EASA’s regulatory role: increasing safety, environmental protection and enabling innovation via rulemaking

As a regulatory agency, EASA plays a leading role in civil aviation “Rulemaking”, the process for the development and maintenance of regulatory material.

Amendments to existing Regulations or, in some cases, even new Regulations are needed from time to time to maintain or increase the safety level:

• to promote higher environmental standards; or
• to enable a safe and sustainable integration of new technologies or other innovative concepts.

A good example of the latter is the EASA Opinion on Innovative Air Mobility, which filled a regulatory vacuum for this novelty concept. This Opinion, which was published in 2023, introduced a comprehensive set of operational requirements for piloted electric air taxis, spanning the domains of operations, flight crew licensing and rules of the air, air traffic management, initial and continuing airworthiness, and drones.

But what is an EASA Opinion, how do we get there, and what happens next? 

Overview of the rulemaking process

Let’s face it, developing regulatory materials might not be the most exciting aspect of aviation, but it is an indispensable task to ensure that aviation is safe.

Rulemaking is an elaborate process with several stages that often span several months or – most often – years. Various parties are involved, including advisory bodies, experts, affected parties, and, in many cases, the public .

It is important that EASA listens to those who have the dedicated expertise and to those who are affected. This is guaranteed, where necessary, by engaging experts, and interested and affected parties in the developing the regulatory proposals, and in all cases by consulting the regulatory proposals publicly or with a focused group of affected and interested parties. In this way citizens and aviation stakeholders can provide their views and comments and actively contribute to the process. 

It is equally important that EASA is transparent on who it engages with when developing regulatory proposals and which comments during consultation influenced the final regulatory material and how. Therefore, EASA provides this information when finalising a rulemaking process.
The final approval of the rules is the responsibility of either the European Commission (“hard law”) or EASA (“soft law”). 

Some key highlights:

• Safety is always paramount: Maintaining a high level of safety in aviation is non-negotiable for EASA. When proposing new rules or amendments thereto, EASA always guarantees that the level of safety is proven to be at least as safe as current standards. 
• New rules do not happen in a vacuum: the rationale behind each new rule or amendment is explained, the need for them is justified, impacts are assessed and the process is transparent to those who will have to apply the rules.  
   

 

Initiation of a rulemaking action 
 

The Agency’s rulemaking programme is published in the European Plan for Aviation Safety (EPAS), which is updated at least annually. Think of the EPAS as the bible of aviation safety: it identifies the main safety risks and other issues affecting the European aviation safety system and sets out the necessary actions to mitigate those risks. One of those mitigating actions may be to initiate a rulemaking task.

A rulemaking task (and any other action in EPAS) does not come out of the blue into the EPAS.  It is preceded by a thorough assessment of e.g. a safety risk, and whether and how an intervention by EASA is needed.

Once the time has come to initiate a rulemaking task as shown in the EPAS, EASA informs the public that time has come to start working on this action by issuing the Terms of Reference of the rulemaking task. This allows, for example, for stakeholders to be prepared to make their voices heard.

The Terms of Reference sets the scene for the rulemaking task: it explains the rationale (the “why”) behind the required rulemaking activity and working methods that EASA will be taken in the rulemaking process (the “how”).

In exceptional cases, a rulemaking action may be initiated even if it is not described in the latest EPAS edition. The EASA Executive Director then consults the European Commission and the EASA Advisory Bodies before initiating the action. That action is then included in the following EPAS update.

EASA will prepare a first draft of the regulatory material, when necessary, with support of external experts like the Agency’s advisory bodies, or interested or affected parties.

The draft regulatory material may include one or more of the following:

• draft regulations;
• draft acceptable means of compliance;
• draft guidance material;
• draft certification specifications;
• draft detailed specifications.

(An explanation of acceptable means of compliance, guidance material, certification specifications, and detailed specifications can be found at the end of this article). 

EASA consults every draft regulatory material in the form of a Notice of Proposed Amendments to collect views from a wider range of stakeholders and amend, if needed, the initial draft proposal accordingly, before issuing the  final regulatory material.

Depending on the subject and the regulatory domain and affected parties, EASA reaches out either to the public, or in a more focused manner to certain groups of its Advisory Bodies and/or other affected and interested parties.

Every Notice of Proposed Amendments also contains an explanatory part which describes:

• how the regulatory material was developed;
• why it was decided to regulate the issue;
• an assessment of the impacts (from a social, economic, environmental and proportionality perspective);
• an explanation on how the proposal is intended to mitigate the safety risk or to address other issues that triggered the rulemaking action.

For ‘hard law’, having considered the comments received during the consultation phase, EASA issues the final draft regulatory material in the form of an Opinion. An EASA Opinion is an official publication submitted to the European Commission, containing proposals for new regulations or for amendments thereto. It also contains an explanatory part and describes which comments EASA has received during the Notice of Proposed Amendments consultation and how those have been taken into consideration.

When EASA publishes an Opinion, the legislative process in the European Commission starts, and thus is continued outside EASA’s mandate. The European Commission will decide whether to amend or issue regulations based on the contents of the EASA Opinion. In this process the European Commission also involves the EU Member States in the form of committee or expert group hearings. Once adopted, the new or amended Regulations are published in the Official Journal of the European Union and enter into force usually after 20 days. They may, though, include a transition period by which the new requirements become applicable only later.

For “soft law”, having considered the comments received during the consultation phase, EASA issues the final regulatory material in the form of a Decision of the EASA Executive Director. Where this soft law is related to an ongoing legislative process within the Commission, e.g. for acceptable means of compliance to requirements which are introduced by the Commission in a Regulation, as described above, EASA will only issue its Decision once the new or amended Regulations are adopted and published in the Official Journal of the EU. EASA’s decision on “soft law (are published on the Official Publication of EASA (ie. the EASA website).