# EUR-Lex - 32003R1702 - EN

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# 32003R1702

**Commission Regulation (EC) No 1702/2003 of 24 September 2003 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 (Text with EEA relevance) **

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Official Journal L 243 , 27/09/2003 P. 0006 - 0079 *

Commission Regulation (EC) No 1702/2003

of 24 September 2003

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 1592/2002 of the European Parliament and of the Council of 15 July 2002 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency(1) (hereinafter referred to as "the basic Regulation"), as adapted by Regulation (EC) No 1701/2003(2), and in particular Articles 5 and 6 thereof,

Whereas:

(1) The basic Regulation establishes common essential requirements to provide for a high uniform level of civil aviation safety and environmental protection; it requires the Commission to adopt the necessary implementing rules to ensure their uniform application; it establishes the "European Aviation Safety Agency" (hereinafter referred to as the "Agency") to assist the Commission in the development of such implementing rules.

(2) Existing aviation requirements in the field of airworthiness as listed in Annex II to Council Regulation (EEC) No 3922/91(3), as last amended by Commission Regulation (EC) No 2871/2000(4), will be repealed as from 28 September 2003.

(3) It is necessary to adopt common technical requirements and administrative procedures to ensure the airworthiness and environmental compatibility of aeronautical products, parts and appliances, subject to the basic Regulation; such requirements and procedures should specify the conditions to issue, maintain, amend, suspend or revoke the appropriate certificates.

(4) Organisations involved in the design and production of products, parts and appliances should be required to comply with certain technical requirements in order to demonstrate their capability and means to discharge their obligations and associated privileges; the Commission is required to adopt measures to specify conditions to issue, maintain, amend, suspend or revoke certificates attesting such compliance.

(5) In adopting measures for the implementation of common essential requirements in the field of airworthiness, the Commission must take care that they reflect the state of the art and the best practices, take into account worldwide aircraft experience and scientific and technical progress and allow for immediate reaction to established causes of accidents and serious incidents.

(6) The need to ensure uniformity in the application of common airworthiness and environmental requirements for aeronautical products, parts and appliances requires that common procedures be followed by the competent authorities of the Member States and, where applicable, the Agency to assess compliance with these requirements; the Agency should develop certification specifications and guidance material to facilitate the necessary regulatory uniformity.

(7) For this purpose, it is necessary to permit a smooth transition to the new regulatory framework of the Agency ensuring that a high and uniform level of civil aviation safety in the Community is maintained; it is necessary to provide sufficient time for the aeronautical industry and Member State administrations to adapt to this new framework and to recognise the continuing validity of certificates issued before the entry into force of this Regulation, in accordance with Article 57 of the basic Regulation.

(8) The measures provided by this Regulation are based on the opinion issued by the Agency(5) in accordance with Articles 12(2)(b) and 14(1) of the basic Regulation.

(9) The measures provided for in this Regulation are in accordance with the opinion of the European Aviation Safety Agency Committee established by Article 54(3) of the basic Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

Scope and definitions

1. This Regulation lays down, in accordance with Article 5(4) and 6(3) of the basic Regulation, 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;

(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.

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 annexed to this Regulation.

(d) "Part M" means the applicable continuing airworthiness requirements adopted in pursuance to the basic Regulation.

Article 2

Products, parts and appliances certification

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

2. By way of derogation from paragraph 1, 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 Part 21.

3. With regard to a product that has a type-certificate issued before 28 September 2003 by a Member State, the following provisions shall apply:

(a) Such a product shall be deemed to have a type-certificate issued in accordance with this Regulation when:

(i) its type-certification basis is:

- the JAA type-certification basis, for products that have been certificated under JAA procedures, as defined in their JAA data sheet; or

- for other products, the type-certification basis as defined in the type-certificate data sheet of the State of design, if that State of design is:

- a Member State, unless the Agency determines, taking into account, in particular, airworthiness codes used and service experience, that such type-certification basis does not provide for a level of safety equivalent to that required by the basic Regulation and this Regulation; or

- a State with which a Member State has concluded a bilateral airworthiness agreement or similar arrangement under which such products have been certificated on the basis of that State of design airworthiness codes, unless the Agency determines that such airworthiness codes or service experience or the safety system of that State of design do not provide for a level of safety equivalent to that required by the basic Regulation and this Regulation;

- The Agency shall make a first evaluation of the implication of these two above provisions in view of producing an opinion to the Commission including possible amendments to the present Regulation.

(ii) the environmental protection requirements are those laid down in Annex 16 to the Chicago Convention, as applicable to the product;

(iii) the applicable airworthiness directives are those of the State of design.

(b) The design of an individual aircraft, which is on the register of a Member State before 28 September 2003, shall be deemed to have been approved in accordance with this Regulation when:

(i) its basic type design is part of a type-certificate referred to in paragraph (a);

(ii) all changes to this basic type design, which are not under the responsibility of the type-certificate holder, have been approved; and

(iii) the airworthiness directives issued or adopted by the Member State of registry before 28 September 2003 are complied with, including any variations to the airworthiness directives of the State of design agreed by the Member State of registry.

(c) The Agency shall determine the type-certificate of the products not meeting paragraph (a) before 28 March 2007.

(d) The Agency shall determine the type-certificate data sheet for noise for all products covered by paragraph (a) before 28 March 2007. Until such determination, Member States may continue to issue noise certificates in accordance with applicable national regulations.

4. With regard to products for which a type-certification process is proceeding through the JAA or a Member State on 28 September 2003:

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

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

(c) by way of derogation from 21A.17(a) of 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 purpose of complying with 21A.20(a) and (b) of Part 21;

5. 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 is not finalised at the time when the type-certificate is determined in accordance with this Regulation:

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

(b) 21A.93 of 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 purpose of complying with 21A.103(a)(2) and (b) of Part 21.

6. With regard to supplemental type-certificates for which a certification process is being carried out by a Member State on 28 September 2003 under applicable JAA supplemental type-certificate procedures; and with regard to major changes to products, proposed by persons other than the type-certificate holder of the product, for which a certification process is being carried out by a Member State on 28 September 2003 under applicable national procedures:

(a) if a certification process is being carried out by several Member States, the most advanced project shall be used as the reference;

(b) 21A.113 (a) and (b) of Part 21 shall not apply;

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

(d) the compliance findings made under JAA or Member State procedures shall be deemed to have been made by the Agency for the purpose of complying with 21A.115(a) of Part 21.

7. With regard to products that have a national type-certificate, or equivalent, and for which the approval process of a major repair design carried out by a Member State is not finalised at the time when the type-certificate is determined in accordance with this Regulation, compliance findings made under JAA or Member State procedures shall be deemed to have been made by the Agency for the purpose of complying with 21A.433(a) of Part 21.

8. With regard to parts and appliances for which an approval or authorisation process is being carried out by a Member State on 28 September 2003:

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

(b) 21A.603 of Part 21 shall not apply;

(c) the applicable data requirements under 21A.605 of Part 21 shall be those established by the relevant Member State, at the date of application for the approval or authorisation;

(d) compliance findings made by the relevant Member State shall be deemed to have been made by the Agency for the purpose of complying with 21A.606(b) of Part 21.

9. A certificate of airworthiness issued by a Member State attesting conformity with a type-certificate determined in accordance with paragraph 3 shall be deemed to comply with this Regulation.

10. Pending Agency determination under point (c) of paragraph 3, aircraft types which are permitted to fly by a Member State before 28 September 2003 and which cannot be issued a type-certificate in accordance with paragraph 3 shall remain under the responsibility of the Member State of registry under applicable national regulations.

11. Until 28 March 2007, Member States shall make the findings that the aircraft and appropriate associated restrictions compensating for departure from the essential requirements permit the aircraft to perform safely a basic flight. In such case, permits to fly shall contain a limitation for use in the airspace of the Member State whose competent authority is issuing the permit. Flights outside of this airspace shall entail validation of the permit by the competent authorities of the States concerned.

Until 28 March 2007, an aircraft which was permitted by a Member State to fly before 28 September 2003 without an airworthiness certificate may remain under the responsibility of the Member State under applicable national regulations. Such aircraft shall fly only within the airspace of the relevant Member State. Flights outside of this airspace shall require the permission of the competent authority of the State concerned.

12. Where reference is made in Part 21 to apply and/or to comply with the provisions of Part M and Part M is not in force, the relevant national rules shall apply instead.

13. Approvals of parts and appliances issued by a Member State and valid on 28 September 2003 shall be deemed to have been issued in accordance with this Regulation.

14. With regard to supplemental type-certificates issued by a Member State under JAA procedures or applicable national procedures and with regard to changes to products proposed by persons other than the type-certificate holder of the product, approved by a Member State under applicable national procedures, where the supplemental type-certificate, or change, is valid on 28 September 2003, the supplemental type-certificate, or change, shall be deemed to have been issued under this Regulation.

Article 3

Design organisations

1. An organisation responsible for the design of products, parts and appliances or for changes or repairs thereto shall demonstrate its capability in accordance with Part 21.

2. By way of derogation from paragraph 1, 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, provided:

(a) that State is the State of design; and

(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.

3. Design organisation approvals issued or recognised by a Member State in accordance with the JAA requirements and procedures and valid before 28 September 2003 shall be deemed to comply with this Regulation. In such case, the period for closure of level two findings, referred to in Subpart J of Part 21, shall not exceed one year when those findings are associated with differences with previous applicable JAR.

4. A type-certificate holder who does not hold on 28 September 2003 an appropriate design organisation approval issued under applicable JAA procedures shall demonstrate its capability under the conditions laid down in 21A.14 of Part 21 before 28 September 2005.

5. An organisation, being the applicant for a supplemental type-certificate, a major repair design approval or an Auxiliary Power Unit design approval which does not hold on 28 September 2003 an appropriate design organisation approval issued by a Member State under applicable JAA procedures shall demonstrate its capability before 28 September 2005 in accordance with Part 21, 21A.112, 21A.432B, or in the case of an Auxiliary Power Unit, 21A.602B.

6. With regard to organisations for which a design organisation approval is proceeding through a Member State on 28 September 2003 under applicable JAA procedures:

1. 21A.234 of Part 21 shall not apply;

2. compliance findings made under JAA procedures shall be deemed to have been made by the Agency for the purpose of complying with 21A.245 of Part 21.

Article 4

Production organisations

1. An organisation responsible for the manufacture of products, parts and appliances shall demonstrate its capability in accordance with the provisions of Part 21.

2. By way of derogation from paragraph 1, a manufacturer 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, provided:

(a) that State is the State of manufacture; and

(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.

3. Production organisation approvals issued or recognised by a Member State in accordance with the JAA requirements and procedures and valid before 28 September 2003 shall be deemed to comply with this Regulation. In such case, the period for closure of level two findings, referred to in Subpart G of Part 21, shall not exceed one year when those findings are associated with differences with previous applicable JAR.

4. An organisation shall demonstrate its capability under this Regulation before 28 September 2005.

5. Until an organisation has demonstrated its capability under Subparts F and G of Part 21, statements of conformity and authorised release certificates issued by that organisation under applicable national regulations shall be deemed to have been issued under this Regulation.

6. With regard to organisations for which a production organisation approval is proceeding through a Member State on 28 September 2003 under applicable JAA procedures:

(a) 21A.134 of Part 21 shall not apply;

(b) compliance findings made under JAA procedures shall be deemed to have been made by the Agency for the purpose of complying with 21A.145 of Part 21.

Article 5

Entry into force

1. This Regulation shall enter into force on 28 September 2003, except for 21A.804(a)(3) of Part 21 which shall enter into force on 28 March 2004 and Subparts H of Part 21 which shall enter into force on 28 September 2004.

2. By way of derogation from 21A.159 of Part 21, Member States may issue approvals of a limited duration until 28 September 2005.

3. By way of derogation from 21A.181 of Part 21, Member States may issue certificates of a limited duration until 28 September 2008.

4. When a Member State makes use of the provisions of paragraphs 2 or 3 it shall notify the Commission and the Agency.

5. The Agency shall make, in due time, an evaluation of the implication of the provisions of this Regulation on the duration of the validity of approvals in view of producing an opinion to the Commission including possible amendments to it.

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

Done at Brussels, 24 September 2003.

For the Commission

Loyola De Palacio

Vice-President

(1) OJ L 240, 7.9.2002, p. 1.

(2) See page 5 of this Official Journal.

(3) OJ L 373, 31.12.1991, p. 4.

(4) OJ L 333, 29.12.2000, p. 47.

(5) 1.9.2003.

ANNEX

PART 21

Certification of aircraft and related products, parts and appliances, and of design and production organisations

Contents (detailed layout)

>TABLE>

21.1 General

For the purpose of this Part, "Competent Authority" shall be:

(a) for organisations having their principal place of business in a Member State, the authority designated by that Member State; or the Agency if so requested by that Member State; or

(b) for organisations having their principal place of business in a non-member State, the Agency.

SECTION A REQUIREMENTS FOR APPLICANTS AND ACQUIRED RIGHTS AND OBLIGATIONS

SUBPART A - GENERAL PROVISIONS

21A.1 Scope

This Section establishes general provisions governing the rights and obligations of the applicant for, and holder of, any certificate issued or to be issued in accordance with this Section.

21A.2 Undertaking by another person than the applicant for, or holder of, a certificate

The actions and obligations required to be undertaken by the holder of, or applicant for, a certificate for a product, part or appliance under this Section may be undertaken on its behalf by any other natural or legal person, provided the holder of, or applicant for, that certificate can show that it has made an agreement with the other person such as to ensure that the holder's obligations are and will be properly discharged.

21A.3 Failures, malfunctions and defects

(a) System for Collection, Investigation and Analysis of Data. The holder of a type-certificate, restricted type-certificate, supplemental type-certificate, European Technical Standard Order (ETSO) authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation shall have a system for collecting, investigating and analysing reports of and information related to failures, malfunctions, defects or other occurrences which cause or might cause adverse effects on the continuing airworthiness of the product, part or appliance covered by the type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation. Information about this system shall be made available to all known operators of the product, part or appliance and, on request, to any person authorised under other associated implementing Regulations.

(b) Reporting to the Agency.

1. The holder of a type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation shall report to the Agency any failure, malfunction, defect or other occurrence of which it is aware related to a product, part, or appliance covered by the type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation, and which has resulted in or may result in an unsafe condition.

2. These reports shall be made in a form and manner established by the Agency, as soon as practicable and in any case dispatched not later than 72 hours after the identification of the possible unsafe condition, unless exceptional circumstances prevent this.

(c) Investigation of Reported Occurrences.

1. When an occurrence reported under paragraph (b), or under 21A.129(f)(2) or 21A.165(f)(2) results from a deficiency in the design, or a manufacturing deficiency, the holder of the type-certificate, restricted type-certificate, supplemental type-certificate, major repair design approval, ETSO authorisation, or any other relevant approval deemed to have been issued under this Regulation, or the manufacturer as appropriate, shall investigate the reason for the deficiency and report to the Agency the results of its investigation and any action it is taking or proposes to take to correct that deficiency.

2. If the Agency finds that an action is required to correct the deficiency, the holder of the type-certificate, restricted type-certificate, supplemental type-certificate, major repair design approval, ETSO authorisation, or any other relevant approval deemed to have been issued under this Regulation, or the manufacturer as appropriate, shall submit the relevant data to the Agency.

21A.3B Airworthiness directives

(a) An airworthiness directive means a document issued or adopted by the Agency which mandates actions to be performed on an aircraft to restore an acceptable level of safety, when evidence shows that the safety level of this aircraft may otherwise be compromised.

(b) The Agency shall issue an airworthiness directive when:

1. an unsafe condition has been determined by the Agency to exist in an aircraft, as a result of a deficiency in the aircraft, or an engine, propeller, part or appliance installed on this aircraft; and

2. that condition is likely to exist or develop in other aircraft.

(c) When an airworthiness directive has to be issued by the agency to correct the unsafe condition referred to in paragraph (b), or to require the performance of an inspection, the holder of the type-certificate, restricted type-certificate, supplemental type-certificate, major repair design approval, ETSO authorisation or any other relevant approval deemed to have been issued under this Regulation, shall:

1. Propose the appropriate corrective action or required inspections, or both, and submit details of these proposals to the Agency for approval.

2. Following the approval by the Agency of the proposals referred to under subparagraph (1), make available to all known operators or owners of the product, part or appliance and, on request, to any person required to comply with the airworthiness directive, appropriate descriptive data and accomplishment instructions.

(d) An airworthiness directive shall contain at least the following information:

1. An identification of the unsafe condition;

2. An identification of the affected aircraft;

3. The action(s) required;

4. The compliance time for the required action(s);

5. The date of entry into force.

21A.4 Coordination between design and production

Each holder of a type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, approval of a change to type design or approval of a repair design, shall collaborate with the production organisation as necessary to ensure:

(a) The satisfactory coordination of design and production required by 21A.122 or 21A.133 or 21A.165(c)(2) as appropriate, and

(b) The proper support of the continued airworthiness of the product, part or appliance.

SUBPART B - TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES

21A.11 Scope

This Subpart establishes the procedure for issuing type-certificates for products and restricted type-certificates for aircraft, and establishes the rights and obligations of the applicants for, and holders of, those certificates.

21A.13 Eligibility

Any natural or legal person that has demonstrated, or is in the process of demonstrating, its capability in accordance with 21A.14 shall be eligible as an applicant for a type-certificate or a restricted type-certificate under the conditions laid down in this Subpart.

21A.14 Demonstration of capability

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

(b) By way of derogation from paragraph (a), as an alternative procedure to demonstrate its capability, an applicant may seek Agency agreement for the use of procedures setting out the specific design practices, resources and sequence of activities necessary to comply with this Part, when the product is one of the following:

1. a very light aeroplane or rotorcraft, a sailplane or a powered sailplane, a balloon, a hot air airship; or

2. a small aeroplane meeting all of the following elements:

(i) Single piston engine, naturally aspirated, of not more than 250 hp Maximum Take-Off Power (MTOP);

(ii) Conventional configuration;

(iii) Conventional material and structure;

(iv) Flights under VFR, outside icing conditions;

(v) Maximum 4 seats including the pilot and maximum take off mass limited to 3000 lb. (1361 kg);

(vi) Unpressurised cabin;

(vii) Non-power assisted controls;

(viii) Basic aerobatic flights limited to +6/-3g; or

3. a piston engine; or

4. an engine or a propeller type-certificated under the applicable airworthiness code for powered sailplanes; or

5. a fixed or variable pitch propeller.

21A.15 Application

(a) An application for a type-certificate or restricted type-certificate shall be made in a form and manner established by the Agency.

(b) An application for an aircraft type-certificate or restricted type-certificate shall be accompanied by a three-view drawing of that aircraft and preliminary basic data, including the proposed operating characteristics and limitations.

(c) An application for an engine or propeller type-certificate shall be accompanied by a general arrangement drawing, a description of the design features, the operating characteristics, and the proposed operating limitations, of the engine, or propeller.

21A.16A Airworthiness codes

The Agency shall issue in accordance with Article 14 of the basic Regulation airworthiness codes as standard means to show compliance of products, parts and appliances with the essential requirements of Annex I to the basic Regulation. Such codes shall be sufficiently detailed and specific to indicate to applicants the conditions under which certificates will be issued.

21A.16B Special conditions

(a) The Agency shall prescribe special detailed technical specifications, named special conditions, for a product, if the related airworthiness code does 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 airworthiness code is based; or

2. The intended use of the product is unconventional; or

3. Experience from other similar products in service or products having similar design features, has shown that unsafe conditions may develop.

(b) The special conditions contain such safety standards as the Agency finds necessary to establish a level of safety equivalent to that established in the applicable airworthiness code.

21A.17 Type-certification basis

(a) The type-certification basis to be notified for the issuance of a type-certificate or a restricted type-certificate shall consist of:

1. The applicable airworthiness code established by the Agency that is effective on the date of application for that certificate unless:

(i) Otherwise specified by the Agency; or

(ii) Compliance with later effective amendments is elected by the applicant or required under paragraphs (c) and (d).

2. Any special condition prescribed in accordance with 21A.16B(a).

(b) An application for type-certification of large aeroplanes and large rotorcraft shall be effective for five years and an application for any other type-certificate shall be effective for three years, unless an applicant shows at the time of application that its product requires a longer period of time for design, development, and testing, and the Agency approves a longer period.

(c) In the case where a type-certificate has not been issued, or it is clear that a type-certificate will not be issued, within the time limit established under paragraph (b); the applicant may:

1. File a new application for a type-certificate and comply with all the provisions of paragraph (a) applicable to an original application; or

2. File for an extension of the original application and comply with the applicable airworthiness codes that were effective on a date, to be selected by the applicant, not earlier than the date which precedes the date of issue of the type-certificate by the time limit established under paragraph (b) for the original application.

(d) If an applicant elects to comply with an amendment to the airworthiness codes that is effective after the filing of the application for a type-certificate, the applicant shall also comply with any other amendment that the Agency finds is directly related.

21A.18 Designation of applicable environmental protection requirements and certification specifications

(a) The applicable noise requirements for the issue of a type-certificate for an aircraft are prescribed according to the provisions of Chapter 1 of Annex 16, Volume I, Part II to the Chicago Convention and:

1. for subsonic jet aeroplanes, in Volume I, Part II, Chapters 2, 3 and 4, as applicable;

2. for propeller-driven aeroplanes, in Volume I, Part II, Chapters 3, 4, 5, 6 and 10, as applicable;

3. for helicopters, in Volume I, Part II, Chapters 8 and 11, as applicable; and

4. for supersonic aeroplanes, in Volume I, Part II, Chapter 12, as applicable.

(b) The applicable emission requirements for the issue of a type-certificate for an aircraft and engine are prescribed in Annex 16 to the Chicago Convention:

1. for prevention of intentional fuel venting, in Volume II, Part II, Chapter 2;

2. for emissions of turbo-jet and turbofan engines intended for propulsion only at subsonic speeds, in Volume II, Part III, Chapter 2; and

3. for emissions of turbo-jet and turbofan engines intended for propulsion only at supersonic speeds, in Volume II, Part III, Chapter 3.

(c) The Agency shall issue, in accordance with Article 14 of the basic Regulation, certification specifications providing for acceptable means to demonstrate compliance with the noise and the emission requirements laid down in paragraphs (a) and (b) respectively.

21A.19 Changes requiring a new type-certificate

Any natural or legal person proposing to change a product shall apply for a new type-certificate if the Agency finds that the change in design, power, thrust, or mass is so extensive that a substantially complete investigation of compliance with the applicable type-certification basis is required.

21A.20 Compliance with the type-certification basis and environmental protection requirements

(a) The applicant for a type-certificate or a restricted type-certificate shall show compliance with the applicable type-certification basis and environmental protection requirements and shall provide to the Agency the means by which such compliance has been shown.

(b) The applicant shall declare that it has shown compliance with all applicable type-certification basis and environmental protection requirements.

(c) Where the applicant holds an appropriate design organisation approval, the declaration of paragraph (b) shall be made according to the provisions of Subpart J.

21A.21 Issue of a type-certificate

The applicant shall be entitled to have a product type-certificate issued by the Agency after:

(a) demonstrating its capability in accordance with 21A.14;

(b) submitting the declaration referred to in 21A.20(b); and

(c) it is shown that:

1. The product to be certificated meets the applicable type-certification basis and environmental protection requirements designated in accordance with 21A.17 and 21A.18;

2. Any airworthiness provisions not complied with are compensated for by factors that provide an equivalent level of safety;

3. No feature or characteristic makes it unsafe for the uses for which certification is requested; and

4. The type-certificate applicant has expressly stated that it is prepared to comply with 21A.44.

(d) In the case of an aircraft type-certificate, the engine or propeller, or both, if installed in the aircraft, have a type-certificate issued or determined in accordance with this Regulation.

21A.23 Issue of a restricted type-certificate

(a) For an aircraft that does not meet the provisions of 21A.21(c), the applicant shall be entitled to have a restricted type-certificate issued by the Agency after:

1. complying with the appropriate type-certification basis established by the Agency ensuring adequate safety with regard to the intended use of the aircraft, and with the applicable environmental protection requirements;

2. expressly stating that it is prepared to comply with 21A.44.

(b) The engine or propeller installed in the aircraft, or both, shall:

1. have a type-certificate issued or determined in accordance with this Regulation; or

2. have been shown to be in compliance with the certification specifications necessary to ensure safe flight of the aircraft.

21A.31 Type design

(a) The type design shall consist of:

1. The drawings and specifications, and a listing of those drawings and specifications, necessary to define the configuration and the design features of the product shown to comply with the applicable type-certification basis and environmental protection requirements;

2. Information on materials and processes and on methods of manufacture and assembly of the product necessary to ensure the conformity of the product;

3. An approved airworthiness limitations section of the instructions for continued airworthiness as defined by the applicable airworthiness code; and

4. Any other data necessary to allow by comparison, the determination of the airworthiness, the characteristics of noise, fuel venting, and exhaust emissions (where applicable) of later products of the same type.

(b) Each type design shall be adequately identified.

21A.33 Investigation and tests

(a) The applicant shall perform all inspections and tests necessary to show compliance with the applicable type-certification basis and environmental protection requirements.

(b) Before each test required by paragraph (a) is undertaken, the applicant shall have determined:

1. For the test specimen:

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

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

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

2. That the test equipment and all measuring equipment used for tests are adequate for the test and are appropriately calibrated.

(c) The applicant shall allow the Agency to make any inspection necessary to check compliance with paragraph (b).

(d) The applicant shall allow the Agency to review any report and make any inspection and to perform or witness any flight and ground test necessary to check the validity of the declaration of compliance submitted by the applicant under 21A.20(b) and to determine that no feature or characteristic makes the product unsafe for the uses for which certification is requested.

(e) For tests performed or witnessed by the Agency under paragraph (d):

1. The applicant shall submit to the Agency a statement of compliance with paragraph (b); and

2. No change relating to the test that would affect the statement of compliance may be made to a product, part or appliance between the time compliance with paragraph (b) is shown and the time it is presented to the Agency for test.

21A.35 Flight Tests

(a) Flight testing for the purpose of obtaining a type-certificate shall be conducted in accordance with conditions for such flight testing specified by the Agency.

(b) The applicant shall make all flight tests that the Agency finds necessary:

1. To determine compliance with the applicable type-certification basis and environmental protection requirements, and

2. For aircraft to be certificated under this Section, except sailplanes and powered sailplanes and except aeroplanes of 2722 kg or less Maximum Take-Off Mass (MTOM), to determine whether there is reasonable assurance that the aircraft, its parts and appliances are reliable and function properly.

(c) (Reserved)

(d) (Reserved)

(e) (Reserved)

(f) The flight tests prescribed in subparagraph (b)(2) shall include:

1. For aircraft incorporating turbine engines of a type not previously used in a type-certificated aircraft, at least 300 hours of operation with a full complement of engines that conform to a type-certificate; and

2. For all other aircraft, at least 150 hours of operation.

21A.41 Type-certificate

The type-certificate and restricted type-certificate are both considered to include the type design, the operating limitations, the type-certificate data sheet for airworthiness and emissions, the applicable type-certification basis and environmental protection requirements with which the Agency records compliance, and any other conditions or limitations prescribed for the product in the applicable certification specifications and environmental protection requirements. The aircraft type-certificate and restricted type-certificate, in addition, both include the type-certificate data sheet for noise. The engine type-certificate data sheet includes the record of emission compliance.

21A.44 Obligations of the holder

Each holder of a type-certificate or restricted type-certificate shall:

(a) undertake the obligations laid down in 21A.3, 21A.3B, 21A.4, 21A.55, 21A.57 and 21A.61; and, for this purpose, shall continue to meet the qualification requirements for eligibility under 21A.14; and

(b) specify the marking in accordance with Subpart Q.

21A.47 Transferability

Transfer of a type-certificate or restricted type-certificate may only be made to a natural or legal person that is able to undertake the obligations under 21A.44, and, for this purpose, has demonstrated its ability to qualify under the criteria of 21A.14.

21A.51 Duration and continued validity

(a) A type-certificate and restricted type-certificate shall be issued for an unlimited duration. They shall remain valid subject to:

1. The holder remaining in compliance with this Part; and

2. The certificate not being surrendered or revoked under the applicable administrative procedures established by the Agency.

(b) Upon surrender or revocation, the type-certificate and restricted type-certificate shall be returned to the Agency.

21A.55 Record keeping

All relevant design information, drawings and test reports, including inspection records for the product tested, shall be held by the type-certificate or restricted type-certificate holder at the disposal of the Agency and shall be retained in order to provide the information necessary to ensure the continued airworthiness and compliance with applicable environmental protection requirements of the product.

21A.57 Manuals

The holder of a type-certificate or restricted type-certificate shall produce, maintain and update master copies of all manuals required by the applicable type-certification basis and environmental protection requirements for the product, and provide copies, on request, to the Agency.

21A.61 Instructions for continued airworthiness

(a) The holder of the type-certificate or restricted type-certificate shall furnish at least one set of complete instructions for continued airworthiness, comprising descriptive data and accomplishment instructions prepared in accordance with the applicable type-certification basis, to each known owner of one or more aircraft, engine or propeller upon its delivery or upon issue of the first certificate of airworthiness for the affected aircraft, whichever occurs later and thereafter make those instructions available on request to any other person required to comply with any of the terms of those instructions. The availability of some manual or portion of the instructions for continued airworthiness, dealing with overhaul or other forms of heavy maintenance, may be delayed until after the product has entered into service, but shall be available before any of the products reaches the relevant age or flight-hours/cycles.

(b) In addition, changes to the instructions for continued airworthiness shall be made available to all known operators of the product and shall be made available on request to any person required to comply with any of those instructions. A programme showing how changes to the instructions for continued airworthiness are distributed shall be submitted to the Agency.

(SUBPART C - NOT APPLICABLE)

SUBPART D - CHANGES TO TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES

21A.90 Scope

This Subpart establishes the procedure for the approval of changes to type designs and type-certificates, and establishes the rights and obligations of the applicants for, and holders of, those approvals. In this Subpart, references to type-certificates include type-certificate and restricted type-certificate.

21A.91 Classification of changes in type design

Changes in type design are classified as minor and major. A "minor change" is one that has no appreciable effect on the mass, balance, structural strength, reliability, operational characteristics, noise, fuel venting, exhaust emission, or other characteristics affecting the airworthiness of the product. Without prejudice to 21A.19, all other changes are "major changes" under this Subpart. Major and minor changes shall be approved in accordance with 21A.95 or 21A.97 as appropriate, and shall be adequately identified.

21A.92 Eligibility

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

(b) Any natural or legal person may apply for approval of a minor change to a type design under this Subpart.

21A.93 Application

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

(a) A description of the change identifying

1. All parts of the type design and the approved manuals affected by the change; and

2. The certification specifications and environmental protection requirements with which the change has been designed to comply in accordance with 21A.101.

(b) Identification of any re-investigations necessary to show compliance of the changed product with the applicable certification specifications and environmental protection requirements.

21A.95 Minor changes

Minor changes in a type design shall be classified and approved either:

(a) By the Agency; or

(b) By an appropriately approved design organisation under a procedure agreed with the Agency.

21A.97 Major changes

(a) An applicant for approval of a major change shall:

1. Submit to the Agency substantiating data together with any necessary descriptive data for inclusion in the type design;

2. Show that the changed product complies with applicable certification specifications and environmental protection requirements, as specified in 21A.101;

3. Declare that it has shown compliance with the applicable type-certification basis and environmental protection requirements and shall provide to the Agency the basis on which such a declaration is made; and

4. Where the applicant holds an appropriate design organisation approval, make the declaration of subparagraph (a)(3) according to the provisions of Subpart J;

5. Comply with 21A.33 and, where applicable, 21A.35.

(b) Approval of a major change in a type design is limited to that or those specific configuration(s) in the type design upon which the change is made.

21A.101 Designation of applicable certification specifications and environmental protection requirements

(a) An applicant for a change to a type-certificate shall demonstrate that the changed product complies with the airworthiness code that is applicable to the changed product and that is in effect at the date of the application for the change, and with the applicable environmental protection requirements laid down in 21A.18.

(b) By derogation from paragraph (a), an applicant may show that the changed product complies with an earlier amendment of the airworthiness code defined in paragraph (a), and of any other certification specification the Agency finds is directly related. However, the earlier amended airworthiness code may not precede the corresponding airworthiness code incorporated by reference in the type-certificate. The applicant may show compliance with an earlier amendment of an airworthiness code for any of the following:

1. A change that the Agency finds not to be significant. In determining whether a specific change is significant, the Agency considers the change in context with all previous relevant design changes and all related revisions to the applicable certification specifications incorporated in the type-certificate for the product. Changes that meet one of the following criteria are automatically considered significant:

(i) The general configuration or the principles of construction are not retained.

(ii) The assumptions used for certification of the product to be changed do not remain valid.

2. Each area, system, part or appliance that the Agency finds is not affected by the change.

3. Each area, system, part or appliance that is affected by the change, for which the Agency finds that compliance with an airworthiness code described in paragraph (a) would not contribute materially to the level of safety of the changed product or would be impractical.

(c) An applicant for a change to an aircraft (other than a rotorcraft) of 2722 kg (6000 lbs.) or less maximum weight or to a non-turbine rotorcraft of 1361 kg (3000 lbs.) or less maximum weight may show that the changed product complies with the type-certification basis incorporated by reference in the type-certificate. However, if the Agency finds that the change is significant in an area, the Agency may designate compliance with an amendment to the type-certification basis incorporated by reference in the type-certificate, in effect at the date of the application, and any certification specification that the Agency finds is directly related, unless the Agency also finds that compliance with that amendment or certification specification would not contribute materially to the level of safety of the changed product or would be impractical.

(d) If the Agency finds that the airworthiness code in effect at the date of the application for the change does not provide adequate standards with respect to the proposed change, the applicant shall also comply with any special conditions, and amendments to those special conditions, prescribed under the provisions of 21A.16B, to provide a level of safety equivalent to that established in the airworthiness code in effect at the date of the application for the change.

(e) An application for a change to a type-certificate for large aeroplanes and large rotorcraft is effective for five years, and an application for a change to any other type-certificate is effective for three years. In a case where the change has not been approved, or it is clear that it will not be approved under the time limit established under this subparagraph, the applicant may:

1. File a new application for a change to the type-certificate and comply with all the provisions of paragraph (a) applicable to an original application for a change; or

2. File for an extension of the original application and comply with the provisions of paragraph (a) for an effective date of application, to be selected by the applicant, not earlier than the date which precedes the date of approval of the change by the time period established under this subparagraph for the original application for the change.

21A.103 Issue of approval

(a) The applicant shall be entitled to have a major change to a type design approved by the Agency after:

1. submitting the declaration referred to in 21A.97(a)(3); and

2. It is shown that:

(i) The changed product meets the applicable certification specifications and environmental protection requirements, as specified in 21A.101;

(ii) Any airworthiness provisions not complied with are compensated for by factors that provide an equivalent level of safety; and

(iii) No feature or characteristic makes the product unsafe for the uses for which certification is requested.

(b) A minor change to a type design shall only be approved in accordance with 21A.95 if it is shown that the changed product meets the applicable certification specifications, as specified in 21A.101.

21A.105 Record keeping

For each change, all relevant design information, drawings and test reports, including inspection records for the changed product tested, shall be held by the applicant at the disposal of the Agency and shall be retained in order to provide the information necessary to ensure the continued airworthiness and compliance with applicable environmental protection requirements of the changed product.

21A.107 Instructions for continued airworthiness

(a) The holder of a minor change approval to type design shall furnish at least one set of the associated variations, if any, to the instructions for continued airworthiness of the product on which the minor change is to be installed, prepared in accordance with the applicable type-certification basis, to each known owner of one or more aircraft, engine, or propeller incorporating the minor change, upon its delivery, or upon issuance of the first certificate of airworthiness for the affected aircraft, whichever occurs later, and thereafter make those variations in instructions available, on request, to any other person required to comply with any of the terms of those instructions.

(b) In addition, changes to those variations of the instructions for continued airworthiness shall be made available to all known operators of a product incorporating the minor change and shall be made available, on request, to any person required to comply with any of those instructions.

21A.109 Obligations and EPA marking

The holder of a minor change approval to type design shall:

(a) undertake the obligations laid down in 21A.4, 21A.105 and 21A.107; and

(b) specify the marking, including EPA (hereinafter "European Part Approval") letters, in accordance with 21A.804(a).

SUBPART E - SUPPLEMENTAL TYPE-CERTIFICATES

21A.111 Scope

This Subpart establishes the procedure for the approval of major changes to the type design under supplemental type-certificate procedures, and establishes the rights and obligations of the applicants for, and holders of, those certificates.

21A.112 Eligibility

Any natural or legal person ("organisation") that has demonstrated, or is in the process of demonstrating, its capability under 21A.112B shall be eligible as an applicant for a supplemental type-certificate under the conditions laid down in this Subpart.

21A.112B Demonstration of capability

(a) Any organisation applying for a supplemental type-certificate shall demonstrate its capability by holding a design organisation approval, issued by the Agency in accordance with Subpart J.

(b) By way of derogation from paragraph (a), as an alternative procedure to demonstrate its capability, an applicant may seek Agency agreement for the use of procedures setting out the specific design practices, resources and sequence of activities necessary to comply with this Subpart.

21A.113 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) An application for a supplemental type-certificate shall include the descriptions and identification required by 21A.93. In addition, such an application shall include a justification that the information on which those identifications are based is adequate either from the applicant's own resources, or through an arrangement with the type-certificate holder.

21A.114 Showing of compliance

Any applicant for a supplemental type-certificate shall comply with 21A.97.

21A.115 Issue of a supplemental type-certificate

The applicant shall be entitled to have a supplemental type-certificate issued by the Agency after:

(a) complying with 21A.103(a);

(b) demonstrating its capability in accordance with 21A.112B;

(c) where, under 21A.113(b), the applicant has entered into an arrangement with the type-certificate holder,

1. The type-certificate holder has advised that its has no technical objection to the information submitted under 21A.93; and

2. The type-certificate holder has agreed to collaborate with the supplemental type-certificate holder to ensure discharge of all obligations for continued airworthiness of the changed product through compliance with 21A.44 and 21A.118A.

21A.116 Transferability

A supplemental type-certificate shall only be transferred to a natural or legal person that is able to undertake the obligations of 21A.118A and for this purpose has demonstrated its ability to qualify under the criteria of 21A.112B.

21A.117 Changes to that part of a product covered by a supplemental type-certificate

(a) Minor changes to that part of a product covered by a supplemental type-certificate shall be classified and approved in accordance with Subpart D.

(b) Each 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 paragraph (b), a major change to that part of a product covered by a supplemental type-certificate submitted by the supplemental type-certificate holder itself may be approved as a change to the existing supplemental type-certificate.

21A.118A Obligations and EPA marking

Each holder of a supplemental type-certificate shall:

(a) undertake the obligations:

1. Laid down in 21A.3, 21A.3B, 21A.4, 21A.105, 21A.119 and 21A.120;

2. Implicit in the collaboration with the type-certificate holder under 21A.115(c)(2);

and for this purpose continue to meet the criteria of 21A.112B

(b) specify the marking, including EPA letters, in accordance with 21A.804(a).

21A.118B Duration and continued validity

(a) A supplemental type-certificate shall be issued for an unlimited duration. It shall remain valid subject to:

1. The holder remaining in compliance with this Part; and

2. the certificate not being surrendered or revoked under the applicable administrative procedures established by the Agency.

(b) Upon surrender or revocation, the supplemental type-certificate shall be returned to the Agency.

21A.119 Manuals

The holder of a supplemental type-certificate shall produce, maintain, and update master copies of variations in the manuals required by the applicable type-certification basis and environmental protection requirements for the product, necessary to cover the changes introduced under the supplemental type-certificate, and furnish copies of these manuals to the Agency on request.

21A.120 Instructions for continued airworthiness

(a) The holder of the supplemental type-certificate for an aircraft, engine, or propeller, shall furnish at least one set of the associated variations to the instructions for continued airworthiness, prepared in accordance with the applicable type-certification basis, to each known owner of one or more aircraft, engine, or propeller incorporating the features of the supplemental type-certificate, upon its delivery, or upon issuance of the first certificate of airworthiness for the affected aircraft, whichever occurs later, and thereafter make those variations in instructions available, on request, to any other person required to comply with any of the terms of those instructions. Availability of some manual or portion of the variations to the instructions for continued airworthiness, dealing with overhaul or other forms of heavy maintenance, may be delayed until after the product has entered into service, but shall be available before any of the products reaches the relevant age or flight-hours/cycles.

(b) In addition, changes to those variations of the instructions for continued airworthiness shall be made available to all known operators of a product incorporating the supplemental type-certificate and shall be made available, on request, to any person required to comply with any of those instructions. A programme showing how changes to the variations to the instructions for continued airworthiness are distributed shall be submitted to the Agency.

SUBPART F - PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL

21A.121 Scope

(a) This Subpart establishes the procedure for demonstrating the conformity with the applicable design data of a product, part and appliance that is intended to be manufactured without a production organisation approval under Subpart G.

(b) This Subpart establishes the rules governing the obligations of the manufacturer of a product, part, or appliance being manufactured under this Subpart.

21A.122 Eligibility

Any natural or legal person may apply to show conformity of individual products, parts or appliances under this Subpart, if;

(a) it holds or has applied for an approval covering the design of that product, part or appliance, or

(b) it has ensured satisfactory coordination between production and design, through an appropriate arrangement with the applicant for, or holder of, an approval of such a design.

21A.124 Application

(a) Each application for an agreement to the showing of conformity of individual products, parts and appliances under this Subpart shall be made in a form and manner established by the Competent Authority.

(b) Such application shall contain:

1. evidence which demonstrate, where applicable, that:

(i) the issuance of a production organisation approval under Subpart G would be inappropriate; or

(ii) the certification or approval of a product, part or appliance under this Subpart is needed pending the issuance of a production organisation approval under Subpart G.

2. An outline of the information required by 21A.125(b).

21A.125 Issue of a letter of agreement

The applicant shall be entitled to have a letter of agreement issued by the Competent Authority agreeing to the showing of conformity of individual products, parts and appliances under this Subpart, after:

(a) having established a production inspection system that ensures that each product, part or appliance conforms to the applicable design data and is in condition for safe operation.

(b) providing a manual that contains:

1. a description of the production inspection system required under paragraph (a),

2. a description of the means for making the determinations of the production inspection system,

3. a description of the tests of 21A.127 and 21A.128, and the names of persons authorised for the purpose of 21A.130(a).

(c) demonstrating that it is able to provide assistance in accordance with 21A.3 and 21A.129(d).

21A.125B Findings

(a) When objective evidence is found showing non-compliance of the holder of a letter of agreement with the applicable requirements of this Part, the finding shall be classified as follows:

1. A level one finding is any non-compliance with this Part which could lead to uncontrolled non-compliances with applicable design data and which could affect the safety of the aircraft.

2. A level two finding is any non-compliance with this Part which is not classified as level one.

(b) A level three finding is any item where it has been identified, by objective evidence, to contain potential problems that could lead to a non-compliance under paragraph (a).

(c) After receipt of notification of findings according to 21B.143:

1. In case of a level one finding, the holder of the letter of agreement shall demonstrate corrective action to the satisfaction of the Competent Authority within a period of no more than 21 working days after written confirmation of the finding;

2. In case of level two findings, the corrective action period granted by the Competent Authority shall be appropriate to the nature of the finding but in any case initially shall not be more than six months. In certain circumstances and subject to the nature of the finding the Competent Authority may extend the six month period subject to a satisfactory corrective action plan agreed by the Competent Authority.

3. A level three finding shall not require immediate action by the holder of the letter of agreement.

(d) In case of level one or level two findings, the letter of agreement may be subject to a partial or full limitation, suspension and revocation under 21B.145. The holder of the letter of agreement shall provide confirmation of receipt of the notice of limitation, suspension or revocation of the letter of agreement in a timely manner.

21A.125C Duration and continued validity

(a) The letter of agreement shall be issued for a limited duration not exceeding one year. It shall remain valid unless:

1. The holder of the letter of agreement fails to demonstrate compliance with the applicable requirements of this Subpart; or

2. There is evidence that the manufacturer cannot maintain satisfactory control of the manufacture of products, parts, or appliances under the agreement; or

3. The manufacturer no longer meets the requirements of 21A.122; or

4. The letter of agreement has been surrendered, revoked under 21B.145, or has expired.

(b) Upon surrender, revocation or expiry, the letter of agreement shall be returned to the Competent Authority.

21A.126 Production inspection system

(a) The production inspection system required under 21A.125 shall provide a means for determining that:

1. Incoming materials, and bought or subcontracted parts, used in the finished product are as specified in the applicable design data.

2. Incoming materials, and bought or subcontracted parts, are properly identified.

3. Processes, manufacturing techniques and methods of assembly affecting the quality and safety of the finished product are accomplished in accordance with specifications accepted by the Competent Authority.

4. Design changes, including material substitutions, have been approved under Subpart D or E and controlled before being incorporated in the finished product.

(b) The production inspection system required by 21A.125(a), shall also be such as to ensure that:

1. Parts in process are inspected for conformity with the applicable design data at points in production where accurate determinations can be made.

2. Materials subject to damage and deterioration are suitably stored and adequately protected.

3. Current design drawings are readily available to manufacturing and inspection personnel, and used when necessary.

4. Rejected materials and parts are segregated and identified in a manner that precludes installation in the finished product.

5. Materials and parts that are withheld because of departures from design data or specifications, and that are to be considered for installation in the finished product, are subjected to an approved engineering and manufacturing review procedure. Those materials and parts determined by this procedure to be serviceable shall be properly identified and reinspected if rework or repair is necessary. Materials and parts rejected by this procedure shall be marked and disposed of to ensure that they are not incorporated in the final product.

6. Records produced under the production inspection system are maintained, identified with the completed product or part where practicable, and retained by the manufacturer in order to provide the information necessary to ensure the continued airworthiness of the product.

21A.127 Tests: aircraft

(a) Each manufacturer of an aircraft manufactured under this Subpart shall establish an approved production ground and flight test procedure and check-off forms, and in accordance with those forms, test each aircraft produced, as a means of establishing relevant aspects of compliance with 21A.125(a).

(b) Each production test procedure shall include at least the following:

1. A check on handling qualities;

2. A check on flight performance (using normal aircraft instrumentation);

3. A check on the proper functioning of all aircraft equipment and systems;

4. A determination that all instruments are properly marked, and that all placards and required flight manuals are installed after flight test;

5. A check of the operational characteristics of the aircraft on the ground;

6. A check on any other items peculiar to the aircraft being tested.

21A.128 Tests: engines and propellers

Each manufacturer of engines, or propellers manufactured under this Subpart shall subject each engine, or variable pitch propeller, to an acceptable functional test as specified in the type-certificate holder's documentation, to determine if it operates properly throughout the range of operation for which it is type-certificated, as a means of establishing relevant aspects of compliance with 21A.125(a).

21A.129 Obligations of the manufacturer

Each manufacturer of a product, part or appliance being manufactured under this Subpart shall:

(a) Make each product, part or appliance available for inspection by the Competent Authority.

(b) Maintain at the place of manufacture the technical data and drawings necessary to determine whether the product conforms to the applicable design data.

(c) Maintain the production inspection system that ensures that each product conforms to the applicable design data and is in condition for safe operation.

(d) Provide assistance to the holder of the type-certificate, restricted type-certificate or design approval in dealing with any continuing airworthiness actions that are related to the products, parts or appliances that have been produced.

(e) Establish and maintain an internal occurrence reporting system in the interest of safety, to enable the collection and assessment of occurrence reports in order to identify adverse trends or to address deficiencies, and to extract reportable occurrences. This system shall include evaluation of relevant information relating to occurrences and the promulgation of related information.

(f) 1. Report to the holder of the type-certificate, restricted type-certificate or design approval, all cases where products, parts or appliances have been released by the manufacturer and subsequently identified to have deviations from the applicable design data, and investigate with the holder of the type-certificate, restricted type-certificate or design approval to identify those deviations which could lead to an unsafe condition.

2. Report to the Agency and the competent authority of the Member State the deviations which could lead to an unsafe condition identified according to subparagraph (1). Such reports shall be made in a form and manner established by the Agency under 21A.3(b)(2) or accepted by the competent authority of the Member State.

3. Where the manufacturer acts as supplier to another production organisation, report also to that other organisation all cases where it has released products, parts or appliances to that organisation and subsequently identified them to have possible deviations from the applicable design data.

21A.130 Statement of conformity

(a) Each manufacturer of a product, part or appliance manufactured under this Subpart shall raise a Statement of Conformity, an EASA Form 52, for complete aircraft, or EASA Form 1, for other products, parts or appliances (see Appendix). This statement shall be signed by an authorised person who holds a responsible position in the manufacturing organisation.

(b) A statement of conformity shall include:

1. For each product, part or appliance a statement that the product, part or appliance conforms to the approved design data and is in condition for safe operation;

2. For each aircraft, a statement that the aircraft has been ground and flight checked in accordance with 21A.127(a); and

3. For each engine, or variable pitch propeller, a statement that the engine or propeller has been subjected by the manufacturer to a final functional test, in accordance with 21A.128, and additionally in case of engines, a determination according to data provided by the engine type-certificate holder that each completed engine is in compliance with the applicable emissions requirements current at the date of manufacture of the engine.

(c) Each manufacturer of such a product, part or appliance shall:

1. Upon the initial transfer by it of the ownership of such a product, part or appliance; or

2. Upon application for the original issue of an aircraft certificate of airworthiness; or

3. Upon application for the original issue of an airworthiness release document for an engine, a propeller, a part or appliance,

present a current statement of conformity, for validation by the Competent Authority.

(d) The Competent Authority shall validate by counter-signature the Statement of Conformity if it finds after inspection that the product, part or appliance conforms to the applicable design data and is in condition for safe operation.

SUBPART G - PRODUCTION ORGANISATION APPROVAL

21A.131 Scope

This Subpart establishes:

(a) The procedure for the issuance of a production organisation approval for a production organisation showing conformity of products, parts and appliances with the applicable design data.

(b) The rules governing the rights and obligations of the applicant for, and holders of, such approvals.

21A.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 ensured, through an appropriate arrangement with the applicant for, or holder of, an approval of that specific design, satisfactory coordination between production and design.

21A.134 Application

Each application for a production organisation approval shall be made to the Competent Authority in a form and manner established by that authority, and shall include an outline of the information required by 21A.143 and the terms of approval requested to be issued under 21A.151.

21A.135 Issue of production organisation approval

An organisation shall be entitled to have a production organisation approval issued by the Competent Authority when it has demonstrated compliance with the applicable requirements under this Subpart.

21A.139 Quality System

(a) The production organisation shall demonstrate that it has established and is able to maintain a quality system. The quality system shall be documented. This quality system shall be such as to enable the organisation to 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 condition for safe operation, and thus exercise the privileges set forth in 21A.163.

(b) The quality system shall contain:

1. As applicable within the scope of approval, 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) Airworthiness coordination with the applicant for, or holder of, the design approval.

(x) Records completion and retention.

(xi) Personnel competence and qualification.

(xii) Issue of airworthiness release documents.

(xiii) Handling, storage and packing.

(xiv) Internal quality audits and resulting corrective actions.

(xv) Work within the terms of approval performed at any location other than the approved facilities.

(xvi) Work carried out after completion of production but prior to delivery, to maintain the aircraft in a condition for safe operation.

The control procedures need to include specific provisions for any critical parts.

2. An independent quality assurance function to monitor compliance with, and adequacy of, the documented procedures of the quality system. This monitoring shall include a feedback system to the person or group of persons referred to in 21A.145(c)(2) and ultimately to the manager referred to in 21A.145 (c)(1) to ensure, as necessary, corrective action.

21A.143 Exposition

(a) The organisation shall submit to the Competent Authority a production organisation exposition providing the following information:

1. A statement signed by the accountable manager confirming that the production organisation exposition and any associated manuals which define the approved organisation's compliance with this Subpart will be complied with at all times.

2. The title(s) and names of managers accepted by the Competent Authority in accordance with 21A.145(c)(2).

3. The duties and responsibilities of the manager(s) as required by 21A.145(c)(2) including matters on which they may deal directly with the Competent Authority on behalf of the organisation.

4. An organisational chart showing associated chains of responsibility of the managers as required by 21A.145(c)(1) and (2).

5. A list of certifying staff as referred to in 21A.145(d).

6. A general description of man-power resources.

7. A general description of the facilities located at each address specified in the production organisation's certificate of approval.

8. A general description of the production organisation's scope of work relevant to the terms of approval.

9. The procedure for the notification of organisational changes to the Competent Authority.

10. The amendment procedure for the production organisation exposition.

11. A description of the quality system and the procedures as required by 21A.139(b)(1).

12. A list of those outside parties referred to in 21A.139(a).

(b) The production organisation exposition shall be amended as necessary to remain an up-to-date description of the organisation, and copies of any amendments shall be supplied to the Competent Authority.

21A.145 Approval requirements

The production organisation shall demonstrate, on the basis of the information submitted in accordance with 21A.143 that:

(a) with regard to general approval requirements, facilities, working conditions, equipment and tools, processes and associated materials, number and competence of staff, and general organisation are adequate to discharge obligations under 21A.165.

(b) with regard to all necessary airworthiness, noise, fuel venting and exhaust emissions 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, to determine conformity with the applicable design data.

2. The production organisation has established a procedure to ensure that airworthiness, noise, fuel venting and exhaust emissions data are correctly incorporated in its production data.

3. Such data are 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. A manager has been nominated by the production organisation, and is accountable to the Competent Authority. His or her responsibility within the organisation shall consist of ensuring that all production is performed to the required standards and that the production organisation is continuously in compliance with the data and procedures identified in the exposition referred to in 21A.143.

2. A person or group of persons have been nominated by the production organisation to ensure that the organisation is in compliance with the requirements of this Part, and are identified, together with the extent of their authority. Such person(s) shall act under the direct authority of the accountable manager referred to in subparagraph (1). The persons nominated shall be able to show 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 production organisation in respect of airworthiness, noise, fuel venting and exhaust emission data matters.

(d) with regard to certifying staff, authorised by the production organisation to sign the documents issued under 21A.163 under the scope or terms of approval:

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

2. The production organisation maintains a record of all certifying staff which shall include details of the scope of their authorisation.

3. Certifying staff are provided with evidence of the scope of their authorisation.

21A.147 Changes to the approved production organisation

(a) After the issue of a production organisation approval, each change to the approved production organisation that is significant to the showing of conformity or to the airworthiness and characteristics of noise, fuel venting and exhaust emissions of the product, part or appliance, particularly changes to the quality system, shall be approved by the Competent Authority. An application for approval shall be submitted in writing to the Competent Authority and the organisation shall demonstrate to the Competent Authority before implementation of the change, that it will continue to comply with this Subpart.

(b) The Competent Authority shall establish the conditions under which a production organisation approved under this Subpart may operate during such changes unless the Competent Authority determines that the approval should be suspended.

21A.148 Changes of location

A change of the location of the manufacturing facilities of the approved production organisation shall be deemed of significance and therefore shall comply with 21A.147.

21A.149 Transferability

Except as a result of a change in ownership, which is deemed significant for the purposes of 21A.147, a production organisation approval is not transferable.

21A.151 Terms of approval

The terms of approval shall identify the scope of work, the products or the categories of parts and appliances, or both, for which the holder is entitled to exercise the privileges under 21A.163.

Those terms shall be issued as part of a production organisation approval.

21A.153 Changes to the terms of approval

Each change to the terms of approval shall be approved by the Competent Authority. An application for a change to the terms of approval shall be made in a form and manner established by the Competent Authority. The applicant shall comply with the applicable requirements of this Subpart.

21A.157 Investigations

A production organisation shall make arrangements that allow the Competent Authority to make any investigations, including investigations of partners and subcontractors, necessary to determine compliance and continued compliance with the applicable requirements of this Subpart.

21A.158 Findings

(a) When objective evidence is found showing non compliance of the holder of a production organisation approval with the applicable requirements of this Part, the finding shall be classified as follows:

1. A level one finding is any non-compliance with this Part which could lead to uncontrolled non-compliances with applicable design data and which could affect the safety of the aircraft.

2. A level two finding is any non-compliance with this Part which is not classified as level one.

(b) A level three finding is any item where it has been identified, by objective evidence, to contain potential problems that could lead to a non-compliance under paragraph (a).

(c) After receipt of notification of findings according to 21B.225,

1. In case of a level one finding, the holder of the production organisation approval shall demonstrate corrective action to the satisfaction of the Competent Authority within a period of no more than 21 working days after written confirmation of the finding,

2. In case of level two findings, the corrective action period granted by the Competent Authority shall be appropriate to the nature of the finding but in any case initially shall not be more than six months. In certain circumstances and subject to the nature of the finding the Competent Authority may extend the six month period subject to a satisfactory corrective action plan agreed by the Competent Authority.

3. A level three finding shall not require immediate action by the holder of the production organisation approval.

(d) In case of level one or level two findings, the production organisation approval may be subject to a partial or full limitation, suspension or revocation under 21B.245. The holder of the production organisation approval shall provide confirmation of receipt of the notice of limitation, suspension or revocation of the production organisation approval in a timely manner.

21A.159 Duration and continued validity

(a) A production organisation approval shall be issued for an unlimited duration. It shall remain valid unless:

1. The production organisation fails to demonstrate compliance with the applicable requirements of this Subpart; or

2. The Competent Authority is prevented by the holder or any of its partners or subcontractors to perform the investigations in accordance with 21A.157; or

3. There is evidence that the production organisation cannot maintain satisfactory control of the manufacture of products, parts or appliances under the approval; or

4. The production organisation no longer meets the requirements of 21A.133; or

5. the certificate has been surrendered or revoked under 21B.245.

(b) Upon surrender or revocation, the certificate shall be returned to the Competent Authority.

21A.163 Privileges

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

(a) Perform production activities under this Part.

(b) In the case of complete aircraft and upon presentation of a Statement of Conformity (EASA Form 52) under 21A.174, 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 21A.307 without further showing.

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

21A.165 Obligations of the holder

The holder of a production organisation approval shall:

(a) Ensure that the production organisation exposition furnished in accordance with 21A.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 and are in condition for safe operation before issuing EASA Form 1 to certify airworthiness, and additionally in case of engines, determine according to data provided by the engine type-certificate holder that each completed engine is in compliance with the applicable emissions requirements as defined in 21A.18(b), current at the date of manufacture of the engine, to certify emissions compliance, or

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

(d) Record all details of work carried out.

(e) Establish and maintain an internal occurrence reporting system in the interest of safety, to enable the collection and assessment of occurrence reports in order to identify adverse trends or to address deficiencies, and to extract reportable occurrences. This system shall include evaluation of relevant information relating to occurrences and the promulgation of related information.

(f) 1. Report to the holder of the type-certificate or design approval, all cases where products, parts or appliances have been released by the production organisation and subsequently identified to have possible deviations from the applicable design data, and investigate with the holder of the type-certificate or design approval in order to identify those deviations which could lead to an unsafe condition.

2. Report to the Agency and the competent authority of the Member State the deviations which could lead to an unsafe condition identified according to subparagraph (1). Such reports shall be made in a form and manner established by the Agency under 21A.3(b)(2) or accepted by the competent authority of the Member State.

3. Where the holder of the production organisation approval is acting as a supplier to another production organisation, report also to that other organisation all cases where it has released products, parts or appliances to that organisation and subsequently identified them to have possible deviations from the applicable design data.

(g) Provide assistance to the holder of the type-certificate or design approval in dealing with any continuing airworthiness actions that are related to the products parts or appliances that have been produced.

(h) Establish an archiving system incorporating requirements imposed on its partners, suppliers and subcontractors, ensuring conservation of the data used to justify conformity of the products, parts or appliances. Such data shall be held at the disposal of the Competent Authority and be retained in order to provide the information necessary to ensure the continuing airworthiness of the products, parts or appliances.

(i) Where, under its terms of approval, the holder issues a certificate of release to service, determine that each completed aircraft has been subjected to necessary maintenance and is in condition for safe operation, prior to issuing the certificate.

SUBPART H - AIRWORTHINESS CERTIFICATES

21A.171 Scope

This Subpart establishes the procedure for issuing airworthiness certificates.

21A.172 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"), or its representative, shall be eligible as an applicant for an airworthiness certificate for that aircraft under this Subpart.

21A.173 Classification

Airworthiness certificates shall be classified as follows:

(a) Certificates of airworthiness shall be issued to aircraft which conform to a type-certificate that has been issued in accordance with this Part.

(b) Restricted certificates of airworthiness shall be issued to aircraft:

1. which conform to a restricted type-certificate that has been issued in accordance with this Part; or

2. which have been shown to the Agency to comply with specific certification specifications ensuring adequate safety.

(c) Permits to fly shall be issued to aircraft that do not meet, or have not been shown to meet, applicable certification specifications but are capable of safe flight under defined conditions.

21A.174 Application

(a) Pursuant to 21A.172, an application for an airworthiness certificate shall be made in a form and manner established by the competent authority of the Member State of registry.

(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 21A.163(b), or

- issued under 21A.130 and validated by the Competent Authority,

- or, for an imported aircraft, 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.

(iii) The flight manual, when required by the applicable airworthiness code for the particular aircraft.

3. with regard to used aircraft:

(i) originating from a Member State, an airworthiness review certificate issued in accordance with Part M.

(ii) originating from 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 time of transfer.

- a weight and balance report with a loading schedule.

- the flight manual when such material is required by the applicable airworthiness code for the particular aircraft.

- historical records to establish the production, modification, and maintenance standard of the aircraft, including all limitations associated with a restricted certificate of airworthiness under 21A.184(c).

- a recommendation for the issuance of a certificate of airworthiness or restricted certificate of airworthiness and an airworthiness review certificate following an airworthiness review in accordance with Part M.

(c) Unless otherwise agreed, the statements referred to in subparagraphs (b)(2)(i) and (b)(3)(ii) shall be issued no more than 60 days before presentation of the aircraft to the competent authority of the Member State of registry.

(d) Each application for a permit to fly shall include:

1. The purpose of the flight(s);

2. The itineraries or airspace, or both, used for the flight;

3. Minimum flight crew and its qualification, required to operate the aircraft;

4. Restrictions for carriage of persons other than flight crew;

5. The ways in which the aircraft does not comply with the applicable certification specifications;

6. Any restriction considered necessary for safe operation of the aircraft;

7. Any other information considered necessary for the purpose of prescribing operating limitations.

21A.175 Language

The manuals, placards, listings, and instrument markings and other necessary information required by applicable certification specifications shall be presented in one or more of the official language(s) of the European Community acceptable to the competent authority of the Member State of registry.

21A.177 Amendment or modification

An airworthiness certificate may be amended or modified only by the competent authority of the Member State of registry.

21A.179 Transferability and re-issuance within Member States

(a) Where ownership of an aircraft has changed:

1. if it remains on the same register, the certificate of airworthiness, or the restricted certificate of airworthiness conforming to a restricted type-certificate only, shall be transferred together with the aircraft;

2. if the aircraft is registered in another Member State, the certificate of airworthiness, or the restricted certificate of airworthiness conforming to a restricted type-certificate only, shall be issued:

(i) upon presentation of the former certificate of airworthiness and of a valid airworthiness review certificate issued under Part M, and

(ii) when satisfying 21A.175.

(b) Where ownership of an aircraft has changed, and the aircraft has:

1. a restricted certificate of airworthiness not conforming to a restricted type-certificate, or

2. a permit to fly,

such airworthiness certificates shall be transferred together with the aircraft provided the aircraft remains on the same register, or issued only with the formal agreement of the competent authority of the Member State of registry to which it is transferred.

21A.180 Inspections

The holder of the airworthiness certificate shall provide access to the aircraft for which that airworthiness certificate has been issued upon request by the competent authority of the Member State of registry.

21A.181 Duration and continued validity

(a) An airworthiness certificate shall be issued for an unlimited duration. It shall remain valid subject to:

1. compliance with the applicable type-design and continuing airworthiness requirements; and

2. the aircraft remaining on the same register; and

3. the type-certificate or restricted type-certificate under which it is issued not being previously invalidated under 21A.51.

4. the certificate not being surrendered or revoked under 21B.330.

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

21A.182 Aircraft identification

Each applicant for an airworthiness certificate under this Subpart shall demonstrate that its aircraft is identified in accordance with Subpart Q.

21A.183 Issue of certificates of airworthiness

The competent authority of the State of registry shall issue a certificate of airworthiness for:

1. new aircraft:

(i) Upon presentation of the documentation required by 21A.174(b)(2).

(ii) When the aircraft conforms to an approved design and is in condition for safe operation. This may include inspections by the competent authority of the Member State of registry.

2. used aircraft:

(i) upon presentation of the documentation required by 21A.174(b)(3) demonstrating that:

- the aircraft conforms to a type design approved under a type-certificate and any supplemental type-certificate, change or repair approved in accordance with this Part, and to applicable airworthiness directives, and

- the aircraft has been inspected in accordance with the applicable provisions of Part M; and

(ii) when the aircraft conforms to an approved design and is in condition for safe operation. This may include inspections by the competent authority of the Member State of registry.

21A.184 Issue of restricted certificates of airworthiness

(a) The competent authority of the Member State of registry shall issue a restricted certificate of airworthiness for:

1. new aircraft, upon presentation of the documentation required by 21A.174(b)(2) demonstrating that the aircraft conforms to a design approved by the Agency under a restricted type-certificate or in accordance with specific certification specifications, and is in condition for safe operation.

2. used aircraft:

(i) upon presentation of the documentation required by 21A.174(b)(3) demonstrating that:

- the aircraft conforms to a design approved by the Agency under a restricted type-certificate or in accordance with specific certification specifications, and

- the applicable airworthiness directives have been complied with, and

- the aircraft has been inspected in accordance with the appropriate provisions of Part M; and

(ii) when the competent authority of the Member State of registry is satisfied that the aircraft conforms to the approved design and is in condition for safe operation. This may include inspections by the competent authority of the Member State of registry.

(b) For an aircraft that cannot comply with the essential requirements referred to in the basic Regulation and which is not eligible for a restricted type-certificate, the Agency shall, as necessary to take account of deviations from these essential requirements:

1. issue and check compliance with specific certification specifications ensuring adequate safety with regard to the intended use, and

2. specify limitations for use of this aircraft.

(c) Limitations for use will be associated with restricted certificates of airworthiness including airspace restrictions as necessary to take account of deviations from essential requirements for airworthiness laid down in the basic Regulation.

21A.185 Issue of permits to fly

The competent authority of the Member State of registry shall issue a permit to fly after the Agency has found that the aircraft and appropriate associated restrictions compensating for departure from the essential requirements permit the aircraft to perform safely a basic flight. For that purpose, the Agency may make or require the applicant to make appropriate inspections or tests necessary to ensure safety.

SUBPART I - NOISE CERTIFICATES

21A.201 Scope

This Subpart establishes the procedure for issuing noise certificates.

21A.203 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), or its representative, shall be eligible as an applicant for a noise certificate for that aircraft under this Subpart.

21A.204 Application

(a) Pursuant to 21A.203, an application for a noise certificate shall be made in a form and manner established by the competent authority of the Member State of registry.

(b) Each application shall include:

1. with regard to new aircraft:

(i) A statement of conformity:

- issued under 21A.163(b), or

- issued under 21A.130 and validated by the Competent Authority

- or, for an imported aircraft, 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. This information shall be included in the flight manual, when a flight manual is required by the applicable airworthiness code for the particular aircraft.

2. with regard to used aircraft:

(i) The noise information determined in accordance with the applicable noise requirements. This information shall be included in the flight manual, when a flight manual is required by the applicable airworthiness code for the particular aircraft, and

(ii) Historical records to establish the production, modification, and maintenance standard of the aircraft.

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

21A.205 Issue of noise certificates

The competent authority of the Member State of registry shall issues a noise certificate upon presentation of the documents required by 21A.204(b).

21A.207 Amendment or modification

A noise certificate may be amended or modified only by the competent authority of the Member State of registry.

21A.209 Transferability and re-issuance within Member States

Where ownership of an aircraft has changed:

(a) if the aircraft remains on the same register, the noise certificate shall be transferred together with the aircraft; or

(b) if the aircraft moves to the register of another Member State, the noise certificate shall be issued upon presentation of the former noise certificate.

21A.210 Inspections

The holder of the noise certificate shall provide access to the aircraft for which that noise certificate has been issued upon request by the competent authority of the Member State of registry or by the Agency for inspection.

21A.211 Duration and continued validity

(a) A noise certificate shall be issued for an unlimited duration. It shall remain valid subject to:

1. compliance with the applicable type-design, environmental protection and continuing airworthiness requirements; and

2. the aircraft remaining on the same register; and

3. the type-certificate or restricted type-certificate under which it is issued not being previously invalidated under 21A.51.

4. the certificate not being surrendered or revoked under 21B.430.

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

SUBPART J - DESIGN ORGANISATION APPROVAL

21A.231 Scope

This Subpart establishes the procedure for the approval of design organisations and rules governing the rights and obligations of applicants for, and holders of, such approvals.

21A.233 Eligibility

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

(a) in accordance with 21A.14, 21A.112B, 21A.432B or 21A.602B; or

(b) for approval of minor changes or minor repair design, when requested for the purpose of obtaining privileges under 21A.263.

21A.234 Application

Each application for a design organisation approval shall be made in a form and manner established by the Agency and shall include an outline of the information required by 21A.243, and the terms of approval requested to be issued under 21A.251.

21A.235 Issue of design organisation approval

An organisation shall be entitled to have a design organisation approval issued by the Agency when it has demonstrated compliance with the applicable requirements under this Subpart.

21A.239 Design assurance system

(a) The design organisation shall demonstrate that it has established and is able to maintain a design assurance system for the control and supervision of the design, and of design changes, of products, parts and appliances covered by the application. This design assurance system shall be such as to enable the organisation:

1. To ensure that the design of the products, parts and appliances or the design change thereof, comply with the applicable type-certification basis and environmental protection requirements; and

2. To ensure that its responsibilities are properly discharged in accordance with:

(i) The appropriate provisions of this Part; and

(ii) The terms of approval issued under 21A.251.

3. To independently monitor the compliance with, and adequacy of, the documented procedures of the system. This monitoring shall include a feed-back system to a person or a group of persons having the responsibility to ensure corrective actions.

(b) The design assurance system shall include an independent checking function of the showings of compliance on the basis of which the organisation submits compliance statements and associated documentation to the Agency.

(c) The design organisation shall specify the manner in which the design assurance system accounts for the acceptability of the parts or appliances designed or the tasks performed by partners or subcontractor according to methods which are the subject of written procedures.

21A.243 Data

(a) The design organisation shall furnish a handbook to the Agency describing, directly or by cross-reference, the organisation, the relevant procedures and the products or changes to products to be designed.

(b) Where any parts or appliances or any changes to the products are designed by partner organisations or subcontractors, the handbook shall include a statement of how the design organisation is able to give, for all parts and appliances, the assurance of compliance required by 21A.239(b), and shall contain, directly or by cross-reference, descriptions and information on the design activities and organisation of those partners or subcontractors, as necessary to establish this statement.

(c) The handbook shall be amended as necessary to remain an up-to-date description of the organisation, and copies of amendments shall be supplied to the Agency.

(d) The design organisation shall furnish a statement of the qualifications and experience of the management staff and other persons responsible for making decisions affecting airworthiness and environmental protection in the organisation.

21A.245 Approval requirements

The design organisation shall demonstrate, on the basis of the information submitted in accordance with 21A.243 that, in addition to complying with 21A.239:

(a) The staff in all technical departments are of sufficient numbers and experience and have been given 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 achieve the airworthiness, noise, fuel venting and exhaust emissions objectives for the product.

(b) There is full and efficient coordination between departments and within departments in respect of airworthiness and environmental protection matters.

21A.247 Changes in design assurance system

After the issue of a design organisation approval, each change to the design assurance system that is significant to the showing of compliance or to the airworthiness and environmental protection of the product, shall be approved by the Agency. An application for approval shall be submitted in writing to the Agency and the design organisation shall demonstrate to the Agency, on the basis of submission of proposed changes to the handbook, and before implementation of the change, that it will continue to comply with this Subpart after implementation.

21A.249 Transferability

Except as a result of a change in ownership, which is deemed significant for the purposes of 21A.247, a design organisation approval is not transferable.

21A.251 Terms of approval

The terms of approval shall identify the types of design work, the categories of products, parts and appliances for which the design organisation holds a design organisation approval, and the functions and duties that the organisation is approved to perform in regard to the airworthiness and characteristics of noise, fuel venting and exhaust emissions of products. For design organisation approval covering type-certification or ETSO authorisation for Auxiliary Power Unit (APU), the terms of approval shall contain in addition the list of products or APU. Those terms shall be issued as part of a design organisation approval.

21A.253 Changes to the terms of approval

Each change to the terms of approval shall be approved by the Agency. An application for a change to the terms of approval shall be made in a form and manner established by the Agency. The design organisation shall comply with the applicable requirements of this Subpart.

21A.257 Investigations

(a) The design organisation shall make arrangements that allow the Agency to make any investigations, including investigations of partners and subcontractors, necessary to determine compliance and continued compliance with the applicable requirements of this Subpart.

(b) The design organisation shall allow the Agency to review any report and make any inspection and perform or witness any flight and ground test necessary to check the validity of the compliance statements submitted by the applicant under 21A.239(b).

21A.258 Findings

(a) When objective evidence is found showing non-compliance of the holder of a design organisation approval with the applicable requirements of this Part, the finding shall be classified as follows:

1. A level one finding is any non-compliance with this Part which could lead to uncontrolled non-compliances with applicable requirements and which could affect the safety of the aircraft.

2. A level two finding is any non-compliance with this Part which is not classified as level one.

(b) A level three finding is any item where it has been identified, by objective evidence, to contain potential problems that could lead to a non-compliance under paragraph (a).

(c) After receipt of notification of findings under the applicable administrative procedures established by the Agency,

1. In case of a level one finding, the holder of the design organisation approval shall demonstrate corrective action to the satisfaction of the Agency within a period of no more than 21 working days after written confirmation of the finding;

2. In case of level two findings, the corrective action period granted by the Agency shall be appropriate to the nature of the finding but in any case initially shall not be more than six months. In certain circumstances and subject to the nature of the finding the Agency may extend the six month period subject to a satisfactory corrective action plan agreed by the Agency.

3. A level three finding shall not require immediate action by the holder of the design organisation approval.

(d) In case of level one or level two findings, the design organisation approval may be subject to a partial or full suspension or revocation under the applicable administrative procedures established by the Agency. The holder of the design organisation approval shall provide confirmation of receipt of the notice of suspension or revocation of the design organisation approval in a timely manner.

21A.259 Duration and continued validity

(a) A design organisation approval shall be issued for an unlimited duration. It shall remain valid unless:

1. The design organisation fails to demonstrate compliance with the applicable requirements of this Subpart; or

2. The Agency is prevented by the holder or any of its partners or subcontractors to perform the investigations in accordance with 21A.257; or

3. There is evidence that the design assurance system cannot maintain satisfactory control and supervision of the design of products or changes thereof under the approval; or

4. the certificate has been surrendered or revoked under the applicable administrative procedures established by the Agency.

(b) Upon surrender or revocation, the certificate shall be returned to the Agency.

21A.263 Privileges

(a) The holder of a design organisation approval shall be entitled to perform design activities under this Part and within its scope of approval.

(b) Subject to 21A.257(b), compliance documents submitted by the applicant for the purpose of obtaining:

1. a type-certificate or approval of a major change to a type design; or

2. a supplemental type-certificate; or

3. an ETSO authorisation under 21A.602(b)(1);

4. a major repair design approval;

shall be accepted by the Agency without further verification.

(c) The holder of a design organisation approval shall be entitled, within its terms of approval and under the relevant procedures of the design assurance system:

1. to classify changes to type design and repairs as "major" or "minor".

2. to approve minor changes to type design and minor repairs.

3. to issue information or instructions containing the following statement: "The technical content of this document is approved under the authority of DOA nr. [EASA]. J. [xyz]."

4. to approve documentary changes to the aircraft flight manual, and issue such changes containing the following statement: "Revision nr. xx to AFM ref. yyy, is approved under the authority of DOA nr.[EASA].J.[xyz]."

5. to approve the design of major repairs to products for which it holds the type-certificate or the supplemental type-certificate.

21A.265 Obligations of the holder

The holder of a design organisation approval shall:

(a) Maintain the handbook in conformity with the design assurance system;

(b) Ensure that this handbook is used as a basic working document within the organisation;

(c) Determine that the design of products, or changes or repairs thereof, as applicable, comply with applicable requirements and have no unsafe feature;

(d) Except for minor changes or repairs approved under the privilege of 21A.263, provide to the Agency statements and associated documentation confirming compliance with paragraph (c);

(e) Provide to the Agency information or instructions related to required actions under 21A.3B.

SUBPART K - PARTS AND APPLIANCES

21A.301 Scope

This Subpart establishes the procedure relating to the approval of parts and appliances.

21A.303 Compliance with applicable requirements

The showing of compliance of parts and appliances to be installed in a type-certificated product shall be made:

(a) In conjunction with the type-certification procedures of Subpart B, D or E for the product in which it is to be installed; or

(b) Where applicable, under the ETSO authorisation procedures of Subpart O; or

(c) In the case of standard parts, in accordance with officially recognised Standards.

21A.305 Approval of parts and appliances

In all cases where the approval of a part or appliance is explicitly required by Community law or Agency measures, the part or appliance shall comply with the applicable ETSO or with the specifications recognised as equivalent by the Agency in the particular case.

21A.307 Release of parts and appliances for installation

No part or appliance (except a standard part), shall be eligible for installation in a type-certificated product unless it is:

(a) Accompanied by an authorised release certificate (EASA Form 1), certifying airworthiness; and

(b) Marked in accordance with Subpart Q.

(SUBPART L - NOT APPLICABLE)

SUBPART M - REPAIRS

21A.431 Scope

(a) This Subpart establishes the procedure for the approval of repair design, and establishes the rights and obligations of the applicants for, and holders of, those approvals.

(b) A 'repair' means elimination of damage and/or restoration to an airworthy condition following initial release into service by the manufacturer of any product, part or appliance.

(c) Elimination of damage by replacement of parts or appliances without the necessity for design activity shall be considered as a maintenance task and shall therefore require no approval under this Part.

(d) A repair to an ETSO article shall be treated as a change to the ETSO design and shall be processed in accordance with 21A.611.

21A.432 Eligibility

(a) Any natural or legal person that has demonstrated, or is in the process of demonstrating, its capability under 21A.432 B shall be eligible as an applicant for a major repair design approval under the conditions laid down in this Subpart.

(b) Any natural or legal person shall be eligible to apply for approval of a minor repair design.

21A.432B Demonstration of capability

(a) An applicant for a major repair design approval shall demonstrate its capability by holding a design organisation approval, issued by the Agency in accordance with Subpart J.

(b) By way of derogation from paragraph (a), as an alternative procedure to demonstrate its capability, an applicant may seek Agency agreement for the use of procedures setting out the specific design practices, resources and sequence of activities necessary to comply with this Subpart.

21A.433 Repair design

(a) The applicant for approval of a repair design shall:

1. Show compliance with the type-certification basis and environmental protection requirements incorporated by reference in the type-certificate or supplemental type-certificate, as applicable, or those in effect on the date of application (for repair design approval), plus any amendments to those certification specifications or special conditions the Agency finds necessary to establish a level of safety equal to that established by the type-certification basis incorporated by reference in the type-certificate or supplemental type-certificate.

2. Submit all necessary substantiation data, when requested by the Agency.

3. Declare compliance with the certification specifications and environmental protection requirements of subparagraph (a)(1).

(b) Where the applicant is not the type-certificate or supplemental type-certificate holder, as applicable, the applicant may comply with the requirements of paragraph (a) through the use of its own resources or through an arrangement with the type-certificate or supplemental type-certificate holder as applicable.

21A.435 Classification of repairs

(a) A repair may be 'major' or 'minor'. The classification shall be made in accordance with the criteria of 21A.91 for a change in the type design.

(b) A repair shall be classified "major" or "minor" under paragraph (a) either:

1. By the Agency, or

2. By an appropriately approved design organisation under a procedure agreed with the Agency.

21A.437 Issue of a repair design approval

When it has been declared and has been shown that the repair design meets the applicable certification specifications and environmental protection requirements of 21A.433(a)(1), it shall be approved:

(a) by the Agency, or

(b) by an appropriately approved organisation that is also the type-certificate or the supplemental type-certificate holder, under a procedure agreed with the Agency, or

(c) for minor repairs only, by an appropriately approved design organisation under a procedure agreed with the Agency.

21A.439 Production of repair parts

Parts and appliances to be used for the repair shall be manufactured in accordance with production data based upon all the necessary design data as provided by the repair design approval holder:

(a) Under Subpart F, or

(b) By an organisation appropriately approved in accordance with Subpart G, or

(c) By an appropriately approved maintenance organisation.

21A.441 Repair embodiment

(a) The embodiment of a repair shall be made by an appropriately approved maintenance organisation, or by a production organisation appropriately approved in accordance with Subpart G, under 21A.163 privilege.

(b) The design organisation shall transmit to the organisation performing the repair all the necessary installation instructions.

21A.443 Limitations

A repair design may be approved subject to limitations, in which case the repair design approval shall include all necessary instructions and limitations. These instructions and limitations shall be transmitted by the repair design approval holder to the operator in accordance with a procedure agreed with the Agency.

21A.445 Unrepaired damage

(a) When a damaged product, part or appliance, is left unrepaired, and is not covered by previously approved data, the evaluation of the damage for its airworthiness consequences may only be made;

1. by the Agency, or

2. by an appropriately approved design organisation under a procedure agreed with the Agency.

Any necessary limitations shall be processed in accordance with the procedures of 21A.443.

(b) Where the organisation evaluating the damage under paragraph (a) is neither the Agency nor the type-certificate or supplemental type-certificate holder, this organisation shall justify that the information on which the evaluation is based is adequate either from its organisation's own resources or through an arrangement with the type-certificate or supplemental type-certificate holder, or manufacturer, as applicable.

21A.447 Record keeping

For each repair, all relevant design information, drawings, test reports, instructions and limitations possibly issued in accordance with 21A.443, justification for classification and evidence of the design approval, shall:

(a) be held by the repair design approval holder at the disposal of the Agency, and

(b) be retained by the repair design approval holder in order to provide the information necessary to ensure the continued airworthiness of the repaired products, parts or appliances.

21A.449 Instructions for continued airworthiness

(a) The holder of the repair design approval shall furnish at least one complete set of those changes to the instructions for continued airworthiness which result from the design of the repair, comprising descriptive data and accomplishment instructions prepared in accordance with the applicable requirements, to each operator of aircraft incorporating the repair. The repaired product, part or appliance may be released into service before the changes to those instructions have been completed, but this shall be for a limited service period, and in agreement with the Agency. Those changes to the instructions shall be made available on request to any other person required to comply with any of the terms of those changes to the instructions. The availability of some manual or portion of the changes to the instructions for continued airworthiness, dealing with overhaul or other forms of heavy maintenance, may be delayed until after the product has entered into service, but shall be available before any of the products reaches the relevant age or flight - hours/cycles.

(b) If updates to those changes to the instructions for continued airworthiness are issued by the holder of the repair design approval after the repair has been first approved, these updates shall be furnished to each operator and shall be made available on request to any other person required to comply with any of the terms of those changes to the instructions. A programme showing how updates to the changes to the instructions for continued airworthiness are distributed shall be submitted to the Agency.

21A.451 Obligations and EPA marking

(a) Each holder of a major repair design approval shall:

1. undertake the obligations:

(i) laid down in 21A.3, 21A.3B, 21A.4, 21A.439, 21A.441, 21A.443, 21A.447 and 21A.449;

(ii) implicit in the collaboration with the type-certificate or supplemental type-certificate holder, or both, under 21A.433 (b), as appropriate.

2. specify the marking, including EPA ("European Part Approval") letters, in accordance with 21A.804(a).

(b) Except for type-certificate holders for which 21A.44 applies, the holder of a minor repair design approval shall:

1. undertake the obligations laid down in 21A.4, 21A.447 and 21A.449; and

2. specify the marking, including EPA letters, in accordance with 21A.804(a).

(SUBPART N - NOT APPLICABLE)

SUBPART O - EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS

21A.601 Scope

(a) This Subpart establishes the procedure for issuing European Technical Standard Order authorisations and the rules governing the rights and obligations of applicants for, or holders of, such authorisations.

(b) For the purpose of this Subpart:

1. "article" means any part and appliance to be used on civil aircraft.

2. "European Technical Standard Order" (referred to in this Part as "ETSO") is a detailed airworthiness specification issued by the Agency to ensure compliance with the essential requirements of the basic Regulation, and is a minimum performance standard for specified articles.

3. An article produced under an ETSO authorisation is an approved article for the purpose of Subpart K.

21A.602A Eligibility

Any natural or legal person that produces or is preparing to produce an ETSO article, and that has demonstrated, or is in the process of demonstrating, its capability under 21A.602B shall be eligible as an applicant for an ETSO authorisation.

21A.602B Demonstration of capability

Any applicant for an ETSO authorisation shall demonstrate its capability as follows:

(a) for production, by holding a production organisation approval, issued in accordance with Subpart G, or through compliance with Subpart F procedures; and

(b) for design:

1. for an Auxiliary Power Unit, by holding a design organisation approval, issued by the Agency in accordance with Subpart J;

2. for all other articles, by using procedures setting out the specific design practices, resources and sequence of activities necessary to comply with this Part.

21A.603 Application

(a) An application for an ETSO authorisation shall be made in a form and manner established by the Agency and shall include an outline of the information required by 21A.605.

(b) When a series of minor changes in accordance with 21A.611 is anticipated, the applicant shall set forth in its application the basic model number of the article and the associated part numbers with open brackets after it to denote that suffix change letters or numbers (or combinations of them) will be added from time to time.

21A.604 ETSO Authorisation for an Auxiliary Power Unit (APU)

With regard to ETSO authorisation for an Auxiliary Power Unit:

(a) 21A.15, 21A.16B, 21A.17, 21A.20, 21A.21, 21A.31, 21A.33, 21A.44 shall apply by way of derogation from 21A.603, 21A.606(c), 21A.610 and 21A.615, except that an ETSO Authorisation shall be issued in accordance with 21A.606 instead of the type-certificate;

(b) Subpart D or Subpart E of this Part 21 is applicable for the approval of design changes by way of derogation from 21A.611. When Subpart E is used, a separate ETSO authorisation shall be issued instead of a supplemental type-certificate.

21A.605 Data requirements

The applicant shall submit the following documents, to the Agency:

(a) A statement of compliance certifying that the applicant has met the requirements of this Subpart.

(b) A Declaration of Design and Performance (DDP).

(c) One copy of the technical data required in the applicable ETSO.

(d) The exposition (or a reference to the exposition) referred to in 21A.143 for the purpose of obtaining an appropriate production organisation approval under Subpart G or the manual (or a reference to the manual) referred to in 21A.125(b) for the purpose of manufacturing under Subpart F without production organisation approval.

(e) For an APU, the handbook (or a reference to the handbook) referred to in 21A.243 for the purpose of obtaining an appropriate design organisation approval under Subpart J.

(f) for all other articles, the procedures referred to in 21A.602B(b)(2).

21A.606 Issue of ETSO authorisation

The applicant shall be entitled to have an ETSO authorisation issued by the Agency after:

(a) demonstrating its capability in accordance with 21A.602B; and

(b) demonstrating that the article complies with the technical conditions of the applicable ETSO, and submitting the corresponding statement of compliance.

(c) showing that it is able to comply with 21A.3(b) and (c).

21A.607 ETSO authorisation privileges

The holder of an ETSO authorisation is entitled to produce and to mark the article with the appropriate ETSO marking.

21A.608 Declaration of Design and Performance (DDP)

(a) The DDP shall contain at least the following information:

1. Information corresponding to 21A.31(a) and (b), identifying the article and its design and testing standard.

2. The rated performance of the article, where appropriate, either directly or by reference to other supplementary documents.

3. A statement of compliance certifying that the article has met the appropriate ETSO.

4. Reference to relevant test reports.

5. Reference to the appropriate Maintenance, Overhaul and Repair Manuals.

6. The levels of compliance, where various levels of compliance are allowed by the ETSO.

7. List of deviations accepted in accordance with 21A.610.

(b) The DDP shall be endorsed with the date and signature of the holder of the ETSO authorisation, or its authorised representative.

21A.609 Obligations of holders of ETSO authorisations

The holder of an ETSO authorisation under this Subpart shall:

(a) Manufacture each article in accordance with Subpart G or Subpart F that ensures that each completed article conforms to its design data and is safe for installation;

(b) Prepare and maintain, for each model of each article for which an ETSO authorisation has been issued, a current file of complete technical data and records in accordance with 21A.613;

(c) Prepare, maintain and update master copies of all manuals required by the applicable airworthiness specifications for the article;

(d) Make available to users of the article and to the Agency on request those maintenance, overhaul and repair manuals necessary for the usage and maintenance of the article, and changes to those manuals;

(e) Mark each article in accordance with 21A.807; and

(f) Comply with 21A.3(b), (c), 21A.3B and 21A.4.

(g) Continue to meet the qualification requirements of 21A.602B.

21A.610 Approval for deviation

(a) Each manufacturer who requests approval to deviate from any performance standard of an ETSO shall demonstrate that the standards from which a deviation is requested are compensated for by factors or design features providing an equivalent level of safety.

(b) The request for approval to deviate, together with all pertinent data, shall be submitted to the Agency.

21A.611 Design changes

(a) The holder of the ETSO authorisation may make minor design changes (any change other than a major change) without further authorisation by the Agency. In this case, the changed article keeps the original model number (part number changes or amendments shall be used to identify minor changes) and the holder shall forward to the Agency any revised data that are necessary for compliance with 21A.603(b).

(b) Any design change by the holder of the ETSO authorisation that is extensive enough to require a substantially complete investigation to determine compliance with an ETSO is a major change. Before making such a change, the holder shall assign a new type or model designation to the article and apply for a new authorisation under 21A.603.

(c) No design change by any natural or legal person other than the holder of the ETSO authorisation who submitted the statement of compliance for the article is eligible for approval under this Subpart O unless the person seeking the approval applies under 21A.603 for a separate ETSO authorisation.

21A.613 Record keeping

Further to the record keeping requirements appropriate to or associated with the quality system, all relevant design information, drawings and test reports, including inspection records for the article tested, shall be held at the disposal of the Agency and shall be retained in order to provide the information necessary to ensure the continued airworthiness of the article and of the type-certificated product in which it is fitted.

21A.615 Inspection by the Agency

Upon a request of the Agency, each applicant for, or holder of an ETSO authorisation for an article shall allow the Agency to:

(a) Witness any tests.

(b) Inspect the technical data files on that article.

21A.619 Duration and continued validity

(a) An ETSO authorisation shall be issued for an unlimited duration. It shall remain valid unless:

1. The conditions required when ETSO authorisation was granted are no longer being observed; or

2. The obligations of the holder specified in 21A.609 are no longer being discharged; or

3. The article has proved to give rise to unacceptable hazards in service; or

4. the authorisation has been surrendered or revoked under the applicable administrative procedures established by the Agency.

(b) Upon surrender or revocation, the certificate shall be returned to the Agency.

21A.621 Transferability

Except for a change in ownership of the holder, which shall be regarded as a change of significance, and shall therefore comply with 21A.147 and 21A.247 as applicable, an ETSO authorisation issued under this Part is not transferable.

(SUBPART P - NOT APPLICABLE)

SUBPART Q - IDENTIFICATION OF PRODUCTS, PARTS AND APPLIANCES

21A.801 Identification of products

(a) The identification of products shall include the following information:

1. Manufacturer's name.

2. Product designation.

3. Manufacturer's Serial number.

4. Any other information the Agency finds appropriate.

(b) Any natural or legal person that manufactures an aircraft or engine under Subpart G or Subpart F shall identify that aircraft or engine by means of a fireproof plate that has the information specified in paragraph (a) marked on it by etching, stamping, engraving, or other approved method of fireproof marking. 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.

(c) Any natural or legal person that manufactures a propeller, propeller blade, or propeller hub under Subpart G or Subpart F shall identify it by means of a plate, stamping, engraving, etching or other approved method of fireproof identification that is placed on it on a non-critical surface, contains the information specified in paragraph (a), and will not likely be defaced or removed during normal service or lost or destroyed in an accident.

(d) For manned free balloons, the identification plate prescribed in paragraph (b) 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 and any heater assembly shall be permanently and legibly marked with the manufacturer's name, part number, or equivalent, and serial number, or equivalent.

21A.803 Handling of identification data

(a) No person shall remove, change, or place identification information referred to in 21A.801(a) on any aircraft, engine, propeller, propeller blade, or propeller hub, or in 21A.807(a) on an APU, without the approval of the Agency.

(b) No person shall remove or install any identification plate referred to in 21A.801, or in 21A.807 for an APU, without the approval of the Agency.

(c) By way of derogation from paragraphs (a) and (b), any natural or legal person performing maintenance work under the applicable associated implementing rules may, in accordance with methods, techniques and practices established by the Agency:

1. Remove, change, or place the identification information referred to in 21A.801(a) on any aircraft, engine, propeller, propeller blade, or propeller hub, or in 21A.807(a) on an APU; or

2. Remove an identification plate referred to in 21A.801, or 21A.807 for an APU, when necessary during maintenance operations.

(d) No person shall install an identification plate removed in accordance with subparagraph (c)(2) on any aircraft, engine, propeller, propeller blade, or propeller hub other than the one from which it was removed.

21A.804 Identification of parts and appliances

(a) Each manufacturer of a part or appliance shall permanently and legibly mark the part or appliance with:

1. a name, trademark, or symbol identifying the manufacturer; and

2. the part number, as defined in the applicable design data; and

3. the letters EPA (European Part Approval) for parts or appliances produced in accordance with approved design data not belonging to the type-certificate holder of the related product, except for ETSO articles.

(b) By way of derogation from paragraph (a), if the Agency agrees that a part or appliance is too small or that it is otherwise impractical to mark a part or appliance with any of the information required by paragraph (a), the authorised release document accompanying the part or appliance or its container shall include the information that could not be marked on the part.

21A.805 Identification of critical parts

In addition to the requirement of 21A.804, each manufacturer of a part to be fitted on a type-certificated product which has been identified as a critical part shall permanently and legibly mark that part with a part number and a serial number.

21A.807 Identification of ETSO articles

(a) Each holder of an ETSO authorisation under Subpart O shall permanently and legibly mark each article with the following information:

1. The name and address of the manufacturer;

2. The name, type, part number or model designation of the article;

3. The serial number or the date of manufacture of the article or both; and

4. The applicable ETSO number.

(b) By way of derogation from paragraph (a), if the Agency agrees that a part is too small or that it is otherwise impractical to mark a part with any of the information required by paragraph (a), the authorised release document accompanying the part or its container shall include the information that could not be marked on the part.

(c) Each person who manufactures an APU under Subpart G or Subpart F shall identify that APU by means of a fireproof plate that has the information specified in paragraph (a) marked on it by etching, stamping, engraving, or other approved method of fireproof marking. 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.

SECTION B PROCEDURES FOR COMPETENT AUTHORITIES

SUBPART A - GENERAL PROVISIONS

21B.5 Scope

(a) This Section establishes the procedure for the competent authority of the Member State when exercising its tasks and responsibilities concerned with the issuance, maintenance, amendment, suspension and revocation of certificates, approvals and authorisations referred to in this Part.

(b) The Agency shall develop in accordance with Article 14 of the basic Regulation certification specifications and guidance material to assist Member States in the implementation of this Section.

21B.20 Obligations of the competent authority

Each competent authority of the Member State is responsible for the implementation of Section A, Subparts F, G, H and I only for applicants, or holders, whose principal place of business is in its territory.

21B.25 Requirements for the organisation of the competent authority

(a) General:

The Member State shall designate a competent authority with allocated responsibilities for the implementation of Section A, Subparts F, G, H and I with documented procedures, organisation structure and staff.

(b) Resources:

1. The number of staff shall be sufficient to perform the allocated tasks.

2. The competent authority of the Member State shall appoint a manager, or managers, who are responsible for the execution of the related task(s) within the authority, including the communication with the Agency and the other national authorities as appropriate.

(c) Qualification and training:

All staff shall be appropriately qualified and have sufficient knowledge, experience and training to perform their allocated task.

21B.30 Documented procedures

(a) The competent authority of the Member State shall establish documented procedures to describe its organisation, means and methods to fulfil the requirements of this Part. The procedures shall be kept up to date and serve as the basic working documents within that authority for all related activities.

(b) A copy of the procedures and their amendments shall be available to the Agency.

21B.35 Changes in organisation and procedures

(a) The competent authority of the Member State shall notify any significant change in its organisation and documented procedures to the Agency.

(b) The competent authority of the Member State shall update its documented procedures relating to any change to regulations in a timely manner to ensure effective implementation.

21B.40 Resolution of disputes

(a) The competent authority of the Member State shall establish a process for the resolution of disputes within its organisation documented procedures.

(b) Where a dispute, which cannot be resolved, exists between the competent authorities of the Member States it is the responsibility of the managers as defined in 21B.25(b)(2) to raise the issue with the Agency for mediation.

21B.45 Reporting/coordination

(a) The competent authority of the Member State shall ensure coordination as applicable with other related certification, investigation, approval or authorisation teams of that authority, other Member States and the Agency to ensure efficient exchange of information relevant for safety of the products, parts and appliances.

(b) The competent authority of the Member State shall notify any difficulty in the implementation of this Part to the Agency.

21B.55 Record keeping

The competent authority of the Member State shall keep, or maintain access to, the appropriate records related to the certificates, approvals and authorisations it has granted in accordance with the respective national regulations, and for which responsibility is transferred to the Agency, as long as these records have not been transferred to the Agency.

21B.60 Airworthiness directives

When the a competent authority of a Member State receives an airworthiness directive from the competent authority of a non-member State, that airworthiness directive shall be transferred to the Agency for dissemination in accordance with Article 15 of the basic Regulation.

SUBPART B - TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES

Administrative procedures established by the Agency shall apply.

(SUBPART C - NOT APPLICABLE)

SUBPART D - CHANGES TO TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES

Administrative procedures established by the Agency shall apply.

SUBPART E - SUPPLEMENTAL TYPE-CERTIFICATES

Administrative procedures established by the Agency shall apply.

SUBPART F - PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL

21B.120 Investigation

(a) The Competent Authority shall appoint an investigation team for each applicant for, or holder of, a letter of agreement to conduct all relevant tasks related to this letter of agreement, consisting of a team-leader to manage and lead the investigation team and, if required, one or more team members. The team-leader reports to the manager responsible for the activity, as defined in 21B.25 (b)(2).

(b) The Competent Authority shall perform sufficient investigation activities for an applicant for, or holder of, a letter of agreement to justify recommendations for the issuance, maintenance, amendment, suspension or revocation of the letter of agreement.

(c) The Competent Authority shall prepare procedures for the investigation of applicants for, or holders of, a letter of agreement as part of the documented procedures covering at least the following elements:

1. evaluation of applications received;

2. determination of investigation team;

3. investigation preparation and planning;

4. evaluation of the documentation (manual, procedures, etc.);

5. auditing and inspection;

6. follow up of corrective actions; and

7. recommendation for issuance, amendment, suspension or revocation of the letter of agreement.

21B.130 Issue of letter of agreement

(a) When satisfied that the manufacturer is in compliance with the applicable requirements of Section A, Subpart F, the Competent Authority shall issue a letter of agreement to the showing of conformity of individual products, parts or appliances (EASA Form 65, see Appendix) without undue delay.

(b) The letter of agreement shall contain the scope of the agreement, a termination date and, where applicable, the appropriate limitations relating to the authorisation.

(c) The duration of the letter of agreement shall not exceed one year.

21B.135 Maintenance of the letter of agreement

The Competent Authority shall maintain the letter of agreement as long as:

(a) The manufacturer is properly using the EASA Form 52 (see Appendix) as a Statement of Conformity for complete aircraft, and the EASA Form 1 (see Appendix) for products other than complete aircraft, parts and appliances; and

(b) Inspections performed by the Competent Authority of the Member State before validation of the EASA Form 52 (see Appendix) or the EASA Form 1 (see Appendix), as per 21A.130(c) and did not reveal any findings of non-compliance against the requirements or the procedures as contained in the manual provided by the manufacturer, or against the conformity of the respective products, parts or appliances. These inspections shall check at least that:

1. The agreement covers the product, part or appliance being validated, and remains valid;

2. The manual described in 21A.125(b) and its change status referred in the letter of agreement is used as basic working document by the manufacturer. Otherwise, the inspection shall not continue and therefore the release certificates shall not be validated;

3. Production has been carried out under the conditions prescribed in the letter of agreement and satisfactorily performed;

4. Inspections and tests (including flight tests, if appropriate), as per 21A.130(b)(2) and/or (b)(3), have been carried out under the condition prescribed in the letter of agreement and satisfactorily performed;

5. The inspections by the Competent Authority described or addressed in the letter of agreement have been performed and found acceptable;

6. The statement of conformity complies with 21A.130, and the information provided by it does not prevent its validation; and

(c) Any termination date for the letter of agreement has not been reached.

21B.140 Amendment of a letter of agreement

(a) The Competent Authority shall investigate, as appropriate, in accordance with 21B.120 any amendment of the letter of agreement.

(b) When the Competent Authority is satisfied that the requirements of Section A, Subpart F continue to be complied with it shall amend the letter of agreement accordingly.

21B.143 Notification of findings

(a) When objective evidence is found by the Competent Authority, showing non compliance of the holder of a letter of agreement with the applicable requirements of this Part, this finding shall be classified in accordance with 21A.125B and:

1. A level one finding shall be notified to the holder of the letter of agreement immediately and shall be confirmed in writing within 3 working days after determination.

2. A level two finding shall be confirmed in writing to the holder of the letter of agreement within 14 working days after determination.

(b) The Competent Authority shall identify to the holder of the letter of agreement any level three finding, as defined in 21A.125B(b), by appropriate means, at its convenience.

21B.145 Suspension and revocation of a letter of agreement

(a) In case of level one or level two findings, the Competent Authority shall partly or fully limit, suspend or revoke a letter of agreement as follows:

1. In case of a level one finding the letter of agreement shall be immediately limited or suspended. If the holder of the letter of agreement fails to comply with 21A.125B(c)(1), the letter of agreement shall be revoked.

2. In case of a level two finding, the Competent Authority shall decide on any restriction to the letter of agreement by temporary suspension of the letter of agreement or parts thereof. If the holder of the letter of agreement fails to comply with 21A.125B(c)(2), the letter of agreement shall be revoked.

(b) The suspension or revocation of the letter of agreement shall be communicated in writing to the holder of the letter of agreement. The Competent Authority shall state the reasons for the limitation, suspension or revocation and inform the holder of the letter of agreement on its right to appeal.

(c) When a letter of agreement has been suspended it shall only be reinstated after compliance with Section A, Subpart F has been re-established.

21B.150 Record keeping

(a) The Competent Authority shall establish a system of record keeping that allows adequate traceability of the process to issue, maintain, amend, suspend or revoke each individual letter of agreement.

(b) The records shall at least contain:

1. the documents provided by the applicant for, or holder of, a letter of agreement,

2. documents established during investigation and inspection, in which the activities and the final results of the elements defined in 21B.120 are stated,

3. the letter of agreement, including changes, and

4. minutes of the meetings with the manufacturer.

(c) The records shall be archived for a minimum retention period of six years after termination of the letter of agreement.

(d) The Competent Authority shall also maintain records of all Statements of Conformity (EASA Form 52, see Appendix) and Authorised Release Certificates (EASA Form 1, see Appendix) that it has validated.

SUBPART G - PRODUCTION ORGANISATION APPROVAL

21B.220 Investigation

(a) The Competent Authority shall appoint a production organisation approval team for each applicant, or holder of, a production organisation approval to conduct all relevant tasks related to this production organisation approval, consisting of a team leader to manage and lead the approval team and, if required, one or more team members. The team leader reports to the manager responsible for the activity as defined in 21B.25(b)(2).

(b) The Competent Authority shall perform sufficient investigation activities for an applicant for, or holder of, a production organisation approval to justify recommendations for the issuance, maintenance, amendment, suspension or revocation of the approval.

(c) The Competent Authority shall prepare procedures for the investigation of a production organisation approval as part of the documented procedures covering at least the following elements:

1. evaluation of applications received;

2. determination of production organisation approval team;

3. investigation preparation and planning;

4. evaluation of the documentation (production organisation exposition, procedures, etc.);

5. auditing;

6. follow up of corrective actions;

7. recommendation for issuance, amendment, suspension or revocation of production organisation approval;

8. continued surveillance.

21B.225 Notification of findings

(a) When objective evidence is found showing non compliance of the holder of a production organisation approval with the applicable requirements of this Part, this finding shall be classified in accordance with 21A.158(a) and:

1. A level one finding shall be notified to the holder of a production organisation approval immediately and shall be confirmed in writing within 3 working days after determination.

2. A level two finding shall be confirmed in writing to the holder of the production organisation approval within 14 working days after determination.

(b) The Competent Authority shall identify to the holder of the production organisation approval any level three finding, as defined in 21A.158(b), by appropriate means, at its convenience.

21B.230 Issue of certificate

(a) When satisfied that the production organisation is in compliance with the applicable requirements of Section A, Subpart G, the Competent Authority shall issue a Production Organisation Approval (EASA Form 55, see Appendix ) without undue delay.

(b) The reference number shall be included on the EASA Form 55 in a manner specified by the Agency.

21B.235 Continued surveillance

(a) In order to justify the maintenance of the production organisation approval the Competent Authority competent authority shall perform continued surveillance:

1. to verify that the production organisation approval holder's quality system still complies with Section A, Subpart G; and

2. to verify that the organisation of the production organisation approval holder operates in accordance with the production organisation exposition; and

3. to verify the effectiveness of the production organisation exposition procedures; and

4. to monitor by sample the standards of the product, part or appliance.

(b) Continued surveillance shall be performed in accordance with 21B.220.

(c) The Competent Authority shall provide through planned continued surveillance that a production organisation approval is completely reviewed for compliance with this Part during a period of 24 months. The continued surveillance may be made up of several investigation activities during this period. The number of audits may vary depending upon the complexity of the organisation, the number of sites and the criticality of the production. As a minimum the holder of a production organisation approval shall be subject to continued surveillance activity by the Competent Authority at least once every year.

21B.240 Amendment of a production organisation approval

(a) The Competent Authority shall monitor any minor change through the continued surveillance activities.

(b) The Competent Authority shall investigate as appropriate in accordance with 21B.220 any significant change of a production organisation approval or application by the holder of a production organisation approval for an amendment of the scope and terms of approval.

(c) When the Competent Authority is satisfied that the requirements of Section A, Subpart G continue to be complied with it shall amend the production organisation approval accordingly.

21B.245 Suspension and revocation of a production organisation approval

(a) In case of a level one or level two finding, the Competent Authority shall partly or fully limit, suspend or revoke a production organisation approval as follows:

1. In case of a level one finding the production organisation approval shall be immediately limited or suspended. If the holder of the production organisation approval fails to comply with 21A.158(c)(1), the production organisation approval shall be revoked.

2. In case of a level two finding, the Competent Authority shall decide on any restriction to the scope of approval by temporary suspension of the production organisation approval or parts thereof. If the holder of a production organisation approval fails to comply with 21A.158(c)(2), the production organisation approval shall be revoked.

(b) The limitation, suspension or revocation of the production organisation approval shall be communicated in writing to the holder of the production organisation approval. The Competent Authority shall state the reasons for the suspension or revocation and inform the holder of the production organisation approval on its right to appeal.

(c) When a production organisation approval has been suspended it shall only be reinstated after compliance with Section A, Subpart G has been re-established.

21B.260 Record keeping

(a) The Competent Authority shall establish a system of record keeping that allows adequate traceability of the process to issue, maintain, amend, suspend or revoke each individual production organisation approval.

(b) The records shall at least contain:

1. the documents provided by the applicant for, or holder of, a production organisation approval certificate,

2. documents established during the investigation, in which the activities and the final results of the elements defined in 21B.220 are stated, including findings established in accordance with 21B.225

3. the continued surveillance programme, including records of investigations performed

4. the production organisation approval certificate, including changes

5. minutes of the meetings with the holder of the production organisation approval.

(c) The records shall be archived for a minimum retention period of six years.

SUBPART H - AIRWORTHINESS CERTIFICATES

21B.320 Investigation

(a) The competent authority of the Member State of registry shall perform sufficient investigation activities for an applicant for, or holder of, an airworthiness certificate to justify the issuance, maintenance, amendment, suspension or revocation of the certificate or permit.

(b) The competent authority of the Member State of registry shall prepare evaluation procedures covering at least the following elements:

1. evaluation of eligibility of the applicant;

2. evaluation of the eligibility of the application;

3. classification of airworthiness certificates;

4. evaluation of the documentation received with the application;

5. inspection of aircraft;

6. determination of necessary conditions, restrictions or limitations to the airworthiness certificates.

21B.325 Issue of airworthiness certificates

(a) The competent authority of the Member State of registry shall, as applicable, issue, or amend a Certificate of Airworthiness (EASA Form 25, see Appendix), Restricted Certificate of Airworthiness (EASA Form 24, see Appendix) or Permit to Fly (EASA Form 20, see Appendix) without undue delay when it is satisfied that the applicable requirements of Section A, Subpart H are met.

(b) In addition to an airworthiness certificate for a new aircraft or used aircraft originating from a non-member State, the competent authority of the Member State of registry shall issue an initial airworthiness review certificate (EASA Form 15a, see Appendix).

21B.330 Suspension and revocation of airworthiness certificates

(a) Upon evidence that any of the conditions specified in 21A.181(a) is not met, the competent authority of the Member State of registry shall suspend or revoke an airworthiness certificate.

(b) Upon issuance of the notice of suspension and revocation of a certificate of airworthiness, restricted certificate of airworthiness or permit to fly the competent authority of the Member State of registry shall state the reasons for the suspension or revocation and inform the holder of the certificate or permit on its right to appeal.

21B.345 Record keeping

(a) The competent authority of the Member State of registry shall establish a system of record keeping that allows adequate traceability of the process to issue, maintain, amend, suspend or revoke each individual airworthiness certificate.

(b) The records shall at least contain:

1. the documents provided by the applicant,

2. documents established during the investigation, in which the activities and the final results of the elements defined in 21B.320(b) are stated, and

3. a copy of the certificate or permit, including amendments.

(c) The records shall be archived for a minimum retention period of six years after leaving that national register.

SUBPART I - NOISE CERTIFICATES

21B.420 Investigation

(a) The competent authority of the Member State of registry shall perform sufficient investigation activities for an applicant for, or holder of, a noise certificate to justify the issuance, maintenance, amendment, suspension or revocation of the certificate.

(b) The competent authority of the Member State of registry shall prepare evaluation procedures as part of the documented procedures covering at least the following elements:

1. evaluation of eligibility;

2. evaluation of the documentation received with the application;

3. inspection of aircraft.

21B.425 Issue of noise certificates

The competent authority of the Member State of registry shall, as applicable, issue, or amend noise certificates (EASA Form 45, see Appendix ) without undue delay when it is satisfied that the applicable requirements of Section A, Subpart I are met.

21B.430 Suspension and revocation of a noise certificate

(a) Upon evidence that some of the conditions specified in 21A.211(a) are not met, the competent authority of the Member State of registry shall suspend or revoke a noise certificate.

(b) Upon issuance of the notice of suspension and revocation of a noise certificate the competent authority of the Member State of registry shall state the reasons for the suspension and revocation and shall inform the holder of the certificate on its right to appeal.

21B.445 Record keeping

(a) The competent authority of the Member State of registry shall establish a system of record keeping with minimum retention criteria that allows adequate traceability of the process to issue, maintain, amend, suspend or revoke each individual noise certificate.

(b) The records shall at least contain:

1. the documents provided by the applicant,

2. documents established during the investigation, in which the activities and the final results of the elements defined in 21B.420(b) are stated,

3. a copy of the certificate including amendments.

(c) The records shall be archived for a minimum retention period of six years after leaving that national register.

SUBPART J - DESIGN ORGANISATION APPROVAL

Administrative procedures established by the Agency shall apply.

SUBPART K - PARTS AND APPLIANCES

Administrative procedures established by the Agency shall apply.

(SUBPART L - NOT APPLICABLE)

SUBPART M - REPAIRS

Administrative procedures established by the Agency shall apply.

(SUBPART N - NOT APPLICABLE)

SUBPART O - EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS

Administrative procedures established by the Agency shall apply.

(SUBPART P - NOT APPLICABLE)

SUBPART Q - IDENTIFICATION OF PRODUCTS, PARTS AND APPLIANCES

Administrative procedures established by the Agency shall apply.

Appendices

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