Author Archives: Sigourney Rose

Competition in transport by rail, road and inland waterway

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Competition in transport by rail, road and inland waterway

Outline of the Community (European Union) legislation about Competition in transport by rail, road and inland waterway

Topics

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

Competition in transport by rail, road and inland waterway

Document or Iniciative

Council Regulation (EC) No 169/2009 of 26 February 2009 applying rules of competition to transport by rail, road and inland waterway.

Summary

This regulation repeals Regulation (EEC) No 1017/68 with the exception of Article 13(3) of that regulation, which continues to apply to decisions adopted under Article 5 of Regulation (EEC) No 1017/68 before 1 May 2004 until the date of expiration of those decisions.

As provided for by Articles 101 and 102 of the Treaty on the Functioning of the European Union (TFEU) (ex-Articles 81 and 82 of the Treaty Establishing the European Community (TEC)), anticompetitive agreements and concerted practices, as well abuses of dominance are prohibited. This regulation applies to agreements, decisions and concerted practices which have as their object or effect:

  • the fixing of transport rates and conditions;
  • the limitation or control of the supply of transport;
  • the sharing of transport markets;
  • the application of technical improvements or technical cooperation;
  • the joint financing or acquisition of transport equipment or supplies where such operations are directly related to the provision of transport services and are necessary for the joint operation of services by a grouping of road or inland waterway transport firms.

Exception for technical agreements

The prohibition provided for in Article 101(1) TFEU does not apply to agreements, decisions or concerted practices which have the object and effect of applying technical improvements or achieving technical cooperation by means of:

  • the standardisation of equipment, transport supplies, vehicles or fixed installations;
  • the exchange or pooling, for the purpose of operating transport services, of staff, equipment, vehicles or fixed installations;
  • the organisation and execution of successive, complementary, substitute or combined transport operations, and the fixing and application of inclusive rates and conditions for such operations, including special competitive rates;
  • the use, for journeys by a single mode of transport, of the routes which are most rational from the operational point of view;
  • the coordination of transport timetables for connecting routes;
  • the grouping of single consignments;
  • the establishment of uniform rules as to the structure of tariffs and their conditions of application, provided such rules do not lay down transport rates and conditions.

Exemption for groups of small and medium-sized undertakings

This regulation also provides an exemption for groups of small and medium-sized undertakings, where the individual capacity of each firm belonging to a grouping may not exceed 1 000 tonnes for road transport or 50 000 tonnes for inland waterway transport (the total carrying capacity of any grouping must not exceed 10 000 tonnes for road transport and 500 000 tonnes for inland waterway transport). However, if the implementation of agreements, decisions or concerted practices has effects which are incompatible with the requirements of Article 101(3) TFEU, undertakings may be required to make such effects cease.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 169/2009

25.3.2009

–

O J L 61 of 5.3.2009

Rules of Procedure of the European Economic and Social Committee

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Rules of Procedure of the European Economic and Social Committee

Outline of the Community (European Union) legislation about Rules of Procedure of the European Economic and Social Committee

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

Anti-discrimination and relations with civil society

Rules of Procedure of the European Economic and Social Committee

Document or Iniciative

Rules of procedure of the European Economic and Social Committee.

Summary

Article 303 of the Treaty on the Functioning of the European Union (EU) confers upon the European Economic and Social Committee (EESC) the power to self-regulate. These rules of procedure establish the functioning and organisation of the EESC.

THE MEMBERS

In accordance with Article 300 of the Treaty on the Functioning of the EU, the Committee consists of representatives of organisations of employers and of the employed. It also includes representatives of civil society, notably in socio-economic, civic, professional and cultural areas.

Moreover, the members are proposed by the governments of the Member States and are appointed by the Council, for five years. Their number cannot exceed 350.

THE COMMITTEE’S CONSTITUENT WORKING BODIES

The bureau

It consists of:

  • the President and the two Vice-Presidents;
  • the three Group Presidents (Group I: employers; Group II: employees; Group III: various economic and social interests);
  • the six section Presidents;
  • a variable number of members, which cannot exceed the number of Member States.

The President is elected from among the members of the three Groups and the Vice-Presidents are elected from among the members of the two Groups to which the President does not belong. They are elected for a period of two years, in accordance with the principle of group rotation.

The Bureau’s chief tasks are as follows:

  • it lays down the organisation and working procedures of the Committee and has political responsibility for its general management;
  • together with the President of the Committee, it exercises the budgetary and financial powers provided for in the Financial Regulation and the Committee’s Articles of Procedure;
  • it lays down the Implementing Provisions of the Rules of Procedure, whose interpretation it clarifies;
  • every six months it examines, on the basis of a report drawn up for this purpose, the action taken on opinions delivered by the Committee.

The Presidency and the President

The Presidency (the President and the two Vice-Presidents) meets with the Group Presidents to prepare the work of the Bureau and the assembly.

The President, elected for two and a half years, directs the work of the Committee. He involves the Vice-Presidents in his activities on a permanent basis. He represents the Committee in its external relations. He reports to the Committee on action and measures taken on its behalf. After his election, he presents his work programme for his term of office at the plenary assembly and presents a review of achievements at the end of his term.

The specialised sections

The Committee comprises six specialised sections:

  • Agriculture, Rural Development and the Environment;
  • Economic and Monetary Union and Economic and Social Cohesion;
  • Employment, Social Affairs and Citizenship;
  • External Relations;
  • Single Market, Production and Consumption;
  • Transport, Energy, Infrastructure and the Information Society.

Other sections may be set up by the plenary assembly on a proposal from the Bureau, in the fields covered by the Treaties. Apart from the President, every member of the Committee must be a member of at least one specialised section and a maximum of two (with exceptions). The members of the sections are appointed by for two and a half years.

The task of the specialised sections is to draw up opinions or information reports on questions referred to them. They may set up from among their members a study group or drafting group or appoint a rapporteur working alone. The rapporteur is responsible for preparing opinions and monitoring action taken on opinions by the European institutions, once the opinion has been adopted in plenary session.

The subcommittees

For some subjects, especially those where different specialised section remits overlap, the Committee may set up ad hoc sub-committees. These subcommittees operate in the same way as the specialised sections and their draft opinions are submitted directly to the Committee for discussion.

The observatories, hearings, experts

The Committee may set up observatories when the nature, extent and specific character of the subject to be dealt with calls for particular flexibility in terms of the working methods, procedures and instruments to be used.

Likewise, if an issue under discussion is of sufficient importance, the various bodies and working units of the Committee may invite guest speakers from outside the Committee to a hearing.

Finally, the President may appoint experts to clarify technical questions posed by the activities.

The consultative commissions

The Committee has the option of setting up consultative commissions. These commissions are made up of members of the Committee and of delegates from areas of civil society that the Committee wishes to involve in its work.

Dialogue between the EU’s social and economic organisations and third countries

Because of its specific mission, the Committee may maintain structured relations with economic and social councils and similar institutions and with civil society organisations in the European Union and third countries. The Committee appoints the delegations responsible for maintaining these relations.

The groups and categories

The Committee is made up of three Groups representing respectively employers, employees and the various other economic and social components of organised civil society. The Groups elect their Presidents and Vice-Presidents. They participate in the preparation, organisation and coordination of the business of the Committee.

  • The Employers’ Group (Group I) has members from private and public sectors of industry, small businesses, chambers of commerce, wholesale and retail trade, banking and insurance, transport and agriculture.
  • The employees’ group (Group II) has members from national trade union organisations, both at the level of confederations and that of sectoral federations.
  • The group including the other components of civil society (Group III) consists of members of farmers’ organisations, consumers’ organisations, small businesses, the crafts sector, liberal professions and NGOs in the field of social protection and environmental protection.

Members of the three groups of the Committee may, on a voluntary basis, form categories representing the various economic and social components of organised civil society in the European Union.

PROCEDURE OF THE COMMITTEE

Consultation of the Committee

The Committee produces opinions requested by the Council, the Commission or the European Parliament.

The Committee may also deliver opinions on its own initiative, information reports or resolutions on any question pertaining to the tasks assigned to the European Union.

Furthermore, the Committee’s opinions set out its position on the issue referred to it. They are generally accompanied by concrete proposals. In its opinions, the Committee defends the interests of civil society in particular, which it represents at European level.

Work of the specialised sections

When an opinion or information report is to be produced, the Bureau designates the specialised section that is to be responsible for preparing the work in question.

The rapporteur, assisted where appropriate by one or more co-rapporteurs and an expert, studies the question referred, collect the views expressed and, on this basis, compile the draft opinion, which is sent to the specialised section for discussion and approval by voting.

Proceedings of the plenary sessions

The Committee meets in plenary assembly during the different sessions (ten sessions each year as a rule). The Committee’s plenary assembly adopts its opinions on the basis of the opinions of the specialised sections and sends them to the Council, the Commission and the European Parliament.

The draft agenda is drawn up by the Bureau on a proposal from the Presidency in collaboration with the Group Presidents. It is sent to all Committee members and to the Council, the Commission and the European Parliament. It is submitted for approval by the assembly before the opening of the relevant session.

Opinions adopted by the Committee and minutes of Committee sessions are sent to the European Parliament, the Council and the Commission. They are published in the Official Journal of the European Union. Regardless of the legal basis for consultation (mandatory or optional referral) the Committee’s opinions are a legally necessary component in the Council’s final decisions.

FINAL PROVISIONS

Methods of voting

Except where otherwise provided, adoption of the texts and decisions of the Committee and its constituent bodies shall be by a majority of the votes. Voting is by open ballot, by recorded vote, or by secret ballot.

The urgency procedure

Where the urgency results from a deadline for the submission of its opinion imposed on the Committee, the urgency procedure may be applied. The President may, immediately and without consulting the Bureau beforehand, take all requisite steps to enable the Committee to carry out its work. He informs the members of the Bureau of the steps which he takes.

Publication and distribution of Committee texts

The Committee publishes its opinions in the Official Journal of the European Union. Likewise, the names of the members of the Committee, its Bureau and its specialised sections are published in the Official Journal.

The Secretary-General of the Committee is responsible for taking the measures necessary to guarantee the public’s right of access to the corresponding documents. Any citizen of the European Union may write to the Committee in one of the official languages and receive a reply written in the same language

Plenary sessions and meetings of the specialised sections are public. Moreover, the members of the European institutions may attend and address meetings of the Committee and its.

This summary is for information only. It is not designed to interpret or replace the reference document, which remains the only binding legal text.

Control measures: fish diseases

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Control measures: fish diseases

Outline of the Community (European Union) legislation about Control measures: fish diseases

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

Control measures: fish diseases

Community measures have been adopted to combat certain fish diseases effectively in order to stop them spreading.

Document or Iniciative

Council Directive 93/53/EEC of 24 June 1993 introducing minimum Community measures for the control of certain fish diseases [See amending acts].

Summary

This Directive establishes minimum Community measures for combating certain fish diseases in order to stop them spreading within the European Union (EU). It will be repealed on 1 August 2008 in accordance with the Directive on animal health requirements for aquaculture animals and products thereof (See “related acts” below).

The diseases covered by the Directive are divided into two groups in accordance with the classification set out in the Directive on animal health requirements for aquaculture animals and products thereof:

  • infectious salmon anaemia,
  • viral haemorrhagic septicaemia, haematopoietic necrosis, bonamiosis and marteiliosis.

All farms that have fish susceptible to these diseases must keep an up-to-date register listing all fish arriving, leaving or dying at the farm.

If fish are suspected of being infected with one of these diseases, Member States must inform the official service that is to carry out the investigations necessary to confirm or rule out the presence of the disease.

This official service must immediately place the farm under surveillance until the presence of the suspected disease has been ruled out.

If the disease is confirmed to be present, the official service must take a number of additional measures, such as removing all live fish, disinfecting the pools and disposing of the diseased fish.

If there are suspected cases of one of these diseases on an approved farm, Member States must carry out an epizootic investigation. If this confirms the presence of the disease, the farm is considered suspect and the appropriate measures must be applied.

Where fish on a non-approved farm are suspected of being infected with one of these diseases, Member States must take a number of measures, including taking steps to confirm whether or not the disease is present and drawing up a list of infected farms.

Each Member State must designate a reference laboratory to carry out the analyses required by this Directive. These laboratories must cooperate with the Community reference laboratory in Aarhus (Denmark), whose role is coordinate and provide assistance.

Commission experts may carry out on-the-spot checks to verify that this Directive is being properly applied.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Directive 93/53/EEC 19.7.1993 1.7.1994 OJ L 175, 19.7.1993
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Directive 2000/27/EC 13.5.2000 1.12.2000 OJ L 114, 13.5.2000
Decision 2001/288/EC 10.4.2001 – OJ L 99, 10.4.2001
Act of Accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia 1.5.2004 – OJ L 236, 23.9.2003
Decision 2006/911/EC 12.12.2006 – OJ L 346, 9.12.2006
Directive 2006/88/EC 13.12.2007 1.5.2008 OJ L 328, 24.11.2006
Directive 2006/104/EC 1.1.2007 – OJ L 363, 20.12.2006
Decision 2007/729/CE 13.11.2007 – OJ L 294, 13.11.2007

Related Acts

Councilof 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals [Official Journal L 328 of 24.11.2006].
This Directive updates, recasts and consolidates the animal health rules for trade in aquaculture products (fish, molluscs and crustaceans), including those on the prevention and control of diseases that affect these animals and products.

Commission Decision 2003/466/EC of 13 June 2003 establishing criteria for zoning and official surveillance following suspicion or confirmation of the presence of infectious salmon anaemia (ISA) [Official Journal L 156 of 25 June 2003].

Commission Decision 2001/183/EC of 22 February 2001 laying down the sampling plans and diagnostic methods for the detection and confirmation of certain fish diseases and repealing Decision 92/532/EEC [Official Journal L 67 of 9 March 2001].

 

Petrol vapour recovery during refuelling of vehicles

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Petrol vapour recovery during refuelling of vehicles

Outline of the Community (European Union) legislation about Petrol vapour recovery during refuelling of vehicles

Topics

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

Environment > Air pollution

Petrol vapour recovery during refuelling of vehicles

Document or Iniciative

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.

Summary

This Directive aims at ensuring that harmful petrol vapour displaced from the fuel tank of a motor vehicle during refuelling at a service station is recovered. The petrol pumps of many service stations in the European Union (EU) will have to be equipped to recover this vapour.

Service stations

This Directive applies to new service stations or those having undergone major refurbishment, of which the annual throughput must be in excess of 500 m3 of petrol. It imposes upon operators of these service stations an obligation to install a Stage II Petrol Vapour Recovery system or “Stage II PVR”. Furthermore, service stations with a throughput in excess of 100 m3 per year which are located under living accommodation must also install this equipment.

Larger existing service stations with a throughput in excess of 3 000 m3 per year must also apply Stage II PVR by 2018.

Stage II PVR equipment has already been installed in service stations in almost 50 % of the Member States. This Directive extends this practice to the whole European Union.

Minimum level of petrol vapour recovery

The Stage II PVR equipment installed on petrol pumps in service stations must capture 85 % of petrol vapour. The petrol vapour capture efficiency of such systems must be certified by the manufacturer in accordance with the relevant European technical standards or type approval procedures or, if there are no such standards or procedures, with any relevant national standard.

Stage II PVR equipment draws off petrol vapour. It is then transferred to a storage tank at the service station. The vapour/petrol ratio shall be equal to or greater than 0.95 but less than or equal to 1.05.

Periodic checks

The petrol vapour capture efficiency of Stage II petrol vapour recovery systems must be tested at least once a year. This test may be carried out either by checking the vapour/petrol ratio defined above under simulated petrol flow conditions, or by any other appropriate methodology.

If the service station has automatic monitoring equipment, capture efficiency shall be tested at least once every three years. If the tests detect anomalies, the service station operator must rectify the fault within seven days.

Consumer information

All service stations which have installed Stage II petrol vapour recovery systems must inform consumers thereof. In order to do this, the operator may place a sign, sticker or other notification on, or in the vicinity of, the petrol dispenser.

Context

This Directive comes under the Sixth Environment Action Programme adopted in July 2002 which established the need to reduce air pollution to levels which minimise harmful effects on human health and the environment.

This Directive supplements the technical specifications for the storage of petrol. These technical specifications are harmonised at European level by Directive 94/63/EC which forms Stage I of petrol vapour recovery.

References

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

Directive 2009/126/EC

31.10.2009

1.1.2012

OJ L 285 of 31.10.2009

Enlargement 2004 and 2007

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Enlargement 2004 and 2007

Outline of the Community (European Union) legislation about Enlargement 2004 and 2007

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

Enlargement 2004 and 2007

The fifth enlargement is historic and unprecedented in the history of the European Union. The ten Central and Eastern European countries, together with Cyprus and Malta, joined the EU in two successive waves in 2004 and 2007. In this context, the EU paved the way for the current enlargement process by establishing suitable instruments to be able to respond not only to the needs of the candidate countries, but also to the specific needs of the EU to receive them.

  • Bulgaria – adoption of the community acquis
  • Romania – adoption of the community acquis
  • Cyprus – adoption of the community acquis
  • Estonia – adoption of the community acquis
  • Hungary – adoption of the community acquis
  • Latvia – adoption of the community acquis
  • Lithuania – adoption of the community acquis
  • Malta – adoption of the community acquis
  • Poland – adoption of the community acquis
  • Czech republic – adoption of the community acquis
  • Slovakia – adoption of the community acquis
  • Slovenia – adoption of the community acquis
  • Partnership for the accession of Cyprus
  • Partnership for the accession of Estonia
  • Partnership for the accession of Hungary
  • Partnership for the accession of Latvia
  • Partnership for the accession of Lithuania
  • Partnership for the accession of Malta
  • Partnership for the accession of Poland
  • Partnership for the accession of the Czech Republic
  • Partnership for the accession of Slovakia
  • Partnership for the accession of Slovenia

HISTORY OF EASTERN ENLARGEMENT

General Provisions

  • The 2004 enlargement: the challenge of a 25-member EU
  • Enlargement, two years after – an economic success
  • The communication strategy on enlargement
  • Participation of the Central and Eastern European candidate countries in Community programmes
  • The challenge of enlargement
  • Agenda 2000: for a stronger and wider Union

Sectoral approach

  • Enlargement of the euro area after 1 May 2004
  • Joint assessments of employment policies in the candidate countries
  • Community response to the flooding in central Europe
  • Strengthening administrative and judicial capacity
  • Nuclear safety in the Newly Independent States and Central and Eastern Europe
  • Accession strategies for the environment
  • Community action for regions bordering the candidate countries

PRE-ACCESSION INSTRUMENTS 2000-2006

  • Phare Programme
  • Pre-accession agricultural instrument (SAPARD)
  • Instrument for structural policy for pre-accession
  • Cross-border cooperation programme
  • Coordination instrument

ENLARGEMENT 2007

  • Roadmaps for Bulgaria and Romania

Bulgaria

  • Partnership for the accession of Bulgaria

Romania

  • The Accession Partnership with Romania

ENLARGEMENT 2004

Cyprus

  • Partnership for the accession of Cyprus

Estonia

  • Partnership for the accession of Estonia

Hungary

  • Partnership for the accession of Hungary

Latvia

  • Partnership for the accession of Latvia

Lithuania

  • Partnership for the accession of Lithuania

Malta

  • Partnership for the accession of Malta

Poland

  • Partnership for the accession of Poland

Czech Republic

  • Partnership for the accession of the Czech Republic

Slovakia

  • Partnership for the accession of Slovakia

Slovenia

  • Partnership for the accession of Slovenia

Promoting young people's initiative, enterprise and creativity

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Promoting young people’s initiative, enterprise and creativity

Outline of the Community (European Union) legislation about Promoting young people’s initiative, enterprise and creativity

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

Promoting young people’s initiative, enterprise and creativity

Document or Iniciative

Resolution of the Council and of the representatives of the Governments of the Member States meeting within the Council of 28 June 2001 on promoting young people’s initiative, enterprise and creativity: from exclusion to empowerment [Official Journal C 196 of 12 July 2001].

Summary

Involvement of the Commission and the Member States

This resolution invites the Commission:

  • to associate young people in the preparation of Community cooperation policy geared to youth, education and training;
  • to ensure that the “youth” dimension is taken into account in Community activities;
  • to take stock of the experience gained from the Youth programme;
  • to take the “youth” dimension into account in devising new strategies for lifelong learning.

This resolution invites the Member States:

  • to encourage young people’s initiative, enterprise and creativity in all fields;
  • to provide young people with better information about the opportunities and support available;
  • to promote pupil participation, initiative and creativity for active citizenship;
  • to promote student participation in higher education, in vocational training and in research;
  • to take note of young people’s initiative, enterprise and creativity in devising innovative methods of teaching and learning;
  • to integrate young people’s initiative, enterprise and creativity into practical employment-oriented measures;
  • to promote the sharing of good practice.

This resolution invites the Commission and Member States:

  • to integrate young people’s initiative, enterprise and creativity in combating social exclusion;
  • to encourage young people’s initiative and creativity in combating racism, xenophobia and intolerance;
  • to promote dissemination of best practice;
  • to encourage young people’s initiative, enterprise and creativity as a driving force for employment policy;
  • to take stock of the experience gained from the Socrates and Leonardo programmes in order to make the most of young people’s initiative and creativity;
  • to promote research and sharing of experience;
  • to develop young people’s initiative, enterprise and creativity through non-formal learning;
  • to promote cooperation between the Member States, the Commission and international organisations;
  • to clarify how young people’s initiative, enterprise and creativity are put to use as a resource;
  • to educate young people as critical consumers and practitioners in sectors such as music, film and other creative industries.

Context

Many Community initiatives have been launched to encourage young people’s initiative, enterprise and creativity, most of them stemming from education and training policy (e.g. the Youth and Youth for Europe programmes, the resolution on the social inclusion of young people, the resolution on youth participation, the memorandum on lifelong learning) and employment policy (e.g. the multiannual programme for enterprise and entrepreneurship, and the guidelines for employment).

Related Acts

Communication from the Commission to the Council, the European Parliament, the European Economic and Social committee and the Committee of the Regions – Implementing the Community Lisbon Programme: Fostering entrepreneurial mindsets through education and learning

Council Decision 2001/63/ECof 19 January 2001 on guidelines for Member States’ employment policies for the year 2001 [Official Journal L 022 of 24.01.2001].

Council Decision 2000/819/EC of 20 December 2000 on a multiannual programme for enterprise and entrepreneurship, and in particular for small and medium-sized enterprises (SMEs) (2001-2005) [Official Journal L 333 of 29.12.2000].

 

A new impetus for cooperation in vocational education and training

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A new impetus for cooperation in vocational education and training

Outline of the Community (European Union) legislation about A new impetus for cooperation in vocational education and training

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

A new impetus for cooperation in vocational education and training

Document or Iniciative

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 9 June 2010 – A new impetus for European cooperation in Vocational Education and Training to support the Europe 2020 strategy [COM(2010) 296 final – Not published in the Official Journal].

Summary

Building on and contributing to the Europe 2020 strategy and the ET 2020 strategic framework, this communication proposes a new vision for vocational education and training (VET) in the European Union (EU). It focuses on elements central to the Copenhagen process, drawing on the ET 2020 strategic objectives.

Making lifelong learning and mobility a reality

Access to all levels of training must be maximised, which might entail significant changes to the current provision of VET. It is essential that the manner in which learning outcomes are acquired, assessed and lead to qualifications is made more flexible. This includes an enhanced role of, and the need to improve the provision of continuing VET by, employers, traditional initial training providers and higher education institutions. An outcomes-based approach for vocational qualifications based on the European Qualifications Framework (EQF) and the European Credit systems for Vocational Education and Training (ECVET) can help validate skills acquired outside of formal education and training. At the same time, the pathways between VET and higher education must be opened up and tertiary VET programmes should be developed. The transition from training to employment as well as between jobs must also be facilitated, to which end guidance and counselling services should be provided.

Transnational mobility must become the norm in VET pathways, particularly in initial VET, for both learners and trainers. It is also essential that mobility periods are recognised via the ECVET. Appropriate support structures should be established to facilitate training placements, and virtual mobility (through eLearning) should be used to complement physical mobility.

Improving the quality and efficiency of education and training

The quality and efficiency of VET, the high standards of VET teachers and trainers, the relevance of VET to labour market needs and the pathways VET opens to further learning contribute to its attractiveness. To improve the quality and efficiency of VET:

  • quality assurance systems must be implemented at national level on the basis of the European Quality Assurance Reference Framework for VET;
  • the continuing development of skills and competencies of teachers and trainers must be reviewed in light of their evolving roles;
  • the continuing development of key competences together with vocational skills that are relevant to labour market needs must be ensured, in particular through different forms of work-based learning;
  • forward planning tools to match skills and jobs should be developed and partnerships with relevant stakeholders should be created to strengthen labour market relevance.

Promoting equity, social cohesion and active citizenship

VET systems have an important role in combating social exclusion and promoting inclusive growth. Disadvantaged learners may profit more from non-classroom work-based learning that is relevant to the local labour market. Integrated in mainstream VET, training should be flexible and modularised, providing individualised learning pathways. Upward social mobility can be strengthened by facilitating the transition from VET to higher education. At the same time, accessible and targeted guidance services must be provided. The constant monitoring of VET learners’ employment rates, particularly those of disadvantaged learners, is also essential.

Enhancing creativity, innovation and entrepreneurship

The framework in which VET is provided should foster creativity and innovation, encouraging risk-taking and experimentation. To provide accessible and flexible training, experience-based and active learning should be promoted, including through eLearning. Education for entrepreneurship should also be promoted in order to instil a sense of initiative and creativity and the ability to concretise ideas. Entrepreneurship should also form part of VET teachers’ and trainers’ competence framework.

International dimension

Dialogue and mutual learning on EU VET policy should be further developed with the international community. With the support of the European Training Foundation (ETF), structured cooperation on VET should be strengthened with neighbourhood and enlargement countries, with a view to improving:

  • transnational collaboration;
  • regional development;
  • the management of legal mobility;
  • the fight against illegal migration.

In particular, cooperation in research activities and evidence-based policy making should be further strengthened with the Organisation for Economic Cooperation and Development (OECD), the United Nations Educational, Scientific and Cultural Organisation (UNESCO) and the International Labour Organisation (ILO).

The way forward

At the end of 2010, cooperation in VET should be re-launched in close partnership with relevant stakeholders in EU countries and the Commission. An ambitious modernisation agenda for VET must be set out with priorities for the next 10 years, including reviewable short term objectives. The Europe 2020 national programmes should implement this VET reform.

Official controls on products of animal origin intended for human consumption

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Official controls on products of animal origin intended for human consumption

Outline of the Community (European Union) legislation about Official controls on products of animal origin intended for human consumption

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

Official controls on products of animal origin intended for human consumption

Document or Iniciative

Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption [See amending acts].

Summary

Community establishments and imports are subject to the controls laid down by this Regulation.

COMMUNITY ESTABLISHMENTS

The competent authorities approve establishments that comply with Community regulations on hygiene of food.

Food business operators must provide the competent authority with all the assistance needed in carrying out the control, notably as regards access to premises and the presentation of documentation or records.

The official controls include audits of good hygiene practices and HACCP principles (Hazard Analysis and Critical Control Points), as well as specific controls whose requirements are determined by sector (fresh meat, bivalve molluscs, fishery products, milk and dairy products).

FRESH MEAT

Official veterinarian

Appointed and authorised by the competent authority, the official veterinarian will have solid professional qualifications, recognised by having passed an aptitude test covering all the subjects for which he is competent. He will audit:

  • the permanent application of good hygiene practice (maintenance of plant structure and equipment, plant hygiene, staff hygiene, training, processing of animal by-products not intended for human consumption, etc.);
  • the procedures based on the HACCP (Hazard Analysis and Critical Control Point) system, notably in the following areas: compliance of products of animal origin with microbiological criteria, absence of excessive quantities of prohibited substances, contaminants or chemical residues, absence of physical hazards, such as foreign bodies, absence of patho-physiological abnormalities or changes, absence of contamination.

The inspection tasks of the official veterinarian concern the following aspects:

  • food chain information giving health data concerning animals which have been sent or will be sent for slaughter.
  • ante-mortem inspections (except for wild game). Within 24 hours of arrival at the slaughterhouse and less than 24 hours before slaughter, all animals must undergo ante-mortem inspections. The official veterinarian verifies the existence of any sign indicating that the welfare of the animals has been compromised or signs of any condition which might adversely affect human or animal health.
  • animal welfare during transport and during slaughter.
  • post-mortem inspections. Carcases and offal of slaughtered animals are subjected to visual inspection and mandatory incisions. With a view to a definitive diagnosis, or to detect the presence of an animal disease or other factors rendering the meat unfit for consumption, the official veterinarian may conduct an additional examination and take samples for scientific analysis in the laboratory. Adequate precautions must be taken to avoid contamination during examination.
  • specified Risk Material. In compliance with Community legislation on transmissible spongiform encephalopathy (TSEs), specified risk material is sampled, separated and, where appropriate, marked.
  • laboratory testing. The official veterinarian takes samples to detect the possible presence of zoonoses, TSE, other diseases or unauthorised substances.
  • health marking for stock cattle, and large farmed and wild game. After completion of the post-mortem inspection, meat fit for consumption must be health-marked in ink or by hot branding. This mark is oval, legible, indelible, and readily visible to the controlling authorities, showing the name of the consigning country and the approval number of the establishment. The nature and content of this marking must follow specific provisions, depending on the type of meat and the type of packaging.

The results of inspections must be recorded in writing and incorporated in the relevant databases. Whenever a problem is identified, this information must be communicated to the operator of the meat establishment, the competent authority and the persons responsible for supervising the holding of provenance of the animals. The official veterinarian shall take all necessary measures and precautions to prevent the possible spread of the infectious agent.

Decisions following controls

Where controls reveal deficiencies or irregularities, appropriate measures must be taken. These include:

  • decisions concerning food chain information. The animals are not accepted for slaughter intended for human consumption in the following cases: they come from a region which is subject to a movement prohibition, rules on the use of veterinary medical products have not been complied with, or there is a risk for human or animal health. When the information on the animals provided by the operator does not correspond with the true situation, the competent authority may take action against the operator such as extra controls at the operator’s expense.
  • decisions concerning live animals. When the animals’ identity is not ascertainable, they must be killed separately and declared unfit for human consumption. The same applies to animals presenting a transmissible pathological risk; these must undergo detailed ante-mortem examination. In addition, the veterinary official supervises the slaughter of animals in the framework of specific disease eradication schemes (TSE, brucellosis tuberculosis, salmonella).
  • decisions concerning animal welfare. The official veterinarian will make sure the rules concerning animal welfare during transport and slaughter are complied with and, if necessary, take the necessary corrective measures.
  • decisions concerning meat. All meat which may constitute a danger to human health shall be declared unfit for human consumption. This includes meat from animals which have not undergone ante-mortem inspection (excluding wild game), meat from animals whose offal has not undergone post-mortem inspection, meat from animals which were dead before slaughter, stillborn, unborn or slaughtered under the age of seven days, meat from animals affected by a notifiable animal disease, meat not in conformity with the biological and radioactivity criteria, meat containing specified risk materials, chemical residues or veterinary medicinal products in excess of the permitted limits. In addition, the veterinarian may impose requirements concerning the use of meat derived from animals having undergone emergency slaughter outside the slaughterhouse.

Responsibilities and frequency of controls

The national authority shall guarantee appropriate official supervision in meat establishments. The nature and intensity of the official supervision shall be based on a regular assessment of the risks to human and animal health and the animal welfare aspects. At least one official veterinarian should be present throughout both the ante-mortem and post-mortem inspections, although some flexibility may be applied in the case of some establishments slaughtering or processing game.

In order to carry out official inspections, a certain number of professional qualifications are required. The veterinarian must also pass a test organised by the competent authority, confirming candidates’ knowledge in all the areas relating to their work (in particular national and Community legislation on health, good hygiene and farming practices, HACCP principles, and relevant aspects as regards epidemiology and TSEs). Moreover, each veterinarian must have 200 hours of practical training before being allowed to work on their own.

When carrying out inspections, the official veterinarian may be assisted by official auxiliaries placed under his authority. Auxiliaries, whose tasks are clearly defined, must first have received training (at least 500 hours of theoretical training and 400 hours of practical training) which must be approved by an aptitude test covering all the subjects for which they are competent.

Moreover, Member States may authorise staff of poultry and rabbit slaughterhouses to carry out certain inspection activities normally carried out by official auxiliaries. The staff in question must have received specific prior training.

LIVE BIVALVE MOLLUSCS

The competent authority must fix the location and the boundaries of production areas for bivalve molluscs. The production areas from which harvesting of bivalve molluscs is authorised are divided into three classes:

  • Class A areas: areas from which molluscs may be collected for direct human consumption;
  • Class B areas: areas from which molluscs may be collected but may be placed on the market for human consumption only after treatment in a purification centre or after relaying;
  • Class C areas: areas from which molluscs may be collected but may be placed on the market only after relaying over a long period (at least two months), whether or not combined with purification.

In order to enable production areas to be classified the competent authority must make an inventory of the sources of pollution from human or animal origin and examine the quantities of organic pollutants released during the different periods of the year and their circulation characteristics. It must establish a sampling programme to verify the microbiological quality of the bivalve molluscs and check for the presence of toxin-producing plankton and chemical contaminants. This programme is based on sampling plans that determine the frequency of these controls.

Where the results of sampling reveal non-compliance with the essential health standards, the harvesting of molluscs shall be prohibited within the production area concerned. The production area may not be re-opened until two consecutive analyses separated by at least 48 hours produce satisfactory results.

In addition to the monitoring of relaying and production zones, a control system including laboratory tests must be set up in order to verify compliance with the requirements applicable to the end products.

FISHERY PRODUCTS

In addition to the common control requirements, specific official controls on fishery products shall be carried out at the time of landing or before first sale at an auction or wholesale market. The official controls shall include:

  • organoleptic surveillance testing;
  • total volatile basic nitrogen tests;
  • histamine testing;
  • surveillance testing for contaminants;
  • microbiological checks;
  • parasite screening tests;
  • checks for the possible presence of poisonous fish species or fish containing biotoxins.

Fishery products shall be declared unfit for human consumption if organoleptic, chemical or microbiological checks on such products reveal the presence in excessive quantities of substances dangerous to human health.

MILK AND DAIRY PRODUCTS

In addition to the common control requirements, specific official controls shall include:

  • Inspection of holdings. Animals must undergo regular veterinary inspections to ensure compliance with the health requirements for raw milk production (health status of the animals, use of veterinary medicinal products).
  • Control of raw milk upon collection. The competent authority shall organise control schemes in order to ensure compliance with the standards that apply to raw milk. When the raw milk fails to meet mandatory food safety criteria the competent authority may suspend the delivering of the milk in question and ask the farmer to take the necessary measures.

IMPORTATION OF PRODUCTS OF ANIMAL ORIGIN FROM NON-EU MEMBER COUNTRIES

List of Non-EU Member Countries

The Commission, assisted by the Standing Committee on the Food Chain, draws up lists of third countries or parts of third countries from which the importation of products of animal origin is authorised. A third country may only be listed if the country in question provides the appropriate guarantees and after a Community inspection has been carried out in the country.

Furthermore, the Commission draws up a list of establishments from which products of animal origin may be imported or dispatched. An establishment may only be listed if the competent authority in the third country of origin guarantees that the said establishment complies with the relevant Community requirements. Regular Community inspections are carried out in order to check these guarantees.

CONTEXT

This Regulation forms part of the ‘hygiene package’ – a body of law laying down hygiene rules for foodstuffs, which, in addition to this Regulation, includes the following acts:

  • Regulation (EC) No 852/2004 defining the food safety objectives to be achieved, leaving the food operators responsible for adopting the safety measures to be implemented in order to guarantee food safety;
  • Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin in order to guarantee a high level of food safety and public health.

The following acts supplement Community legislation on the hygiene of foodstuffs:

  • Regulation (EC) No 178/2002 containing general principles of food law, which explains food safety procedures and establishes the European Food Safety Authority;
  • Regulation (EC) No 882/2004 reorganising official controls on foodstuffs and feedingstuffs so as to integrate controls at all stages of production and in all sectors;
  • Directive 2002/99/EC laying down the conditions for placing products of animal origin on the market and the restrictions applicable to products from non-EU countries or regions of non-EU countries subject to animal health restrictions.

References

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

Regulation (EC) No 854/2004

20.05.2004

–

OJ L 139 of 30.4.2004
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 882/2004

20.05.2004

–

OJ L 165 of 30.4.2004

Regulation (EC) No 219/2009

20.4.2009

–

OJ L 87 of 31.3.2009

Successive amendments and corrections to Regulation (EC) No 854/2004 have been incorporated in the basic text. This consolidated versionhas a purely documentary value”.

AMENDMENT OF ANNEXES

Annexe I – Fresh meat:

Regulation (EC) No 2074/2005 [Official Journal L 338 of 22.12.2005];
Regulation (EC) No 2076/2005 [Official Journal L 338 of 22.12.2005];
Regulation (EC) No 1663/2006 [Official Journal L 320 of 18.11.2006];
Regulation (EC) No 1791/2006 [Official Journal L 636 of 20.12.2006];
Regulation (EC) No 1021/2008 [Official Journal L 277 of 18.10.2008].

Annexe II – Live bivalve molluscs:

Regulation (EC) No 2074/2005 [Official Journal L 338 of 22.12.2005];
Regulation (EC) No 1021/2008 [Official Journal L 277 of 18.10.2008];
Regulation (EU) No 505/2010 [Official Journal L 149 of 15.6.2010].

Annexe III – Fishery products:
Regulation (EC) No 2074/2005 [Official Journal L 338 of 22.12.2005];
Regulation (EC) No 1021/2008 [Official Journal L 277 of 18.10.2008].

Annexe IV – Raw milk, colustrum, dairy products and colostrum based products
Regulation (EC) No 1663/2006 [Official Journal L 320 of 18.11.2006].

Annexe VI – Requirements regarding certificates accompanying imports
Regulation (EC) No 1663/2006 [Official Journal L 320 of 18.11.2006].

Related Acts

Report from the Commission to the Council and the European Parliament on the experience gained from the application of the hygiene Regulations (EC) No 852/2004, (EC) No 853/2004 and (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 on they hygiene of foodstuffs [COM(2009) 403 final – Not published in the Official Journal].
The Commission reviews the experience gained from the application of the aforementioned regulations. It presents the progress achieved and the difficulties encountered by all the interested actors in the implementation of the 2006 – 2008 hygiene package. It concludes that overall Member States have taken the necessary administrative and control steps to ensure compliance, but that there is still room for improvement in relation to implementation. The main difficulties identified are in relation to:

  • certain exemptions from the scope of the hygiene Regulations;
  • certain definitions laid down in these Regulations;
  • certain practical aspects concerning the approval of establishments handling foods of animal origin and the marking of such foods;
  • the import regime for certain foods;
  • the implementation of HACCP-based procedures in certain food businesses; and
  • the implementation of official controls in certain sectors.

This report does not suggest any detailed solutions. However, on the basis of the difficulties identified, the Commission will consider the need for any proposals to improve the food hygiene package.

Quality and safety standards for human blood and blood components

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Quality and safety standards for human blood and blood components

Outline of the Community (European Union) legislation about Quality and safety standards for human blood and blood components

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 and safety standards for human blood and blood components

Document or Iniciative

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC [See amending acts].

Summary

The purpose of this Directive is to set standards of quality and safety for blood * and blood components * throughout the blood transfusion chain. To this end, it applies to the collection and testing of human blood and blood components, irrespective of their final destination. It also applies to the processing, storage and distribution * of human blood and blood components intended for transfusion.

Obligations incumbent upon the authorities of the Member States

With regard to the licensing of blood establishments, Member States shall ensure that activities relating to the collection and testing of human blood and blood components are undertaken only by the blood establishments * which have been designated, authorised, accredited or licensed by the competent authority for that purpose.

All the information to be provided by blood establishments to the competent authority for the purposes of designation, authorisation, accreditation or licensing is specified in Annex I. This includes general information (identification of the blood establishment, qualifications and contact details of responsible persons, etc.) and a description of the quality system (quality manual, qualifications of personnel, hygiene provisions, details of procedures for assessment of donors, etc.).

The competent authority must organise inspections * and appropriate control measures in blood establishments at least once every two years. It must also organise appropriate measures in the event of any serious adverse event * or reaction or suspicion thereof.

Responsible person

Blood establishments must designate a person responsible for:

  • ensuring that every unit of blood or of blood components has been collected and tested and, when intended for transfusion, has been prepared, stored and distributed in compliance with the laws in force in the Member State;
  • communicating to the competent authority the information necessary for the designation, authorisation, accreditation or licensing procedure;
  • implementing the requirements relating to quality management in blood establishments (cf. below).

These various tasks may be delegated to other persons who possess the necessary qualifications and experience.

The Directive stipulates minimum conditions of qualification for the person responsible for the blood establishment (university-level qualification in the field of medical or biological sciences and at least two years’ post-graduate practical experience).

The personnel of the establishment must also possess the necessary qualifications and receive relevant and regular training.

Quality management

A quality system based on the principles of good practice must be introduced by each blood establishment and hospital blood banks *. The Commission is responsible for establishing the Community standards and specifications relating to this system.

With regard to documentation and record-keeping, the blood establishments must keep the following up to date:

  • documentation on operational procedures, guidelines, training and reference manuals, and reporting forms;
  • records of the information required in Annexes II (report concerning the preceding year’s activity) and IV (basic testing requirements for whole blood and plasma donations).

The competent authority must keep records of applications made by establishments for accreditation, provisions relating to existing establishments and notifications of any serious adverse reactions or events.

Haemovigilance *

The traceability of blood and blood components, from donor to recipient and vice versa, must be guaranteed. In order to ensure full traceability, blood establishments and hospital blood banks must implement a system permitting unmistakable identification of each single blood donation and each unit of blood and components thereof.

A system permitting an equivalent level of traceability must be operated with regard to blood and blood components imported from third countries.

Product labelling must match the requirements listed in Annex III.

Any serious adverse events must be notified to the competent authority. Blood establishments and hospital blood banks must have in place a procedure for the efficient withdrawal from distribution of blood or blood components associated with a serious adverse event.

Conditions relating to donations and donors in order to ensure the quality and safety of blood and blood components

Donors must be provided with certain information when giving blood. This includes information on the characteristics of blood and blood products, and an undertaking by the blood collection centre to contact the donor if the results of the tests reveal any form of pathology.

Certain information must be obtained from donors, for example their identification, their state of health and medical history, and a signature confirming that the donor has read and understood the information provided.

The donor is subject to an evaluation procedure and must satisfy the criteria concerning physical suitability, such as age, and donation criteria, such as the time interval between donations. Permanent deferral criteria are also drawn up in order to protect both the donor and the recipient (for example in case of diseases that could place either the donor or the recipient in danger).

An examination of the donor, including an interview, shall be carried out before any donation of blood or blood components.

Measures must be taken to encourage voluntary and unpaid blood donations, with a view to ensuring that blood and blood components are as far as possible provided from such donations.

Each donation of blood or blood components must undergo certain tests (listed in Annex IV). The same applies to blood or blood components imported into the Community.

Data protection and confidentiality

All data, including genetic information, must be rendered anonymous so that the donor is no longer identifiable.

Community code relating to medicinal products for human use

This Directive amends the Community code relating to medicinal products for human use in order to ensure that the safety and quality standards are the same whatever the intended purpose of blood or blood components, including their use as raw materials in the production of medicinal products.

Background

The purpose of this Directive is to set standards of quality and safety for blood and blood components throughout the blood transfusion chain in the European Union (EU). It is a response not only to the need to protect public health but also to the need to ensure that the internal market functions properly by facilitating the movement of these products within the EU.

Key terms used in the act
  • Blood component: a therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods (centrifugation, filtration and freezing).
  • Hospital blood bank: a hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities.
  • Distribution: the act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood and plasma derived products. It does not include the issuing of blood or blood components for transfusion.
  • Blood establishment: any structure or body that is involved in any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage, and distribution when intended for transfusion.
  • Haemovigilance: a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors.
  • Serious adverse event: any untoward occurrence associated with the collection, testing, processing, storage and distribution of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity.
  • Inspection: formal and objective control according to adopted standards to assess compliance with this Directive and other relevant legislation and to identify problems.
  • Blood product: any therapeutic product derived from human blood or plasma.
  • Blood: whole blood collected from a donor and processed either for transfusion or for further manufacturing.
  • Autologous transfusion: a transfusion in which the donor and the recipient are the same person and in which pre-deposited blood and blood components are used.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Directive 2002/98/EC

8.2.2003

8.2.2005

OJ L 33 of 8.2.2003
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 Directive 2009/135/EC of 3 November 2009 allowing temporary derogations to certain eligibility criteria for whole blood and blood components donors laid down in Annex III to Directive 2004/33/EC in the context of a risk of shortage caused by the Influenza A(H1N1) pandemic [Official Journal L 288 of 4.11.2009].
This implementing Directive, applicable until 30 June 2009, gave Member States the possibility to derogate exceptionally and conditionally from certain eligibility criteria for blood donors in order to guarantee blood supply in the case of an Influenza A(H1N1) pandemic, whilst ensuring the health of blood and blood component donors and recipients is protected.

Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments [Official Journal L 256 of 1.10.2005].

This implementing Directive lays down the specific technical requirements for a quality system for blood establishments.
Member States must ensure that the quality system in place in all blood establishments and hospital blood banks complies with the Community standards and specifications set out in the Annex to the Directive.

Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events [Official Journal L 256 of 1.10.2005].

This implementing Directive lays down the technical requirements to ensure traceability of blood and blood components from the donor to the recipient, and the procedures.
Member States must ensure that the systems and procedures for traceability and notification of serious adverse reactions in place at national level and in all blood establishments and hospital blood banks comply with the Community standards and specifications set out in the Annex to the Directive.

Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components [Official Journal L 91 of 30.3.2004].
In application of Directive 2002/98/EC, this text provides more detailed information, criteria and requirements relating to donations and donors, storage, transport and distribution of blood and blood components and to the quality and safety of blood and blood components.

Implementation reports

Communication from the Commission of 19 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 2002/98/EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC [COM(2010) 3 final – Not published in the Official Journal].

This Communication reports a satisfactory implementation of Directive 2002/98/EC. Member States have now successfully designated and set up their competent authorities, as well as inspection systems, control measures and haemovigilance systems.
However, Member States must pursue the finalisation of the accreditation/designation/authorisation/licensing process for all blood establishments.
The Commission encourages the good practice of collecting reports on blood establishments in the preceding year. These reports could be a valuable source of information for both regulators and citizens.

Report from the Commission of 19 June 2006 – First report on the application of the Blood Directive [COM(2006) 313 final – Not published in the Official Journal].
This report sets out the measures adopted by the Member States in application of the Blood Directive. It covers the 15 Member States which belonged to the EU on 31 December 2003.
The report points out that ten Member States adopted more stringent protective measures than those provided for in the Directive, particularly with regard to donor selection, biological control of donations and haemovigilance.
The document describes the application, at national level, of the Directive’s provisions relating to:

  • the obligations of the competent national authorities, in particular those relating to inspection and control;
  • blood establishments and the obligation to designate a responsible person with at least the minimum qualifications;
  • quality management in each blood establishment;
  • haemovigilance;
  • the quality and safety of blood and blood components;
  • data protection.

Report from the Commission of 17 May 2006 on the promotion by Member States of voluntary unpaid blood donations [COM(2006) 217 final – Not published in the Official Journal].
This report summarises the measures taken by Member States to encourage voluntary unpaid donations (allowances, possibility of time off work, information campaigns, awareness programmes, etc.).
It also presents the measures the Commission intends to take in order to promote self-sufficiency in human blood and human plasma in the European Community. Such measures include:

  • a Europe-wide study to identify best practices with a view to developing a methodology and basic set of principles for awareness campaigns;
  • continuation of the discussion on self-sufficiency in the Community with an examination of the question of the optimal use of blood.