Author Archives: Aaric Hawke

Guidelines on State aid for developing regional airports

Guidelines on State aid for developing regional airports

Outline of the Community (European Union) legislation about Guidelines on State aid for developing regional airports

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These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Competition > Rules applicable to specific sectors > Competition in transport

Guidelines on State aid for developing regional airports

Document or Iniciative

Commission Communication of 9 December 2005 “Community guidelines on financing of airports and start-up aid to airlines departing from regional airports” [PDF ] [Official Journal C 312 of 09.12.2005].

Summary

The purpose of these guidelines is to clarify how the competition rules apply to the financing of airports and to start-up aid granted to airlines by the State. The Commission’s aim is to tackle air transport congestion in the main European airports and make it easier for the European public to travel, while ensuring that the competition rules are complied with. It also takes the view that developing the regional airports also helps to develop the regional economies concerned.

Financing of airports

The Commission makes it clear that the financing and provision of airport infrastructure by the public authorities must comply with the Community rules on State aid. Aid may be justified and declared compatible provided it meets an objective of general interest, such as regional development or accessibility. Additional conditions are that the aid must be in proportion to the objective set and must not adversely affect the development of trade within the EU.

Addressing the issue of subsidies for the operation of airport infrastructure, the Commission makes a distinction according to airport size since, while funding granted to airports with fewer than one million passengers a year is unlikely to distort competition or affect trade to an extent contrary to the common interest, an operating subsidy for an airport with more than one million passengers a year may constitute State aid and must therefore be notified to the Commission, which will examine its impact on competition and trade between Member States and, where appropriate, its compatibility. On the other hand, the Commission has decided that public service compensation constituting State aid granted to airports with fewer than one million passengers entrusted with a mission of general economic interest should be exempted from the notification obligation and declared compatible.

Start-up aid for airlines

Start-up aid granted to airlines operating from regional airports is a way of attracting airlines to new destinations. Operating aid of this kind is justifiable, temporarily, only in the case of small airports that do not yet have the critical mass needed to reach break-even point. In addition, the aid must provide airlines with the necessary incentive to create new routes or new schedules operated from the regional airports in question.

Large airports, on the other hand, benefit from economies of scale and are able to attract connections. This results in air traffic being concentrated on a small number of hubs which are then faced with major congestion problems. Encouraging the development of regional airports will help to make air traffic in Europe less congested and provide scope for economic development in the regions concerned.

Consequently, the Commission considers that start-up aid for the operation of new routes should be allowed for a maximum of three years (five years in the case of the outermost regions). The duration of start-up aid is clearly a sensitive issue. A balance needs to be found between facilitating the development of regional airports in their formative years and open and fair competition between European airports. The Commission takes the view that a period of three years (five years in the case of the outermost regions) meets the objectives of regional development while satisfying the requirements of fair competition.

This type of State aid may be granted to airlines either by a public authority (central, regional or local government) or through the airports that receive public subsidies. The Commission emphasises the fact that subsidies must be granted only for new routes or new schedules.

In addition, it will not be acceptable to grant start-up aid for a new air route corresponding to an existing high-speed rail link. This concern to ensure that the different modes of transport are mutually complementary is a reflection of the intermodal approach that the Commission is seeking to promote, e.g. by encouraging cooperation between the rail and air transport sectors in an effort to deal more effectively with the effects of saturation and pollution around urban areas.

The State aid guidelines apply equally to both private and public airports. The term “State aid” refers to the origin of the funds not the status of the airport. For example, a public airport may act as a private investor by granting subsidies to airlines from its own resources on the basis of commercial profitability considerations. Conversely, if a private airport uses public resources, granted by a regional or local authority for example, this constitutes State aid.

The Commission recognises the role of airlines and airports in the process of opening up European airspace and certain regions. The exponential growth of low-cost carriers in Europe has done much to help the establishment of a network of interregional air routes, making it easier for the general public to travel and promoting the growth of the local economies and job creation.

Background

These guidelines set out a legal framework for the financing of airports and for State start-up aid used by regional airports for the benefit of airlines. They thus spell out the principles underlying Commission Decision 2004/393/EC of 12 February 2004 in the Ryanair/Charleroi case. These new guidelines add to rather than replace the 1994 guidelines. They are the outcome of extensive consultation of the various parties involved in air transport and its effects on regional development.

Related Acts

Commission Decision 2004/393/EC of 12 February 2004 concerning advantages granted by the Walloon Region and Brussels South Charleroi Airport to the airline Ryanair in connection with its establishment at Charleroi [OJ L 137 of 30.04.2004].

Community guidelines on the application of Articles 92 and 93 of the EC Treaty and Article 61 of the EEA Agreement to State aids in the aviation sector [OJ C 350 of 10.12.1994].

 

Budget

Budget

Outline of the Community (European Union) legislation about Budget

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Budget

Budget

Own resources

  • Own resources mechanism
  • Decision on the system of own resources
  • Report on the system of own resources
  • Harmonisation of the compilation of GNP
  • European system of national and regional accounts in the Community
  • Common rules for the provision of basic information on Purchasing Power Parities and for their calculation and dissemination

The financial perspectives

  • Financial perspectives system and the multiannual financial framework
  • A budget for Europe (2014-2020)
  • Interinstitutional Agreement on cooperation in budgetary matters
  • Towards a new financial framework 2007-2013
  • New interinstitutional agreement and financial perspective (2000-2006)
  • The financial framework of 2000-06 (Agenda 2000)

The financial regulation

  • Financial Regulation
  • The Former Financial Regulation
  • Guarantee Fund for external actions
  • Commission Action Plan towards an Integrated Internal Control Framework
  • Mutual administrative assistance in the fight against fraud

European Anti-Fraud Office

European Anti-Fraud Office

Outline of the Community (European Union) legislation about European Anti-Fraud Office

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These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Fight against fraud > Anti-fraud offices

European Anti-Fraud Office (OLAF)

Acts

Commission Decision 1999/352/EC, ECSC, Euratom of 28 April 1999 establishing the European Anti-Fraud Office (OLAF).

Operating modalities:

Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF).

Council Regulation (EURATOM) No 1074/1999 of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF).

Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-Fraud Office (OLAF).

Summary

This Decision establishes the European Anti-Fraud Office (OLAF), which is part of the European Commission with a special independent status for conducting anti-fraud investigations. Two Regulations and an Interinstitutional Agreement stipulate how it is to operate.

OLAF’s competences

The Commission Decision establishes OLAF and sets out its powers, which are to:

  • carry out external administrative investigations as part of the fight against fraud, corruption and any other illegal activity that adversely affects the Community’s financial interests and for the purpose of combating fraud involving any other act or activity in breach of Community provisions;
  • carry out internal administrative investigations for the purposes of:
    1. combating fraud, corruption and any other illegal activity that adversely affects the Community’s financial interests,
    2. investigating serious situations relating to the discharge of professional duties that may constitute a failure to comply with the obligations of officials and servants of the Communities liable to result in disciplinary or, where appropriate, criminal proceedings, or a failure to comply with the analogous obligations of the members of the institutions, bodies, offices or agencies or their staff who are not subject to the Staff Regulations of Officials of the European Communities and the Conditions of Employment of Other Servants of the European Communities,
  • carry out investigative assignments in other areas at the request of Community institutions and bodies;
  • help strengthen cooperation with the Member States in the field of fraud prevention;
  • develop strategies for the fight against fraud (preparing legislative and regulatory initiatives in the areas of activity of the Office);
  • set in motion any other operational activity in the fight against fraud (developing infrastructure, collecting and analysing information, providing technical support);
  • maintain direct contact with the national law enforcement and judicial authorities;
  • represent the Commission in the field of fraud prevention.

OLAF’s external investigative powers are mainly those that were conferred upon the Commission under Regulations (EC, Euratom) Nos 2988/95 (the European Communities’ financial interests) and 2185/96 (on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests). Furthermore, OLAF works on the basis of Regulation (EC) 515/97 on mutual administrative assistance.

How OLAF goes about its investigations

The two Regulations on investigations by OLAF, one applying to the EC and the other to Euratom, restate the Office’s main functions and define the practical arrangements for carrying out the administrative investigations for which it is responsible.

The checks and verifications OLAF carries out externally (in the Member States and in certain non-member countries with which the Community has cooperation agreements) and internally (inside the institutions and bodies established by or on the basis of the Treaties) do not affect the powers of the Member States in the area of criminal prosecution.

The Director of OLAF launches and directs investigations on his own initiative or at the request of a Member State with an interest in the matter (in the case of external investigations) or of the institution or body concerned (in the case of internal investigations).

As part of its external investigations, OLAF carries out the on-the-spot checks for which the Commission is responsible under Regulations (EC, Euratom) Nos 2988/95 and 2185/96.

For its internal investigations, OLAF has the right of immediate and unannounced access to any information held by the Community institutions, bodies, offices and agencies. It may also ask anyone concerned for oral information, and carry out on-the-spot checks on economic operators.

Where the Office discovers, in the course of an internal investigation, that a member, manager, official or other servant may be personally involved, it informs the institution, body, office or agency to which that person belongs, unless divulging such information is incompatible with the need to maintain complete strict confidentiality for the purposes of the investigation or a possible national investigation.

At the request of OLAF or on their own initiative, the Member States, institutions, bodies, offices and agencies are required to provide the Office with any document or information they hold that relates to an investigation under way.

All information passed on to the Office will be properly protected.

On completion of an investigation, OLAF draws up a report including recommendations as to the action to be taken. The report is sent to the Member States in the case of external investigations and to the institutions, bodies, offices and agencies in the case of internal investigations.

Information may also be sent to the competent authorities in the Member States and to the institutions, bodies, offices and agencies concerned, while an investigation is still under way (the Office is in direct contact with the national law enforcement and judicial authorities).

OLAF’s operational independence is protected by a Supervisory Committee consisting of five independent outsiders appointed by common agreement of the European Parliament, the Council and the Commission. Furthermore, if the Director considers that a measure taken by the Commission calls his independence in question, he is entitled to bring an action against it before the Court of Justice.

Any member of the staff of a Community institution, body, office or agency who feels that his interests are adversely affected in the course of an internal investigation may submit a complaint to the Director of OLAF or bring an action before the Court of Justice.

Interinstitutional Agreement between the Parliament, the Council and the Commission

The object of the Interinstitutional Agreement between the European Parliament , the Council and the Commission is to guarantee that internal investigations can be carried out under equivalent conditions in the three institutions and in all the other Community bodies, offices and agencies, including the European Investment Bank (EIB) and the European Central Bank (ECB).

To bring this about, the three institutions have agreed to adopt an internal decision based on the standard model annexed to the Agreement, and to call on the other institutions, bodies, offices and agencies to accede to the Agreement.

The model decision requires the Secretary-General, departments and all members of staff of the institution, body, office or agency concerned to cooperate fully with OLAF’s agents and to supply all useful information.

Where there is a presumption of fraud, corruption or any other illegal activity detrimental to the Communities’ interests:

  • any member who becomes aware of such evidence must without delay inform his Head of Service or Director-General or, if he considers it useful, his Secretary-General or OLAF directly;
  • the Secretary-General, the Directors-General and the Heads of Service or managers must transmit to OLAF without delay any evidence from which the existence of irregularities may be presumed;
  • members of the institutions, bodies, offices or agencies must inform the President or, where appropriate, OLAF directly.

Where it becomes clear during an internal investigation that a member, manager, official or other servant is involved, the person concerned is informed rapidly. He/she will be called upon to give his/her views on the matters concerning him/her. The invitation may be deferred where necessary for the purposes of the investigation or any subsequent national judicial inquiries.

OLAF delivers an opinion on any request for a waiver of immunity from the police or judicial authorities in a Member State, if the request relates to a manager, official or other servant of an institution, body, office or agency. If a request concerns a member of an institution or body, the Office is informed.

Background

The EC Treaty provides an explicit legal basis for operations by the Community and the Member States to combat fraud and other unlawful activities that are damaging to the Community’s financial interests (Article 280). The entry into force of the Amsterdam Treaty has given the Community much more substantial means for combating fraud and stamping out economic and financial crime.

The Commission’s Task Force for the Coordination of Fraud Prevention was thus replaced by the European Anti-Fraud Office (OLAF), which, in addition to carrying out investigations, is responsible for devising and preparing legislation for the protection of the Community’s financial interests and the fight against fraud. OLAF enjoys greater independence than its predecessor in conducting investigations.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Decision 1999/352/EC, CECA, Euratom

28.4.1999

OJ L 136 of 31.5.1999

Regulation (EC) No 1073/1999

1.6.1999

OJ L 136 of 31.5.1999

Regulation (Euratom) No 1074/1999

1.6.1999

OJ L 136 of 31.5.1999

Interinstitutional Agreement

1.6.1999

OJ L 136 of 31.5.1999

Related Acts

Proposal for a European Parliament and Council Regulation amending Regulation (EC) No 1073/1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) [COM(2006) 244 final – Not published in the Official Journal].

In substance, the proposal has the following main objectives:

  • Governance, cooperation between the institutions and the Supervisory Committee. The Commission sees a need for political governance regarding priorities related to investigative activities. It proposes regular meetings between the Supervisory Committee and the other European institutions as part of a structured dialogue, without interfering in the investigative activities.
  • Guarantee of the rights of persons implicated. The Commission proposes including in the Regulation a detailed provision on the procedural guarantees to be respected in the conduct of internal and external investigations.
  • Improved monitoring of investigations. Monitoring that ensures the specific procedures are followed should be improved and the possibility of requesting an opinion should be introduced. A review adviser is provided for to fulfil such a role.
  • Improving the information flow. With this proposal, the Commission intends to improve the flow of information between OLAF and European bodies and institutions, between OLAF and the Member States, as well as between OLAF and whistleblowers.
  • Strengthening OLAF’s operational efficiency. The Commission is proposing measures that will allow OLAF to concentrate on its priority actions. For example, the opening and closing of investigations need clarification.
  • Improving the effectiveness of OLAF’s investigations. The Commission proposes to clarify OLAF’s powers of investigation in the context of external investigations involving economic operators receiving Community funds on the basis of contracts, agreements or grant awards (direct expenditure).
  • Term of office of the Director-General. A non-renewable term of office should be introduced for the OLAF Director-General in order to strengthen independence.

Codecision procedure (COD/2006/0084)

Activity reports:

Report of the European Anti-Fraud Office – Eighth Activity Reportfor the period 1 January 2007 to 31 December 2007 [Not published in the Official Journal].
This eighth activity report substantiates the principal trends of previous years. The volume and quality of information received by OLAF has steadily increased in the past years, confirming the public’s confidence in the Office. In the course of 2007, OLAF opened more cases than in 2006. Similarly, the number of cases closed increased as well, as opposed to previous years that have been characterised by a declining number of closed cases. Furthermore, the amount of “own investigations” OLAF carries out has exceeded the amount of investigations in which it merely provides assistance to national authorities. The average duration of cases increased slightly in 2007, due to the complexity of the cases the Office faces nowadays and to the necessity of involving Member States or outside partners in the investigations. OLAF has actively continued its cooperation with Member States, EU bodies in charge of police and judicial cooperation and international partners in the fight against fraud.

Report of the European Anti-Fraud Office – Seventh Activity Reportfor the period 1 January 2006 to 31 December 2006 [Not published in the Official Journal].

This report follows on from the sixth activity report. In it, the Commission assesses the irregularities committed and presents the most important measures taken in 2006 by the Member States and by itself to improve fraud prevention and the fight against fraud. The report also describes in detail the way OLAF decides to open an anti-fraud investigation and explains how cases are managed.

Report of the European Anti-Fraud Office – Sixth Activity Reportfor the period 1 July 2004 to 31 December 2005 [Not published in the Official Journal].

Evaluation report: Commission Report of 2 April 2003 – Evaluation of the activities of the European Anti-Fraud Office (OLAF) [COM(2003) 154 final – Official Journal C 76 of 25.3.2004].

Decisions by the institutions:

Council Decision 1999/394/EC of 25 May 1999 concerning the terms and conditions for internal investigations in relation to the prevention of fraud, corruption and any illegal activity detrimental to the Community’s interests [Official Journal L 149 of 16.6.1999].

As laid down in the Interinstitutional Agreement, this Decision states that the Council is to cooperate with the Office and keep it informed; it also requires the Security Office to assist OLAF’s staff in their work. In return, OLAF is required to inform anyone implicated in one of its investigations.

Commission Decision 1999/396/EC of 2 June 1999 concerning the terms and conditions for internal investigations in relation to the prevention of fraud, corruption and any illegal activity detrimental to the Community’s interests [Official Journal L 149 of 16.6.1999].

As laid down in the Interinstitutional Agreement, this Decision states that the Commission is to cooperate with the Office and keep it informed; it also requires the Security Office to assist OLAF’s staff in their work. In return, OLAF is required to inform anyone implicated in one of its investigations.

Decision of the European Parliament of 18 November 1999 concerning the terms and conditions for internal investigations in relation to the prevention of fraud, corruption and any illegal activity detrimental to the Community’s interests [European Parliament Rules of Procedure, Annex XI – Official Journal L 44 of 15.2.2005].

As laid down in the Interinstitutional Agreement, this Decision states that the European Parliament is to cooperate with the Office and keep it informed. The Decision obliges Parliament’s Security Office to assist OLAF staff in their work. It also obliges OLAF to inform anyone who is implicated in one of its investigations.

Decision 1999/726/EC of the European Central Bank of 7 October 1999 on fraud prevention – [Official Journal L 291 of 12.11.1999].

The Decision seeks to provide adequate protection against fraud and other illegal activities at the European Central Bank (ECB), while maintaining the distribution and balance of responsibilities between the ECB and the European institutions.
Accordingly, the Decision sets up an anti-fraud committee to be responsible for monitoring the independence and functioning of the ECB Directorate for Internal Audit. The anti-fraud committee is also responsible for relations with the Supervisory Committee of OLAF. These relations are governed by the principles established by an ECB decision.

Decision of the Court of Justice of 26 October 1999 concerning the terms and conditions for internal investigations in relation to the prevention of fraud, corruption and any illegal activity detrimental to the Community’s interests [Not published in the Official Journal].

In accordance with the provisions of the Regulations setting up OLAF, this Decision requires the Court to cooperate with the Office and to keep it informed. It also lays down the procedures to be followed by OLAF staff when carrying out internal investigations. In line with the principle of confidentiality, it denies OLAF access to documents held in connection with legal proceedings that are in progress or have been terminated.

Judgment of the Court of Justice of 10 July 2003 setting aside Decision 1999/726/EC of the European Central Bank on fraud prevention and protection of the Communities’ financial interests (Case C-11/00).

Avian influenza

Avian influenza

Outline of the Community (European Union) legislation about Avian influenza

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal health

Avian influenza

Document or Iniciative

Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing Directive 92/40/EEC [See Amending act(s)].

Summary

The European Union (EU) lays down measures to control avian influenza as soon as there is any suspicion of the presence of this disease.

The Member States are responsible for:

  • carrying out surveillance programmes intended to detect the virus and increase knowledge in this area;
  • ensuring that the presence of this disease is notified to the competent authority and that epidemiological inquiries take place in accordance with an action plan approved by the Commission.

When an outbreak is suspected, the competent authority opens an epidemiological investigation, places the affected holding under surveillance and implements a series of measures including counting the animals, compiling a list of the animals that are sick, dead or likely to be infected, isolating the holding and carrying out the appropriate disinfection. These measures are withdrawn when the suspicion of the disease is officially ruled out.

Following the epidemiological inquiry, further measures may be taken on the holding.

This Directive provides for specific measures to be taken depending on the type of disease.

Highly pathogenic avian influenza (HPAI)

Once the presence of HPAI is confirmed, the competent authority ensures that the following measures are applied:

  • all poultry and other captive birds are to be killed;
  • all carcasses are to be disposed of under official supervision;
  • poultry hatched from eggs before the application of the initial measures is to be placed under official surveillance;
  • meat of poultry slaughtered and eggs collected before the application of the initial measures are to be identified and disposed of;
  • all substances likely to be contaminated are to undergo the appropriate treatment;
  • manure, slurry, bedding and all materials likely to be contaminated are to be cleaned and disinfected;
  • any movements of animals entering and leaving the holding must take place under supervision;
  • the virus is to be isolated using the most appropriate laboratory procedure.

Additionally, specific measures are to be applied in the zones closest to the holding concerned, known as “protection zone” (within a radius of at least three km around the holding) and “surveillance zone” (within a radius of at least 10 km around the holding). The measures applied in these zones concern – among other things – the census of the holdings, visits by the official veterinarian and the transport of birds, eggs, poultry meat and carcasses. These measures remain in place until completion of the preliminary cleaning operations (at least 21 days afterwards in protection zones and at least 30 days afterwards in surveillance zones).

Low pathogenic avian influenza (LPAI)

Once the presence of LPAI is confirmed, the competent authority ensures that a series of measures are applied on the basis of the appropriate risk assessment. The measures to be taken vary depending on the criteria laid down, which include, among other things, the species concerned, the number of holdings in the area in question, the location of the slaughterhouses and the biosecurity measures. The measures to be applied are as follows:

  • all poultry present on the holding and all other captive birds to be depopulated. This kind of operation must take place in accordance with the common minimum standards on the protection of animals at the time of slaughter or killing;
  • the disposal of carcasses and hatching eggs must take place under official supervision;
  • hatching eggs collected and poultry hatched from eggs before the application of the initial measures to be placed under official surveillance;
  • table eggs produced on the holding before the depopulation are to be disposed of or transported to a packing centre or an establishment for the manufacture of egg products;
  • any material likely to be contaminated is to be disposed of;
  • manure, slurry, bedding, buildings and all material likely to be contaminated are to be cleaned and disinfected;
  • mammals of domestic species are to be prohibited from entering or leaving the holding;
  • the virus is to be isolated.

Additionally, specific measures are to be applied in the zone closest to the holding concerned, known as the “restricted zone” (within a radius of at least one km around the holding). The measures applied in this zone concern – among other things – censuses and tests on commercial holdings and management of the movements of poultry, other captive birds and eggs. These measures remain in place for a length of time that varies at the discretion of the competent authority.

Spread to other species

Following confirmation of an outbreak of avian influenza on a holding, tests are performed on other mammals that may be infected, specifically pigs. If the results of these tests are positive the authority may order the movement of these pigs to other holdings or to slaughterhouses.

Cleansing, disinfection and repopulation

The Member States shall ensure that anything likely to have been contaminated, including holdings, slaughterhouses, vehicles and other equipment, is cleansed and disinfected. The holding may be repopulated in accordance with the provisions of this Directive 21 days following completion of these operations of cleansing and disinfection.

Diagnostic procedures

A diagnostic manual adopted by Directive 2006/437/EC lays down all the requirements, criteria and procedures to be applied to diagnostic tests and post-mortem clinical examinations (see “related acts”). These operations take place exclusively in authorised national laboratories.

Each Member State designates a laboratory at national level, and then communicates the contact details of their laboratory to the other Member States and to the public. The national laboratories work in cooperation with the Community reference laboratory in Surrey (United Kingdom) which is responsible for the coordination of research in the area of avian influenza.

Vaccination

Generally speaking, vaccination against avian influenza is prohibited, except in cases where emergency or preventive vaccination is required. Vaccination plans are subject to approval by the Commission and the farms involved are placed under strict surveillance. The Directive includes guidelines for the application of these measures and provides for the possibility of setting up vaccine banks.

Committee procedure

The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health in the management of measures related to avian influenza. Among other things, this Committee may take a role in the definition of preventive biosecurity measures.

Background

Specific measures for the control of avian influenza were introduced in Community legislation by Directive 92/40/EEC, which remained in force until 1 July 2007. Recent scientific findings on avian influenza, which led to the production of new tests and vaccines and contributed to the amendment of the health code for terrestrial animals, have resulted in the need for renewal of the legislation.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Directive 2005/94/EC

3.2.2006

1.7.2007

OJ L 10 of 14.01.2006

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Directive 2008/73/EC

3.9.2008

1.1.2010

OJ L 219 of 14.8.2008

Related Acts

Commission Decision 2007/598/EC of 28 August 2007 concerning measures to prevent the spread of highly pathogenic avian influenza to other captive birds kept in zoos and approved bodies, institutes or centres in the Member States [Official Journal L 230 of 1.9.2007].

Commission Decision 2007/118/EC of 16 February 2007 laying down detailed rules in relation to an alternative identification mark pursuant to Council Directive 2002/99/EC [Official Journal L 51 of 20.2.2007].

Commission Decision 2006/415/EC of 14 June 2006 concerning certain protection measures in relation to highly pathogenic avian influenza of subtype H5N1 in wild birds in the Community and repealing Decision 2006/135/EC [Official Journal L 164 of 16.6.2006].

Recovery of petrol vapours during storage

Recovery of petrol vapours during storage

Outline of the Community (European Union) legislation about Recovery of petrol vapours during storage

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Environment > Air pollution

Recovery of petrol vapours during storage

Document or Iniciative

European Parliament and Council Directive 94/63/EC of 20 December 1994 on the control of volatile organic compound (VOC) emissions resulting from the storage of petrol and its distribution from terminals to service stations [See amending acts].

Summary

This Directive covers to the operations, installations, vehicles and vessels used for storage, loading and transport of petrol from one terminal to another or from a terminal to a service station.

The Directive lays down harmonised technical specifications for the design and use of:

  • storage installations at terminals;
  • equipment for loading and unloading mobile containers at terminals;
  • mobile containers;
  • equipment for loading into storage installations at service stations.

Transitional periods are laid down for implementing these specifications.

Member States may maintain or require more stringent measures than those laid down in the Directive throughout their territory or in geographical areas where it is established that such measures are necessary for the protection of human health or the environment.

The Directive provides a procedure for adapting the Annexes to technical progress.

The reports on the implementation of this Directive are drawn up in accordance with the provisions of Council Directive 91/692/EEC of 23 December 1991.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 94/63/EC

20.01.1995

31.12.1995

OJ L 365 of 31.12.1994

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1882/2003

20.11.2003

OJ L 284 of 31.10.2003

Regulation (EC) No 1137/2008

11.12.2008

OJ L 311 of 21.11.2008

Related Acts

Directive 2009/126/EC of the European Parliament and of the Council of 21 October 2009 on Stage II petrol vapour recovery during refuelling of motor vehicles at service stations [Official Journal OJ L 285 of 31.10.2009].
This Directive aims at ensuring the recovering of harmful petrol vapours displaced from the fuel tank of a motor vehicle during refuelling at a service station. In a large number of European service stations petrol pumps must be fitted with a system to recover at least 85% of these vapours. These vapours contribute to the emission of atmospheric pollutants such as ground-level ozone and benzene, which are harmful to human health and the environment.

Agenda 2000: for a stronger and wider Union

Agenda 2000: for a stronger and wider Union

Outline of the Community (European Union) legislation about Agenda 2000: for a stronger and wider Union

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Enlargement > Enlargement 2004 and 2007

Agenda 2000: for a stronger and wider Union

With the adoption of about twenty legislative measures, the Union completed its “Agenda 2000” project in 1999. The original Commission Communication on which the project was based, “Agenda 2000: For a stronger and wider Union”, comprises a single complete framework offering a clear and coherent vision of the Union’s future on the threshold of the 21st century. Its primary aim was to ready the Union for its greatest challenges: the reinforcement of its policies and the accession of new members, within a strict financial framework.

The measures adopted, using the communication as a basis, are in line with the Agenda guidelines: the budget effort has been consolidated, there is a greater concentration of resources, stricter implementation (simplification and decentralisation), good preparation for the integration of the new Member States.

Background

The Agenda 2000 legislative package results from the combined effort of all the institutions; it was conceived at the Madrid European Council in December 1995.

At that meeting, and with a view to opening accession negotiations with the applicant countries, the Heads of State and Government invited the Commission to submit its opinions on the various applications, together with a composite paper on enlargement. At the same time, the Commission was invited to prepare, on the basis of a thorough analysis of the Union’s financing system, a communication on the Union’s future financial framework, having regard to the prospects of enlargement.

The communication “Agenda 2000 : For a stronger and wider Union” [COM(97) 2000], which the Commission presented on 16 July 1997, was a comprehensive response to these requests. The communication describes, in a single text, the overall prospects for the development of the European Union and its policies, the horizontal problems occasioned by enlargement and the shape of a future financial framework for the first seven years of the new millennium, in the context of an enlarged Union. The Commission simultaneously made known its opinions on the accession applications of the ten countries of central and eastern Europe.

The Commission communication highlighted a number of priorities in particular: the need to maintain the policy of economic and social cohesion, to pursue the reform of the common agricultural policy, to strengthen growth, employment and living conditions through the Union’s internal policies and to allow the accession of new members, while maintaining budgetary discipline.

To translate these priorities into legal instruments, on 18 March 1998 the Commission presented legislative proposals on the various topics set out in its communication. At its meeting in Berlin on 24 March 1999, the European Council reached a political agreement on the Commission’s proposals, so allowing the institutions to continue examining the Agenda 2000 legislative package and to adopt the final measures before or immediately after the election of the new Parliament in June 1999.

The resulting package of legislation covers four main, closely related areas: the reform of the common agricultural policy, structural policy reform, the pre-accession instruments and the new financial framework. The Commission has also proposed an amendment to the financial regulation on trans-European networks. Some other priority areas covered in the original Commission Communication – internal policies, external action, administrative reforms – did not necessitate a translation into specific legislative measures. They have, nevertheless, an important position in the financial perspectives.

The reform of the common agricultural policy

The agricultural reforms are continuing and they consolidate the changes introduced by the reforms of 1988 and 1992. The reforms have many aims: to increase the competitiveness of Community agricultural products on the domestic and world markets, to integrate environmental and structural considerations more into the implementation of the common agricultural policy, to ensure a fair income for farmers, to simplify agricultural legislation and decentralise its application, to improve food safety, to strengthen the Union’s position in the new round of WTO negotiations and to stabilise agricultural spending in real terms at its 1999 level.

Two types of measures will assist in achieving these objectives. Firstly, new regulations amending the common organisations of the markets in wine, arable crops, beef and veal and milk and, secondly, measures of a more horizontal nature.

Both the arable crops and milk sectors will see gradual reductions in their intervention prices. In the case of beef and veal, the basic price will be reduced, while the intervention price will be maintained at its existing level, as a safety net.

These reductions will be partly offset by a series of direct aids to farmers, calculated on the basis of the annual production of the agricultural product involved. In the beef and veal sector, slaughter premiums and an increase in extensification and suckler cow premiums are also provided for. The reform of the milk sector will enter into force in the 2005/06 marketing year, with a three-stage reduction of 15 % in the intervention price and an increase in the quotas of 1.5 %.

The new regulation governing the market in wine will ensure a controlled increase in production potential by maintaining the current ban on new plantings until 2010. Some less-favoured regions may, however, qualify for an exemption from this ban. The new rules also replace the various existing forms of distillation with one kind, called “crisis distillation”, applicable on a voluntary basis where the market is exceptionally disrupted. Furthermore, to simplify matters, the 23 regulations that previously governed the wine sector have been consolidated into a single new regulation.

The Community premiums can be supplemented by national aids, within limits.

A horizontal regulation, applying to the various common market organisations, urges the Member States to take account of the farmers’ compliance with environmental requirements and employment thresholds when granting their direct aids.

The reductions in the market support prices are accompanied by an increase in aids to farmers with a view to improving competitiveness on both domestic and world markets, thereby reducing the risk of a return to costly overproduction, some of which cannot be sold.

A second horizontal regulation aims to decentralise the management of the European Agricultural Guidance and Guarantee Fund (EAGGF). Under this new regulation on the financing of the common agricultural policy, the Member States will be able to administer their share of the EAGGF appropriations, while having to comply with certain Community criteria.

The Agenda 2000 package for agriculture has been supplemented by a Regulation on rural development, a genuinely second pillar of the common agricultural policy, which will secure the future of the Community’s rural areas by promoting:

  • the accompanying measures introduced in 1992 (early retirement, agro-environmental measures and forestry);
  • measures to diversify agricultural holdings (support for the processing and marketing of agricultural products, vocational training, promotion and diversification of agriculture, etc.);
  • structural adaption of the holdings and the installation of young people.

The common agricultural policy has been one of the bedrock policies of European integration since its inception. Placed as it is at the heart of the social model advocated by the European Union, it will remain important for the construction of Europe.

Structural policy reform

As the Berlin European Council has stressed, improving the effectiveness of the Structural Funds and the Cohesion Fund is the cornerstone of the Agenda 2000 reforms. This means ensuring that structural assistance is more concentrated both in geographic terms and in terms of the object of assistance and it means improving the management of the Funds, while continuing to pursue the objective of economic and social cohesion in an increasingly diverse Union. The funding ceiling for the structural policy has been set at EUR 213 billion for the 2000-06 period for the current Member States; this represents a slight increase on the preceding period (1994-99: EUR 208 billion).

The policy changes agreed upon relate to the Structural Funds proper (the European Social Fund, the European Regional Development Fund, the Financial Instrument for Fisheries Guidance, the European Agricultural Guidance and Guarantee Fund, Guidance Section), and to the Cohesion Fund.

The new general conditions applying to assistance from the Structural Funds are laid down in a horizontal regulation containing general provisions on the Structural Funds.

Under this regulation, Community aid will henceforth concentrate on three priority Objectives instead of the previous six:

  • the development and adjustment of regions whose development is lagging behind (Objective 1),
  • the economic and social conversion of regions experiencing structural difficulties (Objective 2),
  • the adjustment and modernisation of education, training and employment policies and systems (Objective 3).

The principle of greater concentration has also been applied to the Community Initiatives, which fall in number from 13 to 4. The only Initiatives kept are Interreg (cross-border cooperation), Leader (rural development), Equal (the fight against discrimination in the labour market) and Urban (regeneration of cities, towns and suburbs in crisis).

The regulation also provides for more decentralised management of the Structural Funds by the Member States under the Commission’s general supervision, as well as greater participation on the part of civil society, the regional and local authorities and the social partners in drawing up and implementing the structural programmes.

The general regulation on the Structural Funds is supplemented by three more specific regulations setting out, for each of the Funds involved (the European Regional Development Fund, the European Social Fund and the Financial Instrument for Fisheries Guidance) the aims to be achieved and the types of measure qualifying for assistance. The Guidance Section of the EAGGF is henceforth covered by the new regulation on rural development.

Like the Structural Funds, the Cohesion Fund will continue to be a central pillar of economic and social cohesion in the Union in the period 2000-06.

The Cohesion Fund ‘s main objective remains unchanged: to fund environmental and trans-European transport projects in those Member States with a gross national product (GNP) below 90 % of the Community average. An additional criterion for eligibility, requiring the beneficiary Member States to draw up and comply with an economic stability programme, will continue to apply.

A mid-term review, planned for 2003, will decide which Member States no longer meet the eligibility criteria.

Internal policies

The general thrust of Agenda 2000 as regards the Union’s internal policies has been kept.
The allocation for internal policies in the perspective has been increased and should grow gradually each year from EUR 5.9 billion in 2000 to EUR 6.2 billion in 2006. Expenditure will focus on the following priorities: research, training and major networks. In the case of trans-European networks (transport, energy and telecommunications infrastructure), the new financial regulation adopted under Agenda 2000 encourages private investment and the use of venture capital for financing projects of common interest. It also encourages multi-annual programming. The networks will thus be able to mobilise enough funding to help to improve competitiveness and strengthen economic and social cohesion in the context of enlargement.

External action

The European Union will become a global player in the 2000-06 period and its commitments for foreign policies will grow gradually, from EUR 4.55 billion to EUR 4.61 billion. These resources will be mobilised through an approach that integrates all the policies while ensuring a well balanced geographic distribution, having regard to the political commitments and to the priorities given to those countries in greatest need.

Maintenance of the financial resources as a percentage of GDP will ensure a strong European presence on the world stage. The Union will continue to be the largest donor of international aid, whether humanitarian, development or reconstruction aid.

Administrative expenditure

Rising from EUR 4.56 billion in 2000 to EUR 5.1 billion in 2006, administrative expenditure will be subject to the same constraints as those imposed on the administrative budgets of the Member States; this discipline will apply equally to all the institutions.

As in the case of the other headings of the financial perspective, the intention is to add value to, and mobilise better, the human resources of a public service founded on competence, independence and permanence. The new Commission’s priority will be to rethink its own role and redefine its mission on the basis of what has already been undertaken.

The challenge of enlargement

The prospect of Union enlargement to take in ten countries of central and eastern Europe (Bulgaria, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, Slovenia) and Cyprus was one of the main reasons for the Agenda 2000 reforms.

In Part Two of the 1997 Agenda 2000 communication, the Commission included, along with its opinions on the various accession applications, recommendations on reinforcing the applicant countries’ preparations.

The main element of this “reinforced pre-accession strategy” – the conclusion of the Accession Partnerships with the eleven applicant countries – was already implemented in March 1998, two weeks before negotiations started with the six countries in the first wave to accede (Cyprus, Czech Republic, Estonia, Hungary, Poland and Slovenia).

Each Partnership takes the form of a multiannual programme comprising, in a single document, specific commitments on the part of the applicant country (on democracy, macroeconomic stabilisation and nuclear safety), a national programme to transpose the Community acquis, and the funding which the Union will employ to support the applicant country’s preparations.

When the Accession Partnerships were concluded, the Phare Programme was the main financial instrument available to the Union to kick-start the applicant countries’ pre-accession period. The programme has two priority objectives approved by the Luxembourg European Council: the improvement of administrative and legal capabilities (30 %) and investment linked to the adoption and application of the Community acquis (70 %). The Instrument for Structural Policies for Pre-accession (ISPA) and the Special Accession Programme for Agriculture and Rural Development (SAPARD) joined Phare in 1999. All three are involved in the Accession Partnerships concluded with each of the applicant countries.

A horizontal regulation on the coordination of aid to applicant countries aims to ensure coherence between the different aid forms.

Another of the Commission’s recommendations in its 1997 Agenda 2000 communication has been put into effect: while still in their pre-accession phase, all the applicant countries can take part in certain Community programmes relating to education, the environment or research and development.

In accordance with the conclusions of the European Councils in Luxembourg and Cardiff, the presentation and implementation of the future financial framework make a clear distinction between expenditure on the Union as it is currently made up on the one hand and expenditure reserved for the future acceding countries, after enlargement, on the other.

The new financial framework

The new financial framework agreed by the Commission, Parliament and the Council will enable the Union to see enlargement and its internal reforms through without compromising the principle of budgetary discipline.

On the expenditure side, the expenditure planned for the 2000-06 period will remain well below this global ceiling. The new financial perspective (2000-06), which is annexed to the new Interinstitutional Agreement on budgetary discipline and improvement of the budgetary procedure, provides for stabilisation of the ceiling for payment appropriations at EUR 89.62 billion in 2006 (compare this with EUR 89.60 billion in 2000), which represents a smaller percentage of Community GNP (a fall from 1.13 % to 0.97 %).

General budgetary discipline will be reflected in the various expenditure categories, including those considered a priority such as external action, the common agricultural policy, structural policy and certain other internal policies (trans-European networks, research, education and training, environment and small and medium-sized enterprises).

Thanks to this general budget discipline and the expected growth in the Union’s GNP, it will be possible to finance enlargement within the own resources ceiling of 1.27 % of GNP. At the next enlargement, the financial perspective will be revised to include supplementary expenditure linked to the enlargement.

An indicative financial framework established for a hypothetical Union of 21 Member States from 2002 gives, for each heading involved (agriculture, structural measures, internal policies, administration), the additional expenditure that would be occasioned by such an enlargement.

The new financial perspective provides for various mechanisms that allow some flexibility in the application of the financial framework. This involves in particular a procedure to revise the ceilings, an instrument offering general flexibility (to cover specific expenditure that cannot be financed within the ceilings) and three budgetary reserves (monetary reserve, reserve for guaranteeing loans to third countries, reserve for urgent assistance) to which the Union can turn should unexpected expenditure needs arise.

The reserve for loan guarantees to non-member states covers the operation of the Guarantee Fund for external actions. Following the adoption of the new regulation on the Guarantee Fund, which reduces the Fund’s operating parameters, the reserve was proportionately reduced in the financial perspective.

In addition to the financial perspective, the Interinstitutional Agreement includes provisions to improve the annual budgetary procedure and interinstitutional cooperation. Thus, interinstitutional collaboration is reinforced and answers have been provided on a number of issues left unresolved by the previous Agreement (classification of expenditure, inclusion of the financial provisions in legislative instruments, general requirement to have a legal basis for the expenditure).

Union expenditure is henceforth stabilised in a consolidated framework.

As regards Union revenue, the institutions have decided to maintain the general shape of the own resources system. The system is intended to ensure sufficient resources, subject to the need for strict budgetary discipline, to be simple, transparent, fair and in line with each Member State’s ability to contribute, and to have a satisfactory cost-benefit ratio.

The Berlin European Council invited the Commission to present as soon as possible a draft decision on own resources with a view to its entry into force, after ratification, at the start of 2002. The new decision will reduce the imbalances between the Member State’s contributions. Thus, the maximum rate of call on VAT will fall gradually to 0.75 % in 2002 and to 0.50 % in 2004, while the percentage retained by the Member States when collecting customs duties will increase to 25 % with effect from 2001. The UK rebate will remain, with some technical adjustments to neutralise the windfall effects due to other changes in the own resources decision or resulting from enlargement. Furthermore, the financing of the UK rebate by the other Member States will be amended so that Austria, Germany, the Netherlands and Sweden see a reduction in their financing share to 25 % of the normal contribution.

The ceiling on own resources will be maintained at 1.27 % of the Community’s GNP, corresponding to the 1999 level. The Commission has been invited to make a general reappraisal of the own resources system before 1 January 2006.

Framework of European cooperation in the youth field

Framework of European cooperation in the youth field

Outline of the Community (European Union) legislation about Framework of European cooperation in the youth field

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Education training youth sport > Youth

Framework of European cooperation in the youth field

Document or Iniciative

Resolution of the Council and of the representatives of the Governments of the Member States, meeting within the Council of 27 June 2002 regarding the framework of European cooperation in the youth field [Official Journal C 168 of 13.7.2002].

Summary

Adopting the White Paper “A new impetus for European youth”, the Commission suggested a new framework of European cooperation in the youth field, comprising two strands: firstly, the application of the open method of coordination and, secondly, taking greater account of the “youth” dimension in other policies. This resolution follows on from this White Paper by setting the priorities and the timetable for the European Union’s (EU) work up until 2004 in the field of “youth”.

For cooperation based on the open method of coordination

In the updated cooperation framework, based in particular on the open method of coordination, the Council is proposing four priority themes:

  • encouraging young people’s participation in the exercise of active citizenship and civil society. This means supporting the work of youth associations and other forms of active participation in order to improve young people’s participation and social cohesion. The exchange of good practices is essential here;
  • enhancing the information addressed to young people and existing information services for young people (successive reports deal with participation and information together);
  • promoting voluntary activities among young people. Making it easier for young people to find voluntary work so as to develop their sense of responsibility and citizenship and their active participation in society. Public authorities, businesses and civil society are called on to recognise the value of voluntary work so as to improve young people’s opportunities on the labour market;
  • encouraging greater understanding and knowledge of youth. This comprises, in particular, the compilation of studies on youth matters and the networking of research structures.

On the basis of these four priorities, the Commission will be sending targeted questionnaires to EU countries from July 2002 onwards. EU countries’ answers should be based on consultation with young people, youth associations and, where applicable, national youth councils or similar organisations. The Commission will then draw up reports in order to identify good practices of common interest for EU countries and proposals for common objectives to be adopted by the Council.

For their part, EU countries are called on to implement the measures they judge appropriate in order to achieve the common objectives set by the Council.

Taking greater account of the “youth” dimension in other policies

The Council calls on the Commission and EU countries to give the “youth” dimension greater priority in other policies and programmes. The Council, in cooperation with the Commission, reserves the right to add to the priority areas stated in the White Paper (education and lifelong learning, mobility, employment and social integration, combating racism and xenophobia and other priorities).

UPDATED FRAMEWORK FOR COOPERATION

The new framework for cooperation is updated by the resolution adopted by the Council on 24 November 2005. This framework for cooperation comprises three strands:

Promoting active citizenship among young people

The open method of coordination in the field of youth allows EU countries to cooperate with a view to sharing best practice on participation by young people, information for young people, voluntary activities and a greater knowledge of the field of youth, while respecting the areas of responsibility set out in the Treaties.

The European Pact for Youth

The European Pact highlights youth issues in key areas of the Lisbon partnership for growth and jobs, particularly in relation to young people’s access to the labour market, development of their creativity and the acquisition of entrepreneurial skills. The European Pact also highlights skills acquired through high-quality, relevant education, training and mobility experiences in the formal as well as the non-formal sector, and reconciliation of working life and family life.

Incorporating a youth dimension

Incorporating a youth dimension in other European policies will concern in particular anti-discrimination, healthy lifestyles, including sport, and research on youth issues.

Related Acts

Communication from the Commission to the Council of 25 October 2004 – Follow-up to the White Paper on a New Impetus for European Youth: evaluation of activities conducted in the framework of European cooperation in the youth field [COM(2004) 694 final – Not published in the Official Journal].

Right of residence for students

Right of residence for students

Outline of the Community (European Union) legislation about Right of residence for students

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Education training youth sport > Vocational training

Right of residence for students

This Directive will guarantee nationals of the Member States access to vocational training by setting out the framework within which their right of residence is to be exercised.

Document or Iniciative

Council Directive 93/96/EEC of the Council of 29 October 1993 on the right of residence for students.

Repealed by:

Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States amending Regulation (EEC) 1612/68 and repealing Directives 64/221/EEC, 68/360/EEC, 72/194/EEC, 73/148/EEC, 75/34/EEC, 75/35/EEC, 90/364/EEC, 90/365/EEC and 93/96/EEC.

Summary

Following an appeal by the European Parliament, the Court of Justice annulled Council Directive 90/366/EEC on 7 July 1992 but maintained its effects until the entry into force of Directive 93/96/EEC. Each Member State will take the measures necessary to facilitate exercise of the right of residence by nationals of the other Member States in order to guarantee them access to vocational training.

Member States will recognise the right of residence to any student who is a national of a Member State and who does not enjoy this right under other provisions of Community law where the student assures the relevant national authority, by means of a declaration or by such alternative means as the student may choose that are at least equivalent, that he or she has sufficient resources to avoid becoming a burden on the social security system of the host Member State during his or her period of residence. The student must also be enrolled at an accredited establishment for the principal purpose of following a vocational training course there and must be covered by sickness insurance in respect of all risks in the host Member State.

The right of residence is extended to the student’s spouse and dependent children.

The Directive does not establish any entitlement to the payment of maintenance grants by the host Member State to students benefiting from the right of residence.

Member States will issue a residence permit the validity of which may be limited to the duration of the course of studies and which will be renewable annually. Where a member of the family does not hold the nationality of a Member State, he or she will be issued with a residence document of the same validity as that issued to the national on whom he or she depends. The spouse and dependent children of a national of a Member State will be entitled to take up an employed or self-employed activity anywhere within the territory of that Member State, even if they are not nationals of a Member State.

Member States may not derogate from the provisions of this Directive save on grounds of public policy, public security or public health.

Not more than three years following the entry into force of the Directive, and then every three years, the Commission will draw up a report on the implementation of the Directive and present it to the Council and Parliament. The Commission will pay particular attention to any difficulties to which implementation of the Article concerning the granting of the right of residence might give rise in Member States. If appropriate, it will submit proposals to the Council with the aim of remedying such difficulties.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Directive 93/96/EEC 31.12.1993 OJ L 317 of 18.12.1993

Related Acts

Report from the Commission to the Council and the European Parliament of 18 March 1999 on the implementation of Directives 90/364, 90/365 and 93/96 (right of residence) [COM(99) 127 final].
Freedom of movement was originally limited to persons exercising an economic activity, but was subsequently extended to all Member State nationals, even those who were not economically active. This extension to the right of residence, which is subject to certain conditions, was formally confirmed by the incorporation into the EC Treaty of former Article 8a of the Treaty of Maastricht (now Article 18 of the EC Treaty). This Article gives every EU citizen a basic personal right to move and reside within the territory of the Member States.
The implementation of Directives 90/364, 90/365 and 93/96 has given rise to infringement procedures against nearly all the Member States, as only three had implemented the Directives by the deadline. The infringement procedures have, however, gradually been dropped as the Member States in question have adopted implementing measures.
The evaluation of the tangible implementation of the Directives has been based on the correspondence, complaints and petitions to the European Parliament and on a survey carried out among former Commission officials who, on retirement, have settled in a Member State other than that of their origin or last place of employment. Additional information has been provided by the Euro-Jus advisers’ network and by the Citizens Signpost Service. The assessments have highlighted the difficulties that citizens have encountered, such as uncertainties regarding the steps to be taken and the length and complexity of procedures for obtaining a residence permit. The authorities have also experienced difficulties, mainly in interpreting the conditions relating to financial resources and health insurance. The preliminary conclusions are that there is a need:

  • to step up efforts to inform citizens;
  • to continue to ensure strict compliance with existing Community law;
  • to make Community law on the free movement of persons easier to understand and to restructure it around the concept of “citizenship of the Union”;
  • to consider substantive changes to existing law.

Second Commission Report to the Council and Parliament on the implementation of Directives 90/364, 90/365 and 93/96 (right of residence) [COM(2003) 101 final].
This is the second report on the implementation of the three Directives on the right of residence of Union citizens and their family members, of whatever nationality, who are not economically active in the host Member State; it covers the period 1999-2002.

Report from the Commission to the Council and the European Parliament of 5 April 2006 on the implementation of Directives 90/364, 90/365 and 93/96 (right of residence) [COM(2006) 156 final].
Fifteen years after the adoption of Directive 93/66/EEC, the application of the law on the right of residence is basically satisfactory, as the declining number of infringements shows. However, the Commission has received several complaints arising from failure to comply with the Directive.

For example, the Commission decided to send a reasoned opinion to Italy on 13 December 2005 with regard to Decree of the President of the Republic No 54 of 18 January 2002 on the grounds that the text is contrary to Directive 93/96 in that it stipulates that students must provide proof that they have sufficient resources and requires family members to present proof of sufficient resources separate to that presented by the Union citizen. According to the case law of the Court of Justice, in particular in its judgments of 25 May 2000 in Case C-424/98 Commission v Italian Republic and of 20 September 2001 in Case C-184/99 Grzelczyk, Member States may not require students to provide evidence or a guarantee of a given amount of resources but must be satisfied with a declaration or other equivalent means, at the choice of the student.

Placing on the market and administration of bovine somatotrophin

Placing on the market and administration of bovine somatotrophin

Outline of the Community (European Union) legislation about Placing on the market and administration of bovine somatotrophin

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Veterinary checks animal health rules food hygiene

Placing on the market and administration of bovine somatotrophin

Document or Iniciative

Council Decision 1999/879/EC of 17 December 1999 concerning the placing on the market and administration of bovine somatotrophin (BST) and repealing Decision 90/218/EEC.

Summary

This Decision is intended to regulate the marketing and use of bovine somatotrophin, or bovine growth hormone, within the European Union (EU).

The Decision thus prohibits the placing on the market of bovine somatotrophin on EU territory for the purpose of its marketing and the administration thereof to dairy cows by any means whatsoever.

The production or importation of bovine somatotrophin in the Member States for the purposes of exporting it to third countries continues to be authorised.

In addition, undertakings which produce or are authorised to market somatotrophin are required to keep registers detailing, in chronological order, the quantities produced or acquired and the quantities sold or used for purposes other than placing on the market, as well as the names of the persons to whom such quantities were sold or from whom they were purchased.

Background

In accordance with Directive 2001/82/EC, no substance, with the exception of those given for therapeutic or prophylactic purposes, is to be administered to an animal unless it has been demonstrated by scientific studies of animal welfare or established experience that the effect of that substance is not detrimental to the health or welfare of the animal.

Somatotrophin is produced only to enhance milk production, and the Scientific Committee on Animal Health and Animal Welfare (which has been replaced by the European Food Safety Authority) stated in March 1999 that somatotrophin increased the risk of infections in cattle and that it could adversely affect reproduction and induce severe reactions in cattle to which it was administered.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Decision 1999/879/EC 01.01.2000 OJ L 331 of 23.12.1999

Quality standards for human tissues and cells

Quality standards for human tissues and cells

Outline of the Community (European Union) legislation about Quality standards for human tissues and cells

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Public health > Threats to health

Quality standards for human tissues and cells

Document or Iniciative

Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells [See amending act(s)].

Summary

Article 152 of the EC Treaty (henceforth Article 168 TFEU), requires the European Union to establish high quality and safety standards for the use of blood, organs and other substances of human origin.

In 1998, the European Group on Ethics in Sciences and New Technologies (EGE) confirmed the urgency of monitoring the conditions under which human cells and tissues circulate, the donation of which, anonymous and free, should remain basically a voluntary act. Moreover, the growing use of human tissues * and cells * in therapeutic treatment (reconstructive surgery, cancer and diabetes treatment) and the development of intra-Community trade in these substances make it necessary to define a minimum regulatory basis.

Tissues are groups of cells, which may be transplanted or implanted as viable cells, or otherwise preserved, fixed or altered. Originating from a live or dead donor *, they include: bone and musculo-skeletal elements (e.g. cartilage, tendons), cardiovascular tissues (e.g. arteries, veins, and heart valves), ocular tissue (e.g. cornea), nerve and brain cells, skin, foetal tissue, reproductive cells (e.g. semen, sperm, and ova) and stem cells.

SCOPE AND IMPLEMENTATION

This directive applies to the donation, procurement, testing, preservation, storage * and distribution * of human tissues and cells intended for human use. It also relates to manufactured products derived from human tissues and cells intended for human use. In the case of products made industrially from tissues and cells, the directive applies merely to donation, procurement and testing.

Blood and blood constituents, organs, tissues and cells used as an autologous graft * within the same surgical procedure and autologous cells for the manufacture of pharmaceuticals are excluded from the scope.

Member States must designate the competent authorities responsible for implementing the directive. They must keep the option of maintaining or introducing more stringent protective measures.

OBLIGATIONS ON MEMBER STATES’ AUTHORITIES

Supervision of human tissue and cell procurement

Member States must ensure that tissue and cell procurement and testing are carried out by persons with appropriate training and experience and that they take place in conditions approved by the competent authorities.

Accreditation, designation or authorisation of tissue establishments

All tissue establishments * must be accredited, designated or authorised by a competent authority, which may suspend or revoke such accreditation, designation or authorisation if, following inspections, it is shown that the establishment does not meet the requirements of the directive.

Inspection and control measures

The competent authorities must organise inspections and checks at tissue establishments at least every two years. The Member States, at the request of the Commission or another Member State, must provide information with information on the results of these inspections and checks.

Traceability

Member States must ensure traceability from the donor to the recipient and vice versa, of all tissues and cells procured, processed, stored or distributed on their territory. The traceability requirement also applies to all products and materials coming into contact with tissues and cells. To this end Member States shall ensure the implementation of a donor identification system which assigns a unique code to each donation and to each of the products associated with it. All tissues and cells must be identified with a label that contains information on the procedures for procurement and receipt, processing, storage and distribution.

The data necessary to ensure traceability must be kept for at least thirty years after clinical use.

Import/export of human tissues and cells

Member States must ensure that all imports and exports of human tissues and cells from and to third countries comply with the directive’s quality and safety requirements and are undertaken by accredited, designated and authorised tissue establishments so as to ensure the traceability of tissues and cells.

Register of tissue establishments and reporting obligations

The competent authorities must maintain a publicly accessible register of tissue establishments specifying the activities for which they have been accredited, designated or authorised. For their part, tissue establishments must keep a record of their activities and submit an annual report, which is also publicly accessible, to the competent authorities.

Notification of serious adverse events and reactions

Member States must provide for the creation of a system for the notification, registration and transmission of information on any incident linked to the procurement, testing, processing, storage, distribution and transplantation of tissues and cells.

DONOR SELECTION AND EVALUATION

Principles governing tissue and cell donation

Member States must encourage voluntary and unpaid donations of tissues and cells. However, donors may receive compensation strictly limited to making good the expenses and inconveniences related to the donation (e.g. travel expenses). No promotion and publicity activities are allowed in support of the donation of human tissues and cells with a view to offering or seeking financial gain or comparable advantage. The general rule is that Member States must endeavour to ensure that the procurement of tissues and cells is carried out on a non-profit basis.

Consent

The consent of donors, recipients or their next of kin is obligatory. They must receive information on the purpose and nature of the procurement, the associated risks, the analytical examinations, the recording and protection of donor details and medical confidentiality. In the case of a dead donor, all this information must be provided to the next of kin and all the necessary authorisations and consent must be obtained from the next of kin before any operation takes place.

Data confidentiality

Member States must take all necessary measures to ensure that all data collected and to which third parties have access are rendered anonymous. The recipient’s identity must never be divulged to the donor or his or her family, or vice versa. To this end, measures must be adopted to ensure data security and prevent unauthorised modifications to files and records.

Selection, evaluation and procurement

Donors must be evaluated and selected in accordance with strict standards, depending on the nature of the donor (dead or alive, specific case of children) and the type of operation.

QUALITY AND SAFETY OF TISSUES AND CELLS

Quality management

Each tissue centre must put in place a quality control system, which must include at least the following information: guidelines; operating procedures; training and reference manuals; donor records (to be kept for at least 30 years); information on the final destination of tissues or cells. These documents must be available for official inspections by agents of the competent authority.

Tissue and cell reception

Tissue and cell donations must be subjected to tests relating to specific requirements. The same applies in respect of selection, acceptance and packaging of tissues and cells.

Tissue and cell processing

Tissue establishments must include in their operating procedures all the processes that affect quality and safety. They must ensure that the equipment used, the working environment and process monitoring conditions comply with the requirements regarding the processing, storage and distribution of tissues and cells.

Tissue and cell storage conditions

Storage conditions must comply with specific requirements. Storage processes must be carried out under controlled conditions.

EXCHANGE OF INFORMATION, REPORTS AND PENALTIES

Member States must create a system for identifying human tissues and cells in order to ensure their traceability. With their collaboration, the Commission must devise a single European codification system in order to provide information on the main features and properties of the tissues and cells.

Member States must send the Commission, three years after the implementation date for this directive and every three years thereafter, a report on the activities undertaken, with reference to the provisions of this directive, and including an account of the inspection and monitoring measures taken.

Member States must lay down the rules on penalties applicable to infringements of the national provisions and notify those penalties to the Commission by the date when this directive enters into force at the latest.

Ethical considerations remain the responsibility of the Member States

In the course of the adoption process for the directive, many MEPs, concerned by the ethical aspects of the subject, advocated the inclusion of minimum requirements covering, in particular, a ban on human cloning and a guarantee that no abortions could take place with a view to obtaining foetal tissue. The outcome was that ethical considerations did not come under the scope of the directive and would therefore be left to the appreciation of the Member States. On the subject of cloning, the directive does not interfere with decisions made by Member States concerning the use or non-use of any specific type of human cells, including germ cells and embryonic stem cells.

Key terms used in the act
  • cells: individual human cells or a collection of human cells when not bound by any form of connective tissue;
  • tissue: all constituent parts of the human body formed by cells;
  • donor: every human source, whether living or deceased, of human cells or tissues;
  • storage: maintaining the product under appropriate controlled conditions until distribution;
  • distribution: transportation and delivery of tissues or cells intended for human applications;
  • tissue establishment: a tissue bank or a unit of a hospital or another body where activities of processing, preservation, storage or distribution of human tissues and cells are undertaken. It may also be responsible for procurement or testing of tissues and cells;
  • autologous use: cells or tissues removed from and applied in the same person.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 2004/23/EC

7.4.2004

7.4.2006

OJ L 102 of 7.4.2004

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 596/2009

7.8.2009

OJ L 188 of 18.7.2009

Related Acts

Implementing measures

Commission Decision 2010/453/EU of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council [notified under document C(2010) 5278] Text with EEA relevance

This Decision establishes guidelines concerning the implementation of inspection and control measures in the field of human tissues and cells. It defines the responsibilities and the qualificatoin and training requirements of inspectors. However, they are not legally binding.

Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells [Official Journal L 38 of 9.2.2006].
This implementing directive establishes specific technical requirements for each step in the human tissue and cell preparation process, in particular:

  • Requirements for the procurement of human tissues and cells;
  • Selection criteria for donors of tissues and cells;
  • Laboratory tests required for donors;
  • Tissue and/or cell donation and procurement procedures and reception at the tissue establishment;
  • Requirements for direct distribution to the recipient of specific tissues and cells.

Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (Text with EEA relevance)

This Directive applies to the coding, processing, preservation, storage and distribution of human tissues and cells, and products derived from human tissues and cells.

Implementation reports

Communication from the Commission of 6 January 2010 to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells [COM(2009) 708 final – Not published in the Official Journal].

This Communication states that the implementation of Directive 2004/23/EC by Member States is satisfactory. Member States have now appointed their competent authorities. They have also put in place an accreditation, designation, authorisation and licensing system of tissue establishments, as well as systems for reporting, investigating, registering and transmitting information about serious adverse events and reactions, and testing requirements.
However, Member States must still put in place specific systems for authorising the tissue and cell preparation processes, as well as the process of accreditation, designation, authorisation and licensing of different establishments. They must also improve the inspection and monitoring of imports and exports of tissues and cells.