Commission Regulation (EC) 1702/2003 - Initial Airworthiness - FAQ

1. Can manufacturers of raw materials obtain a Production Organisation Approval (POA) under Part 21 Subpart G? (19/11/2004)

The Agency has concluded after a thorough review that the current Basic Regulation and Part 21 do not provide for the approval of manufacturers of raw materials. Only organisations responsible for the manufacturing and subsequent release of a 'product' and 'parts and appliances' as defined in the Basic Regulation (No 1592/2002) article 3 (c) and (d) are required to hold a POA and are therefore eligible to apply for such an approval. ED Decision 2007/012/R introduced an amendment to AMC/GM to Part-21 bringing all AMC and GM to Part 21 back into line with the EC Regulations regarding this issue and thus removing any ambiguity.

2. Design Approval: FAA Supplementary Type Certificates (STC) approved by National Aviation Authorities (NAAs) before 28-09-03 are deemed to be approved by EASA. If the NAA has limited the approval in scope compared to the original FAA STC such that it does not cover all the models, how can we apply for an extension of the scope?

Because Agency ED Decision 2004/04/CF automatically approves minor changes and major level 2 changes to FAA STCs when made by the STC holder on his own STC, the scope of the EASA STC is considered to be the same as the scope of the original FAA STC. Therefore there is no need for an application and the STC can be applied to all models listed on the FAA STC.

3. Should parts fabricated under a maintenance approval (Part 145) be marked with an EPA (European Part Approval) marking in accordance with Part 21A.804(a)(3)?

A Part 145 approved organisation can only fabricate parts for its own use in accordance with approved design data (145.A.42(c)). If that data comes from the Type Certificate holder; 21A.804(a)(3) would not be applicable and those parts will not need EPA marking. If the data comes from a Supplemental Type Certificate holder, minor change approval holder or repair approval holder, the parts will have to be marked as prescribed in the applicable data which should include an EPA marking since 28/3/2004.

4. What is the mandate of the Agency for Environmental issues? What does the Agency concretely do?

Article 6 of the Basic Regulation transposes into Community law the International standards of the International Civil Aviation Organisation (ICAO) related to the environmental certification of aeronautical products. The Agency is involved, together with the Commission, in the further development of such standards to ensure that they do take into account Community objectives in this field. Another important task of the Agency is to verify that the design of products comply with environmental requirements. The Agency shall therefore establish and notify the appropriate environmental requirements for each product for which environmental certification is required and issue the appropriate environmental certificates.

Such powers are established by articles 20(d) and (h) respectively of the Basic regulation and further detailed in Part 21.A.18 "Designation of applicable environmental protection requirements and certification specifications" of Commission Regulation (EC) No 1702/2003

5. Can "Field Loadable Software" be delivered with an EASA Form 1 and is an EASA Form 1 required for installation?

First of all it should be clear that the definition of "parts and appliances" (Refer to article 3 of Regulation (EC) No 216/2008 of 20 February 2008) includes software. This is software that is installed in an aircraft and used in operating or controlling that aircraft. The rest of this response only refers to this type of software.

Secondly, "Subpart K - Parts and appliances" from Part-21 addressing installation, approval and release is applicable to this software and therefore:

  1. this software must be part of the design data; and
  2. the installation of this software in a type-certified aircraft is only accepted when it is accompanied by an EASA Form 1 and properly marked; and
  3. the installation is approved. (Refer to 21A.303).

In order to achieve 1) and 2), the organisation that manufactures and releases the software must meet the requirements of Subpart F or G from Part-21. This means in particular that the software must be part of the scope of that production organisation and there must be a link between the design organisation and the production organisation.

The conclusion for Field Loadable Software is therefore that this software can be delivered with an EASA Form 1 when:

  • it is part of design data for which approval has been applied or granted; and.
  • it is produced by, and within the scope of a production organisation that meets the requirements of Subpart F or G.

Marking of this Field Loadable Software must be in accordance with Subpart Q of Part-21. For practical reasons the marking could be on the software "container" (e.g. the CD carrying the software).

6. What is the definition of "Critical parts"?

The term "critical part" or "critical component" is used in various EASA requirements, certification specifications and also in the EU-US bilateral, however it is not always defined.
A general definition does not exist. There are currently basically three different definitions:

  • for rotorcraft:
    CS 27-29-VLR.602(a): A critical part is a part, the failure of which could have a catastrophic effect upon the rotorcraft, and for which critical characteristics have been identified which must be controlled to ensure the required level of integrity.

  • for engines, propellers and APUs:
    CS-E.510(c) It is recognised that the probability of Primary Failures of certain single elements cannot be sensibly estimated in numerical terms. If the Failure of such elements is likely to result in Hazardous Engine Effects, reliance must be placed on meeting the prescribed integrity specifications of CS-E 515 (Engine critical parts) in order to support the objective of an Extremely Remote probability of Failure.
    (similar for CS-P.150(c) and CS-P.160 and also for CS-APU.210(c) and CS-APU.150)

  • in the EU-US bilateral:
    A "Critical component" means a part identified as critical by the design approval holder during the product type validation process, or otherwise by the exporting authority. Typically, such components include parts for which a replacement time, inspection interval, or related procedure is specified in the Airworthiness Limitations section or certification maintenance requirements of the manufacturer's maintenance manual or Instructions for Continued Airworthiness.

Each of the above definitions should be used only within their own context and for their own purpose i.e. the definition of the bilateral is only relevant for the automatic acceptance of PMA parts and repair design from the US. Where the term "critical part" is not defined the dictionary meaning of "critical" should be used i.e. crucial, decisive, important, etc.
For the application of Part 21A.805 critical parts are those identified as such by the design approval holder, which for rotorcraft, engines, propellers and APUs as a minimum should be those using the definitions of the relevant CS.