Category Archives: Q

Quality of drinking water

Quality of drinking water

Outline of the Community (European Union) legislation about Quality of drinking water

Topics

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

Environment > Water protection and management

Quality of drinking water

Document or Iniciative

Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption [See amending act(s)].

Summary

The Directive is intended to protect human health by laying down healthiness and purity requirements which must be met by drinking water within the European Union (EU).

Drinking water

The Directive applies to all water intended for human consumption apart from natural mineral waters and waters which are medicinal products.

General obligations

Member States shall ensure that such drinking water:

  • does not contain any concentration of micro-organisms, parasites or any other substance which constitutes a potential human health risk;
  • meets the minimum requirements (microbiological and chemical parameters and those relating to radioactivity) laid down by the Directive.

They will take any other action needed in order to guarantee the healthiness and purity of water intended for human consumption.

Quality standards

Member States shall lay down the parametric values corresponding at least to the values set out in the Directive. Where parameters are not set out in the Directive limit values must be laid down by the Member States if necessary to protect health.

Controls

The Directive requires Member States to regularly monitor the quality of water intended for human consumption by using the methods of analysis specified in the Directive, or equivalent methods. For this purpose they shall determine the sampling points and draw up monitoring programmes.

Corrective action and restrictions on use

Where the parametric values are not attained the Member States concerned shall ensure that the corrective action needed is taken as quickly as possible in order to restore water quality.

Regardless of compliance, or otherwise, with the parametric values, Member States shall prohibit the distribution of drinking water or shall restrict its use and shall take any action needed where that water constitutes a potential human health hazard. Consumers shall be informed of any such action.

Exceptions

The Directive shall provide the Member States with scope to provide for exemptions from the parametric values up to a maximum value, provided that:

  • the exemption does not constitute a human health hazard;
  • there is no other reasonable means of maintaining the distribution of drinking water in the area concerned;
  • the exemption must be as restricted in time as possible and not exceed three years (it being possible to renew the exemption for two further three-year periods).

Any exemption granted must be accompanied by a detailed justification except if the Member State concerned feels that failure to meet the limit value is not serious and may be quickly remedied. Water sold in bottles or containers may not be exempted.

Any Member State granting an exemption must inform the following thereof:

  • the population affected;
  • the Commission within a two-month period if the exemption covers the distribution of more than 1000 m³ per day on average, or supplies for more than 5000 persons.

Quality guarantees on the processes, equipment and materials

Neither the materials or substances used in new installations for preparing and distributing drinking water may not continue to be present in drinking water beyond a strictly necessary level.

Re-examination

At least every five years the Commission shall re-examine the parameters laid down by the Directive in the light of scientific and technical progress. It will be assisted in that process by a Committee comprising representatives of the Member States.

Information and reports

Every three years Member States shall publish a report on the quality of drinking water for its consumers. On the basis of those reports the Commission will, every three years, draw up a summary report on the quality of the water intended for human consumption within the Community.

Deadline for compliance

Within five years at the latest Member States shall take any action needed in order to guarantee that water quality complies with the Directive. In exceptional cases that period may be extended provided that it does not exceed three years.

Repeal

Directive 98/83/EC replaces Directive 80/778/EEC from 25 December 2003.

References

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

Directive 98/83/EC

25.12.1998

25.12.2000

OJ L 330 of 05.12.1998

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

The successive amendments and corrections to Directive 98/83/EC have been incorporated in the original text. This consolidated versionis for reference only.

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.

Quality and safety standards for human blood and blood components

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.

 

Quality of higher education

Quality of higher education

Outline of the Community (European Union) legislation about Quality of higher education

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 > Lifelong learning

Quality of higher education

Document or Iniciative

Council Recommendation (EC) No 561/98 of 24 September 1998 on European cooperation in quality assurance in higher education [Official Journal L 270 of 7.10.1998]

Summary

The Council of the European Union recommends to Member States that they establish transparent quality assessment and quality assurance systems in the field of higher education.

The aim is to safeguard and improve the quality of higher education while taking due account of national conditions, the European dimension and international requirements.

The systems of quality assessment and quality assurance must be based on the following principles:

  • autonomy and independence of the bodies responsible for quality assessment and quality assurance;
  • relating evaluation procedures to the way institutions see themselves;
  • internal (self-reflective) and external (experts’ appraisals) assessment;
  • involvement of all the players (teaching staff, administrators, students, alumni, social partners, professional associations, inclusion of foreign experts);
  • publication of evaluation reports.

The Council recommends Member States to ensure that follow-up measures are taken at national or regional level in order to enable higher education institutions to implement their plans for improving quality and for integrating graduates into the labour market more effectively.

The Member States are also recommended to ensure that high priority is given by public authorities and by the management of higher education institutions to continuous exchange of experience with other Member States and with international organisations active in this field.

The Council also recommends Member States to promote cooperation between the authorities responsible for evaluating quality in higher education and encourage their networking. This cooperation should concern:

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  • exchange of information and experience;
  • fulfilling requests for expertise and advice from the authorities in the Member States and promotion of contacts with international experts;
  • support for higher education institutes in the different countries which wish to cooperate.

In pursuing these objectives, the links with other Community activities, notably in the framework of the Socrates and Leonardo da Vinci programmes, should also be taken into account, as well as the “acquis communautaire” in the field of recognition of qualifications for professional purposes.

The Commission is invited to support this cooperation between the authorities responsible for evaluation and quality control in higher education, by involving organisations and associations in the European Community that possess the necessary experience in the field of evaluation and quality assurance in higher education.

The Commission is requested to present, every three years, a report on the development of quality assessment and quality assurance systems in the Member States and on cooperation activities at European level in this field.

Related Acts

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Recommendation of the European Parliament and of the Council of 15 February 2006 on further European cooperation in quality assurance in higher education [Official Journal L 64/60 of 4.3.2006].
9. The Council and the European Parliament recommend Member States to introduce internal quality assurance systems in accordance with the standards and guidelines adopted in Bergen in the context of the Bologna Process.
10. They call on quality assurance agencies to be independent in their assessments, to apply the features of quality assurance laid down in the 1998 Recommendation and to apply the general rules adopted in Bergen.
11. The representatives of national authorities, the higher education sector and quality assurance agencies are encouraged to cooperate with the social partners to set up a European register of quality assurance agencies (EQAR). This register, which will be put in place in summer 2008, should be based on a national review and will take account of the principles set out in the Annex. The registration conditions and register management rules should also be laid down.
12. Member States must take the necessary action to allow higher education institutions to choose from the register the quality assurance agency which meets their needs.
13. The Council and the European Parliament recommend Member States to ensure public access to assessments produced by quality assurance agencies listed in the European register.
14. The Recommendation invites the Commission to continue to support cooperation between higher education institutions, quality assurance agencies and competent authorities.
15. Finally, the Council and the European Parliament invite the Commission to present triennial reports on progress in the development of quality assurance systems.

Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the implementation of Council Recommendation 98/561/EC of 24 September 1998 on European cooperation in quality assurance in higher education [COM(2004) 0620 final – Not published in the Official Journal].

Qualitative assessment of school education

Qualitative assessment of school education

Outline of the Community (European Union) legislation about Qualitative assessment of school education

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 > Lifelong learning

Qualitative assessment of school education

Document or Iniciative

Recommendation 2001/166/EC of the European Parliament and of the Council of 12 February 2001 on European cooperation with regard to the qualitative assessment of school education [Official Journal L 60 of 01.03.2001].

Summary

This recommendation proposes to continue the previous measures in school education by cooperating closely with the authorities responsible for the quality of education and by promoting networking at European level.

Although the quality of a system cannot be defined in absolute terms, it is still possible to set objectives and analyse the ways to achieve them.

The objectives still involve tackling early school-leaving and combating social exclusion in general, and the Recommendation distinguishes between two forms of qualitative assessment: external assessment and self-assessment. The Recommendation encourages all those involved in the school system (teachers, pupils, parents and specialists) to take part in the processes of self-assessment and external assessment. It states that the aim of external assessment is to provide both methodological support for school self-evaluation and an objective view of the school.

One of the most important features of the European education system is its diversity. As a result, it is not possible to devise standard assessment methods that could be applied to all Member States. Any qualitative assessment at European level must take into consideration the socio-cultural, historical and political factors specific to each Member State.

The Recommendation highlights the fact that exchange of information constitutes the bulk of the Community added value. Information exchange should be focused in particular on methodological developments and examples of good practice, especially through the use of new technologies, by organising conferences, seminars and data collection, and by developing tools and publishing results.

The European Parliament and the Council call on the Commission to:

  • create an Internet database for the dissemination of tools, examples of good practice, and effective tools for assessing the quality of educational establishments;
  • make an inventory of the instruments and strategies for quality assessment in primary and secondary education already in use in the various Member States;
  • incorporate the results obtained into existing programmes and develop the existing networks;
  • report every three years to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions;
  • make proposals on the basis of this report.

Background

Several measures have been taken in order to increase European cooperation in the field of quality assessment of school education. The Council of Education Ministers of 6 May 1996 stressed the need to set up a pilot programme on the quality assessment of school education.

The Employment Guidelines for 1999, 2000, 2003-2005 and 2005-2008 and the Council Recommendation of 14 October 2004 also encouraged Member States to improve the quality of their school systems, reduce early school-leaving and do everything in their power to seize the opportunities offered by new technologies.

Related Acts

: Sixteen Quality Indicators. Report of May 2000 based on the work of the Working Committee on Quality Indicators [Not published in the Official Journal].

Council Recommendation (EC) No 561/98 of 24 September 1998 on European cooperation in quality assurance in higher education[Official Journal L 270 of 07.10.1998].

(EC) No 741/04 of 14 October 2004 on the implementation of Member States’ employment policies [Official Journal L 326 of 29.10.2004]

Quality of rail freight

Quality of rail freight

Outline of the Community (European Union) legislation about Quality of rail freight

Topics

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

Transport > Rail transport

Quality of rail freight

Document or Iniciative

Communication from the Commission to the Council and the European Parliament of 8 September 2008 on the “The quality of rail freight services” [COM(2008) 536 final – Not published in the Official Journal].

Summary

This Communication gives an analysis of the quality of rail freight services, the effectiveness of the agreements and voluntary measures implemented by the sector as well as the recommendations for Community action to be implemented in this area. The Commission emphasises that the performance of rail freight has not deteriorated since 2004 and even substantially increased in 2006. It notes however that this trend seems rather fragile since it is the result of external factors such as the increases in oil prices, road congestion and weather conditions unfavourable to inland waterway transport.

The concept of quality can be understood in two ways: the level of service proposed and offered and compliance with contractual commitments. It can also cover other aspects such as availability of the service, safety and security.

Progress made by rail freight

The Commission notes that customer information and the commercial responsiveness of rail freight operators have constantly improved over the last few years. Moreover, the incumbent rail operators have embarked on restructuring their output. The development of competition in particular has stimulated rationalisation, the emergence of new methods, and new production methods and an extension of the services offered. Despite this progress, the Commission regrets that the quality of railway services remains inferior to what the road sector can offer.

The sector as a whole committed itself to improving freight quality, in particular under the framework of a Charter signed in July 2003 by the International Union of Railways (UIC), the Community of European Railway and Infrastructure Companies (CER) and the International Rail Transport Committee (CIT) (Annex I). Furthermore, many incumbent operators have embarked on a policy of certification of the quality of their services (Annex II). Finally, quality clauses are appearing in contracts more and more often.

Guidelines from the Commission

The Commission regrets the lack of information regarding the quality of rail freight. The information most widely available concerns the punctuality of trains, which overall is increasing only very slightly and remains poor (Annexes III and IV). According to the Commission, as a priority, improvements must be made to traffic management, which presupposes in particular the use of new technologies, improvements in infrastructure maintenance, reinforced cooperation between national infrastructure managers and much quicker development of technical and administrative interoperability.

The Commission believes that development of competition is a vital component of improvements in the quality of service, but that this is currently developing too slowly. In order to promote competition, in the short term the Commission will focus on:

  • effective application of the rules concerning competition contained in the 1st and 2nd rail packages;
  • recasting of the 1st rail package.

Monitoring the implementation of the guidelines on State aid to railway undertakings State aid to railway undertakings will also be an important aspect of improving the operation of the rail markets.

Furthermore, the Commission will step up its action to optimise the use of infrastructure, cooperation between infrastructure managers and investment in rail infrastructure, in particular in the context of the following initiatives:

  • the achievement of a European network giving priority to freight COM(2007) 608 final);
  • the TEN-T programme;
  • the Marco Polo programme.

Finally, with the aim of increasing transparency relating to the quality of services and to encourage the sector as a whole, the Commission will continue to encourage:

  • the establishment of schemes for the improvement of performance (Directive 2001/14/EC);
  • the development of tools for measuring the performance of rail freight;
  • the publication of quality indicators.

Context

In 2004 the Commission put forward a proposal for a Regulation on compensation in cases of non-compliance with quality requirements applicable to rail freight services. The proposal, which was prompted by the poor quality of service provided by freight operators and the need for improvements in order to encourage the transport of goods by rail, was withdrawn in the end. Should the current problems not be resolved, the Commission foresees the possibility of putting forward a new proposal.

Quality of petrol and diesel fuels: sulphur and lead

Quality of petrol and diesel fuels: sulphur and lead

Outline of the Community (European Union) legislation about Quality of petrol and diesel fuels: sulphur and lead

Topics

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

Environment > Air pollution

Quality of petrol and diesel fuels: sulphur and lead

Document or Iniciative

Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EEC [See amending acts].

Summary

This Directive meets the commitment given in Directive 94/12/EC that target values would be adopted involving a substantial reduction in pollutant emissions from motor vehicles.

Types of vehicle covered by the Directive

The Directive sets the environmental specifications to be applied to fuels for road vehicles and non-road mobile machinery (including inland waterway vessels when not at sea), agricultural and forestry tractors, and recreational craft when not at sea.

Petrol standards

The standards relating to petrol are detailed in Annex I to this Directive.

Since the year 2000, the marketing of leaded petrol has been banned.

Until 2013, suppliers must place on the market petrol with a maximum oxygen content of 2.7 % and a maximum ethanol content of 5 %.

Derogations may be applied for the outermost regions for the introduction of petrol with a maximum sulphur content of 10 mg/kg. Member States also have the option to place on the market petrol with a maximum vapour pressure of 70 kPa during the summer period. However, the Commission must assess the desirability and duration of the derogation.

Diesel fuel standards

The standards relating to diesel fuel are detailed in Annex II to this Directive.

The sulphur content of gas oils intended for use by non-road mobile machinery must not exceed 1 000 mg/kg. From 1 January 2011, the sulphur content must not exceed 10mg/kg.

However, certain derogations are possible for the outermost regions and for Member States with severe winter weather. In the case of the latter, the maximum distillation point of 65 % at 250 °C for diesel fuels and gas oils may be replaced by a maximum distillation point of 10 % at 180 °C.

Greenhouse gas emissions reductions

Certain suppliers are designated by Member States to be responsible for monitoring and reporting life cycle greenhouse gas emissions per unit of energy from fuel and energy supplied.

With effect from 1 January 2011, suppliers shall report annually, to the authority designated by the Member State, on the greenhouse gas intensity of fuel and energy supplied within each Member State

Suppliers are required to gradually reduce life cycle greenhouse gas emissions by 10 % by 31 December 2020 at the latest. The Directive provides intermediary objectives for the course of this time period.

Biofuels: sustainability criteria

The biofuels taken into account shall not be made from the following raw materials:

  • primary forests and other wooded land;
  • designated areas;
  • highly biodiverse grassland;
  • raw materials with high carbon stock.

The greenhouse gas emission saving from the use of biofuels must reach 35 %. With effect from 1 January 2017, the saving must reach 50 % and 60 % from 2018 onwards.

Member States must comply with the sustainability criteria for biofuels. To this end, they shall subject economic operators to a number of requirements.

References

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

Directive 98/70/EC

28.12.1998

1.7.1999

OJ L 350 of 28.12.1998

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

Directive 2000/71/EC

4.12.2000

1.1.2001

OJ L 287 of 14.11.2000

Directive 2003/17/EC

22.3.2003

30.6.2003

OJ L 76 of 22.3.2003

Regulation (EC) No 1882/2003

20.11.2003

OJ L 284 of 31.10.2003

Directive 2009/30/EC

25.6.2009

31.12.2010

OJ L 140 of 5.6.1010

The successive amendments and corrections to Directive 98/70/EC have been incorporated in the original text. This consolidated versionis of documentary value only.

Related Acts

Reports

Report from the Commission of 1 December 2008: Quality of petrol and diesel fuel used for road transport in the European Union: Fifth annual report (Reporting year 2006) [COM(2008) 799 final – Not published in the Official Journal].
The specifications defined for petrol and diesel fuels by Directive 98/70/EC were in general met in 2006. Very few exceedances were identified. The Commission emphasises that the share of <10 ppm and <50 ppm sulphur fuels increased significantly from 2001 to 2006, and that most Member States are now selling sulphur-free fuels. However, the Commission notes problems related to the absence of labelling of fuels complying with this criterion. It explains that this aspect is an obstacle to the spread of vehicles using this type of fuel, which would have a beneficial effect on the environment in terms of lower pollutant and greenhouse gas emissions. Furthermore, the Commission regrets that most Member States did not provide precise information as to the geographical availability of sulphur-free fuels.

Commission report of 17 October 2007: Quality of petrol and diesel fuel used for road transport in the European Union: Fourth annual report (reporting year 2005) [COM(2007) 617 final – Not published in the Official Journal].
All Member States except France submitted national reports for 2005. This year, once again, no limits have been reported as having been exceeded. Nevertheless, the sulphur content of diesel fuel proved particularly problematic in 2005, principally in those countries which joined the EU in 2004, due to the entry into force of the new mandatory <50 ppm level on 1 January 2005. The report also shows that the proportion of fuel with a sulphur content of less than 10 ppm and 50 ppm increased between 2001 and 2005 in EU Member States prior to the 2004 enlargement. The Commission stressed, once again, the problem of disparity between national systems for monitoring fuel quality.

Report from the Commission of 28 April 2006: Quality of petrol and diesel fuel used for road transport in the European Union – Third annual Report (Reporting year 2004) [COM(2006) 186 final – Official Journal C 151 of 29.6.2006].
As in the previous year, very few incidences of non-compliance can be noted and the Commission has not received any information to indicate negative repercussions for vehicle emissions or engine functioning. There has been little progress made concerning the proportion of fuel with a sulphur content of <10 ppm and <50 ppm between 2003 and 2004 and EU enlargement has triggered a slight reduction in the proportion of such fuels in the total fuel supply. Nevertheless, the absence of the qualities defined for sulphur-free or low-sulphur fuels limits consumers’ opportunities to choose these fuels, with negative repercussions for the launching of vehicles using these fuels. There continues to be a problem of disparity between national monitoring systems for the quality of fuels.

Report from the Commission of 2 March 2005 – Quality of petrol and diesel fuel used for road transport in the European Union – Second annual Report (Reporting year 2003) [COM(2005) 69 final – Not published in the Official Journal].
Fuel quality monitoring in 2003 shows that the specifications for petrol and diesel laid down in Directive 98/70/EC have generally been met. Very few incidences of non-compliance have been reported and the Commission has no indication of any negative repercussions for vehicle emissions or engine functioning due to these violations. The share of fuels with a sulphur content of <10 and <50 ppm increased significantly from 2001 to 2003. Given the considerable disparity between national fuel quality monitoring systems, harmonisation is necessary to obtain transparent and comparable results.

Report from the Commission of 27 April 2004 – Quality of petrol and diesel fuel used for road transport in the European Union – First annual report (Reporting years 2001-2002) [COM(2004) 310 final – Official Journal C 122 of 30.4.2004].
This first report shows that during the period 2001-02, non-compliance with the provisions relating to petrol and diesel were infrequent in Member States. Measures aimed at ensuring compliance with these provisions should be adopted by those countries which have yet to do so. The proportion of fuels with a sulphur content of < 50 ppm increased considerably during this period, while that of fuels with a sulphur content of < 10 ppm remained almost unchanged. Furthermore, a number of Member States have not yet introduced low-sulphur (< 50 ppm) or sulphur-free (<10 ppm) fuels, marketed separately. The report underlines the fact that there is considerable difference between national fuel quality monitoring systems and that transparent and comparable results would depend on greater harmonisation.

Recommendation

Commission Recommendation of 12 January 2005 on what, for the purposes of Directive 98/70/EC of the European Parliament and of the Council concerning petrol and diesel fuels, constitutes availability of unleaded petrol and diesel fuel with a maximum sulphur content on an appropriately balanced geographical basis [Official Journal L 15 of 19.1.2005].

The Commission provides guidelines to help Member States ensure that non-sulphur fuels are available within their territories, with parameters including the proportion of refuelling stations supplying sulphur-free fuel per region and the average distance between refuelling stations supplying sulphur-free fuel.

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

Quality of shellfish waters

Quality of shellfish waters

Outline of the Community (European Union) legislation about Quality of shellfish waters

Topics

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

Maritime Affairs And Fisheries > Management of fisheries resources and the environment

Quality of shellfish waters

Document or Iniciative

Directive 2006/113/EC of the European Parliament and of the Council of 12 December 2006 on the quality required of shellfish waters [See amending act(s)].

Summary

The European Union takes measures to safeguard certain shellfish from the harmful effects of discharging pollutants into the seas.

Waters

The Directive concerns the quality of shellfish waters, i.e. the waters suitable for the development of shellfish (bivalve and gasteropod molluscs).

It applies to those coastal and brackish waters which need protection or improvement in order to allow shellfish to develop and to contribute to the high quality of shellfish products intended for human consumption.

Designation

It is the Member States’ responsibility to designate shellfish waters. The list of designated waters may be amended to take into consideration factors not foreseen at the time of designation.

If waters immediately adjacent to borders with neighbouring Member States are designated as shellfish waters, these States must be consulted.

Quality criteria

The Directive establishes parameters applicable to designated shellfish waters, indicative values, mandatory values, reference methods of analysis and the minimum frequency for taking samples and measures.

The parameters applicable to shellfish waters are set for pH, temperature, coloration, suspended solids, salinity, dissolved oxygen and the presence or concentration of certain substances (hydrocarbons, metals, organohalogenated substances).

On the basis of these criteria, Member States establish the values with which the designated shellfish waters must comply. These limit values may be stricter than those set by this Directive. For metals or organohalogenated substances, these values must respect the emission rules established in line with Directive 2006/11/EC on the discharge of certain substances into the aquatic environment.

Member States must establish programmes allowing them to comply with the limit values they have set within six years of designation.

Samples

The competent authorities for each Member State must take samples from the waters to verify their conformity with the criteria set by the Directive. The following proportions of samples must conform to the established values:

  • 100 % of the samples for the parameters ‘organohalogenated substances’ and ‘metals’;
  • 95 % of the samples for the parameters ‘salinity’ and ‘dissolved oxygen’;
  • 75 % of the samples for the other parameters.

Dispensations

In the event of a disaster, special dispensation may be granted concerning the observance of the limit values and the criteria established.

Samples may be taken less frequently if the water quality is appreciably higher than it would be if the criteria established in accordance with European legislation were applied.

In the event of non-compliance with the limit values or the established criteria, the competent authority must establish whether this is the result of chance, a natural phenomenon or pollution and must take appropriate measures. These measures may on no account lead to increased pollution of coastal and brackish waters.

Context

The Directive replaces Directive 79/923/EEC, but does not change its fundamental provisions.

Directive 2000/60/EC on water provides for the repeal of the Directive on the quality required of shellfish waters by 2013. This Directive integrates requirements relating to the quality of shellfish waters into its provisions relating to the analysis and protection of hydrographic basins.

References

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

Directive 2006/113/EC

16.1.2007

OJ L 376, 27.12.2006

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

Regulation (EC) No 1137/2008

11.12.2008

OJ L 311, 21.11.2008

The successive amendments and corrections to Directive 2006/113/EC have been incorporated into the original text. This consolidated versionis of documentary value only.