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Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations (recast) Text with EEA relevance

Type Regulation

Publication 2012-08-21

Last updated 2026-08-07

State In force

Department European Commission

Source EUR-Lex

articles 13

Reform history JSON API

(d) The declared design organisation shall ensure that:
1. the staff in all technical departments are of sufficient numbers and experience and have been given the appropriate authority to be able to discharge their allocated responsibilities and that these, together with the accommodation, facilities and equipment, are adequate to enable the staff to ensure that the products designed are airworthy and environmentally compatible;
1. there is full and efficient coordination within the declared design organisation in respect of airworthiness and environmental compatibility matters.

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

21L.A.176 Scope of work

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

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

A declared design organisation shall:

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

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

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

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

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

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

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

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

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

SUBPART K – PARTS

21L.A.191 Scope

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

21L.A.192 Showing of compliance

(a) The showing of compliance with the airworthiness requirements of parts to be installed in a type-certified product or an aircraft for which design compliance has been declared shall be made:
1. in conjunction with the type-certification procedures of Subpart B, D or E of this Annex for the product in which it is to be installed; or
1. in conjunction with the declaration of design compliance procedures of Subpart C or F of this Annex for the product in which it is to be installed; or
1. under the ETSO authorisation procedure of Subpart O of Section A of Annex I (Part 21); or
1. in the case of standard parts, in accordance with officially recognised standards.

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

21L.A.193 Release of parts for installation

(a) A part or product shall only be installed in a product when it is identified by the holder of a type certificate, supplemental type certificate, design change, repair design approval or with a declaration of design compliance as being suitable for installation, and when it is:
1. in a condition for safe operation;
1. marked in accordance with Subpart Q of this Annex; and
1. accompanied by an authorised release certificate (EASA Form 1) certifying that the item was manufactured in conformity with the applicable design data.

(b) By way of derogation from point (a)(3) and provided that the conditions in point (c) are met, the following parts do not require an authorised release certificate (EASA Form 1) in order to be installed in a type-certified product or in an aircraft for which design compliance has been declared:
1. a standard part;
1. a part that is:
(i) not life limited, nor part of the primary structure, nor part of the flight controls;
(ii) identified for installation in the specific aircraft by the holder of a type certificate, supplemental type certificate, design change, repair design approval or a declaration of design compliance;
(iii) to be installed in an aircraft whose owner has verified compliance with the applicable conditions in (i) and (ii), and has accepted responsibility for this compliance;
1. a part for which the consequences of a non-conformity with its approved design data or declared design data has a negligible safety effect on the product and which is identified as such by the holder of the design approval or the declarant of design compliance in the instructions for continued airworthiness. In order to determine the safety effects of a non-conforming part, the design approval holder or declarant of a declaration of design compliance may establish in the instructions for continued airworthiness specific verification activities to be conducted by the installer of the part on the product;
1. in the case of the embodiment of a standard change as per point 21L.A.102 or a standard repair as per point 21L.A.202, a part for which the consequences of a non-conformity with its design data have a negligible safety effect on the product, and the part is identified as such in the certification specifications for standard changes and standard repairs issued in accordance with point 21.B.70 of Annex I (Part 21). In order to determine the safety effects of a non-conforming part, specific verification activities to be conducted by the person that installs the part in the product may be established in these certification specifications;
1. a part that is exempted from an airworthiness approval in accordance with Commission Regulation (EU) No 965/2012 ([^E0029]); and
1. a part that is an item of a higher assembly identified in points (b)(1) to (b)(5).

(c) Parts listed in point (b) are eligible for installation in a type-certified product or in an aircraft for which design compliance has been declared without being accompanied by an EASA Form 1, provided that the installer holds a document issued by the person or organisation that manufactured the part, which declares the name of the part, the part number, and the conformity of the part with its design data, and which contains the date of issuance.

SUBPART M – DESIGN OF REPAIRS TO TYPE-CERTIFIED PRODUCTS

21L.A.201 Scope

This Subpart establishes:

(a) the procedure for applying for the approvals of repair designs to type-certified products;

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

21L.A.202 Standard repairs

(a) Standard repairs are repair designs to a type-certified product approved in accordance with Subpart B of Section B of this Annex and which:
1. follow the design data included in the certification specifications issued by the Agency, containing the acceptable methods, techniques and practices for carrying out and identifying standard repairs, including the associated instructions for continued airworthiness; and
1. are not in conflict with the data of the holder of that type certificate.

(b) Points 21L.A.203 to 21L.A.211 are not applicable to standard repairs.

21L.A.203 Classification of repair designs to a type-certified product

(a) Repair designs to a type-certified product shall be classified as minor or major.

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

(d) The requirements for the approval of minor repair designs are those established in point 21L.A.207.

(e) The requirements for the approval of major repair designs are those established in point 21L.A.208.

21L.A.204 Eligibility

(a) Any natural or legal person who has demonstrated, or is in the process of demonstrating, their design capability in accordance with point 21L.A.23, may apply for the approval of a major repair design to a type-certified product under the conditions laid down in this Subpart.

(b) Any natural or legal person may apply for the approval of a minor repair design to a type-certified product under the conditions laid down in this Subpart.

21L.A.205 Application for the approval of a repair design to a type-certified product

(a) An application for an approval of a repair design to a type-certified product shall be made in a form and manner established by the Agency.

(b) For the approval of a major repair design, the applicant shall include in the application, or submit after the initial application, a compliance demonstration plan:
1. containing a description of the damage and the repair design, identifying the configuration of the type design upon which the repair design is made;
1. identifying all the areas of the type design and the approved manuals that are changed or affected by the repair design;
1. identifying any reinvestigations necessary to demonstrate the compliance of the repair design and the areas affected by the repair design with the type-certification basis and the applicable environmental protection requirements, incorporated by reference in, as applicable, either the type certificate or the supplemental type certificate;
1. identifying any proposed amendments to the type-certification basis incorporated by reference in, as applicable, either the type certificate or supplemental type certificate;
1. specifying whether the certification data has been or will be prepared completely by the applicant or on the basis of an arrangement with the owner of the type-certification data.

21L.A.206 Demonstration of compliance

(a) The applicant for the approval of a major repair design shall demonstrate compliance with the applicable type-certification basis and applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with point 21L.B.201 and shall provide the Agency with the means by which such compliance has been demonstrated.

(b) The applicant for the approval of a major repair design shall provide the Agency with a recorded justification of the means of compliance within compliance documents according to the compliance demonstration plan.

(c) When carrying out testing and inspections to demonstrate compliance in accordance with point (a), the applicant shall have verified and documented this verification prior to carrying out any test:
1. for the test specimen, that:
(i) the materials and processes adequately conform to the specifications for the proposed type design;
(ii) the constituent parts of the products adequately conform to the drawings in the proposed type design;
(iii) the manufacturing processes, construction and assembly adequately conform to those specified in the proposed type design; and
1. that the test and measuring equipment used for the test were adequate for the test and appropriately calibrated.

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

(e) An applicant for the approval of a major repair design shall allow the Agency to:
1. review any data and information related to the demonstration of compliance;
1. witness or carry out any test or inspection conducted for the purpose of the demonstration of compliance; and
1. if it is considered necessary, conduct a physical inspection of the repaired product to verify the compliance of the design with the type-certification basis and the applicable environmental protection requirements.

(f) Upon completion of the compliance demonstration, the applicant shall declare to the Agency that:
1. they have demonstrated compliance with the type-certification basis and the applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with points 21L.B.201, according to the compliance demonstration plan; and
1. no feature or characteristic has been identified that may make the product with the repair design unsafe or environmentally incompatible for the uses for which certification is requested.

21L.A.207 Requirements for the approval of a minor repair design

In order to be issued with an approval of a minor repair design to a type-certified product, the applicant shall:

(a) demonstrate that the repair design and the areas affected by the repair design comply:
1. with the type-certification basis and the applicable environmental protection requirements incorporated by reference in the type certificate; or
1. if the applicant chooses to, with the certification specifications that are applicable to the product on the date of the application for the approval of the repair design;

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

21L.A.208 Requirements for the approval of a major repair design

In order to be issued with an approval of a major repair design to a type-certified product, the applicant shall:

(a) demonstrate that the repair design and the areas affected by the repair design comply with the type-certification basis and the applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with point 21L.B.201;

(b) demonstrate compliance in accordance with point 21L.A.206;

(c) if the applicant has specified that they provided certification data on the basis of an arrangement with the owner of the type-certification data in accordance with point 21L.A.205(b)(5), demonstrate that the type-certificate holder:
1. has no technical objection to the information submitted under point 21L.A.205; and
1. has agreed to collaborate with the applicant to ensure the discharge of all the obligations for continued airworthiness of the repaired product through compliance with points 21L.A.28 and 21L.A.88;

(d) demonstrate that there are no unresolved issues from the physical inspection of the first article of that product with the repair design in the final changed configuration carried out by the Agency in accordance with point 21L.A.206(e)(3).

21L.A.209 Approval of a repair design under a privilege

(a) The approval of a repair design that it has designed may be issued by an approved design organisation without an application according to point 21L.A.205 in accordance with the scope of its privileges provided for in points (2) and (5) of point 21.A.263(c) of Annex I (Part 21) instead of the Agency, as recorded in the terms of approval.

(b) When issuing a repair approval in accordance with point (a), the design organisation shall:
1. ensure that all the substantiation data and justifications are available;
1. ensure that the compliance of the change with the type-certification basis and the applicable environmental protection requirements according to point (a) of point 21L.A.207 or point (a) of point 21L.A.208 has been demonstrated and declared in accordance with point 21L.A.206;
1. confirm that it has not found:
(i) any non-compliances with the type-certification basis or, where applicable, with the applicable environmental protection requirements, or with the certification specifications chosen;
(ii) any feature or characteristic of the repair that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested;
1. limit the approval of a repair to a type certificate to the specific configuration(s) in the type certificate to which the repair relates.

21L.A.210 Obligations of a holder of a repair design approval

The holder of a repair design approval shall:

(a) if they are not the type-certificate or supplemental type-certificate holder, and certification data has been supplied in accordance with 21L.A.205 (b)(5), establish an arrangement with the relevant holder;

(b) provide to the organisation performing the repair all the necessary instructions to install or embody the repair design;

(c) support any production organisation producing parts for the repair design, and ensure that those parts are produced using production data that is based upon the design data that is provided by the repair design approval holder;

(d) ensure that the repair design includes all the necessary instructions and limitations, if a repair design is approved subject to limitations. These instructions and limitations shall be transmitted to the operator by the holder of the repair design approval in accordance with a procedure agreed with the Agency;

(e) undertake the obligations of a repair design approval holder of Subpart A of this Annex.

21L.A.211 Unrepaired damage

Damage to a product, the design of which has been approved in accordance with Section B, may not require a repair design if an evaluation of the airworthiness consequences justifies it. Such an evaluation is to be made by either the Agency or by a design organisation which is appropriately approved in accordance with Subpart J of Section A of Annex I (Part 21), under a procedure accepted by the Agency. If the evaluation concludes that the unrepaired damage requires limitations, those shall be processed in accordance with point (d) of point 21L.A.210.

SUBPART N – DESIGN OF REPAIRS TO AIRCRAFT FOR WHICH DESIGN COMPLIANCE HAS BEEN DECLARED

21L.A.221 Scope

This Subpart establishes:

(a) the procedure for declaring the compliance of repair designs to an aircraft which was subject to a declaration made in accordance with Subpart C of this Annex;

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

21L.A.222 Standard repairs

(a) Standard repairs are repair designs to an aircraft which was subject to a declaration made in accordance with Subpart C of this Annex and which:
1. follow the design data included in the certification specifications issued by the Agency, containing the acceptable methods, techniques and practices for carrying out and identifying standard repairs, including the associated instructions for continued airworthiness; and
1. are not in conflict with the design data covered by the declaration of aircraft design compliance made in accordance with Subpart C of this Annex.

(b) Points 21L.A.223 to 21L.A.229 are not applicable to standard repairs.

21L.A.223 Classification of repair designs to an aircraft for which design compliance has been declared

(a) Repair designs to an aircraft which was subject to a declaration made in accordance with Subpart C of this Annex shall be classified as either a major or minor, using the criteria laid down in points (b) and (c) of 21L.A.203.

(b) The design compliance of a minor repair design shall be declared in accordance with point 21L.A.225.

21L.A.224 Eligibility

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

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

(c) By derogation from point (b), if the declarant who made a declaration of aircraft design compliance in accordance with Subpart C of this Annex is no longer active or is unresponsive to requests for repair designs, the compliance of a changed aircraft design may also be declared in accordance with Subpart C of this Annex by a design organisation approved in accordance with point (c)(2) of point 21.A.263 of Annex I (Part 21) within the scope of their terms of approval, or by any other natural or legal person who is able to undertake the obligations laid down in point 21L.A.47 with respect to that changed aircraft.

21L.A.225 Declaration of design compliance for minor repair designs

(a) Prior to incorporating or embodying or agreeing with a production organisation to incorporate or embody a minor repair design to an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex, the declarant or the organisation that has designed the minor repair shall declare that the minor repair design complies with the detailed technical specifications and the applicable environmental protection requirements with which compliance had been declared according to point 21L.A.43.

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

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

21L.A.226 Declaration of design compliance of major repair designs

(a) Prior to incorporating or embodying or agreeing with a production organisation to incorporate or embody a major repair design to an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex, the declarant shall declare that the design of the major repair complies with the detailed technical specifications and the applicable environmental protection requirements with which compliance had been declared according to point 21L.A.43.

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

(c) The declaration shall contain at least the following information:
1. the name of the person submitting the declaration, and their address/place of business;
1. the declaration reference number of the aircraft to which the major repair design relates;
1. a unique reference for identifying the major repair design;
1. indication of the detailed technical specifications and the applicable environmental protection requirements with which the compliance of the aircraft had been declared by the declarant according to point 21L.A.43;
1. a signed statement made under the sole responsibility of the person making the declaration that the design of the major repair is in compliance with the detailed technical specifications and the applicable environmental protection requirements referred to in point (4), according to the compliance demonstration plan referred to in point (d)(3);
1. a signed statement made under the sole responsibility of the person making the declaration that no features or characteristics have been identified by that person that may make the aircraft unsafe or environmentally incompatible for the intended use;
1. a description of the damage and the repair design identifying the configuration of the type design upon which the repair is made;
1. identification of all the areas of the type design and the approved manuals that are changed or affected by the repair design.

(d) The declarant that designs a major repair shall submit the declaration referred to in point (c) to the Agency. Together with this declaration, the declarant shall provide to the Agency:
1. a description of the major repair;
1. basic data about the major repair, including the operating characteristics, design features and any limitations;
1. a compliance demonstration plan detailing the means for compliance demonstration that was followed during the compliance demonstration;
1. recorded justifications of compliance within compliance data obtained from the compliance activities that have been conducted according to the compliance demonstration plan;
1. the means by which compliance with the detailed technical specifications and the applicable environmental protection requirements with which the declarant had declared that aircraft compliance according to point 21L.A.43 has been demonstrated;
1. where compliance is demonstrated by carrying out tests, a recorded justification of the conformity of the test articles and equipment, demonstrating:
(i) for the test specimen, that:
(A) the materials and processes adequately conformed to the specifications for the design;
(B) the constituent parts of the products adequately conformed to the drawings in the design; and
(C) the manufacturing processes, construction and assembly adequately conformed to those specified in the design;
(ii) that the test and measuring equipment used for the tests were adequate for the tests and appropriately calibrated;
1. reports, results of inspections or tests that the declarant found necessary to determine that the aircraft complies with the detailed technical specifications and the applicable environmental protection requirements.

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

21L.A.227 Compliance activities for declaring compliance of a major repair design

Prior to making a declaration of compliance in accordance with point 21L.A.226, the declarant shall, for that specific design:

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

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

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

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

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

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

21L.A.228 Obligations of the declarant of a declaration of design compliance of a repair design

The declarant of a declaration of design compliance shall:

(a) for minor repair designs maintain a register of those declarations and shall make those declarations available to the Agency upon request;

(b) provide to the organisation performing the repair all the necessary instructions to install or embody the repair design;

(c) support any production organisation producing parts for the repair design, and ensure that those parts are produced using production data that is based upon the design data that is provided by the declarant;

(d) if a repair design is declared subject to limitations, transmit these limitations to the operator using a documented procedure that is made available to the Agency upon request;

(e) undertake the obligations of a declarant of design compliance of a repair design of Subpart A of this Annex.

21L.A.229 Unrepaired damage

The declarant of design compliance of an aircraft in accordance with Subpart C of this Annex or an approved design organisation with privileges provided in accordance with point (c)(3) of point 21.A.263 of Annex I (Part 21) and with the appropriate scope of approval shall conduct an evaluation of the airworthiness and environmental compatibility consequences of any damage to such aircraft that is left unrepaired and that is not covered by previously declared data. Any necessary limitations shall be processed in accordance with point (d) of point 21L.A.228.

SUBPART O – EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS

(Reserved)

SUBPART P – PERMIT TO FLY

21L.A.241 Permit to fly and flight conditions

(a) The procedures for applying for the issuance of permits to fly and related flight conditions for aircraft within the scope of this Annex shall be those established in Subpart P of Section A of Annex I (Part 21) and those established in points (b) and (c) of point 21L.A.241.

(b) When applying for a permit to fly in accordance with point 21.A.707 of Annex I (Part 21), the applicant shall arrange for the competent authority to conduct a conformity inspection of the aircraft when the application for a permit to fly relates to:
1. the demonstration of compliance activities in point 21L.A.25 for an aircraft which is, or is intended to be, type-certified;
1. the demonstration of compliance activities in point 21L.A.44 for an aircraft for which design compliance is, or is intended to be, declared.

(c) When applying for flight conditions in accordance with point 21.A.709 of Annex I (Part 21), the applicant shall arrange for the Agency:
1. to physically inspect and assess the aircraft if the flight conditions are related to the demonstration of compliance to support a declaration of design compliance in point 21L.A.44 and if requested by the Agency during the demonstration of compliance activities as referred to in point (b) of point 21L.B.121 and point (c) of point 21L.B.203; or
1. to physically inspect and assess the aircraft and to conduct a critical design review if the flight conditions are related to the demonstration of compliance associated with the certification of the design in point 21L.A.25 and if requested by the Agency in point 21L.B.83, point 21L.B.102 and point 21L.B.203.

SUBPART Q – IDENTIFICATION OF PRODUCTS AND PARTS

21L.A.251 Scope

This Subpart establishes the requirements for the identification of products and parts designed and produced under this Annex.

21L.A.252 Design of markings

(a) The holder of a type certificate, supplemental type certificate, approval of a change to type certificate or approval of a repair design, or the declarant of a declaration of design compliance shall specify in the design data the marking of products and parts designed in accordance with this Annex.

(b) The specifications of the marking shall include the following information:
1. for products:
(i) the name of the production organisation;
(ii) the product designation;
(iii) the serial number of the product;
(iv) any other information appropriate to identify the product;
1. for parts:
(i) a name, trademark, or symbol identifying the production organisation;
(ii) the part number;
(iii) the serial number, in cases where a part to be fitted on a product has been identified as a critical part.

(c) The specification of parts in accordance with point (ii) of point (b)(2) shall include the letter ‘(R)’ at the end of the part number when:
1. the part is from a design subject to a declaration of design compliance in accordance with Subpart C of this Annex;
1. the part is to be released on an EASA Form 1 in accordance with point (a) of point 21L.A.193; and
1. the part has been produced in accordance with Subpart R of this Annex.

21L.A.253 Identification of products

(a) Any natural or legal person who produces products under Subpart G of Section A of Annex I (Part 21) or under Subpart G or R of this Annex for which the design has been approved or declared in accordance with this Annex shall identify that product as specified in accordance with 21L.A.252 by means of a fireproof marking on a fireproof plate.

(b) The identification plate shall be secured in such a manner that it is accessible and legible, and will not likely be defaced or removed during normal service, or lost or destroyed in an accident, and in the case of a propeller, propeller blade, or propeller hub, placed on a non-critical surface of the item.

(c) For manned balloons, the identification plate shall be secured to the balloon envelope and shall be located, if practicable, where it is legible to the operator when the balloon is inflated. In addition, the basket, load frame assembly and any heater assembly shall be permanently and legibly marked with the name of the production organisation, part number, or its equivalent, and the serial number, or its equivalent.

21L.A.254 Handling of identification data

(a) Any natural or legal person performing maintenance work in accordance with Regulation (EU) No 1321/2014 may, in accordance with methods, techniques and practices established by the Agency:
1. remove, change, or place the identification information referred to in point 21L.A.253; or
1. remove or install an identification plate referred to in point 21L.A.253, when necessary during maintenance operations.

(b) Unless for the purposes stated in point (a) of point 21L.A.254, no person shall remove, change, or place the identification information referred to in point (a) of point 21L.A.253.

(c) Unless for the purposes stated in point (a) of point 21L.A.254, no person shall remove or install any identification plate referred to in point (a) of point 21L.A.253.

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

21L.A.255 Identification of parts

Any natural or legal person who produces parts under Subpart G of Section A of Annex I (Part 21) or under Subpart G or R of this Annex for a product for which the design has been approved or declared in accordance with this Annex shall permanently and legibly mark that part as specified in accordance with point 21L.A.252.

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

21L.A.271 Scope

This Subpart establishes the procedures for the issuance of statements of conformity for aircraft (EASA Form 52B) and authorised release certificates (EASA Form 1) for engines and propellers, or parts thereof, that have been produced in conformity with the design data of a declaration of design compliance, and the rights and obligations of the declarant.

21L.A.272 Eligibility

Any natural or legal person who is granted access to the applicable design data and is able to undertake the obligations stated in point 21L.A.275 may issue a statement of conformity (EASA Form 52B) for an aircraft or an authorised release certificate (EASA Form 1) for an engine or propeller, or a part thereof, under the conditions laid down in this Subpart.

21L.A.273 Production control system

A natural or legal person issuing a statement of conformity (EASA Form 52B) or an authorised release certificate (EASA Form 1) with the applicable declared design data of an aircraft, engine or propeller, or a part thereof, that they have produced, shall establish, implement and maintain a system for controlling production that:

(a) includes processes and procedures that ensure that the aircraft, engine or propeller, and any part thereof, conforms with the applicable declared design data;

(b) ensures that each statement of conformity (EASA Form 52B) or authorised release certificate (EASA Form 1) is only signed by authorised persons;

(c) if flight tests are necessary within the scope of production, has processes in place that ensure that any flight tests are conducted in a safe manner;

(d) ensures that the natural or legal person is in receipt of all the necessary airworthiness and environmental compatibility data to determine conformity;

(e) has procedures in place that ensure that the airworthiness and environmental compatibility data is correctly incorporated in its production data, kept up to date and made available to all the personnel who need access to such data to perform their duties;

(f) includes an inspection system that ensures that any aircraft, engine or propeller, and any part thereof, that are produced by the natural or legal person including their partners, or are supplied from or subcontracted to outside parties, conform with the applicable declared design data and are in a condition for safe operation;

(g) includes an archiving system that records the requirements that have been placed on other organisations such as suppliers and subcontractors. The archived data shall be made available to the competent authority for continuing airworthiness purposes;

(h) ensures that the maintenance of a newly manufactured aircraft is conducted in accordance with the applicable maintenance instructions and that the aircraft is kept in an airworthy condition, and if applicable, a certificate of release to service is issued for any maintenance that has been completed;

(i) includes an internal occurrence reporting system in the interest of safety, to enable the collection and assessment of the occurrence reports collected in accordance with point 21L.A.3 in order to identify adverse trends or to address deficiencies, and to extract reportable occurrences. This system shall include the evaluation of relevant information relating to occurrences and the promulgation of the related information.

21L.A.274 Issuance of a statement of conformity (EASA Form 52B) or an authorised release certificate (EASA Form 1)

(a) When issuing a statement of conformity (EASA Form 52B) or an authorised release certificate (EASA Form 1), the natural or legal person shall include all of the following:
1. a statement that the aircraft, engine or propeller, or any part thereof, conforms to the applicable declared design data and is in a condition for safe operation;
1. for each aircraft, a statement that the aircraft has been ground- and flight-checked;
1. for each engine or variable pitch propeller, a statement that the engine or variable pitch propeller has been subjected to a final functional test;
1. if applicable, a statement that the completed engine is in compliance with the applicable engine exhaust emissions requirements in force on the date of production of the engine.

(b) The natural or legal person shall issue a statement of conformity (EASA Form 52B) or an authorised release certificate (EASA Form 1) upon:
1. the initial transfer of the ownership of the aircraft, engine or propeller, or parts thereof; or
1. for aircraft, the application for the issue of the restricted certificate of airworthiness for the aircraft.

21L.A.275 Obligations of a natural or legal person issuing a statement of conformity (EASA Form 52B) or an authorised release certificate (EASA Form 1)

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

(a) inform the competent authority that they intend to produce an aircraft, engine or propeller, or a part thereof, in conformity with the design data of a declaration of design compliance and that they will issue statements of conformity (EASA Form 52B) or authorised release certificates (EASA Form 1) in accordance with this Subpart;

(b) ensure that the details of any completed work are recorded;

(c) maintain, at the place of production, the technical data and drawings necessary to determine whether the aircraft, engine or propeller, or a part thereof, conforms to the applicable declared design data;

(d) provide continuing airworthiness support to the declarant of a declaration of design compliance for any aircraft, engine or propeller, or a part thereof, that they have produced;

(e) for new aircraft that they have produced, ensure that the aircraft is kept in an airworthy condition and that maintenance is performed, unless Regulation (EU) No 1321/2014 requires the maintenance to be performed under such rules, including any necessary repairs in accordance with the applicable design data prior to the issuance of an aircraft statement of conformity (EASA Form 52B);

(f) when issuing a certificate of release to service after such maintenance, determine that each completed aircraft has been subjected to the necessary maintenance and is in a condition for safe operation, prior to issuing the certificate;

(g) undertake the obligations of a natural or legal person issuing statements of conformity (EASA Form 52B) or authorised release certificates (EASA Form 1) of Subpart A of this Annex;

(h) inform the competent authority about the cessation of their activities under this Subpart.

SECTION B

PROCEDURES FOR COMPETENT AUTHORITIES

SUBPART A – GENERAL PROVISIONS

21L.B.11 Oversight documentation

The competent authority shall provide all the legislative acts, standards, rules, technical publications, and related documents to the relevant personnel in order to allow them to perform their tasks and to discharge their responsibilities.

21L.B.12 Exchange of information

(a) The competent authority of the Member State and the Agency shall share the information available to them through their investigation conducted and oversight performed in accordance with this Section, which is relevant for the other party when performing certification, oversight or enforcement tasks under this Section.

(b) The competent authority of the Member State and the Agency shall coordinate a product-focused investigation and oversight of the design and production of products and parts under this Annex, including, where necessary, conducting joint oversight visits.

21L.B.13 Information to the Agency

(a) The competent authority of the Member State shall notify the Agency in case of any significant problems with the implementation of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, within 30 days from the manifestation of such problems.

(b) Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, the competent authority of the Member State shall provide the Agency as soon as possible with any safety-significant information stemming from the occurrence reports stored in the national database as specified in Article 6(6) of Regulation (EU) No 376/2014.

21L.B.14 Airworthiness directives received from non-Member States

When the 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.

21L.B.15 Immediate reaction to a safety problem

(a) Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, the competent authority of the Member State shall implement a system to appropriately collect, analyse, and disseminate safety information.

(b) The Agency shall implement a system to appropriately analyse any relevant safety information received, and without undue delay, provide Member States and the Commission with any information, including recommendations or corrective actions to be taken, that is necessary for them to react in a timely manner to a safety problem involving products, parts, persons or organisations that are subject to Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof.

(c) Upon receiving the information referred to in points (a) and (b), the competent authority of the Member State shall take adequate measures to address the safety problem.

(d) Measures taken under point (c) of point 21L.B.15 shall immediately be notified to all persons or organisations that need to comply with them under Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof. The competent authority of the Member State shall also notify those measures to the Agency and, when combined action is required, to the other Member States concerned.

21L.B.16 Management system

(a) The competent authority shall establish and maintain a management system, including as a minimum:
1. documented policies and procedures to describe its organisation, means and methods to achieve compliance with Regulation (EU) 2018/1139 and Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof. The procedures shall be kept up to date, and serve as the basic working documents within that competent authority for all related tasks;
1. a sufficient number of personnel to perform its tasks and discharge its responsibilities. A system shall be in place to plan the availability of personnel, in order to ensure the proper completion of all tasks;
1. personnel who are qualified to perform their allocated tasks and who have the necessary knowledge, experience, initial and recurrent training to ensure continuing competency;
1. adequate facilities and office accommodation to perform the allocated tasks;
1. a function to monitor the compliance of the management system with the relevant requirements, and the adequacy of the procedures, including the establishment of an internal audit process, and a safety risk management process. The compliance monitoring function shall include a system to provide feedback about audit findings to the senior management of the competent authority to ensure the implementation of corrective actions as necessary;
1. a person or group of persons having a responsibility to the senior management of the competent authority for the compliance monitoring function.

(b) The competent authority shall, for each field of activity, including the management system, appoint one or more persons with the overall responsibility for the management of the relevant task(s).

(c) The competent authority shall establish procedures for participation in a mutual exchange of all the necessary information with any other competent authorities concerned and provide them with assistance, whether from within the Member State or in other Member States, including on:
1. all the findings raised and any follow-up actions taken as a result of the oversight of persons and organisations that carry out activities in the territory of a Member State, but certified by the competent authority of another Member State, or by the Agency;
1. any information stemming from mandatory and voluntary occurrence reporting as required by point 21L.A.3.

(d) A copy of the procedures related to the management system of the competent authority of the Member State and any amendments to those procedures shall be made available to the Agency for the purpose of standardisation.

21L.B.17 Allocation of tasks to qualified entities

(a) A competent authority may allocate the tasks related to the initial certification or to the continuing oversight of products and parts, and of natural or legal persons subject to Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, to qualified entities. When allocating tasks, the competent authority shall ensure that it has:
1. put a system in place to initially and continuously assess whether the qualified entity complies with Annex VI ‘Essential requirements for qualified entities’ to Regulation (EU) 2018/1139. This system and the results of the assessments shall be documented;
1. established a documented agreement with the qualified entity, approved by both parties at the appropriate management level, which defines:
(i) the tasks to be performed;
(ii) the declarations, reports, and records to be provided;
(iii) the technical conditions to be met in performing such tasks;
(iv) the related liability coverage;
(v) the protection given to the information acquired in carrying out such tasks.

(b) The competent authority shall ensure that the internal audit process and the safety risk management process required by point (a)(5) of point 21L.B.16 cover all the certification and continuing oversight tasks performed on its behalf by the qualified entity.

21L.B.18 Changes in the management system

(a) The competent authority shall have a system in place to identify changes that affect its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU) 2018/1139 and Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof. This system shall enable it to take the action necessary to ensure that its management system remains adequate and effective.

(b) The competent authority shall update its management system to reflect any change to Regulation (EU) 2018/1139 and Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof in a timely manner, so as to ensure its effective implementation.

(c) The competent authority of the Member State shall notify the Agency of any changes affecting its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU) 2018/1139 and Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof.

21L.B.19 Resolution of disputes

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

21L.B.20 Record-keeping

(a) The competent authority shall establish a system of record-keeping that allows the adequate storage, accessibility, and reliable traceability of:
1. the management system’s documented policies and procedures;
1. the training, qualifications, and authorisation of its personnel;
1. the allocation of tasks covering the elements required by point 21L.B.17, as well as the details of the tasks allocated;
1. certification processes and the continuing oversight of certified and declared organisations, including:
(i) applications for a certificate;
(ii) declarations of capability;
(iii) declarations of design compliance;
(iv) the competent authority’s continuing oversight programme, including all assessments, audits and inspection records;
(v) the certificates issued, including any changes to them;
(vi) a copy of the oversight programme listing the dates when audits are due and when audits were carried out;
(vii) copies of all formal correspondence;
(viii) recommendations for the issue or continuation of a certificate or continuation of the registration of a declaration, details of findings, and actions taken by organisations to close these, including the date of closure of each item, enforcement actions, and observations;
(ix) any assessment, audit or inspection report issued by another competent authority;
(x) copies of all organisation handbooks, procedures and processes or manuals and amendments to them;
(xi) copies of any other documents approved by the competent authority;
1. statements of conformity of aircraft (EASA Form 52B) or authorised release certificates (EASA Form 1) for engines, propellers or parts that it has inspected according to Subpart R of this Annex.

(b) The competent authority of the Member State shall include in the record-keeping:
1. the evaluation and notification to the Agency of any alternative means of compliance proposed by organisations, and the assessment of any alternative means of compliance used by the competent authority itself;
1. safety information in accordance with point 21L.B.13 and follow-up measures;
1. the use of safeguard and flexibility provisions in accordance with Articles 71(1) and 76(4) of Regulation (EU) 2018/1139.

(c) The competent authority shall maintain a list of all the certificates that it has issued and any declarations that it has registered.

(d) All the records referred to in points (a), (b) and (c) shall be kept for a minimum period of 5 years, subject to the applicable data protection law.

(e) All the records referred to in points (a), (b) and (c) shall be made available upon request to the competent authorities of another Member State or the Agency.

21L.B.21 Findings and observations

(a) When the competent authority, during investigation or oversight or by any other means, detects a non-compliance with the applicable requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, of a procedure or manual required by those Regulations, or of a certificate or declaration issued in accordance with those Regulations, it shall, without prejudice to any additional action required by those Regulations, raise a finding.

(b) The competent authority shall have a system to analyse findings for their safety significance. A level 1 finding shall be issued by the competent authority when any significant non-compliance is detected which lowers safety or seriously endangers flight safety, or in the case of design organisations may lead to an uncontrolled non-compliance and to a potential unsafe condition as per point 21L.B.23; level 1 findings shall also include but not be limited to the following:
1. any failure to grant the competent authority access to the organisation’s or natural or legal person’s facilities as defined in point 21L.A.10 during normal operating hours and after two written requests;
1. providing wrong information or falsification of documentary evidence;
1. any evidence of malpractice or of fraudulent use of a certificate, declaration or statement issued in accordance with this Annex;
1. the lack of an accountable manager or head of the design organisation, as applicable. A level 2 finding shall be issued by the competent authority when any non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, of a procedure or manual required by those Regulations, or of a declaration issued in accordance with those Regulations, which is not classified as a level 1 finding.

(c) The competent authority shall communicate the finding to the organisation or the natural or legal person in writing, and request corrective action to address the non-compliance(s) identified.

(d) If there are any level 1 findings, the competent authority shall take immediate and appropriate action in accordance with point 21L.B.22, unless the finding is on a design organisation which has declared its design capabilities, in which case the Agency shall first grant the organisation a corrective action implementation period that is appropriate to the nature of the finding, which in any case shall not be more than 21 working days. The period shall commence from the date of the written communication of the finding to the organisation, requesting corrective action to address the non-compliance identified. If the level 1 finding directly relates to an aircraft, the competent authority shall inform the competent authority of the Member State in which the aircraft is registered.

(e) For level 2 findings, the competent authority shall grant the organisation or the natural or legal person a corrective action implementation period that is appropriate to the nature of the finding. The period shall commence from the date of the written communication of the finding to the organisation or the natural or legal person, requesting corrective action to address the non-compliance identified. At the end of this period, and subject to the nature of the finding, the competent authority may extend the period, provided that a corrective action plan has been agreed by the competent authority. The competent authority shall assess the corrective action and the implementation plan proposed by the organisation or the natural or legal person, and if the assessment concludes that they are sufficient to address the non-compliance(s), accept these. If an organisation or natural or legal person fails to submit an acceptable corrective action plan, or to perform the corrective action within the time period accepted or extended by the competent authority, the finding shall be raised to a level 1 finding, and action shall be taken as laid down in point (d).

(f) The competent authority may issue observations for those cases not requiring level 1 or level 2 findings:
1. for any item the performance of which has been assessed to be ineffective;
1. when it has been identified that an item has the potential to cause a non-compliance; or
1. when suggestions or improvements are of interest for the overall safety performance of the organisation. Observations issued under this point shall be communicated to the organisation or the natural or legal person in writing and recorded by the competent authority.

21L.B.22 Enforcement measures

(a) The competent authority shall:
1. suspend a certificate if the competent authority considers that there are reasonable grounds that such action is necessary to prevent a credible threat to aircraft safety;
1. issue an airworthiness directive under the conditions of point 21L.B.23;
1. suspend, revoke or limit a certificate if such action is required pursuant to point (d) of point 21L.B.21;
1. suspend or revoke a certificate of airworthiness or a restricted certificate of airworthiness when the conditions specified in point (b) of point 21L.B.163 are met;
1. suspend or revoke a noise certificate or a restricted noise certificate when the conditions specified in point (b) of point 21L.B.173 are met;
1. take immediate and appropriate action necessary to limit or prohibit the activities of an organisation or natural or legal person if the competent authority considers that there are reasonable grounds that such action is necessary to prevent a credible threat to aircraft safety;
1. limit or prohibit the activities of an organisation or a natural or legal person that have declared their capabilities to design or produce products or parts in accordance with Section A or that issue statements of conformity (EASA Form 52B) or authorised release certificates (EASA Form 1) in accordance with Subpart R of Section A of this Annex pursuant to point (d) of point 21L.B.21;
1. not register a declaration of design compliance as long as there are unresolved findings from the initial oversight investigation;
1. temporarily or permanently de-register a declaration of design compliance or a declaration of capability pursuant to point (d) of point 21L.B.21;
1. take any further enforcement measures necessary in order to ensure the termination of a non-compliance with the essential requirements set out in Annex II to Regulation (EU) 2018/1139 and with this Annex, and, where necessary, remedy the consequences thereof.

(b) Upon taking an enforcement measure in accordance with point (a), the competent authority shall notify it to the addressee, state the reasons for it, and inform the addressee of their right to appeal.

21L.B.23 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 or part installed on this aircraft; and
1. that condition is likely to exist or develop in other aircraft.

(c) An airworthiness directive shall contain at least information identifying:
1. the unsafe condition;
1. the affected aircraft;
1. the action(s) required;
1. the compliance time for the required action(s);
1. the date of entry into force.

21L.B.24 Means of compliance

(a) The Agency shall develop acceptable means of compliance (‘AMC’) that may be used to establish compliance with Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof.

(b) Alternative means of compliance may be used to establish compliance with this Regulation.

(c) Competent authorities shall inform the Agency of any alternative means of compliance used by natural or legal persons under their oversight for establishing compliance with this Regulation.

SUBPART B – TYPE CERTIFICATES

21L.B.41 Certification specifications

The Agency, in accordance with Article 76(3) of Regulation (EU) 2018/1139, shall issue certification specifications and other detailed specifications, including certification specifications for airworthiness, and environmental compatibility that competent authorities, organisations and personnel may use to demonstrate the compliance of products and parts with the relevant essential requirements set out in Annexes II, IV and V to that Regulation, as well as with those for environmental protection set out in Article 9(2) of and Annex III to that Regulation. Such specifications shall be sufficiently detailed and specific to indicate to applicants the conditions under which certificates are to be issued, amended or supplemented.

21L.B.42 Initial investigation

(a) Upon receiving an application for a type certificate under this Annex, the Agency shall verify whether the product is within the scope established in point 21L.A.21 and whether the applicant is eligible in accordance with point 21L.A.22 to apply for a type certificate for the product.

(b) When the conditions of point (a) are not fulfilled, the Agency shall reject the application.

21L.B.43 Type-certification basis for a type certificate

(a) The Agency shall establish the type-certification basis and notify it to the applicant. The type-certification basis shall consist of:
1. the certification specifications for airworthiness designated by the Agency from those applicable to the product at the date of application for that certificate, unless:
(i) the applicant chooses to comply with certification specifications which became applicable after the date of the application; if an applicant chooses to comply with a certification specification which became applicable after the date of the application, the Agency shall include in the type-certification basis any other certification specification that is directly related; or
(ii) the Agency accepts any alternative to a designated certification specification that cannot be complied with, for which compensating factors have been found that provide an equivalent level of safety; or
(iii) the Agency accepts or prescribes other means that demonstrate compliance with the essential requirements of Annex II to Regulation (EU) 2018/1139;
1. any special condition prescribed by the Agency in accordance with point 21L.B.44(a).

(b) The Agency may amend the type-certification basis at any point before the issuance of the type certificate if it has determined that experience from other similar products in service, or products that have similar design features, has shown that unsafe conditions may develop, and the type-certification basis that was established and notified to the applicant does not address this unsafe condition.

21L.B.44 Special conditions

(a) The Agency shall prescribe special detailed technical specifications, named ‘special conditions’, for a product if the related certification specifications do not contain adequate or appropriate safety standards for the product because:
1. the product has novel or unusual design features relative to the design practices on which the applicable certification specifications are based;
1. the intended use of the product is unconventional; or
1. experience from other similar products in service or products having similar design features or newly identified hazards have shown that unsafe conditions may develop.

(b) Special conditions contain such safety standards as the Agency finds necessary in order to establish a level of safety equivalent to that of the applicable certification specifications.

21L.B.45 Designation of the applicable environmental protection requirements for a type certificate

The Agency shall designate and notify to the applicant for a type certificate for an aircraft or for an engine, the applicable environmental requirements in accordance with point 21.B.85 of Annex I (Part 21).

21L.B.46 Investigation

Upon receiving an application for a type certificate under this Annex, the Agency shall:

(a) conduct a review of the initial compliance demonstration plan and any subsequent update provided by the applicant in order to establish the completeness of the plan and the appropriateness of the proposed means and methods of demonstrating compliance with the type-certification basis established in accordance with point 21L.B.43 and with the applicable environmental protection requirements designated in accordance with point 21L.B.45; if the compliance demonstration plan is incomplete or the means and methods are not appropriate to achieve compliance demonstration, the Agency shall inform the applicant and request an amendment of it;

(b) when satisfied that the compliance demonstration plan provided is appropriate so that the applicant can demonstrate compliance, approve the compliance demonstration plan and any subsequent updates of the compliance demonstration plan;

(c) after receiving the declaration of compliance in accordance with point (f) of point 21L.A.25, conduct a physical inspection and assessment of the first article of that product in the final configuration, taking into consideration the critical design review carried out in accordance with point (a) of point 21L.B.242, in order to verify the compliance of the product with the applicable type-certification basis and the applicable environmental protection requirements; the Agency shall verify the compliance of the product, considering the likelihood of an unidentified non-compliance with the type-certification basis or the applicable environmental protection requirements, and the potential impact of that non-compliance on the safety or environmental compatibility of the product;

(d) if during the establishment of the type-certification basis, designation of the applicable environmental protection requirements or during the review of the compliance demonstration plan the Agency determines that the product design contains any element for which an unidentified non-compliance with the type-certification basis or the applicable environmental protection requirements may have an adverse impact on the safety or environmental compatibility of the product, the Agency shall determine which investigations are necessary in addition to those described in point (c) in order to verify the compliance demonstration; the Agency shall notify the applicant of any additional investigations and which elements of the design would be subject to those investigations.

21L.B.47 Issuance of a type certificate

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