Explanatory Memorandum to COM(2015)613 - Common rules in the field of civil aviation and establishing a EU Aviation Safety Agency

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1. CONTEXT OF THE PROPOSAL

Reasons for and objectives of the proposal

This initiative is part of the 2015 European Commission’s Aviation Strategy to Enhance the Competitiveness of the EU Aviation Sector. Its objective is to prepare the EU aviation safety regulatory framework for the challenges of the next ten to fifteen years and thus to continue to ensure safe, secure and environmentally friendly air transport for passengers and the general public. This initiative builds on over twelve years of experience in the implementation of Regulation (EC) No 216/2008 1 and its predecessor 2 .

Safety and consideration for environmental protection are pre-requisites for a competitive aviation sector. With the aviation traffic in Europe predicted to reach 14.4 million flights in 2035 (50% more than in 2012), the Commission's objective is to make sure that the system continues to maintain the current low number of accidents, allowing the EU aviation sector to safely grow in the future and thus to contribute to its competitive edge. For this purpose the present initiative proposes to introduce a risk and performance based approach to safety regulation, close existing safety gaps, and better take into account interdependencies between aviation safety and other technical domains of regulation such as aviation security or environmental protection.

While aviation safety is the principal objective of this proposal, it is not the only one. This proposal must also be seen in the context of the Commission priorities of fostering jobs and growth, developing the internal market and strengthening Europe's role as a global actor. This initiative aims at contributing to a competitive European aviation industry and aeronautical manufacturing which generates high value-jobs and drives technological innovation. It will create an effective regulatory framework for the integration of new business models and emerging technologies. In particular this initiative proposes to create a Union framework for safe integration of unmanned aircraft into the European airspace.

This proposal also responds to the calls from the Member States, industry and airspace users for a more proportionate and flexible approach to safety regulation and to eliminate rules which can stifle entrepreneurship with too prescriptive requirements. It notably proposes to introduce a scalable framework which recognises the differences existing between the various sectors of civil aviation and the risks involved therein. This approach is expected to benefit the whole aviation sector in the Union and will be particularly suited to the needs of small and medium sized enterprises (SMEs).

With the transition to a risk and performance based approach to regulation and oversight, Member States and the European Union Aviation Safety Agency (EASA) will need to develop new skills and competences, as well as to be continuously abreast with the latest technologies developed by the industry. This initiative supports the achievement of these objectives by proposing better arrangements for coordination and development of aviation research and training.

Finally the present proposal addresses the challenges that some national authorities face in maintaining and financing the resources necessary for accomplishing the required certification and oversight work. To this end the present initiative proposes a framework for pooling and sharing of technical resources between the national authorities and the European Union Aviation Safety Agency, and which includes the possibility of transferring responsibilities for implementation of Union legislation on a voluntary basis.

Consistency with existing policy provisions in the policy area

The present initiative builds on the existing Union provisions dealing with civil aviation safety as currently contained in Regulation (EC) No 216/2008.

The proposal is consistent with the 2013 Commission initiative on accelerating the implementation of the Single European Sky (SES II + initiative) 3 . When preparing the present proposal the Commission has taken into account the Commission’s proposal COM(2013)409 of 11.06.2013 and the results of the discussions so far in the European Parliament and in the Council on the proposed SES II+ amendments to Regulation (EC) No 216/2008. In order to avoid two legislative proposals related to Regulation (EC) No 216/2008 being discussed in parallel and this proposal being the more comprehensive one, the proposed SES II+ amendments to Regulation (EC) No 216/2008 have been subsumed into this new proposal, while adapting them to the new structure and drafting style of this proposal. As a result the Commission will not pursue further discussions on the proposal COM(2013)409 of 11.6.2013, which was presented as part of the SES II + initiative.

Where changes proposed by this initiative have impact on other Union legislation adopted by the European Parliament and the Council related to air transport (which is the case for accident investigation, occurrence reporting and licensing of air carriers), appropriate amendments to other Union acts are proposed to ensure consistency of approach.

Consistency with other Union policies

This initiative is linked and fully consistent with the 2014-2019 strategic objectives of the Commission with respect to the promotion of Jobs and Growth and of a Deeper and Fairer Internal Market with a Strengthened Industrial Base.

The present proposal is also consistent with the Common Approach on decentralised agencies agreed in 2012 between the Commission, the European Parliament and the Council, and aligns, where relevant, the provisions dealing with the European Union Aviation Safety Agency with the standard clauses recommended in this common approach.

The initiative also intends to make the design and operations of unmanned aircraft more consistent with the wider aviation policy framework. Unmanned aircraft will become another type of aerial vehicle to provide a range of new services in the European aviation market within the context of Regulation (EC) 1008/2008 on common rules for the operation of air services in the Community. As unmanned aircraft share the same airspace with other aircraft, the safety of their operations must remain coherent with the overall aviation safety policy. Finally, unmanned aircraft operations must also be consistent with air traffic rules as laid down in the Common Rules of the Air. 4

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

Legal basis

The proposal is based on Article 100(2) of the Treaty on the Functioning of the European Union, which is the legal basis for the adoption of Union measures relating to air transport.

Subsidiarity (for non-exclusive competence)

Pursuant to Regulations No (EC) 1592/2002 and No (EC) 216/2008, the Union has been made responsible for tasks regarding the airworthiness and environmental compatibility of aeronautical products, flight operations, aircrew licensing, aerodromes and air traffic management and air navigation services (ATM/ANS), as well as safety of third country operators. Civil aviation safety has therefore now been regulated at Union level for over a decade. This results from the fact that air transport and aeronautical production are, to a large extent, activities of transnational character which can be better addressed at Union level.

Under the present initiative a limited number of specific areas are proposed to be added to this overall Union aviation safety framework, namely unmanned aircraft, safety of ground handling services and security aspects of aircraft and aviation systems’ design, including cybersecurity.

Unmanned aircraft manufacturing has a cross-border dimension since many unmanned aircraft are bought online, are imported or at least have imported parts. Mutual recognition in the internal market is difficult to achieve in the presence of detailed and diverging national standards and rules. Also with regard to unmanned aircraft services, many operators are developing cross-border activities. For instance, infrastructure inspections, from oil rigs to rail tracks, are being organised at an international level. Even if operations have a limited scope, operators should be in a position to use the same unmanned aircraft and the same operating requirements with the same pilot at different places in the Union to develop their businesses, especially if they operate in niche markets. Large delivery companies have expressed their intentions to organise their services at European level which requires common rules. Subsidiarity applies at the level of the implementation of the common operational rules, e.g. Member State authorities will carry out local risk assessments and decide which airspace shall be open or closed to unmanned aircraft operations, and under which conditions. Most of the light unmanned aircraft operations have a local dimension and it should be for the local authorities to assess the level of risk and authorise the specific type of operation.

As regards ground handling services, the need for action at Union level is necessary given the fact that accidents related to ground handling constitute the fourth biggest accident category in the period of the last ten years, while the voluntary initiatives at Member State level have as yet not produced satisfactory results to address this risk. There are at present no safety requirements at Union level which address directly the providers of ground handling services. As ground handling is part of the overall aviation system and interlinks with other domains which are covered by Union competence (such as aerodrome and flight operations), regulating it at Union level will assure a consistent approach in all Member States. In order to ensure a proportionate approach, it is proposed that there is no need for certification of service providers as a condition to start operations. It is also the Commission’s view that the common requirements for ground handling should be based on recognised industry standards and best practices. At the same time Member States should be given the necessary regulatory tools to ensure effective oversight with respect to the providers of such services.

With respect to security aspects of aircraft and systems’ design, it has to be pointed out that the Union is already involved in some of these issues. The interaction between Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 5 and the current Regulation (EC) No 216/2008 is not always clear, however, including on the role of the European Union Aviation Safety Agency. This initiative proposes to clarify the role of the Union in this regard, taking account of the fact that these security aspects are closely linked with safety of aircraft design and flight operations, where the Union is already responsible pursuant to Regulation (EC) No 216/2008.

Proportionality

Proportionality is one of the primary objectives of the present initiative, and measures aiming at making the current regulatory framework for aviation safety more proportional are an integral element of the final package of policy measures proposed, as explained in the accompanying Impact Assessment Report (Chapter 6.6). This initiative proposes to introduce a risk based approach to the regulation of aviation safety, which should benefit the whole aviation sector and which is particularly suited to regulating small and medium sized enterprises.

Choice of the instrument

The present proposal does not change the type of instrument used. Since 2002, when Regulation (EC) No 1592/2002 was adopted, civil aviation safety in the Union has been regulated by means of regulations. The Commission sees no reason to change that.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

Ex-post evaluations/fitness checks of existing legislation

1.

Not applicable


Stakeholder consultations

Stakeholders were consulted in parallel by the Commission and by the European Aviation Safety Agency. The two consultations were complementary. In addition, the services of the Commission conducted a number of meetings with Member States and aviation stakeholders to supplement the public consultations with additional information. The summary of the results of the Commission public consultation has been published on the Europa website . The main findings of the public consultation are as follows:

– There is a strong agreement that the Union has achieved a very high level of safety. Over 90% of contributors agreed or strongly agreed with a statement that it is, at present, safe to travel by plane in the Union;

– At the same time it was recognised that, when it comes to safety, there is no place for complacency. Over 70% of Member States and industry organisations which contributed to the Commission’s on-line survey believe that the ability to identify and mitigate safety risks has to be improved;

– Beyond maintaining the current safety performance, the main concern of Member States and stakeholders is the efficiency and proportionality of the present system. The vast majority of the organisations which contributed to the Commission’s on-line survey (82%), and in particular the SMEs, argue that existing rules are too detailed and prescriptive, and that the current safety levels could be maintained with lower compliance cost (83%). This view is largely shared by Member States;

– There is a concern amongst Member States and industry that the current way the technical resources are being used by the aviation authorities is inefficient, and that some national aviation authorities experience shortages of resources. The majority (63%) of Member States and of the organisations which submitted replies to the Commission’s on-line survey believe that some of the national aviation authorities do not have sufficient financial or human resources to carry out their oversight tasks;

– The aircraft manufacturing industry has advocated a much more active role of the Union in promoting European civil aviation safety standards internationally, including in the International Civil Aviation Organisation (ICAO), and expressed concern about long-term availability of resources at the European Aviation Safety Agency for product certification;

– 73% of organisations which contributed to the Commission’s on-line survey pointed towards possible inconsistencies, gaps and overlaps in the application of the law, in particular stemming from varying interpretations of law by Member States.

The Union social partners (representing both employers and employees) have contributed to the consultations conducted by the Commission and the European Aviation Safety Agency. The organisations representing the aviation personnel pointed in particular to the fact that the performance based approach to aviation safety should complement but not replace the current system of prescriptive regulations. Organisations representing the employees were also concerned about the future availability of resources dedicated by Member States to safety oversight and pointed to the need to pay particular attention to ensuring a high level of training and competency of staff both at the authorities and in the aviation sector at large. Organisations representing the pilots in particular expressed concerned about potential negative impact on safety stemming from certain airline employment practices and other innovative business models.

On the other hand organisations representing the employers drew the Commission's attention to differences in application of law by Member States, overregulation and inefficient use of resources dedicated to certification and oversight. Employers pointed in particular to the fact that, while the aviation industry operates freely within the internal market, oversight is still organised based on the principle of individual Member State responsibility. Level playing field, standardisation and stability in the implementation of rules are considered to be of particular importance for the employers. Some of the organisations representing employers advocated the creation of a single civil aviation authority for the Union.

The Commission largely agrees with the results of the public consultations and has reflected them in the formulation of the present proposal. The ability of the Union to identify and mitigate safety risks should be enhanced by the provisions of the proposal dealing with safety management, the European Plan for Aviation Safety, and national safety programmes. The introduction of a risk and performance based approach to regulation should allow achieving a more proportionate regulatory framework which better takes into account the differences between the different types of aviation activities and the risks involved therein. The proposed framework for pooling and sharing of resources between the national aviation authorities and the European Union Aviation Safety Agency is expected to increase the efficiency in the use of resources.

A separate public consultation was organised for unmanned aircraft, which endorsed the need for urgent action at the Union level to tap the potential of unmanned aircraft. The contribution of these technologies to jobs and growth was confirmed. The consultation confirmed the view that the full range of unmanned aircraft is ready for development and that legal and technological uncertainty impedes a swift expansion. Specific authorizations and fragmentation are a real burden. Respondents identified safety and privacy as the most important concerns which could be managed with an appropriate regulatory framework that keeps rules proportionate to risk and with a strong role for national authorities.

The current division of competence between Union and Member States regarding regulation of unmanned aircraft, which is based on a threshold of 150 kg, is generally deemed obsolete. The rules for unmanned aircraft should evolve towards an operation centric approach, where risk of a particular operation is made dependent on a range of factors. Concerning security and privacy aspects of unmanned aircraft operations, the consultation does not point to the need for new rules, but more to a better application of existing rules, with a closer collaboration between national aviation authorities and national data protection authorities.

Collection and use of expertise

The Commission has sought an Opinion from the European Aviation Safety Agency, which was delivered on 16 March 2015 . The opinion is based on over 6 000 comments submitted by Member States and stakeholders, and suggests a variety of changes to the different areas of technical regulation of aviation, including safety, security, research, environmental protection, and efficient use of resources within the European aviation safety system.

The Commission has also relied on the following expertise and advice:

1. Two studies were contracted to support the impact assessment process:

– The first study analysed the availability, efficiency of utilisation and evolution of human resources of aviation authorities, as well as the financing of the European aviation safety system (support study on resources). This study concluded that the resource to workload balance has deteriorated over the last ten years. Furthermore, according to the study, existing resources could be better allocated across the system. Shortcomings were also identified as regards qualifications of staff. The study argues that, combined, these aspects prevent aviation authorities from performing up to their potential. Finally, the study concluded that differences in working methods between national aviation authorities and differences in the way these authorities are financed impact on a level playing field within the common aviation market.

– The second study, on performance schemes and performance based approach, explored possibilities of introducing performance elements in the management of aviation safety (support study on performance). This study concluded that introducing a safety performance scheme for civil aviation is feasible, but cautioned against its rapid introduction for a number of technical reasons. With respect to a performance based approach to regulation of aviation safety, the study concluded that this approach should have a positive impact on aviation safety and innovation, but the impact of this approach can only be described qualitatively and is very much depending on the specific rules that will be converted from prescriptive to performance based. This makes it impossible to quantify upfront the benefits of a performance based approach to safety regulation in the aviation sector. This study was also subject to a peer review by industry and Member States' experts.

2. The Commission took into account recommendations of the sub-group on the future EU aviation regulatory system set up by the Management Board of the European Aviation Safety Agency, which was made up of the Directors-General of Civil Aviation of 14 EU/EFTA countries, as well as of representatives from EASA and the Commission 6 . Finally the results of the independent external evaluation conducted in accordance with Article 62 of Regulation (EC) No 216/2008 on the implementation of this Regulation were taken into account (Article 62 evaluation) 7 . In both of these evaluations it was recommended, amongst other, that Regulation (EC) No 216/2008 be amended in a number of respects. The summary of the recommendations made by these evaluations are contained in the impact assessment report accompanying this proposal.

Impact assessment

This proposal is accompanied by two Impact Assessment Reports which can be accessed at [link]. The Impact Assessment Report on the Review of Regulation (EC) 216/2008 has been reviewed by the Impact Assessment Board, which has issued a positive opinion [link] on 19 June 2015. The Regulatory Scrutiny Board reviewed the Impact Assessment Report on the Safe Development of Drone Operations in the EU and has issued a positive opinion [link] on 5 November 2015.

Regulatory fitness and simplification

The proposal exempts manned aircraft which are of very simple design or operate mainly on a local basis, and those that are home-built or particularly rare or only exist in a small number. The initiative also exempts aerodromes which are not open to public use, which do not serve commercial air transport, or which do not meet certain minimum technical characteristics related to the size or scope of operations.

Microenterprises and SMEs are not excluded from the scope of the proposal, which is also the case under the current Regulation (EC) No 216/2008. The proposal introduces however a more proportionate and scalable regime which will allow to better take into account the differences which exist between the different sizes of businesses. The introduction of such a scalable regime is one of the primary objectives of the present proposal. More specifically, as regards SMEs and light aviation, a number of measures would reduce the administrative burden for these sectors and make the regulation more favourable for small entrepreneurs. In the domain of aircraft design approval, an alternative procedure to a type certification is proposed for light aircraft used in low risk operations. Manufacturers of ultralight aircraft which are normally excluded from EU rules, would be also allowed - if they wish so - to have their products regulated under EU law and thus benefit from free circulation within the internal market. Aeroclubs and specialised light aviation associations would be allowed to act - within established conditions - as qualified entities on behalf of national aviation authorities.

The proposal will also facilitate the electronic exchange of information and further introduction of digital technologies. The Commission in particular proposes the establishment of an electronic repository of information relevant for certification, oversight and enforcement activities to which all the aviation authorities of the Member States and EASA would have access. Certain information collected in the repository will also be made available to the general public. It is proposed that the Agency is empowered to enter into arrangements with undertakings or associations of undertakings regarding data gathering, exchange and analysis, which would pave the way for the introduction of big data technologies in aviation safety analysis.

Fundamental rights

The present proposal does not have direct consequences for the protection of fundamental rights, except for the particular articles concerning operations of unmanned aircraft. The rules developed for the safe operations of unmanned aircraft will contribute to the more effective application of existing rules on privacy and data protection. So will the safety requirement to equip the unmanned aircraft with an identification device, like an electronic identification chip, also help detecting persons who did not respect privacy or data protection rules.

4. BUDGETARY IMPLICATIONS

The proposal has budgetary implications with regard to the budget of the European Union Aviation Safety Agency set out under article 06 02 02 of the Union budget, as further explained in the Legislative Financial Statement.

The proposal introduces a number of new tasks for the Agency with consequences for its need for posts financed from the Union contribution. The additional staff requests mainly relate to (1) the coordination at Union level of the gathering, exchange and analysis of data and information (known as “big data”), (2) the creation and management of a Union repository of information relevant for certification, oversight and enforcement, (3) new tasks related to rule-making and implementation in the areas of ground handling, environment and security, as well as i the creation of a framework for the transfer of responsibilities within the European aviation safety system aiming at better use of available resources Union-wide.

The identified human resources required will partially be met by present staff through their redeployment, thus reducing the need of the Agency for additional staff financed from budget related to the Union contribution to 5 posts and 4 contract agents.

In Annex X to the Impact Assessment Report a proposal has been made, based on re-attributing charges paid for ATM/ANS-related authority tasks from Eurocontrol to the Agency, without increasing the costs for operators. If the Agency were enabled to finance its activities related to ATM/ANS authority tasks through those charges, budget from its Union contribution would become available to finance additional posts. The proposed Regulation therefore establishes en-route charges as a revenue for the Agency in Article 109(1)(f). Attributing en-route charges to EASA would in addition require an amendment to Commission Implementing Regulation 391/2013 of 3 May 2013 on laying down a common charging scheme for air navigation services.

Furthermore, the proposal aims at introducing a mechanism that would allow better adjusting the Agency's staffing levels financed from budget related to fees and charges to the identified needs.

In this context it is important to note that the European Union Aviation Safety Agency is a Union agency that is partially self-financed from fees and charges. The Union contribution together with contributions from third countries constitutes about one third of its budget, while about two thirds are generated through the collection of fees and charges from industry for certification and other services. The budget from the Union contribution is distinct from the fees and charges budget and the Agency's accounting system strictly distinguishes between Union contribution related activities and fees and charges related activities avoiding any cross financing. In the case of this Agency, the Union contribution therefore does not constitute a 'balancing' contribution, as is the case for other partially self-financed agencies, based on the decision of the legislator that fees and charges should reflect real costs.

The Commission proposes to examine the possibility of introducing more flexibility in adjusting the Agency's establishment plan related to fees and charges from industry for certification and other services, based on fluctuations in industry demand for services. Such flexibility should, however, be conditional upon the development of solid indicators to measure workload and the efficiency of the Agency. This is to ensure that increased flexibility does not lead to an additional burden on industry. Those indicators could take into account elements such as average timeliness of certification activities, response time to industry applications, average effort per certificate and ratio of overhead costs over total activity costs. In case of decreasing demand the Agency has to adjust fee-financed staffing levels downwards. Necessary staff reduction would be achieved making use of fixed-term contracts and natural turn-over in posts underpinned by a sound planning of future tasks.

There are a number of factors that may impact the need for staff financed through fees. Factors that may influence market demand in the next five years include:

• Demand for new aircraft with a focus on Asia-Pacific, where the fleet is expected to grow by a factor of three. This demand will partly be satisfied by new types from manufacturers from these regions which will also be subject to the EASA certification process.

• Global traffic that is expected to rise by an annual rate of 3% having a direct impact on the Agency’s continuing airworthiness activities (safety critical oversight) as the work per type certificate is directly proportionate to the usage of the type by airlines.

• New technologies such as the development of unmanned aircraft, electric aircraft or new airship technology.

Factors that may influence the development of new tasks at the agency include:

• Big data project

• Transfer of responsibilities from Member States to the Agency according to the proposed Articles 53, 54 and 55 on a basis of a fee-financed system.

• Security threats including to cyber security are increasing and may require new approaches to certification.

The Commission intends to discuss the merits of introducing a new model of flexibility to respond to fluctuations in workload from industry, while guaranteeing efficiency through the use of indicators, with the European Parliament and the Council in the context of the inter-institutional working group (IIWG) on resources of decentralised agencies, whose next meeting is tentatively scheduled for March 2016.

In parallel, together with the Agency the Commission will continue working on a set of indicators to measure the Agency's workload and efficiency in relation to fees and charges to set out in detail how a system of flexibility for posts related to fees and charges would work in practice, and what the corresponding impact on the Agency's establishment plan would be.

The request for increased flexibility in adjusting staffing levels for posts related to fees and charges is closely linked to the Commission priority of boosting jobs, growth and investment. With respect to the activities financed from fees and charges industry is expecting a timely and market-driven response to its needs considered essential for the competitiveness of the European aviation industry.

5. OTHER ELEMENTS

Implementation plans and monitoring, evaluation and reporting arrangements

The monitoring, evaluation and reporting framework for the present initiative is described in Chapter 7 of the accompanying Impact Assessment Report. Ample mechanisms for monitoring and evaluation already exist and can be used, due to the fact that in the field of aviation safety the monitoring of performance is an integral element of the Union regulatory framework. The effectiveness of the proposed measure, once adopted, will be subject to a mandatory evaluation every five years, as is the case under the current Regulation (EC) No 216/2008.

Explanatory documents (for directives)

2.

Not applicable


Detailed explanation of the specific provisions of the proposal

The whole text of the proposed Regulation has undergone a thorough quality of legislation check, as a result of which the Commission is proposing a new, clearer structure for the Regulation and standardised language, especially in Chapter III, which deals with the different domains of aviation safety.

All the provisions dealing with activities of national competent authorities and of the Agency with respect to exercise of their certification, oversight and enforcement tasks have been now concentrated in Chapter IV. Chapter III of the proposed Regulation contains exclusively provisions which are applicable to the legal and natural persons subject to the provisions of the Regulation (that is pilots, organisations responsible for aircraft manufacturing, aerodrome operators etc.).

Chapter I Principles:

Article 1: Additional objectives and means to achieve these objectives are added to the proposed Regulation, as compared to the current Regulation (EC) No 216/2008.

Article 2: This article merges Articles 1 and 4 of Regulation (EC) No 216/2008. The text has been simplified. The main change is the introduction of the possibility for Member States to apply certain provisions of the new Regulation to activities and services performed by state aircraft, such as customs, police, search and rescue, firefighting, coastguard or similar activities or services, as well as to ATM/ANS provided by the military. The opt-in is modular, meaning that for example a Member State may use it for one or more activities or services concerned. It is also up to the Member State concerned to decide in which domains of aviation regulation (airworthiness, aircrew, operations etc.) it wishes to use the opt-in. Where a Member State makes use of the opt-in for an activity, it will have to comply with the relevant provisions of the new Regulation and the acts adopted on the basis thereof. Member States will also be able to decide at any moment to stop the application of the provisions of the Regulation to state aircraft or ATM/ANS provided by the military, subject to providing an adequate transition period.

In addition, the list of aircraft excluded from the scope of the Regulation (Annex I aircraft) has been revised (for example small aircraft with electric engines have been added). It is also proposed that the Commission be authorised to adjust by means of a delegated act the weight limits and other technical criteria of aircraft listed in Annex I. Finally, it is proposed that manufacturers of aircraft listed in Annex I may request to have individual types of such aircraft regulated under the provisions of the Regulation. This opt-in has been designed specifically for aircraft that are built in serial production and that could benefit from free circulation in the single market and under common requirements.

In all cases, these opt-in and opt-out possibilities are subject to certain conditions, including a prior Commission decision, meant to ensure, in particular, the correct application of the new Regulation, respect for the objectives set out in its Article 1 and transparency and legal certainty for all parties concerned.

Article 3: A number of definitions are amended and new definitions added as required by the changes in the substantive provisions of the proposed Regulation. Definitions of complex motor powered aircraft and of commercial operation have been removed in line with the risk based approach. The specific criteria to which these definitions refer can be better laid down in the delegated acts. Transitional provisions have been added at the end of the proposed Regulation (Article 126) in order to ensure an orderly transition where a definition has been changed or removed.

Article 4: A new Article dealing with basic principles is added, as compared to Regulation (EC) No 216/2008. It introduces in particular the principle of proportionality, reflecting also the position taken by the Council on the SESII+ initiative proposed earlier by the Commission, and criteria that should be taken into account in the conduct of risk assessments leading to the formulation and implementation of the measures taken under the new Regulation.

Chapter II Aviation Safety Management:

Articles 5-8: A new chapter dealing with safety management is introduced, which requires the adoption of the European Aviation Safety Programme and the European Plan for Aviation Safety, and transposes ICAO Annex 19 standards and recommended practices related to State Safety Programmes. Article 6, dealing with the European Plan for Aviation Safety, introduces the concept of acceptable level of safety performance at Union level. The introduction of this concept does not result however in establishing any binding safety targets for the Union or its Member States.

Chapter III Substantive Requirements:

Articles 9-18: The provisions of the Regulation (EC) No 216/2008 dealing with airworthiness have been revised taking into account existing experience and to reflect the new concept of non-installed equipment. The scope of the provisions dealing with airworthiness certification is also extended to environmental compatibility of aeronautical products. The environmental standards for products should continue to be based on ICAO Annex 16, but the Union would now be given the flexibility to adapt the ICAO standards to its specific needs, as already is the case for safety. Finally, for low risk operations, the possibility of assessing the airworthiness and environmental compatibility of the design of products and parts without the need to issue a certificate is being proposed. This possibility could be implemented especially for certain aircraft used in the general aviation sector. It is also expected that the manufacturers of aircraft listed in Annex I to the Regulation would make use of this flexibility when opting into the Union regulatory system under Article 2.

Environmental compatibility of products, as set out in Article 6 of Regulation (EC) No 216/2008, is now also dealt with in Articles 9-18 of the proposed Regulation (Airworthiness and environmental protection). New provisions on environmental protection have been also added under Article 75.

Articles 19-25: Article 7 of Regulation (EC) No 216/2008 has been restructured into Articles 19 to 25. The scope of the articles is extended to include cabin crew and the relevant provisions on cabin crew from Article 10 of Regulation (EC) No 216/2008 are moved to this section. The text concerning the leisure pilot licence has been simplified and the text concerning the general medical practitioner has been moved to Chapter IV which deals with certification activities.

Articles 26-28: Article 8 of Regulation (EC) No 216/2008 has been restructured into Articles 26-28. The certification requirement is now limited to commercial air transport operations. Other types of operations to be subject to a certification or declaration requirement are to be defined in the delegated acts based on a risk assessment.

Articles 29-34: Article 8a of Regulation (EC) No 216/2008 has been restructured into Articles 29-34. Ground handling services have been added to the scope of this section. It is also proposed that providers of apron management services are allowed to declare their compliance with the applicable requirements instead of being certified.

Articles 35-39: Article 8b of Regulation (EC) No 216/2008 has been restructured into Articles 35-39. The text is based on the compromise reached in the Council on the SES II+ initiative. In particular the provisions dealing with declarations by organisations involved in the design, manufacture and maintenance of ATM/ANS systems and constituents have been added.

Article 40-44: Article 8c of Regulation (EC) No 216/2008 has been restructured into Articles 40-44. The substance of the provisions has not changed as compared to the Regulation (EC) No 216/2008.

Articles 45-47: These Articles create the legal basis to provide for more detailed rules on unmanned aircraft, in view of the extended scope of the proposed Regulation.

More specifically:

Article 45 refers to the relevant Annex IX which contains the essential requirements concerning the design, production, operation and maintenance of unmanned aircraft that need to be complied with to ensure safe operations.

Article 46 describes the range of means to demonstrate that the essential requirements are complied with. As unmanned aircraft are able to perform operations that were not possible with manned aircraft, the range of risks associated with unmanned aircraft operations is very wide - ranging from the traditional high risk operations similar to ‘manned aviation risks’ to very low risk. In order to keep the rules and procedures proportionate to the risk of the operation, it is necessary to move towards an operation centric approach that assesses the exact risk of an operation or of a type of operations.

For mass produced unmanned aircraft which pose a low risk, it is proposed to use existing market surveillance mechanisms, as governed by Regulation 765/2008 and Decision 768/2008, which are specifically devised for the production and marketing of such type of products. However even in this case, aviation authorities remain indirectly involved, as the operational capability limitations that would be imposed (e.g. that the unmanned aircraft should not fly higher as, for instance, 50m to keep risks low) will have to stem directly from traditional aviation requirements. While the Agency would not be responsible for the oversight of the market surveillance mechanisms, the Commission is always entitled to verify if the Member States fulfil their responsibilities. Moreover, the market surveillance mechanism relies on justified complaints from citizens or undertakings to detect non-compliant products. Findings of non-compliance in one particular Member State are then communicated throughout the common market.

Articles 48-50: Article 9 of Regulation (EC) No 216/2008 has been restructured into Articles 48-50. The authorisation requirement is now limited to third country operators engaged in commercial air transport. Other categories of third country operations to be subject to an authorisation or declaration requirement are to be defined in the delegated acts based on a risk assessment. It has also been clarified, in line with the current practice, that the requirement of an authorisation for a third country operator does not apply to overflights.

Chapter IV Joint Oversight and Enforcement System:

Article 51: All the provisions of the present Regulation (EC) No 216/2008 concerning the certification, oversight and enforcement tasks of the national competent authorities and of the Agency have been concentrated in this Article. Furthermore a clear legal basis is being proposed to empower the Commission to adopt, by means of delegated acts, requirements with respect to management systems of authorities, qualification of inspectors, conditions for conducting the inspections and other oversight activities, ramp inspections, and grounding of aircraft in case of non-compliances.

Articles 52-54: A set of new provisions has been added as compared to Regulation (EC) No 216/2008, concerning the cooperation between the competent authorities of the Member States, the Commission and the European Union Aviation Safety Agency as regards certification, oversight and enforcement. A mechanism for pooling and sharing of aviation inspectors and other experts is introduced, along with a dedicated financing mechanism to assist Member States in cooperative oversight. Furthermore, the possibility to transfer responsibilities from Member States to the Agency (which today exists for production facilities and flight simulation training devices) is extended to all types of activities. Similarly a framework is introduced for transfers of responsibilities between Member States. Article 54 introduces possibility for organisations operating multi-nationally to opt for the Agency as their competent authority. Most of the measures proposed under these Articles are of voluntary nature.

Article 55: A new provision for mitigating possible systemic safety oversight deficiencies identified at Member State level is proposed. This emergency oversight mechanism is to be used as a measure of last resort of temporary nature and it is proposed that it can be activated/deactivated by a decision taken by the Commission based on clear criteria established in law.

Article 56: Declarations are added to the scope of this provision.

Article 57: The possibility of accepting foreign certificates and similar documentation on the basis of conditions specified in delegated acts is added to this Article. It is further proposed that the provisions of the current Regulation (EC) No 216/2008 dealing with national bilateral aviation safety agreements are deleted.

Article 58: The provisions on accreditation of qualified entities have been clarified. It is proposed that qualified entities may be granted a privilege to issue, revoke, and suspend certificates on behalf of the Agency or national competent authority. The principle of recognition of accreditations of qualified entities is introduced. This is without prejudice to the rights of Member States to decide to which qualified entity they wish to allocate certification and oversight tasks. It is also proposed that Member States may accredit a qualified entity jointly.

Articles 59 and 60: Article 14 of Regulation (EC) No 216/2008 has been split into two separate articles. Article 59 deals with measures of urgent nature, while Article 60 deals with flexibility measures. In line with the risk-based approach, it is proposed that the Agency and the Commission assess only those measures which last longer than one airline scheduling season (eight months).

Articles 61-63: These articles deal with information, including data, relevant for the implementation of the proposed new Regulation. The new elements concern the role of the Agency in coordinating the gathering, exchange and analysis of information at Union level. The provisions on protection of information and information sources are aligned with Regulation (EU) No 376/2014 on occurrence reporting. A legal basis is created for a new repository of information relevant for certification, oversight and enforcement activities, to be managed by the Agency. It is proposed that this repository is also used by the Member States for the purpose of exchanging information concerning medical fitness of pilots.

Chapter V The European Union Aviation Safety Agency:

Articles 64-65: Three new functions of the Agency have been added in Article 64 (assistance to national competent authorities, support to the Commission in the implementation of aviation performance schemes, and cooperation with other Union bodies, such as the European Chemicals Agency or the European Defence Agency on technical matters related to civil aviation). Articles 18 and 19 of Regulation (EC) No 216/2008 on Agency measures have been merged into Article 65.

Articles 66-67: These articles have been aligned with the changes made in Sections I and II of Chapter III of the proposed Regulation. The responsibility of the Agency to approve organisations not established in the Union has been limited to organisations located outside the territory for which a Member State is responsible under the Chicago Convention. This clarifies the issue of competent authority for approval of organisations located in Member State overseas countries and territories. Changes have also been made, based on experience gained, with respect to the responsibility of the Agency to approve flight simulation training devices.

Article 22 of Regulation (EC) No 216/2008: Its provisions on flight time limitations have been added to Articles 28(1)(f) and 65(7), while its provisions on the measures to be taken by the Agency in case of urgency have been moved to Article 65(6).

Article 68: The changes are largely based on the compromise reached in the Council on the SES II+ initiative. In particular the concept of declarations of conformity is reflected in this Article. For the sake of clarity this article proposes a new structure, where paragraph 1 deals with organisations and paragraph 2 deals with systems and constituents. With respect to the systems and constituents, the competence of the Agency is conditional – the Agency will be responsible for certification of systems and constituents only if the delegated acts adopted by the Commission so provide.

Article 69: The responsibility of the Agency to approve organisations not established in the Union has been limited to organisations located outside the territory for which a Member State is responsible under the Chicago Convention. This clarifies the issue of competent authority for approval of organisations located in Member State overseas countries and territories.

Article 70: As compared to the corresponding provision of Regulation (EC) No 216/2008, a new paragraph has been added concerning the assistance the Agency provides to the Commission in the implementation of Regulation (EC) No 2111/2005.

Article 71: This provision corresponds to Article 55 of the Regulation (EC) No 216/2008. The language of this Article has been updated to reflect the latest approach of the Commission to investigations conducted by Union institutions and bodies in the territories of the Member States. In particular it has been further clarified that the investigative powers of the Agency must be exercised in compliance with the applicable provisions of national law of the Member State where the investigation takes place.

Article 72: The Article has been adapted based on experience from implementation so far. In particular, it has been clarified that fines are in principle to be imposed only if other enforcement measures would be inadequate or disproportionate.

Article 73: Article 24 and Article 54 of Regulation (EC) No 216/2008 have been merged into this article. The language of this Article has been updated to reflect the latest approach of the Commission to investigations conducted by EU institutions and bodies in the territories of the Member States. In particular it has been further clarified that the investigative powers of the Agency must be exercised in compliance with the applicable provisions of national law of the Member State where the investigation takes place. A provision has been also added obliging the Agency to include in its Annual Safety Review a summary of information about the application by each of the Member States of the provisions of the new regulation and of the detailed rules adopted on the basis thereof.

Article 74: The existing article has been expanded by mandating the Agency to assist the Commission in identifying key research themes related to the areas covered by the Regulation. The Agency is furthermore given a supporting role in the preparation and implementation of Union research programmes. In addition, the Article gives the Agency the possibility to participate in research projects in the area of its expertise on the basis of ad hoc grants under the Union Framework Programme for research and innovation or other funding programmes.

Article 75: A new article has been added dealing with environmental protection in civil aviation. While not extending the current scope of Union action, this article focuses on interdependencies which may exist between environmental measures (e.g. banning certain chemical substances) and other technical domains of aviation regulation. It also mandates the Agency to assist the Commission in the definition and coordination of aviation environmental protection policies, and it creates a legal basis for an aviation environmental review to be published by the Agency every three years.

Article 76: A new article has been added concerning technical aspects of aviation security directly linked with safety. The article first of all deals with interdependencies which may exist between aviation security measures (e.g. cockpit door locking systems) and aviation safety. The article also opens the possibility for the Commission to rely on the Agency's expertise when implementing Regulation (EC) No 300/2008. Finally, the article proposes to establish a process allowing the Agency to take measures which are within the scope of its competence, such as airworthiness directives or safety information bulletins, to protect civil aviation against acts of unlawful interference. It is proposed that such measures be taken by the Agency in agreement with the Commission and following consultation of the Member States. Prior to granting its agreement to the measure envisaged by the Agency, the Commission could seek the opinion of the aviation security committee established under Regulation (EC) No 300/2008.

Article 77: The new provisions in this article propose in paragraph 4 to establish a repository of information on differences between ICAO standards and recommended practices on the one hand, and the provisions of this proposed Regulation and the delegated and implementing acts to be adopted on the basis thereof on the other hand. A provision on the collaboration of the Commission, the Agency and the national competent authorities through a network of experts is proposed in paragraph 5. Finally paragraph 6 clarifies the possibility for the Agency to engage in technical cooperation with and assistance to third countries on the basis of ad hoc grants.

Articles 78-80: These three new articles are proposed dealing with the role of the Agency in crisis management, provision of aviation training and the implementation of the Single European Sky.

Articles: 81-103: The changes proposed as compared to Regulation (EC) No 216/2008 reflect the experience to date and the standard clauses for Union Agencies introduced on the basis of the 2012 Common Approach on decentralised agencies. In particular, the creation of an Executive Board assisting the Management Board of the Agency is proposed. The establishment of local offices has been made dependent upon the approval of the Commission, the Management Board and the Member State concerned. The rules for the Board of Appeal have been clarified.

Articles 104-105: The provisions on the Agency's working methods have been revised, taking into account the existing practice.

Articles 106-108: The changes proposed as compared to Regulation (EC) No 216/2008 reflect the experience to date and the standard clauses for Union Agencies introduced on the basis of the 2012 Common Approach on decentralised agencies as well as Commission Delegated Regulation (EU) No 1271/2013 of 30 September 2013 on the framework financial regulation for the bodies referred to in Article 208 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council 8 . In addition, the provisions on translation of documents by the Agency have been simplified (translation will be done taking into account the safety relevance of the document).

Article 109-114: The changes proposed as compared to Regulation (EC) No 216/2008 reflect the experience to date and the standard clauses for Union Agencies introduced on the basis of the 2012 Common Approach on decentralised agencies as well as Commission Delegated Regulation (EU) No 1271/2013. Furthermore, under Article 109(1), it is proposed to authorise the Agency to receive ad hoc grants by introducing grants as additional source of revenue of the Agency. Air navigation charges for authority tasks related to ATM/ANS are identified as a further source of revenue. Those two additional sources of funding as well as the possibility to adjust the staffing levels financed from fees and charges according to market demand were also elements suggested by the European Parliament in the context of the discussion of the Commission's SESII+ initiative. Article 109(5) sets out that the Agency has to have a staff planning and management of resources related to fees and charges that enable it to swiftly respond to fluctuation in revenue from fees and charges. This should be read in connection with Article 109(6) which sets out that the draft establishment plan with regard to the Agency's staff financed from budget related to fees and charges proposed by the Agency on the basis of workload and efficiency indicators, reflects the resources required to meet industry demand for certification and other services in an efficient and timely manner, thus contributing to the competitiveness of the European aviation sector. This approach should also apply to possible transfers of responsibilities from Member States to the Agency as proposed under Articles 53 to 55. Finally, resources required to meet market demand should also be taken into account in the preparation of the draft general budget.

Article 115: The article has been modified to more clearly describe which activities are to be financed from fees and charges. Furthermore, the article clarifies that fees and charges have to be adapted where significant positive or negative budget results become recurrent.

Chapter VI Final Provisions:

Articles 116-117: These provisions concern the Commission's empowerments to adopt the delegated and implementing acts necessary under the new Regulation and they establish the conditions for the exercise of this delegation.

Article 118: The article has been modified to clarify participation of European third countries in the work of the Agency as well as the role of the Agency in establishing working arrangements with these countries.

Article 119: This is a new article stemming from the 2012 Common Approach on decentralised agencies which establishes the requirement for a Headquarters Agreement between the Agency and the host Member State.

Article 120: This article refers to penalties laid down by Member States for infringement of rules and corresponds to Article 68 of Regulation (EC) No 216/2008.

Article 121: This article sets out the applicable rules on the processing of personal data.

Article 122: This article repeals the current Regulation (EC) No 216/2008.

Article 123: This article introduces amendments to Regulation (EC) No 1008/2008 which are necessary to enable the transfers of competences for Air Operator Certificates (AOC) between a Member State and the Agency, as well as between Member States. Furthermore, it is proposed to remove the requirement of prior approval for wet leasing arrangements which do not involve a third country operator. Finally, the amendment clarifies that an aircraft used by a Union air carrier can also be registered in a third country in case of a dry leasing.

Article 124: This article introduces amendments to the Union rules on accident investigation laid down in Regulation (EU) No 996/2010, to avoid that the competent bodies have to initiate a full accident investigation for accidents occurred between small unmanned aircraft, which would not have system wide implications.

Article 125: This article amends the Union rules on occurrence reporting as laid down in Regulation (EU) No 376/2014 to avoid that occurrences with small unmanned aircraft having a negligible impact on the safety of the aviation system would create a bottle neck for the lines of occurrence reporting.

Article 126: This article provides for transitional arrangements with respect to the definitions which are being removed from or altered by the Regulation that is now proposed, but which are still reflected in the implementing regulations adopted on the basis of Regulation (EC) No 216/2008.

Annex I: It is proposed to add to the scope of the Annex light electric aircraft (change of the propulsion system and addition of batteries increases the mass of the aircraft for an equivalent type of aircraft). It is also proposed to exclude from the scope of the new Regulation small, single occupancy hot air balloons and to adjust the weight limits for sail planes. Unmanned aircraft have been moved to Annex IX.

Annex II: The main change as compared to Regulation (EC) No 216/2008 concerns clarification that cyber-security aspects are to be taken into account in the design of the aircraft (1.3.5). Furthermore, experience gained through the practical implementation of that Regulation is reflected and the concept of non-installed equipment is introduced (including essential requirements for non-installed equipment).

Annex III: A new Annex with essential requirements for environmental compatibility related to products was added, as provided in Article 9.

Annex IV: The main change concerns introduction of additional essential requirements for cabin crew. Furthermore, experience gained through the practical implementation of Regulation (EC) No 216/2008 is reflected.

Annex V: The environmental compatibility aspects are included in Section 6. Essential requirements for cabin crew included in Regulation (EC) No 216/2008 have been deleted, as they are now comprehensively addressed in Annex IV of the new Regulation. Section 8, dealing with additional essential requirements for certain more complex categories of operations, has been aligned with the wording used in Article 27 of the new Regulation. Cyber-security aspects have been added in Section 8.4. Finally, experience gained through the practical implementation of Regulation (EC) No 216/2008 is reflected.

Annex VI: Clarification has been added concerning conditions under which an organisation created with the aim of promoting aerial sport or leisure aviation can be accredited as a qualified entity. These conditions concern management and prevention of conflict of interest.

Annex VII: Essential requirements for ground handling services have been added (Section 4). Furthermore, experience gained through the practical implementation of Regulation (EC) No 216/2008 has been reflected.

Annex VIII: Cyber-security aspects have been added in the essential requirements dealing with aeronautical information and data (Point 2.1.3) and system and constituent integrity (Point 3.3). Furthermore, the changes reflect the compromise reached in the Council on the SES II+ initiative proposed earlier by the Commission.

Annex IX: This annex, referred to in Articles 45, 46 and 47, contains the essential requirements to cover unmanned aircraft with regard to airworthiness, operations and undertakings involved. The essential requirements also provide the basis for developing more detailed rules that would constitute the Community harmonisation legislation within the meaning of Regulation (EC) 765/2008.

Annex X: The cross-reference table includes correlation between the provisions of Regulation (EC) No 216/2008 and the provisions contained in the present proposal for a new Regulation.