De-Mystifying the EASA Regulatory Environment

Sofema Aviation Services provides clarification regarding the various terms used to describe the European Aviation Safety Agency (EASA) rulemaking.

Introduction – Here’s a quick self-check!

Can you explain the difference between a “Decision” and an “Opinion”? (If like many of Sofema delegates you are not so sure, then you are in good company :) )

Here we take a look at some of the common terms and explain what are the differences.

Can EASA Interpret EU Law?

EASA is not the competent authority to interpret EU Law. The responsibility to interpret EU Law rests with the judicial system, and ultimately with the European Court of Justice. EASA cannot even provide an ‘authentic interpretation’ (which is an official interpretation of a statute issued by the statute’s legislator).

The Regulatory Journey

Rulemaking means the development and issuing of rules for the implementation of the Basic Regulation.

‘Rules’ comprises the following:

Opinions on the scope and content of the Basic Regulation and its implementing rules, consisting of a draft regulation and an explanatory memorandum, Certification Specifications (CSs), Acceptable Means of Compliance (AMC), Guidance Material (GM).

Step 1 – EASA issues a Terms of Reference – for a rulemaking task (RMT) and works towards the creation of a Notice of Proposed Amendment (NPA). The NPA is created following the work of a rulemaking group with the participation of experienced members from industry and civil aviation authorities whose task was the development of this Notice of Proposed Amendment (NPA).

Consideration is given to the Regulatory Impact related to the proposed change. The Regulatory Impact Assessment (RIA) shall be conducted based on the principle of proportionate analysis: in-depth analysis to be performed for rulemaking projects with expected high impact, and light analysis for rulemaking projects with expected lower impact.

Step 2 – EASA Issues a Notice of Proposed Amendment (NPA) and invites comments via a “Comment Response Tool”.

Following the closing of the NPA public consultation period, the Agency will review all comments and perform a focussed consultation which will consist of a workshop.

The outcome of the NPA public consultation will be reflected in the respective Comment-Response Document (CRD).

Step 3 – EASA Issues an “Opinion”. The Opinions which are essentially rulemaking recommendations that are then evaluated by the European Commission through a process which is known as Comitology and through which updated “Implementing Rules” are issued as “Hard Law” (Hard Law is considered as legally binding within EU Countries).

Comitology refers to the set of procedures through which the European Commission exercises the implementing powers conferred on it by the EU legislator, with the assistance of committees of representatives from EU countries.

Such comitology committees are chaired by a Commission official and give an opinion on implementing acts proposed by the Commission.

Step 4 – EASA publishes the Comment Response Document which typically includes a “Decision” regarding the format & structure of the supporting information issued as a draft AMC and Guidance Material (GM).

Note – The AMC & GM can only be formally issued once the associated IR is issued.

Q: What are Implementing Rules?

Implementing Rules are binding in their entirety and used to specify a high and uniform level of safety and uniform conformity and compliance. They detail how to comply with the essential requirements of the Basic Regulation and regulate the subject matters included in its scope.

The IRs are adopted by the European Commission in the form of Regulations.

Note – EU law is directly applicable (full part of Member States’ legal order).

Q: What are the Differences between an Implementing Act and a Delegated Act?

Implementing Acts – Primary responsibility for implementing EU law lies with EU countries. However, in areas where uniform conditions for implementation are needed, the Commission (or exceptionally the Council) adopts an implementing act.

Delegated Acts – The Commission adopts them on the basis of a delegation granted in the text of an EU law, in this case, a legislative act. The delegated act cannot change the essential elements of the law, the legislative act must define the objectives, content, scope, and duration of the delegation of power.

Note 1 – Parliament and Council may revoke the delegation or express objections to the delegated act.

Note 2 – No delegated acts are yet adopted under the EASA Basic Regulation since these two different types of implementing rules were only introduced by the latest Basic Regulation (2018/1139). It is also important to highlight that this difference in procedure for the adoption of DA and IA at Commission level does not affect the EASA rulemaking procedure, which will remain the same regardless of the type of act that will, in the end, be adopted.

Q: What are Certification Specifications?

CS Specification may be considered as equivalent to AMC in respect of Part 21 (Design & Manufacture) and are often “harmonised” with FAA Federal Airworthiness Requirements (FAR).

Certification Specifications (CS) are non-binding technical standards adopted by EASA to meet the essential requirements of the Basic Regulation. CSs are used to establish the certification basis (CB).

Q: What is the Role of AMC’s & Guidance Material?

Acceptable Means of Compliance (AMC) are non-binding. They are also known as “Soft Law” because the responsibility to ensure compliance sits with the National Competent Authority (who have the ability to vary the requirement – see ALTMoC below.

The AMC serves as a means by which the requirements contained in the Basic Regulation and the IRs can be met. The AMC illustrate a means, but not the only means, by which a requirement of an implementing rule can be met.

Satisfactory demonstration of compliance using a published AMC shall provide for a presumption of compliance with the related requirement; it is a way to facilitate certification tasks for the applicant and the competent authority.

However, NAAs and organisations may decide to show compliance with the requirements using other means. Both NAAs and the organisations may propose alternative means of compliance (AltMoCs). ‘Alternative Means of Compliance’ are those that propose an alternative to an existing AMC.

Note 1 – Those AltMoC proposals must be accompanied by evidence of their ability to meet the intent of the IR.

Note 2 – Use of an existing AMC gives the user the benefit of compliance with the IR.

Guidance Material (GM) is a non-binding explanatory and interpretation material on how to achieve the requirements contained in the Basic Regulation, the IRs, the AMCs, and the CSs. It contains information, including examples, to assist the user in the correct understanding and application of the Basic Regulation, its IRs, AMCs, and the CSs.

Sofema Aviation Services (SAS) and SofemaOnline (SOL) are pleased to offer a range of EASA compliant regulatory training courses in support of Multiple Regulatory Compliance and Competence Development.

For details please see: www.sassofia.com, www.sofemaonline.com or email: office@sassofia.com or online@sassofia.com.

Tags:

Acceptable Means of Compliance, aviation, Basic Regulation, EASA, EASA Regulatory Environment, Regulatory Compliance