shall include in this application the former certificate of airworthiness or restricted certificate of airworthiness issued in accordance with Subpart H of Section B of this Annex and a valid airworthiness review certificate issued in accordance with Annex I (Part-M) or Annex Vb (Part-ML) to Regulation (EU) No 1321/2014.

    21L.A.146   Continued validity of a certificate of airworthiness and of a restricted certificate of airworthiness

    (a)

    A certificate of airworthiness or a restricted certificate of airworthiness shall remain valid as long as:

    1.

    the aircraft remains on the same register;

    2.

    the certificate has not been surrendered by the holder;

    3.

    the aircraft remains in compliance with the relevant requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof and with the applicable type design or with the applicable design data of an aircraft for which design compliance has been declared, and with the continuing airworthiness requirements, taking into account the provisions related to the handling of findings as specified under point 21L.B.21;

    4.

    the certificate has not been revoked by the competent authority of the Member State of registry under point 21L.B.22.

    (b)

    Upon surrender or revocation, the certificate shall be returned to the competent authority of the Member State of registry.

    SUBPART I –   NOISE CERTIFICATES AND RESTRICTED NOISE CERTIFICATES

    21L.A.161   Scope

    This Subpart establishes the procedure for applying for a noise certificate or a restricted noise certificate for an aircraft whose design has been certified or declared in accordance with this Annex and establishes the rights and obligations of the applicants for, and holders of, those certificates.

    21L.A.162   Eligibility

    Any natural or legal person under whose name an aircraft is registered or will be registered in a Member State may apply for a noise certificate or a restricted noise certificate for that aircraft under the conditions laid down in this Subpart.

    21L.A.163   Application

    (a)

    A natural or legal person shall apply for a noise certificate or a restricted noise certificate in a form and manner established by the competent authority of the Member State of registry.

    (b)

    A natural or legal person may apply for:

    1.

    a noise certificate for aircraft which conform to a type certificate that has been issued by the Agency in accordance with Subpart B of Section B of this Annex; or

    2.

    a restricted noise certificate for aircraft which conform to a declaration of design compliance submitted in accordance with Subpart C of this Annex which is registered by the Agency in accordance with point 21L.B.63 at the time of application.

    (c)

    The applicant shall include in the application:

    1.

    with regard to new aircraft:

    (i)

    an aircraft statement of conformity (EASA Form 52 or EASA Form 52B) that is either issued or signed by:

    (A)

    a natural or legal person in accordance with Subpart R of this Annex;

    (B)

    a production organisation that has declared their production capability under Subpart G of this Annex and has been registered by the competent authority in accordance with point 21L.B.142; or

    (C)

    a production organisation approval holder under the privileges of point (b) of point 21.A.163 of Annex I (Part 21);

    (ii)

    the reference to the noise record within the Agency database of noise levels reflecting the noise information determined in accordance with the applicable noise requirements;

    2.

    with regard to used aircraft:

    (i)

    the reference to the noise record within the Agency database of noise levels reflecting the noise information determined in accordance with the applicable noise requirements; and

    (ii)

    the historical records to establish the production, modification, and maintenance standard of the aircraft.

    (d)

    Unless otherwise agreed, the statements referred to in point (c)(1)(i) shall be issued no more than 60 days before the presentation of the aircraft to the competent authority of the Member State of registry.

    21L.A.164   Transferability and re-issuance of noise certificates and restricted noise certificates within Member States

    Where the ownership of an aircraft has changed:

    (a)

    if the aircraft remains on the same register, the noise certificate, or the restricted noise certificate issued in accordance with Subpart I of Section B of this Annex, shall be transferred together with the aircraft;

    (b)

    if the aircraft is intended to be registered in another Member State, the natural or legal person under whose name the aircraft will be registered shall apply to the competent authority of the new Member State of registry for a new noise certificate or restricted noise certificate and shall include in this application the former noise certificate or restricted noise certificate issued in accordance with Subpart I of Section B of this Annex.

    21L.A.165   Continued validity of a noise certificate and of a restricted noise certificate

    (a)

    A noise certificate or a restricted noise certificate shall remain valid as long as:

    1.

    the aircraft remains on the same register;

    2.

    the certificate has not been surrendered by the holder;

    3.

    the aircraft remains in compliance with the applicable environmental protection requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof and with the applicable type design or with the applicable design data of an aircraft for which design compliance has been declared, taking into account the provisions related to the handling of findings as specified under point 21L.B.21;

    4.

    the certificate has not been revoked by the competent authority of the Member State of registry under point 21L.B.22.

    (b)

    Upon surrender or revocation, the certificate shall be returned to the competent authority of the Member State of registry.

    SUBPART J –   DECLARED DESIGN ORGANISATIONS

    21L.A.171   Scope

    This Subpart establishes:

    (a)

    the procedure for declaring the design capability by natural and legal persons who design products under this Section; and

    (b)

    the rights and obligations of the persons making declarations of design capability referred to in point (a).

    21L.A.172   Eligibility

    Any natural or legal person (‘organisation’ in this Subpart) required by point 21L.A.22, point 21L.A.82 or point 21L.A.204 to demonstrate their design capability may declare their capability under the conditions laid down in this Subpart.

    21L.A.173   Declaration of design capability

    (a)

    Prior to or at the same time as applying for a design approval under this Section, or prior to submitting the application for the approval of flight conditions in accordance with point 21.A.710 of Annex I (Part 21) of a product designed by it, whatever comes first, the organisation shall submit a declaration of design capability to the Agency.

    (b)

    The declaration, and any subsequent changes thereto, shall be made in a form and manner established by the Agency.

    (c)

    The declaration shall include the information necessary for the Agency to become familiar with the organisation and the intended scope of work, and shall include at least the following:

    1.

    the registered name of the organisation;

    2.

    the contact details of the organisation’s registered address of the principal place of business and, where applicable, of the operating sites of the organisation;

    3.

    the names and contact details of the head of the design organisation;

    4.

    the intended scope of work;

    5.

    a statement confirming that the organisation:

    (i)

    has a management system for design in accordance with point (a) of point 21L.A.174; and

    (ii)

    will maintain the management system for design in compliance with this Subpart;

    6.

    a statement confirming that the organisation will adhere to the processes and procedures established in accordance with point (d) of point 21L.A.174;

    7.

    a statement that the organisation agrees to undertake the obligations of a declared design organisation in accordance with point 21L.A.177.

    (d)

    The declaration of design capability shall be submitted to the Agency.

    21L.A.174   Management system for design

    (a)

    The declared design organisation shall establish, implement, and maintain a management system for design with clear accountability and lines of responsibility throughout the organisation that:

    1.

    corresponds to the nature and complexity of its activities and the size of the organisation, and takes into account the hazards and associated risks inherent in these activities;

    2.

    is established under the accountability of a single manager nominated as the head of the design organisation according to point (a) of point 21L.A.175.

    (b)

    The declared design organisation shall have, as part of their management system for design, a means to provide design assurance by establishing, implementing and maintaining a system for the control and supervision of the design, and of design changes and repairs, of products. This system shall:

    1.

    include an airworthiness function responsible for ensuring that the designs of products and the designs of changes and repairs thereto comply with the applicable type-certification basis and the applicable environmental protection requirements;

    2.

    establish, implement and maintain an independent function to verify the demonstration of compliance on the basis of which the organisation declares compliance with the applicable type-certification basis and with the applicable environmental protection requirements;

    3.

    specify the manner in which the design assurance system accounts for the acceptability of the parts that are designed or the tasks that are performed by partners or subcontractors according to methods which are the subjects of written procedures.

    (c)

    The declared design organisation shall establish, as part of their management system for design, an independent function to monitor the compliance of the organisation with the relevant requirements, and compliance with, and adequacy of, the management system for design. This monitoring shall include a system to provide feedback to the person or a group of persons referred to in point (b) of point 21L.A.175, and to the accountable manager referred to in point (a) of point 21L.A.175 to ensure, as necessary, corrective action.

    (d)

    The declared design organisation shall establish, maintain and keep updated processes and procedures that ensure the design compliance of products with the applicable type-certification basis, applicable detailed technical specifications and applicable environmental protection requirements. The declared design organisation shall make documentary evidence of these processes and procedures available to the Agency upon request.

    (e)

    Where any parts or any changes to the products are designed by partner organisations or subcontractors, the processes and procedures in point (d) shall include a description of how the design organisation is able to give, for all parts, the assurance of compliance required by point (b)(2), and shall contain, directly or by cross-reference, descriptions and information on the design activities and organisation of those partners or subcontractors.

    (f)

    If the declared design organisation holds (an)other organisation certificate(s) issued on the basis of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, the declared design organisation may integrate the design management system with the management system that is required for the issuance of the other certificate(s).

    21L.A.175   Resources of the declared design organisation

    (a)

    The declared design organisation shall nominate a head of the design organisation with the authority for ensuring that, within the organisation, all design activities are performed to the required standards and that the declared design organisation is continuously in compliance with the requirements for the management system for design referred to in points (a) to (c) of point 21L.A.174 and the processes and procedures referred to in point (d) of point 21L.A.174.

    (b)

    The head of the design organisation shall nominate and identify key personnel within the organisation that are responsible for:

    1.

    ensuring that the designs of products and the designs of changes and repairs thereto comply with the applicable type-certification basis, applicable detailed technical specifications and applicable environmental protection requirements;

    2.

    the independent monitoring of the compliance and adequacy function; and

    3.

    depending on the size of the organisation, any other person or group of persons who is or are needed to ensure that the organisation is in compliance with the requirements of this Section.

    (c)

    The person or group of persons identified in point (b) shall:

    1.

    be responsible to the head of the design organisation and have direct access to them;

    2.

    have the appropriate knowledge, background and experience to discharge their allocated responsibilities.

    (d)

    The declared design organisation shall ensure that:

    1.

    the staff in all technical departments are of sufficient numbers and experience and have been given the appropriate authority to be able to discharge their allocated responsibilities and that these, together with the accommodation, facilities and equipment, are adequate to enable the staff to ensure that the products designed are airworthy and environmentally compatible;

    2.

    there is full and efficient coordination within the declared design organisation in respect of airworthiness and environmental compatibility matters.

    (e)

    The declared design organisation shall document the organisational structure of their organisation, along with the key personnel who are responsible for ensuring that the organisation is in compliance with this Subpart, keep them updated and make them available to the Agency upon request.

    21L.A.176   Scope of work

    The declared design organisation shall identify the types of design work, the categories of products for which design activities are conducted, and the functions and duties that the organisation performs in regard to the airworthiness and environmental compatibility of products.

    21L.A.177   Obligations of the declared design organisation

    A declared design organisation shall:

    (a)

    work in accordance with clearly defined procedures, practices and processes;

    (b)

    if the declared design organisation intends to conduct flight testing, maintain and keep updated an operations manual that provides a description of the organisation’s policies and processes for flight testing and make this manual available to the Agency upon request;

    (c)

    determine whether the designs of products, including changes and repairs, do not have any unsafe features and comply with the applicable type-certification basis, and with the applicable environmental protection requirements, and provide the Agency with statements/documentation confirming this;

    (d)

    provide the Agency with information or instructions relating to continued airworthiness actions;

    (e)

    comply with the requirements in Subpart A of this Annex applicable to declared design organisations.

    21L.A.178   Notification of changes and cessation of activities

    The declared design organisation shall notify the Agency without undue delay of the following:

    (a)

    any changes to the information that has been declared in accordance with point (c) of point 21L.A.173;

    (b)

    changes to the management system for design that are significant for the demonstration of compliance of the product designed by them;

    (c)

    the cessation of some or all of the activities covered by the declaration.

    SUBPART K –   PARTS

    21L.A.191   Scope

    This Subpart establishes how the compliance of parts with the airworthiness requirements shall be shown.

    21L.A.192   Showing of compliance

    (a)

    The showing of compliance with the airworthiness requirements of parts to be installed in a type-certified product or an aircraft for which design compliance has been declared shall be made:

    1.

    in conjunction with the type-certification procedures of Subpart B, D or E of this Annex for the product in which it is to be installed; or

    2.

    in conjunction with the declaration of design compliance procedures of Subpart C or F of this Annex for the product in which it is to be installed; or

    3.

    under the ETSO authorisation procedure of Subpart O of Section A of Annex I (Part 21); or

    4.

    in the case of standard parts, in accordance with officially recognised standards.

    (b)

    In all cases where the approval of a part is explicitly required by Union law or Agency measures, the part shall comply with the applicable ETSO or with the specifications recognised as equivalent by the Agency in the particular case.

    21L.A.193   Release of parts for installation

    (a)

    A part or product shall only be installed in a product when it is identified by the holder of a type certificate, supplemental type certificate, design change, repair design approval or with a declaration of design compliance as being suitable for installation, and when it is:

    1.

    in a condition for safe operation;

    2.

    marked in accordance with Subpart Q of this Annex; and

    3.

    accompanied by an authorised release certificate (EASA Form 1) certifying that the item was manufactured in conformity with the applicable design data.

    (b)

    By way of derogation from point (a)(3) and provided that the conditions in point (c) are met, the following parts do not require an authorised release certificate (EASA Form 1) in order to be installed in a type-certified product or in an aircraft for which design compliance has been declared:

    1.

    a standard part;

    2.

    a part that is:

    (i)

    not life limited, nor part of the primary structure, nor part of the flight controls;

    (ii)

    identified for installation in the specific aircraft by the holder of a type certificate, supplemental type certificate, design change, repair design approval or a declaration of design compliance;

    (iii)

    to be installed in an aircraft whose owner has verified compliance with the applicable conditions in (i) and (ii), and has accepted responsibility for this compliance;

    3.

    a part for which the consequences of a non-conformity with its approved design data or declared design data has a negligible safety effect on the product and which is identified as such by the holder of the design approval or the declarant of design compliance in the instructions for continued airworthiness. In order to determine the safety effects of a non-conforming part, the design approval holder or declarant of a declaration of design compliance may establish in the instructions for continued airworthiness specific verification activities to be conducted by the installer of the part on the product;

    4.

    in the case of the embodiment of a standard change as per point 21L.A.102 or a standard repair as per point 21L.A.202, a part for which the consequences of a non-conformity with its design data have a negligible safety effect on the product, and the part is identified as such in the certification specifications for standard changes and standard repairs issued in accordance with point 21.B.70 of Annex I (Part 21). In order to determine the safety effects of a non-conforming part, specific verification activities to be conducted by the person that installs the part in the product may be established in these certification specifications;

    5.

    a part that is exempted from an airworthiness approval in accordance with Commission Regulation (EU) No 965/2012 (2); and

    6.

    a part that is an item of a higher assembly identified in points (b)(1) to (b)(5).

    (c)

    Parts listed in point (b) are eligible for installation in a type-certified product or in an aircraft for which design compliance has been declared without being accompanied by an EASA Form 1, provided that the installer holds a document issued by the person or organisation that manufactured the part, which declares the name of the part, the part number, and the conformity of the part with its design data, and which contains the date of issuance.

    SUBPART M –   DESIGN OF REPAIRS TO TYPE-CERTIFIED PRODUCTS

    21L.A.201   Scope

    This Subpart establishes:

    (a)

    the procedure for applying for the approvals of repair designs to type-certified products;

    (b)

    the rights and obligations of the applicants for, and holders of, those approvals referred to in point (a);

    (c)

    provisions for standard repairs that do not require an approval.

    21L.A.202   Standard repairs

    (a)

    Standard repairs are repair designs to a type-certified product approved in accordance with Subpart B of Section B of this Annex and which:

    1.

    follow the design data included in the certification specifications issued by the Agency, containing the acceptable methods, techniques and practices for carrying out and identifying standard repairs, including the associated instructions for continued airworthiness; and

    2.

    are not in conflict with the data of the holder of that type certificate.

    (b)

    Points 21L.A.203 to 21L.A.211 are not applicable to standard repairs.

    21L.A.203   Classification of repair designs to a type-certified product

    (a)

    Repair designs to a type-certified product shall be classified as minor or major.

    (b)

    A ‘minor repair’ is a repair design that has no appreciable effect on the mass, balance, structural strength, reliability, certified noise or emissions level, operational characteristics, or other characteristics affecting the airworthiness or the environmental compatibility of the product.

    (c)

    All other repair designs are ‘major repairs’.

    (d)

    The requirements for the approval of minor repair designs are those established in point 21L.A.207.

    (e)

    The requirements for the approval of major repair designs are those established in point 21L.A.208.

    21L.A.204   Eligibility

    (a)

    Any natural or legal person who has demonstrated, or is in the process of demonstrating, their design capability in accordance with point 21L.A.23, may apply for the approval of a major repair design to a type-certified product under the conditions laid down in this Subpart.

    (b)

    Any natural or legal person may apply for the approval of a minor repair design to a type-certified product under the conditions laid down in this Subpart.

    21L.A.205   Application for the approval of a repair design to a type-certified product

    (a)

    An application for an approval of a repair design to a type-certified product shall be made in a form and manner established by the Agency.

    (b)

    For the approval of a major repair design, the applicant shall include in the application, or submit after the initial application, a compliance demonstration plan:

    1.

    containing a description of the damage and the repair design, identifying the configuration of the type design upon which the repair design is made;

    2.

    identifying all the areas of the type design and the approved manuals that are changed or affected by the repair design;

    3.

    identifying any reinvestigations necessary to demonstrate the compliance of the repair design and the areas affected by the repair design with the type-certification basis and the applicable environmental protection requirements, incorporated by reference in, as applicable, either the type certificate or the supplemental type certificate;

    4.

    identifying any proposed amendments to the type-certification basis incorporated by reference in, as applicable, either the type certificate or supplemental type certificate;

    5.

    specifying whether the certification data has been or will be prepared completely by the applicant or on the basis of an arrangement with the owner of the type-certification data.

    21L.A.206   Demonstration of compliance

    (a)

    The applicant for the approval of a major repair design shall demonstrate compliance with the applicable type-certification basis and applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with point 21L.B.201 and shall provide the Agency with the means by which such compliance has been demonstrated.

    (b)

    The applicant for the approval of a major repair design shall provide the Agency with a recorded justification of the means of compliance within compliance documents according to the compliance demonstration plan.

    (c)

    When carrying out testing and inspections to demonstrate compliance in accordance with point (a), the applicant shall have verified and documented this verification prior to carrying out any test:

    1.

    for the test specimen, that:

    (i)

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

    (ii)

    the constituent parts of the products adequately conform to the drawings in the proposed type design;

    (iii)

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

    2.

    that the test and measuring equipment used for the test were adequate for the test and appropriately calibrated.

    (d)

    The flight testing for the purpose of obtaining an approval of a major repair design shall be conducted in accordance with methods for such flight testing specified by the Agency. The applicant shall make all the flight tests necessary to determine compliance with the applicable type-certification basis and the applicable environmental protection requirements.

    (e)

    An applicant for the approval of a major repair design shall allow the Agency to:

    1.

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

    2.

    witness or carry out any test or inspection conducted for the purpose of the demonstration of compliance; and

    3.

    if it is considered necessary, conduct a physical inspection of the repaired product to verify the compliance of the design with the type-certification basis and the applicable environmental protection requirements.

    (f)

    Upon completion of the compliance demonstration, the applicant shall declare to the Agency that:

    1.

    they have demonstrated compliance with the type-certification basis and the applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with points 21L.B.201, according to the compliance demonstration plan; and

    2.

    no feature or characteristic has been identified that may make the product with the repair design unsafe or environmentally incompatible for the uses for which certification is requested.

    21L.A.207   Requirements for the approval of a minor repair design

    In order to be issued with an approval of a minor repair design to a type-certified product, the applicant shall:

    (a)

    demonstrate that the repair design and the areas affected by the repair design comply:

    1.

    with the type-certification basis and the applicable environmental protection requirements incorporated by reference in the type certificate; or

    2.

    if the applicant chooses to, with the certification specifications that are applicable to the product on the date of the application for the approval of the repair design;

    (b)

    declare compliance with the type-certification basis and the applicable environmental protection requirements that apply in accordance with point (a)(1), or with the certification specifications chosen in accordance with point (a)(2), record the justifications of compliance in the compliance documents, and record that no feature or characteristic has been identified that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested;

    (c)

    submit to the Agency the justification of compliance for the repair and the declaration of compliance.

    21L.A.208   Requirements for the approval of a major repair design

    In order to be issued with an approval of a major repair design to a type-certified product, the applicant shall:

    (a)

    demonstrate that the repair design and the areas affected by the repair design comply with the type-certification basis and the applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with point 21L.B.201;

    (b)

    demonstrate compliance in accordance with point 21L.A.206;

    (c)

    if the applicant has specified that they provided certification data on the basis of an arrangement with the owner of the type-certification data in accordance with point 21L.A.205(b)(5), demonstrate that the type-certificate holder:

    1.

    has no technical objection to the information submitted under point 21L.A.205; and

    2.

    has agreed to collaborate with the applicant to ensure the discharge of all the obligations for continued airworthiness of the repaired product through compliance with points 21L.A.28 and 21L.A.88;

    (d)

    demonstrate that there are no unresolved issues from the physical inspection of the first article of that product with the repair design in the final changed configuration carried out by the Agency in accordance with point 21L.A.206(e)(3).

    21L.A.209   Approval of a repair design under a privilege

    (a)

    The approval of a repair design that it has designed may be issued by an approved design organisation without an application according to point 21L.A.205 in accordance with the scope of its privileges provided for in points (2) and (5) of point 21.A.263(c) of Annex I (Part 21) instead of the Agency, as recorded in the terms of approval.

    (b)

    When issuing a repair approval in accordance with point (a), the design organisation shall:

    1.

    ensure that all the substantiation data and justifications are available;

    2.

    ensure that the compliance of the change with the type-certification basis and the applicable environmental protection requirements according to point (a) of point 21L.A.207 or point (a) of point 21L.A.208 has been demonstrated and declared in accordance with point 21L.A.206;

    3.

    confirm that it has not found:

    (i)

    any non-compliances with the type-certification basis or, where applicable, with the applicable environmental protection requirements, or with the certification specifications chosen;

    (ii)

    any feature or characteristic of the repair that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested;

    4.

    limit the approval of a repair to a type certificate to the specific configuration(s) in the type certificate to which the repair relates.

    21L.A.210   Obligations of a holder of a repair design approval

    The holder of a repair design approval shall:

    (a)

    if they are not the type-certificate or supplemental type-certificate holder, and certification data has been supplied in accordance with 21L.A.205 (b)(5), establish an arrangement with the relevant holder;

    (b)

    provide to the organisation performing the repair all the necessary instructions to install or embody the repair design;

    (c)

    support any production organisation producing parts for the repair design, and ensure that those parts are produced using production data that is based upon the design data that is provided by the repair design approval holder;

    (d)

    ensure that the repair design includes all the necessary instructions and limitations, if a repair design is approved subject to limitations. These instructions and limitations shall be transmitted to the operator by the holder of the repair design approval in accordance with a procedure agreed with the Agency;

    (e)

    undertake the obligations of a repair design approval holder of Subpart A of this Annex.

    21L.A.211   Unrepaired damage

    Damage to a product, the design of which has been approved in accordance with Section B, may not require a repair design if an evaluation of the airworthiness consequences justifies it. Such an evaluation is to be made by either the Agency or by a design organisation which is appropriately approved in accordance with Subpart J of Section A of Annex I (Part 21), under a procedure accepted by the Agency. If the evaluation concludes that the unrepaired damage requires limitations, those shall be processed in accordance with point (d) of point 21L.A.210.

    SUBPART N –   DESIGN OF REPAIRS TO AIRCRAFT FOR WHICH DESIGN COMPLIANCE HAS BEEN DECLARED

    21L.A.221   Scope

    This Subpart establishes:

    (a)

    the procedure for declaring the compliance of repair designs to an aircraft which was subject to a declaration made in accordance with Subpart C of this Annex;

    (b)

    the rights and obligations of the declarant making a declaration of compliance of the change referred to in point (a);

    (c)

    provisions regarding the standard repairs that do not require a declaration of design compliance.

    21L.A.222   Standard repairs

    (a)

    Standard repairs are repair designs to an aircraft which was subject to a declaration made in accordance with Subpart C of this Annex and which:

    1.

    follow the design data included in the certification specifications issued by the Agency, containing the acceptable methods, techniques and practices for carrying out and identifying standard repairs, including the associated instructions for continued airworthiness; and

    2.

    are not in conflict with the design data covered by the declaration of aircraft design compliance made in accordance with Subpart C of this Annex.

    (b)

    Points 21L.A.223 to 21L.A.229 are not applicable to standard repairs.

    21L.A.223   Classification of repair designs to an aircraft for which design compliance has been declared

    (a)

    Repair designs to an aircraft which was subject to a declaration made in accordance with Subpart C of this Annex shall be classified as either a major or minor, using the criteria laid down in points (b) and (c) of 21L.A.203.

    (b)

    The design compliance of a minor repair design shall be declared in accordance with point 21L.A.225.

    (c)

    The design compliance of a major repair design shall be declared in accordance with point 21L.A.226.

    21L.A.224   Eligibility

    (a)

    A declarant who made a declaration of aircraft design compliance in accordance with Subpart C of this Annex may declare compliance of a minor repair design of that aircraft under the conditions laid down in this Subpart. In addition, such a declaration of compliance may be also made, under the conditions laid down in this Subpart, by a design organisation approved in accordance with point (c)(3) of point 21.A.263 of Annex I (Part 21).

    (b)

    Only the declarant who made a declaration of aircraft design compliance in accordance with Subpart C of this Annex may declare the compliance of a major repair design to an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex, under the conditions laid down in this Subpart.

    (c)

    By derogation from point (b), if the declarant who made a declaration of aircraft design compliance in accordance with Subpart C of this Annex is no longer active or is unresponsive to requests for repair designs, the compliance of a changed aircraft design may also be declared in accordance with Subpart C of this Annex by a design organisation approved in accordance with point (c)(2) of point 21.A.263 of Annex I (Part 21) within the scope of their terms of approval, or by any other natural or legal person who is able to undertake the obligations laid down in point 21L.A.47 with respect to that changed aircraft.

    21L.A.225   Declaration of design compliance for minor repair designs

    (a)

    Prior to incorporating or embodying or agreeing with a production organisation to incorporate or embody a minor repair design to an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex, the declarant or the organisation that has designed the minor repair shall declare that the minor repair design complies with the detailed technical specifications and the applicable environmental protection requirements with which compliance had been declared according to point 21L.A.43.

    (b)

    The declaration of design compliance shall be made in a form and manner established by the Agency.

    (c)

    The declarant or the organisation that has designed the minor change shall maintain a register of minor repair designs to aircraft for which design compliance has been declared, and make any declaration made in accordance with point (a) available to the Agency upon request.

    21L.A.226   Declaration of design compliance of major repair designs

    (a)

    Prior to incorporating or embodying or agreeing with a production organisation to incorporate or embody a major repair design to an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex, the declarant shall declare that the design of the major repair complies with the detailed technical specifications and the applicable environmental protection requirements with which compliance had been declared according to point 21L.A.43.

    (b)

    The declaration of design compliance shall be made in a form and manner established by the Agency.

    (c)

    The declaration shall contain at least the following information:

    1.

    the name of the person submitting the declaration, and their address/place of business;

    2.

    the declaration reference number of the aircraft to which the major repair design relates;

    3.

    a unique reference for identifying the major repair design;

    4.

    indication of the detailed technical specifications and the applicable environmental protection requirements with which the compliance of the aircraft had been declared by the declarant according to point 21L.A.43;

    5.

    a signed statement made under the sole responsibility of the person making the declaration that the design of the major repair is in compliance with the detailed technical specifications and the applicable environmental protection requirements referred to in point (4), according to the compliance demonstration plan referred to in point (d)(3);

    6.

    a signed statement made under the sole responsibility of the person making the declaration that no features or characteristics have been identified by that person that may make the aircraft unsafe or environmentally incompatible for the intended use;

    7.

    a description of the damage and the repair design identifying the configuration of the type design upon which the repair is made;

    8.

    identification of all the areas of the type design and the approved manuals that are changed or affected by the repair design.

    (d)

    The declarant that designs a major repair shall submit the declaration referred to in point (c) to the Agency. Together with this declaration, the declarant shall provide to the Agency:

    1.

    a description of the major repair;

    2.

    basic data about the major repair, including the operating characteristics, design features and any limitations;

    3.

    a compliance demonstration plan detailing the means for compliance demonstration that was followed during the compliance demonstration;

    4.

    recorded justifications of compliance within compliance data obtained from the compliance activities that have been conducted according to the compliance demonstration plan;

    5.

    the means by which compliance with the detailed technical specifications and the applicable environmental protection requirements with which the declarant had declared that aircraft compliance according to point 21L.A.43 has been demonstrated;

    6.

    where compliance is demonstrated by carrying out tests, a recorded justification of the conformity of the test articles and equipment, demonstrating:

    (i)

    for the test specimen, that:

    (A)

    the materials and processes adequately conformed to the specifications for the design;

    (B)

    the constituent parts of the products adequately conformed to the drawings in the design; and

    (C)

    the manufacturing processes, construction and assembly adequately conformed to those specified in the design;

    (ii)

    that the test and measuring equipment used for the tests were adequate for the tests and appropriately calibrated;

    7.

    reports, results of inspections or tests that the declarant found necessary to determine that the aircraft complies with the detailed technical specifications and the applicable environmental protection requirements.

    (e)

    The declaration of a major repair to a declaration of design compliance shall be limited to the specific configuration(s) in the declaration of design compliance to which the change relates.

    21L.A.227   Compliance activities for declaring compliance of a major repair design

    Prior to making a declaration of compliance in accordance with point 21L.A.226, the declarant shall, for that specific design:

    (a)

    establish a compliance demonstration plan detailing the means for compliance demonstration that shall be followed during the compliance demonstration. This document shall be updated as necessary;

    (b)

    record the justification of compliance within compliance documents according to the compliance demonstration plan;

    (c)

    perform testing and inspections as necessary in accordance with the compliance demonstration plan;

    (d)

    ensure and record the conformity of the test articles and equipment and ensure that the test specimen conforms to the specifications, drawings, manufacturing processes, construction and assembly means in the design;

    (e)

    ensure that the test and measuring equipment to be used for testing are adequate for testing and appropriately calibrated;

    (f)

    allow the Agency to conduct or participate in any inspections or tests of aircraft in the final or suitably mature design and production configuration that are necessary to determine that the product with the repair design has no feature or characteristic that makes the aircraft unsafe or environmentally incompatible for the intended use;

    (g)

    carry out flight testing, in accordance with the flight conditions for such flight testing specified by the Agency, as necessary in order to determine that the aircraft complies with the applicable detailed technical specifications and the applicable environmental protection requirements.

    21L.A.228   Obligations of the declarant of a declaration of design compliance of a repair design

    The declarant of a declaration of design compliance shall:

    (a)

    for minor repair designs maintain a register of those declarations and shall make those declarations available to the Agency upon request;

    (b)

    provide to the organisation performing the repair all the necessary instructions to install or embody the repair design;

    (c)

    support any production organisation producing parts for the repair design, and ensure that those parts are produced using production data that is based upon the design data that is provided by the declarant;

    (d)

    if a repair design is declared subject to limitations, transmit these limitations to the operator using a documented procedure that is made available to the Agency upon request;

    (e)

    undertake the obligations of a declarant of design compliance of a repair design of Subpart A of this Annex.

    21L.A.229   Unrepaired damage

    The declarant of design compliance of an aircraft in accordance with Subpart C of this Annex or an approved design organisation with privileges provided in accordance with point (c)(3) of point 21.A.263 of Annex I (Part 21) and with the appropriate scope of approval shall conduct an evaluation of the airworthiness and environmental compatibility consequences of any damage to such aircraft that is left unrepaired and that is not covered by previously declared data. Any necessary limitations shall be processed in accordance with point (d) of point 21L.A.228.

    SUBPART O –   EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS

    (Reserved)

    SUBPART P –   PERMIT TO FLY

    21L.A.241   Permit to fly and flight conditions

    (a)

    The procedures for applying for the issuance of permits to fly and related flight conditions for aircraft within the scope of this Annex shall be those established in Subpart P of Section A of Annex I (Part 21) and those established in points (b) and (c) of point 21L.A.241.

    (b)

    When applying for a permit to fly in accordance with point 21.A.707 of Annex I (Part 21), the applicant shall arrange for the competent authority to conduct a conformity inspection of the aircraft when the application for a permit to fly relates to:

    1.

    the demonstration of compliance activities in point 21L.A.25 for an aircraft which is, or is intended to be, type-certified;

    2.

    the demonstration of compliance activities in point 21L.A.44 for an aircraft for which design compliance is, or is intended to be, declared.

    (c)

    When applying for flight conditions in accordance with point 21.A.709 of Annex I (Part 21), the applicant shall arrange for the Agency:

    1.

    to physically inspect and assess the aircraft if the flight conditions are related to the demonstration of compliance to support a declaration of design compliance in point 21L.A.44 and if requested by the Agency during the demonstration of compliance activities as referred to in point (b) of point 21L.B.121 and point (c) of point 21L.B.203; or

    2.

    to physically inspect and assess the aircraft and to conduct a critical design review if the flight conditions are related to the demonstration of compliance associated with the certification of the design in point 21L.A.25 and if requested by the Agency in point 21L.B.83, point 21L.B.102 and point 21L.B.203.

    SUBPART Q –   IDENTIFICATION OF PRODUCTS AND PARTS

    21L.A.251   Scope

    This Subpart establishes the requirements for the identification of products and parts designed and produced under this Annex.

    21L.A.252   Design of markings

    (a)

    The holder of a type certificate, supplemental type certificate, approval of a change to type certificate or approval of a repair design, or the declarant of a declaration of design compliance shall specify in the design data the marking of products and parts designed in accordance with this Annex.

    (b)

    The specifications of the marking shall include the following information:

    1.

    for products:

    (i)

    the name of the production organisation;

    (ii)

    the product designation;

    (iii)

    the serial number of the product;

    (iv)

    any other information appropriate to identify the product;

    2.

    for parts:

    (i)

    a name, trademark, or symbol identifying the production organisation;

    (ii)

    the part number;

    (iii)

    the serial number, in cases where a part to be fitted on a product has been identified as a critical part.

    (c)

    The specification of parts in accordance with point (ii) of point (b)(2) shall include the letter ‘(R)’ at the end of the part number when:

    1.

    the part is from a design subject to a declaration of design compliance in accordance with Subpart C of this Annex;

    2.

    the part is to be released on an EASA Form 1 in accordance with point (a) of point 21L.A.193; and

    3.

    the part has been produced in accordance with Subpart R of this Annex.

    21L.A.253   Identification of products

    (a)

    Any natural or legal person who produces products under Subpart G of Section A of Annex I (Part 21) or under Subpart G or R of this Annex for which the design has been approved or declared in accordance with this Annex shall identify that product as specified in accordance with 21L.A.252 by means of a fireproof marking on a fireproof plate.

    (b)

    The identification plate shall be secured in such a manner that it is accessible and legible, and will not likely be defaced or removed during normal service, or lost or destroyed in an accident, and in the case of a propeller, propeller blade, or propeller hub, placed on a non-critical surface of the item.

    (c)

    For manned balloons, the identification plate shall be secured to the balloon envelope and shall be located, if practicable, where it is legible to the operator when the balloon is inflated. In addition, the basket, load frame assembly and any heater assembly shall be permanently and legibly marked with the name of the production organisation, part number, or its equivalent, and the serial number, or its equivalent.

    21L.A.254   Handling of identification data

    (a)

    Any natural or legal person performing maintenance work in accordance with Regulation (EU) No 1321/2014 may, in accordance with methods, techniques and practices established by the Agency:

    1.

    remove, change, or place the identification information referred to in point 21L.A.253; or

    2.

    remove or install an identification plate referred to in point 21L.A.253, when necessary during maintenance operations.

    (b)

    Unless for the purposes stated in point (a) of point 21L.A.254, no person shall remove, change, or place the identification information referred to in point (a) of point 21L.A.253.

    (c)

    Unless for the purposes stated in point (a) of point 21L.A.254, no person shall remove or install any identification plate referred to in point (a) of point 21L.A.253.

    (d)

    No person shall install an identification plate removed in accordance with point (a)(2) on any aircraft, engine, propeller, propeller blade, or propeller hub other than the one from which it was removed.

    21L.A.255   Identification of parts

    Any natural or legal person who produces parts under Subpart G of Section A of Annex I (Part 21) or under Subpart G or R of this Annex for a product for which the design has been approved or declared in accordance with this Annex shall permanently and legibly mark that part as specified in accordance with point 21L.A.252.

    SUBPART R –   STATEMENT OF CONFORMITY FOR AIRCRAFT AND AUTHORISED RELEASE CERTIFICATE (EASA FORM 1) FOR ENGINES AND PROPELLERS, OR PARTS THEREOF, WHICH CONFORM TO A DECLARATION OF DESIGN COMPLIANCE

    21L.A.271   Scope

    This Subpart establishes the procedures for the issuance of statements of conformity for aircraft (EASA Form 52B) and authorised release certificates (EASA Form 1) for engines and propellers, or parts thereof, that have been produced in conformity with the design data of a declaration of design compliance, and the rights and obligations of the declarant.

    21L.A.272   Eligibility

    Any natural or legal person who is granted access to the applicable design data and is able to undertake the obligations stated in point 21L.A.275 may issue a statement of conformity (EASA Form 52B) for an aircraft or an authorised release certificate (EASA Form 1) for an engine or propeller, or a part thereof, under the conditions laid down in this Subpart.

    21L.A.273   Production control system

    A natural or legal person issuing a statement of conformity (EASA Form 52B) or an authorised release certificate (EASA Form 1) with the applicable declared design data of an aircraft, engine or propeller, or a part thereof, that they have produced, shall establish, implement and maintain a system for controlling production that:

    (a)

    includes processes and procedures that ensure that the aircraft, engine or propeller, and any part thereof, conforms with the applicable declared design data;

    (b)

    ensures that each statement of conformity (EASA Form 52B) or authorised release certificate (EASA Form 1) is only signed by authorised persons;

    (c)

    if flight tests are necessary within the scope of production, has processes in place that ensure that any flight tests are conducted in a safe manner;

    (d)

    ensures that the natural or legal person is in receipt of all the necessary airworthiness and environmental compatibility data to determine conformity;

    (e)

    has procedures in place that ensure that the airworthiness and environmental compatibility data is correctly incorporated in its production data, kept up to date and made available to all the personnel who need access to such data to perform their duties;

    (f)

    includes an inspection system that ensures that any aircraft, engine or propeller, and any part thereof, that are produced by the natural or legal person including their partners, or are supplied from or subcontracted to outside parties, conform with the applicable declared design data and are in a condition for safe operation;

    (g)

    includes an archiving system that records the requirements that have been placed on other organisations such as suppliers and subcontractors. The archived data shall be made available to the competent authority for continuing airworthiness purposes;

    (h)

    ensures that the maintenance of a newly manufactured aircraft is conducted in accordance with the applicable maintenance instructions and that the aircraft is kept in an airworthy condition, and if applicable, a certificate of release to service is issued for any maintenance that has been completed;

    (i)

    includes an internal occurrence reporting system in the interest of safety, to enable the collection and assessment of the occurrence reports collected in accordance with point 21L.A.3 in order to identify adverse trends or to address deficiencies, and to extract reportable occurrences. This system shall include the evaluation of relevant information relating to occurrences and the promulgation of the related information.

    21L.A.274   Issuance of a statement of conformity (EASA Form 52B) or an authorised release certificate (EASA Form 1)

    (a)

    When issuing a statement of conformity (EASA Form 52B) or an authorised release certificate (EASA Form 1), the natural or legal person shall include all of the following:

    1.

    a statement that the aircraft, engine or propeller, or any part thereof, conforms to the applicable declared design data and is in a condition for safe operation;

    2.

    for each aircraft, a statement that the aircraft has been ground- and flight-checked;

    3.

    for each engine or variable pitch propeller, a statement that the engine or variable pitch propeller has been subjected to a final functional test;

    4.

    if applicable, a statement that the completed engine is in compliance with the applicable engine exhaust emissions requirements in force on the date of production of the engine.

    (b)

    The natural or legal person shall issue a statement of conformity (EASA Form 52B) or an authorised release certificate (EASA Form 1) upon:

    1.

    the initial transfer of the ownership of the aircraft, engine or propeller, or parts thereof; or

    2.

    for aircraft, the application for the issue of the restricted certificate of airworthiness for the aircraft.

    21L.A.275   Obligations of a natural or legal person issuing a statement of conformity (EASA Form 52B) or an authorised release certificate (EASA Form 1)

    The natural or legal person issuing a statement of conformity (EASA Form 52B) or an authorised release certificate (EASA Form 1) shall:

    (a)

    inform the competent authority that they intend to produce an aircraft, engine or propeller, or a part thereof, in conformity with the design data of a declaration of design compliance and that they will issue statements of conformity (EASA Form 52B) or authorised release certificates (EASA Form 1) in accordance with this Subpart;

    (b)

    ensure that the details of any completed work are recorded;

    (c)

    maintain, at the place of production, the technical data and drawings necessary to determine whether the aircraft, engine or propeller, or a part thereof, conforms to the applicable declared design data;

    (d)

    provide continuing airworthiness support to the declarant of a declaration of design compliance for any aircraft, engine or propeller, or a part thereof, that they have produced;

    (e)

    for new aircraft that they have produced, ensure that the aircraft is kept in an airworthy condition and that maintenance is performed, unless Regulation (EU) No 1321/2014 requires the maintenance to be performed under such rules, including any necessary repairs in accordance with the applicable design data prior to the issuance of an aircraft statement of conformity (EASA Form 52B);

    (f)

    when issuing a certificate of release to service after such maintenance, determine that each completed aircraft has been subjected to the necessary maintenance and is in a condition for safe operation, prior to issuing the certificate;

    (g)

    undertake the obligations of a natural or legal person issuing statements of conformity (EASA Form 52B) or authorised release certificates (EASA Form 1) of Subpart A of this Annex;

    (h)

    inform the competent authority about the cessation of their activities under this Subpart.

    SECTION B

    PROCEDURES FOR COMPETENT AUTHORITIES

    SUBPART A –   GENERAL PROVISIONS

    (reserved)

    SUBPART B –   TYPE CERTIFICATES

    21L.B.41   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, 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

    (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

    (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.

    21L.B.44   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.

    21L.B.45   Designation of the applicable environmental protection requirements for a type certificate

    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).

    21L.B.46   Investigation

    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.

    21L.B.47   Issuance of a type certificate

    (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

    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

    (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.

    SUBPART C –   DECLARATIONS OF DESIGN COMPLIANCE

    21L.B.61   Detailed technical specifications and applicable environmental protection requirements for declarations of product design compliance

    (a)

    The Agency, in accordance with Article 76(3) of Regulation (EU) 2018/1139, shall establish and make available the detailed technical specifications that natural and legal persons can use to demonstrate compliance with the relevant essential requirements set out in Annex II to that Regulation when declaring compliance of the aircraft design in accordance with Subpart C of Section A of this Annex.

    (b)

    The detailed technical specifications referred to in point (a) shall provide design standards which reflect the state of the art and best design practices, and which build on the best available experience and scientific and technical progress, and on the best available evidence and analysis of aircraft design, for aircraft that are within the scope established under point 21L.A.41. These detailed technical specifications may include or refer to:

    1.

    certification specifications established by the Agency in accordance with point 21.B.70 of Annex I (Part 21) for the airworthiness of the aircraft design;

    2.

    special conditions that have been prescribed by the Agency in accordance with point 21.B.75 of Annex I (Part 21) or point 21L.B.44 for other aircraft and which are of a general nature;

    3.

    detailed technical standards developed by standardisation and other industry bodies.

    (c)

    For the purposes of ensuring the environmental compatibility of the design, the Agency shall establish and make available the environmental protection requirements to be used as the basis for the declaration of design compliance, which shall include:

    1.

    environmental protection requirements for the relevant product categories as contained in Annex 16 to the Convention on International Civil Aviation, Volumes I to III, at an amendment level referred to in Article 9(2) of Regulation (EU) 2018/1139; for this purpose, the references to:

    (i)

    the date of application for a type certificate contained in those volumes shall be understood as references to the date on which the declaration of design compliance is made by the declarant; and

    (ii)

    the certification requirements contained in those volumes shall be understood as requirements for the declaration of design compliance.

    2.

    [reserved]

    21L.B.62   Initial oversight investigation

    (a)

    Upon receiving a declaration of design compliance, the Agency shall verify that the aircraft is within the scope of Subpart C of Section A of this Annex and that the declaration contains all the information specified in point 21L.A.43. The Agency shall acknowledge the receipt of the declaration, including the assignment of an individual declaration of design compliance reference number to the declarant for that aircraft configuration.

    (b)

    The Agency shall conduct a physical inspection and assessment of the first article of that aircraft in the final configuration, taking into consideration the safety review carried out in accordance with point (a)(2) of point 21L.B.242. If the Agency finds evidence, in the declaration or through the physical inspection and assessment carried out in accordance with the first sentence, indicating that the aircraft could be incapable of conducting a safe flight or could be environmentally incompatible during in-service operations, the Agency shall raise a finding in accordance with point 21L.B.21.

    21L.B.63   Registration of a declaration of design compliance

    The Agency shall register a declaration of design compliance for an aircraft provided that:

    (a)

    the declarant has declared compliance in accordance with point (a) of point 21L.A.43;

    (b)

    the declarant has provided to the Agency the documents required in accordance with point (c) of point 21L.A.43;

    (c)

    the declarant has made a commitment that the obligations in accordance with point 21L.A.47 will be undertaken;

    (d)

    there are no unresolved findings from the physical inspection and assessment of the first article of the aircraft in the final configuration carried out in accordance with point (b) of point 21L.B.62.

    21L.B.64   Continuing airworthiness oversight of aircraft for which design compliance has been declared

    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 applicable detailed technical specifications 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.

    SUBPART D –   CHANGES TO TYPE CERTIFICATES

    21L.B.81   Type-certification basis and applicable environmental protection requirements for a major change to a type certificate

    (a)

    The Agency shall establish the type-certification basis for a major change to a type certificate and notify it to the applicant.

    (b)

    For a major change to a type certificate and the areas affected by the change, the type-certification basis shall consist of the certification specifications incorporated by reference in the type certificate, unless:

    1.

    the Agency finds that the certification specifications referenced in the type certificate do not provide adequate standards with respect to the proposed change, therefore the change and the 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 21L.B.44, to provide a level of safety equivalent to that established by the certification specifications applicable on the date of the application for the change;

    2.

    an applicant chooses to comply with a certification specification set out in an amendment that is applicable on the date of the application for the change.

    (c)

    The Agency shall designate the applicable environmental protection requirements for the major change to a type certificate in accordance with point 21.B.85 of Annex I (Part 21) and notify them to the applicant.

    21L.B.82   Investigation and issuance of an approval of a minor change to a type certificate

    (a)

    Upon receiving an application for the approval of a minor change to a type certificate under this Annex, the Agency shall approve the minor change when:

    1.

    the applicant has provided the substantiation data and justifications, and has demonstrated and declared the compliance of the change with the applicable type-certification basis and the applicable environmental protection requirements, or with the certification specifications chosen in accordance with point 21L.A.67;

    2.

    the Agency, through its verification of the demonstration of compliance, taking into account the design features, complexity and overall criticality of the design or technology, as well as previous experience of design activities with the applicant, has not found:

    (i)

    any non-compliances with the type-certification basis or, where applicable, with the applicable environmental protection requirements, or with the certification specifications chosen;

    (ii)

    any feature or characteristic of the change that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested.

    (b)

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

    21L.B.83   Investigation of a major change to a type certificate

    Upon receiving an application for a major change to 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 and the applicable environmental protection requirements established and designated in accordance with point 21L.B.81; 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 also approve any subsequent updates of the compliance demonstration plan;

    (c)

    determine the likelihood of an unidentified non-compliance of the major change with the type-certification basis or with the applicable environmental protection requirements, and the potential impact of that non-compliance on the safety or environmental compatibility of the product, and determine on that basis whether a physical inspection and assessment of the first article of that product in the final changed configuration is necessary in order to verify the compliance of the product with the applicable type-certification basis and the applicable environmental protection requirements, taking into consideration the critical design review if carried out in accordance with point (a)(3) of point 21L.B.242; the Agency shall notify the applicant before conducting this inspection and assessment;

    (d)

    if during the establishment of the type-certification basis, the designation of the applicable environmental protection requirements or during the review of the compliance demonstration plan, the Agency determines that the design of the major change 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 changed product, the Agency shall determine which investigations are necessary in addition to those of point (c) in order to verify the compliance demonstration; the Agency shall notify the applicant of those additional investigations and which elements of the design would be subject to investigation.

    21L.B.84   Issuance of an approval of a major change to a type certificate

    (a)

    The Agency shall approve the major change when:

    1.

    the applicant has demonstrated that the change and the areas affected by the change comply with the type-certification basis and the applicable environmental protection requirements, as established and designated by the Agency in accordance with point 21L.B.81;

    2.

    the applicant has demonstrated and declared compliance in accordance with point (f) of point 21L.A.66;

    3.

    the Agency through its verification of the demonstration of compliance has not found:

    (i)

    any non-compliances with the type-certification basis or, where applicable, with the applicable environmental protection requirements;

    (ii)

    any feature or characteristic of the change that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested.

    (b)

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

    21L.B.85   Continuing airworthiness oversight of changed products for which a type certificate has been issued

    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 of a product for which a change to a type certificate has been approved, 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.

    SUBPART E –   SUPPLEMENTAL TYPE CERTIFICATES

    21L.B.101   Type-certification basis and applicable environmental protection requirements for a supplemental type certificate

    (a)

    The Agency shall establish the type-certification basis for a supplemental type certificate and notify it to the applicant.

    (b)

    For major changes to a type certificate in the form of a supplemental type certificate, the type-certification basis for the areas affected by the change shall be that which is incorporated by reference in the type certificate, unless:

    1.

    the Agency finds that the certification specifications referenced in the type certificate do not provide adequate standards with respect to the proposed change, therefore the change and the 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 21L.B.44, to provide a level of safety equivalent to that established by the certification specifications applicable on the date of the application for the change;

    2.

    an applicant chooses to comply with a certification specification set out in an amendment that is applicable on the date of the application for the change.

    (c)

    The Agency shall designate the applicable environmental protection requirements for a major change to a type certificate in accordance with point 21.A.85 of Annex I (Part 21) and notify them to the applicant.

    21L.B.102   Investigation

    Upon receiving an application for a supplemental 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 and the applicable environmental protection requirements established and designated in accordance with point 21L.B.101; 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)

    determine the likelihood of an unidentified non-compliance of the major change 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, and determine on that basis whether a physical inspection and assessment of the first article of that product in the final changed configuration is necessary in order to verify the compliance of the product with the applicable type-certification basis and the applicable environmental protection requirements, taking into consideration the critical design review if carried out in accordance with point (a) of point 21L.B.242; the Agency shall notify the applicant before conducting this inspection and assessment;

    (d)

    if during the establishment of the type-certification basis, the designation of the applicable environmental protection requirements or during the review of the compliance demonstration plan, the Agency determines that the major change to the 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 changed product, the Agency shall determine which investigations are necessary in addition to those of point (c) in order to verify the compliance demonstration; the Agency shall notify the applicant of those additional investigations and which elements of the design would be subject to this investigation.

    21L.B.103   Issuance of a supplemental type certificate

    (a)

    Upon receiving an application for a supplemental type certificate under this Annex, the Agency shall issue a supplemental type certificate when:

    1.

    the applicant has demonstrated that the change and the areas affected by the change comply with the type-certification basis and the applicable environmental protection requirements, as established and designated by the Agency in accordance with point 21L.B.101;

    2.

    the applicant has demonstrated and declared compliance in accordance with point (f) of point 21L.A.85;

    3.

    the owner of the type-certificate data, if the applicant has specified in accordance with point (b)(2) of 21L.A.84 that the certification data has been provided on the basis of an arrangement with the owner of the type-certificate data, has:

    (i)

    no technical objection to the information submitted under point (a)(2) of point 21L.B.103; and

    (ii)

    agreed to collaborate with the holder of the repair design approval to discharge all the obligations for the continued airworthiness of the product with the repair design through compliance with point 21L.A.88;

    4.

    the Agency, through its verification of the demonstration of compliance, has not found:

    (i)

    any non-compliances with the type-certification basis or, where applicable, the applicable environmental protection requirements;

    (ii)

    any feature or characteristic of the change that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested.

    (b)

    A supplemental type certificate shall be limited to the specific configuration(s) in the type certificate to which the related major change relates.

    21L.B.104   Continuing airworthiness oversight of products for which a supplemental type certificate has been issued

    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 of a product for which a supplemental type certificate has been issued, 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.

    SUBPART F –   CHANGES TO AIRCRAFT FOR WHICH DESIGN COMPLIANCE HAS BEEN DECLARED

    21L.B.121   Initial oversight investigation of a declaration of design compliance of a major change to the design of an aircraft for which design compliance has been declared

    (a)

    Upon receiving a declaration of design compliance for a major change to the design of an aircraft for which design compliance has been declared, the Agency shall verify that the change is within the scope of point 21L.A.101 and that the declaration contains all the information specified in point 21L.A.107. The Agency shall acknowledge the receipt of the declaration, including the assignment of an individual declaration of design compliance reference number to the declarant.

    (b)

    The Agency shall assess, based upon the risk of a non-compliance leading to a design that is not capable of safe flight or being environmentally incompatible, whether a physical inspection and assessment of the changed product is needed, and subsequently inform the declarant if that is the case. This assessment of the risk shall take into consideration:

    1.

    the complexity of the major change and the overall effect on the aircraft structures, flight characteristics and systems;

    2.

    previous experience of physical inspections of aircraft and major changes that have been designed by the declarant;

    3.

    the response by the declarant to any previous findings that have been raised for non-compliances for the specific aircraft or similar aircraft designed by the declarant that have also been subject to a declaration of design compliance.

    (c)

    If the Agency finds evidence in the declaration, or through the physical inspection and assessment if carried out in accordance with point (b) of point 21L.B.121, indicating that the changed aircraft could be incapable of conducting a safe flight or could be environmentally incompatible during in-service operations, the Agency shall raise a finding in accordance with point 21L.B.21.

    21L.B.122   Registration of a declaration of design compliance for a major change to an aircraft design

    (a)

    The Agency shall register a declaration of design compliance for a major change to the design of an aircraft for which design compliance has been declared, provided that:

    1.

    the declarant has declared compliance in accordance with point (a) of point 21L.A.107;

    2.

    the declarant has provided to the Agency the documents required in accordance with point (d) of point 21L.A.107;

    3.

    the declarant has made a commitment that the obligations in accordance with point 21L.A.47 will also be undertaken in respect of the changed aircraft design;

    4.

    there are no unresolved issues from the physical inspection, if carried out in accordance with point (b) of point 21L.B.121.

    (b)

    The Agency shall only register a declaration of a major change to the design of an aircraft for which design compliance has been declared if it is limited to the specific configuration(s) in the registered declaration of design compliance to which the change relates.

    21L.B.123   Continuing airworthiness oversight of a changed aircraft for which design compliance has been declared

    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 applicable detailed technical specifications or the applicable environmental protection requirements of a change for which design compliance has been declared, the Agency shall act in accordance with point 21L.B.64.

    SUBPART G –   DECLARED PRODCUTION ORGANISATIONS

    (reserved)

    SUBPART H –   CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS

    (reserved)

    SUBPART I –   NOISE CERTIFICATES

    (reserved)

    SUBPART J –   DECLARED DESIGN ORGANISATIONS

    21L.B.181   Initial oversight investigation

    (a)

    Upon receiving a declaration from an organisation declaring their design capability, the Agency shall verify that:

    1.

    the declarant is eligible to declare their design capability in accordance with point 21L.A.172;

    2.

    the declaration contains all the information specified in point (c) of point 21L.A.173; and

    3.

    the declaration does not contain information that indicates a non-compliance with the requirements of Subpart J of Section A of this Annex.

    (b)

    The Agency shall acknowledge the receipt of the declaration, including the assignment of an individual declared design organisation reference number to the declarant.

    21L.B.182   Registration of a declaration of design capability

    The Agency shall register the declaration of design capability on a suitable database, including the declared scope of work, provided that:

    (a)

    the declarant has declared their capability in accordance with point 21L.A.173;

    (b)

    the declarant has made a commitment that the obligations in accordance with point 21L.A.177 will be undertaken;

    (c)

    there are no unresolved issues in accordance with point 21L.B.181.

    21L.B.183   Oversight

    (a)

    The Agency shall oversee the declared design organisation in order to verify the continuous compliance of the organisation with the applicable requirements of Section A.

    (b)

    The oversight shall include a product critical design review or physical inspection, and a first article inspection of every new design of the declared design organisation.

    21L.B.184   Oversight programme

    (a)

    The Agency shall establish and maintain an oversight programme in order to ensure compliance with point 21L.B.183. The oversight programme shall take into account the specific nature of the organisation, the complexity of its activities and the results of past certification and/or oversight activities, and it shall be based on the assessment of the associated risks. It shall include, within each oversight planning cycle:

    1.

    assessments, audits and inspections, including as appropriate:

    (i)

    management system assessments and process audits;

    (ii)

    product audits of a relevant sample of the design and certification of the products, and parts that are under the scope of the organisation;

    (iii)

    sampling of the work performed;

    (iv)

    unannounced inspections;

    2.

    meetings convened between the head of the design organisation and the Agency to ensure that both remain informed of any significant issues.

    (b)

    The oversight programme shall include records of the dates when assessments, audits, inspections and meetings are due, and when assessments, audits, inspections and meetings have been effectively carried out.

    (c)

    An oversight planning cycle that does not exceed 24 months shall be applied.

    (d)

    Notwithstanding point (c), the oversight planning cycle may be extended to 36 months if the Agency has established that during the previous 24 months:

    1.

    the organisation has demonstrated that it can effectively identify aviation safety hazards and manage the associated risks;

    2.

    the organisation has continuously demonstrated compliance with point 21L.A.178 and that it has full control over all changes to the design management system;

    3.

    no level 1 findings have been issued;

    4.

    all corrective actions have been implemented within the time period that was accepted or extended by the Agency as defined in point 21L.B.21.

    (e)

    Notwithstanding point (c), the oversight planning cycle may be further extended to a maximum of 48 months if, in addition to the conditions provided in point (d), the organisation has established, and the Agency has approved, an effective continuous system for reporting to the Agency on the safety performance and regulatory compliance of the organisation itself.

    (f)

    The oversight planning cycle may be reduced if there is evidence that the safety performance of the organisation has decreased.

    (g)

    At the completion of each oversight planning cycle, the Agency shall issue a recommendation report on the continuation of the activities conducted by the declared design organisation based on its declaration of design capability, reflecting the results of the oversight.

    21L.B.185   Oversight activities

    (a)

    When the Agency verifies the compliance of the declared design organisation in accordance with point 21L.B.183 and the oversight programme established in accordance with point 21L.B.184, it shall:

    1.

    provide the personnel responsible for oversight with guidance to perform their functions;

    2.

    conduct assessments, audits, inspections, and, if needed, unannounced inspections;

    3.

    collect the evidence needed in case further action is required, including the measures provided for in point 21L.B.21 and 21L.B.22;

    4.

    inform the declared design organisation about the results of the oversight activities.

    (b)

    The Agency shall collect and process any information deemed necessary for conducting oversight activities.

    (c)

    If the Agency detects a non-compliance of the declared design organisation with the applicable requirements of Section A, with a procedure or manual required by Section A, or with the declaration submitted, the Agency shall act in accordance with points 21L.B.21 and 21L.B.22.

    21L.B.186   Changes to declarations

    (a)

    Upon receiving a notification of changes in accordance with point 21L.A.178, the Agency shall verify the completeness of the notification in accordance with point 21L.B.181.

    (b)

    The Agency shall update its oversight programme established according to point 21L.B.184 and investigate whether it is necessary to establish any conditions under which the organisation may operate during the change.

    (c)

    When the change affects any aspect of the declaration that is registered in accordance with point 21L.B.182, the Agency shall update the register.

    (d)

    Upon completion of the activities required by points (a) to (c), the Agency shall acknowledge the receipt of the notification to the declared design organisation.

    SUBPART K –   PARTS

    (Reserved)

    SUBPART M –   DESIGN OF REPAIRS TO TYPE-CERTIFIED PRODUCTS

    21L.B.201   Type-certification basis and applicable environmental protection requirements for a repair design approval

    The Agency shall designate any amendments to the type-certification basis and the applicable environmental requirements incorporated by reference in, as applicable, either the type certificate or the supplemental type certificate, which the Agency considers necessary for maintaining a level of safety and environmental compatibility equal to that previously established and notify them to the applicant for the approval of a repair design.

    21L.B.202   Investigation and issuance of an approval for a minor repair design

    (a)

    Upon receiving an application for the approval of a minor repair design to a type-certified product under this Annex, the Agency shall approve the minor repair design when:

    1.

    the applicant has provided the substantiation data and justifications and has demonstrated and declared the compliance of the repair design with the applicable type-certification basis and the applicable environmental protection requirements established in accordance with point 21L.B.201;

    2.

    the Agency, through its verification of the demonstration of compliance, taking into account the design features of the repair design, complexity and overall criticality of the repair design, as well as previous experience of design activities with the applicant, has not found:

    (i)

    any non-compliances with the type-certification basis or, where applicable, with the applicable environmental protection requirements;

    (ii)

    any feature or characteristic of the repair design that may make the product with the repair design unsafe for the uses for which certification is requested.

    (b)

    An approval of a minor repair design shall be limited to the specific configuration(s) in the type certificate to which the repair design relates.

    21L.B.203   Investigation of an application for the approval of a major repair design

    Upon receiving an application for the approval of a major repair design 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 and the applicable environmental protection requirements established and designated in accordance with point 21L.B.201; 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)

    determine the likelihood of an unidentified non-compliance of the major repair design with the type-certification basis or with the applicable environmental protection requirements, and the potential impact of that non-compliance on the safety or environmental compatibility of the product, and determine on that basis whether a physical inspection and assessment of the first article of that product in the final configuration with the repair design is necessary in order to verify the compliance of the product with the applicable type-certification basis; the Agency shall notify the applicant before conducting this inspection and assessment;

    (d)

    if, during the review of the compliance demonstration plan, the Agency determines that the major repair design contains any element for which an unidentified non-compliance with the type-certification basis or with the applicable environmental protection requirements may have an adverse impact on the safety or environmental compatibility of the changed product, the Agency shall determine which investigations are necessary in addition to those of point (c) in order to verify the compliance demonstration; the Agency shall notify the applicant of those additional investigations and which elements of the design would be subject to investigation.

    21L.B.204   Issuance of an approval of a major repair design

    (a)

    Upon receiving an application for the approval of a major repair design to a type-certified product under this Annex, the Agency shall approve the major repair design when:

    1.

    the applicant has been demonstrated that the repair design and the areas affected by the repair design comply with the type-certification basis and with the applicable environmental protection requirements, as established by the Agency in accordance with point 21L.B.201; and

    2.

    the applicant has demonstrated and declared compliance in accordance with point 21L.A.208;

    3.

    the owner of the type-certificate data, if the applicant has specified in accordance with point 21L.A.205(b)(5) that they provided the certification data on the basis of an arrangement with the owner of the type-certificate data, has:

    (i)

    no technical objection to the information submitted under point (a)(2) of point 21L.B.204; and

    (ii)

    agreed to collaborate with the holder of the repair design approval to discharge all the obligations for the continued airworthiness of the product with the repair design through compliance with point 21L.A.210;

    4.

    the Agency, through its verification of the demonstration of compliance, has not found:

    (i)

    any non-compliances with the type-certification basis or, where applicable, the applicable environmental protection requirements;

    (ii)

    any feature or characteristic of the change that may make the product with the repair design unsafe for the uses for which certification is requested.

    (b)

    An approval of a major repair design shall be limited to the specific configuration(s) in the type certificate to which the repair design relates.

    21L.B.205   Continuing airworthiness oversight of products for which a repair design has been approved

    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 of a product, for which a repair design has been approved, with the type-certification basis or with 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.206   Unrepaired damage

    An evaluation of the airworthiness consequences shall be conducted by the Agency, when requested to do under point 21L.A.211, in the event that a damaged product is left unrepaired and is not covered by previously approved data. The Agency shall establish any limitations necessary to ensure a safe flight with the damaged product.

    SUBPART N –   DESIGN OF REPAIRS TO AIRCRAFT FOR WHICH DESIGN COMPLIANCE HAS BEEN DECLARED

    21L.B.221   Initial oversight investigation of a declaration of design compliance of a major repair design to an aircraft for which design compliance has been declared

    (a)

    Upon receiving a declaration of design compliance of a major repair design to an aircraft for which design compliance has been declared, the Agency shall verify that that the repair design is within the scope of point 21L.A.221 and that the declaration contains all the information specified in point 21L.A.226. The Agency shall acknowledge the receipt of the declaration, including the assignment of an individual declaration of design compliance reference number to the declarant.

    (b)

    The Agency shall assess, based upon the risk of a non-compliance leading to a design that is not capable of safe flight or being environmentally incompatible, whether a physical inspection and assessment of the aircraft with the major repair design is needed, and subsequently inform the declarant if that is the case. This assessment of the risk shall take into consideration:

    1.

    the complexity of the major repair design and the overall effect on the aircraft structures, flight characteristics and systems;

    2.

    previous experience of physical inspections of aircraft and major repair designs and changes that have been designed by the declarant;

    3.

    the response by the declarant to any previous findings that have been raised for non-compliances of the specific aircraft or similar aircraft designed by the declarant that have also been subject to a declaration of design compliance.

    (c)

    If the Agency finds evidence in the declaration, or through the physical inspection and assessment if carried out in accordance with point (b) of point 21L.B.221, indicating that the aircraft with the major repair design could be incapable of conducting a safe flight or could be environmentally incompatible during in-service operations, the Agency shall raise a finding in accordance with point 21L.B.21.

    21L.B.222   Registration of a declaration of a major repair design to an aircraft for which design compliance has been declared

    (a)

    The Agency shall register a declaration of a major repair design to an aircraft for which design compliance has been declared provided that:

    1.

    the declarant has declared compliance in accordance with point (a) of point 21L.A.226;

    2.

    the declarant has provided to the Agency the documents required in accordance with point (d) of point 21L.A.226;

    3.

    the declarant has made a commitment that the obligations in accordance with point 21L.A.228 will be undertaken;

    4.

    there are no unresolved issues from the physical inspection, if carried out in accordance with point (b) of point 21L.B.221.

    (b)

    The Agency shall only register a declaration of a major repair design to an aircraft for which design compliance has been declared if it is limited to the specific configuration(s) in the registered declaration of design compliance to which the major repair design relates.

    21L.B.223   Continuing airworthiness oversight of a repair design for which design compliance has been declared

    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 of a repair design, for which design compliance has been declared, with the applicable detailed technical specifications or with 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.

    SUBPART O –   EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS

    (Reserved)

    SUBPART P –   PERMIT TO FLY

    (reserved)

    SUBPART Q –   IDENTIFICATION OF PRODUCTS AND PARTS

    SUBPART R –   STATEMENT OF CONFORMITY FOR AIRCRAFT AND AUTHORISED RELEASE CERTIFICATES (EASA FORM 1) FOR ENGINES AND PROPELLERS, AND PARTS THEREOF, THAT CONFORM TO A DECLARATION OF DESIGN COMPLIANCE

    Appendices to ANNEX Ib (Part 21 Light)

    EASA FORMS

    When the Forms of this Annex are issued in a language other than English, they shall include an English translation.

    The EASA (‘European Union Aviation Safety Agency’) Forms referred to in the appendices to this Part shall have the following obligatory features. Member States shall ensure that the EASA Forms they issue are recognisable and shall be responsible for having those Forms printed.

    Appendix I

    EASA Form 24B Restricted certificate of airworthiness

    Appendix II

    EASA Form 45B Restricted noise certificate

    Appendix III

    EASA Form 52B Aircraft statement of conformity

    Appendix IV

    EASA Form 53B Certificate of release to service

    Appendix I

    Restricted certificate of airworthiness – EASA Form 24B

    Competent authority logo

    RESTRICTED CERTIFICATE OF AIRWORTHINESS (DECLARED)

     (4)

    [Member State of registry]

    [COMPETENT AUTHORITY OF THE MEMBER STATE]

    4

    1.

    Nationality and registration marks

    2.

    Manufacturer and manufacturer’s designation of aircraft

    3.

    Aircraft serial number

    4.

    Categories

    5.

    This restricted certificate of airworthiness is issued pursuant to Article 18(2)(a) of Regulation (EU) 2018/1139 in respect of the above-mentioned aircraft which is considered to be airworthy when maintained and operated in accordance with the foregoing and the pertinent operating limitations.

    In addition to above, the following restriction applies:

    This restricted certificate of airworthiness is issued on the basis of a declaration of design compliance made in accordance with Regulation (EU) No 748/2012 and is valid and recognised in all EU Member States without further requirements or evaluation. This certificate does not comply with all of the applicable Standards of Annex 8 to the Convention on International Civil Aviation and therefore may not be valid for international air navigation over non-EU Member States, unless approved by the state(s) being overflown.

    Date of issue:

    Signature:

    6.

    This restricted certificate of airworthiness is valid unless revoked by the competent authority of the Member State of registry.

    A current airworthiness review certificate shall be attached to this certificate.

    EASA Form 24B – Issue 1

    This certificate shall be carried on board during all flights.

    Appendix II

    Restricted noise certificate – EASA Form 45B

    For use by the Member State of registry

    1.

    Member State of registry

    3.

    Document No:

    2.

    		 RESTRICTED NOISE CERTIFICATE (DECLARED)

    4.

    Registration marks:

    …

    5.

    Manufacturer and designation of aircraft:

    …

    6.

    Aircraft serial No:

    …

    7.

    Designation of engine:

    …

    8.

    Designation of propeller:

    …

    9.

    Maximum take-off mass (kg)

    …

     

    10.

    Additional modifications incorporated for the purpose of compliance with the applicable noise certification standards:

    …

    11.

    Noise certification standard:

    …

    12.

    Take-off noise level:

    …

     

    Remarks

    13.

    This restricted noise certificate is issued pursuant to Article 9 of Regulation (EU) 2018/1139, in respect of the above-mentioned aircraft, which is declared by the declarant of a declaration of design compliance in accordance with Annex Ib (Part 21 Light) to Regulation (EU) No 748/2012 to comply with the indicated noise standard when maintained and operated in accordance with the relevant requirements and operating limitations.

    14.

    Date of issue … 15.Signature …

    EASA Form 45B – Issue 1

    Appendix III

    Aircraft statement of conformity – EASA Form 52B

    AIRCRAFT STATEMENT OF CONFORMITY

    1.

    State of manufacture

    2.

    [MEMBER STATE] A Member of the European Union

    3.

    Statement Ref. No:

    4.

    Organisation

    5.

    Aircraft type

    6.

    Type certificate/Declaration of design compliance refs:

    7.

    Aircraft registration or mark

    8.

    Production organisation identification No

    9.

    Engine/propeller details (5)

    10.

    Modifications and/or service bulletins1

    11.

    Airworthiness directives

    12.

    Concessions

    13.

    Exemptions, waivers or derogations1

    14.

    Remarks

    15.

    Restricted/certificate of airworthiness

    16.

    Additional requirements

    17.

    Statement of conformity

    It is hereby certified that this aircraft conforms fully to the:

    ☐

    type-certified design; or

    ☐

    declared design data

    and to the items above in boxes 9, 10, 11, 12 and 13.

    The aircraft is in a condition for safe operation.

    The aircraft has been satisfactorily tested in flight.

    18.

    Signed

    19.

    Name

    20.

    Date (d/m/y)

    21.

    Declared or approved production organisation reference (if applicable)

    EASA Form 52B – Issue 1

    Instructions for the use of the ‘Aircraft statement of conformity – EASA Form 52B’

    1.   PURPOSE AND SCOPE

    1.1.

    		 The purpose of the aircraft statement of conformity (EASA Form 52B) issued under Subpart G or Subpart R of Section A of Annex Ib (Part 21 Light) or under Subpart G of Section A of Annex I (Part 21) is to enable the production organisation to apply for an individual aircraft certificate of airworthiness or restricted certificate of airworthiness from the competent authority of the Member State of registry.

    2.   GENERAL

    2.1.

    		 The statement of conformity must comply with the model format, including the block numbers and the location of each block. The size of each block may, however, be varied to suit the individual application, but not to the extent that would render the statement of conformity unrecognisable. If in doubt, consult the competent authority.

    2.2.

    		 The statement of conformity must be either pre-printed or computer generated, but in either case, the printing of lines and characters must be clear and legible. Pre-printed wording is permitted in accordance with the attached model, but no other certification statements are permitted.

    2.3.

    		 The completion of the statement may be either machine/computer-printed or handwritten, using block letters to allow for easy reading. English, and where relevant, one or more of the official language(s) of the issuing Member State, are acceptable.

    2.4.

    		 A copy of the statement and all the referenced attachments are to be retained by the approved production organisation.

    3.   COMPLETION OF THE STATEMENT OF CONFORMITY BY THE ORIGINATOR

    3.1.

    		 There should be an entry in all blocks to render the document a valid statement.

    3.2.

    		 A statement of conformity may not be issued to the competent authority of the Member State of registry unless the design of the aircraft and its installed products are approved or the declaration of design compliance is registered with the Agency.

    3.3.

    		 The information required in blocks 9, 10, 11, 12, 13 and 14 may be by reference to separate identified documents held on file by the production organisation, unless the competent authority agrees otherwise.

    3.4.

    		 This statement of conformity is not intended to include those items of equipment that may be required to be fitted in order to satisfy the applicable operational rules. However, some of these individual items may be included in block 10 or in the approved type design or the declared aircraft design. Operators are therefore reminded of their responsibility to ensure compliance with the applicable operational rules for their own particular operations.

    Block 1

    Enter the name of the State of manufacture.

    Block 2

    The competent authority that issues the statement of conformity under its authority.

    Block 3

    A unique serial number should be pre-printed in this block for statement control and traceability purposes. An exception is in the case of a computer-generated document: the number need not be pre-printed where the computer is programmed to produce and print a unique number.

    Block 4

    The full name and the address of the location of the organisation that issues the statement. This block may be pre-printed. Logos, etc., are permitted if the logo, etc., can be contained within the block.

    Block 5

    The aircraft type in full as defined in the type certificate and its associated data sheet or the declared aircraft design as registered by the Agency

    Block 6

    The type-certificate reference numbers and issue for the subject aircraft or the registration number of the declaration of design compliance

    Block 7

    If the aircraft is registered, then this mark will be the registration mark. If the aircraft is not registered, then this will be the mark that is accepted by the competent authority of the Member State and, if applicable, by the competent authority of a third country.

    Block 8

    The identification number assigned by the production organisation for control and traceability and product support purposes. This is sometimes referred to as a ‘production organisation serial number’ or ‘constructor’s number’.

    Block 9

    The engine type and the propeller type(s) in full as defined in the relevant type certificate and its associated data sheet or the registered declaration of design compliance. Their production organisation identification/reference number and the associated location should also be stated.

    Block 10

    Approved or declared design changes to the aircraft definition

    Block 11

    A listing of all the applicable airworthiness directives (or equivalent) and a declaration of compliance with the airworthiness directives, together with a description of the method of compliance of the subject individual aircraft, including products and installed parts, appliances and equipment. Any future compliance requirement time should be stated.

    Block 12

    Approved or declared unintentional deviations from the approved type design or declared design, sometimes referred to as ‘concessions’, ‘divergences’ or ‘non-conformances’.

    Block 13

    Only agreed or declared exemptions, waivers or derogations may be included here.

    Block 14

    Remarks. Any statement, information, particular data or limitation which may affect the airworthiness of the subject aircraft. If there is no such information or data, state ‘NONE’.

    Block 15

    Enter ‘certificate of airworthiness’, or ‘restricted certificate of airworthiness’, as the certificate of airworthiness requested.

    Block 16

    Additional requirements such as those notified by an importing country should be noted in this block.

    Block 17

    The validity of the statement of conformity is subject to the full completion of all the blocks on the form. A copy of the flight test report, together with any recorded defects and rectification details, should be kept on file by the production organisation. The report should be signed as satisfactory by the appropriate certifying staff and a flight crew member, e.g. the test pilot or the flight test engineer.

    The flight tests performed are those defined under the control of the quality management element of the production system, as established by either:

    1.

    point (b) of point 21L.A.124; or

    2.

    point (f) of point 21L.A.273,

    to ensure that the aircraft conforms to the applicable design data, and is in a condition for safe operation.

    The listing of items provided (or made available) to satisfy the aspects of this statement that relate to the safe operation of the aircraft should be kept on file by the production organisation.

    Block 18

    The statement of conformity may be signed by the person that is authorised to do so by the production organisation in accordance with point (d) of point 21L.A.125 or point (b) of point 21L.A.273. A rubber stamp signature should not be used.

    Block 19

    The name of the person that signs the statement should be typed or printed in a legible form.

    Block 20

    The date on which the statement of conformity is signed should be given.

    Block 21

    The competent authority approval reference should be quoted.

    Appendix IV

    Certificate of release to service – EASA Form 53B

    CERTIFICATE OF RELEASE TO SERVICE

    [PRODUCTION ORGANISATION NAME]

    Production organisation reference:

    Certificate of release to service in accordance with 21L.A.126(e) or 21L.A.273(8) of Annex Ib (Part 21 Light) to Regulation (EU) No 748/2012 (delete as appropriate).

    Aircraft: …Type: …Constructor No/Registration: …

    has been maintained as specified in work order: …

    Brief description of work performed:

    Certifies that the work specified was carried out in accordance with 21L.A.126(e) or 21L.A.273(8) of Annex Ib (Part 21 Light) to Regulation (EU) No 748/2012 (delete as appropriate) and in respect to that work the aircraft is considered ready for release to service and therefore is in a condition for safe operation.

    Certifying staff (name):

    (signature):

    Location:

    Date:. . -. . -. .. . (day, month, year)

    EASA Form 53B – Issue 1

    COMPLETION INSTRUCTIONS

    The Block BRIEF DESCRIPTION OF WORK PERFORMED appearing in EASA FORM 53B should include a reference to the approved data used to perform the work.

    The Block LOCATION appearing in EASA FORM 53B refers to the location where the maintenance has been performed, not to the location of the facilities of the organisation (if different).

    ”.

    (1)  Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18).

    (2)  Commission Regulation (EU) No 965/2012 of 5 October 2012 laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 296, 25.10.2012, p. 1).

    (4)   2 For use by the Member State of registry.

    (5)  Delete as applicable.

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