Tag Archives: Safety

Action plan on Organ Donation and Transplantation

Outline of the Community (European Union) legislation about Action plan on Organ Donation and Transplantation

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

Action plan on Organ Donation and Transplantation

Document or Iniciative

Communication from the Commission of 8 December 2008 – Action plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States [COM(2008) 819 – Not published in the Official Journal].

Summary

The European Commission is presenting an Action Plan with the aim of strengthening cooperation between Member States in terms of organ donation and transplantation. This plan is also accompanied by a Proposal for a Directive on standards of quality and safety of human organs intended for transplantation.

This Action Plan lays down ten priority actions grouped under three challenges:

increasing organ availability;
enhancing the efficiency and accessibility of transplantation systems;
improving quality and safety.

Priority Actions for increasing organ availability

It is essential to increase the number of organ donors. To this end, the Plan advocates the appointing of transplant donor coordinators in all hospitals practising organ donation.

Hospitals must also promote Quality Improvement Programmes for organ donation, through a specific methodology. Existing methods are to be compared and those giving most results will be promoted.

Exchange of good practice is also strongly encouraged in the field of organ donation from living donors (concerning deceased donors, it is recommended that the potential of donations be maximised). In this regard, altruistic donation programmes should be set up, whilst storing personal data on donors in line with Directive 95/46/EC.

Good communication within families can have positive consequences on willingness to donate organs by family members. This is why health professionals and patient support groups are to strengthen communication and organise training in this field with families in order to increase organ donation potential.

Mobility of patients and donors should also be prioritised as part of cooperation between Member States. It should be possible to identify all donors in the Union. Tools are to be made available by the Commission to this end.

Priority Actions for enhancing the efficiency and accessibility of transplantation systems

Each Member State should prepare a national programme of priority actions to enhance the efficiency of transplantation systems. In particular, a series of common indicators shall be established to monitor organ donation policy.

The Action Plan strongly supports the drawing up of Community agreements on various aspects of transplant medicine. Cooperation is the best framework to generate joint solutions and monitoring mechanisms.

The Action Plan also invites Member States to establish Community agreements on the monitoring of the extent of organ trafficking in Europe. This trafficking is indeed a scourge in that it is one of the causes of the lack of available organs.

Member States are also invited to introduce a system or structure for the exchange of organs in particular for urgent cases and difficult to treat patients (such as children or patients requiring specific treatment).

Priority actions for improving quality and safety

Information concerning organ donations and transplantation should be compiled in registers to facilitate the evaluation of post-transplantation results. This information will be used in particular to develop good medical practices and to prepare a method to compare performance for the monitoring of organ recipients.

An accreditation system for organ donation, procurement and transplantation programmes should be established as part of a common methodology.

Context

As the Communication Organ donation and transplantation: Policy actions at European Union level had already pointed out, demand for organs outweighs supply all over the European territory. There are currently more than 56 000 patients waiting for an organ from a suitable donor. These shortages generate organ trafficking which is a violation of human dignity and fundamental rights. It is for this reason that Member States should strengthen cooperation in order to preserve organ quality and safety.

Related Acts

Proposal for a Directive of the European Parliament and of the Council of 8 December 2008 on standards of quality and safety of human organs intended for transplantation [ – Not published in the Official Journal].

This Proposal for a Directive on quality and safety standards for human organs intended for transplantation establishes a legal framework in this field.

Standards of quality and safety of organs intended for transplantation

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Standards of quality and safety of organs intended for transplantation

Outline of the Community (European Union) legislation about Standards of quality and safety of organs intended for transplantation

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

Standards of quality and safety of organs intended for transplantation

Document or Iniciative

Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation.

Summary

This Directive sets out a common framework on quality and safety standards for organs * of human origin intended for transplantation into the human body. It also aims to protect donors * and optimise exchanges between Member States and third countries.

Scope

This Directive covers only those organs to be transplanted into the human body, and not the use of organs for the purposes of research.

It applies to:

donation *;
procurement *;
testing;
characterisation *;
transport;
transplantation of organs.

It does not apply to:

blood;
blood components;
human tissues and cells;
organs, tissues and cells of animal origin.

Quality and safety of organs

Member States shall implement a quality and safety framework which defines the parameters of all stages of the chain from donation to transplantation *.

These quality and safety frameworks are to fix all of the parameters of the process continuously, from donation to transplantation. They have the following functions in particular:

to define traceability * procedures from donation to transplantation or disposal of the organ;
to implement standard operating procedures *;
to establish the qualifications of personnel.

The procurement of an organ (that has previously been subject to a characterisation) is to be performed in dedicated facilities and under the supervision of a medical doctor as defined in Directive 2005/36/EC.

All procured organs must be characterised before transplantation. The minimum information required includes:

le type of donor;
the blood group;
the cause and date of death of the donor;
the clinical history of the donor, including aspects such as neoplasia, hepatisis, HIV or IV drug abuse.

Other complimentary information may be requested, such as the medical history of the donor or, for example, physical and clinical data.

The transport of organs shall be carried out according to clearly defined criteria. The shipping containers used by organisations or companies must contain information such as contact details for the procurement and transplantation organisations, be marked ‘handle with care’ and contain safety instructions and method of cooling.

All organs procured, allocated and transplanted on the territory must be traceable from the donor to the recipient and vice versa in order to safeguard the health of donors and recipients.

If a serious adverse event should occur following organ transplantation, a reporting system, put in place by Member States, should allow relevant information to be reported and transmitted.

Donor and recipient protection

Organ donation must be voluntary and unpaid. However, compensation may be granted to make good the expenses and loss of income related to the donation, while avoiding any financial incentive.

Member States shall be prohibited from advertising the need for, or availability of, organs.

Living donors are to be provided with comprehensive information as to the purpose and nature of the donation, and the consequences and risks involved.

Qualified medical personnel are to select donors on the basis of their health and medical history including a psychological evaluation. These provisions guarantee the quality and safety of organs.

The personal data of the donor shall be protected in line with Directive 95/46/EC. Anonymity is guaranteed.

Competent authorities

Member States shall designate the competent authorities to implement the Directive. They will, in particular, supervise the implementation of the quality and safety framework and exchanges with Member States or third countries;

Context

Over the last 20 years, the use of human organs for transplantation has increased considerably. This technique makes it possible to compensate for the failure of organs such as the liver, lungs or heart. However, this medical practice is associated with risks which this Directive aims to reduce by introducing strict standards concerning the quality and safety of organs.

Key terms used in the act
Organ: a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of autonomy; Donor: every human source of organs, whether living or deceased; Donation: donating human organs for transplantation; Transplantation: the process of restoring certain functions of the human body by transferring equivalent organs to a recipient; Traceability: the ability for a competent authority to locate and identify the organ at each stage in the chain from donation to transplantation or disposal, this authority, under specified circumstances set out in this Directive being authorised to: identify the donor and the procurement organisation, identify the recipient(s) at the transplantation centre(s), locate and identify all relevant non-personal information relating to products and materials coming into contact with that organ; Standard operating procedures: written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end product; Procurement: a process by which the donated organs become available; Donor characterisation: the collection of the relevant information on the characteristics of the donor needed to undertake a proper risk assessment in order to minimise the risks for the recipient and to optimise organ allocation.

Key terms used in the act

Organ: a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of autonomy;
Donor: every human source of organs, whether living or deceased;
Donation: donating human organs for transplantation;
Transplantation: the process of restoring certain functions of the human body by transferring equivalent organs to a recipient;
Traceability: the ability for a competent authority to locate and identify the organ at each stage in the chain from donation to transplantation or disposal, this authority, under specified circumstances set out in this Directive being authorised to: identify the donor and the procurement organisation, identify the recipient(s) at the transplantation centre(s), locate and identify all relevant non-personal information relating to products and materials coming into contact with that organ;
Standard operating procedures: written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end product;
Procurement: a process by which the donated organs become available;
Donor characterisation: the collection of the relevant information on the characteristics of the donor needed to undertake a proper risk assessment in order to minimise the risks for the recipient and to optimise organ allocation.

Reference

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 2010/53/EU	26.8.2010	27.8.2012	OJ L 207 of 6.8.2010

Related Acts

Communication from the Commission of 8 December 2008 – Action plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States” [COM (2008) 819 final – Not published in the Official Journal].
The Action Plan on Organ Donation and Transplantation (2009-2015) sets out 10 priority actions in this area.

Informing passengers of the carrier's identity and the blacklist of high-risk companies

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Informing passengers of the carrier’s identity and the blacklist of high-risk companies

Outline of the Community (European Union) legislation about Informing passengers of the carrier’s identity and the blacklist of high-risk companies

Topics

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

Transport > Mobility and passenger rights

Informing passengers of the carrier’s identity and the blacklist of high-risk companies

Document or Iniciative

Regulation (EC) No 2111/2005 of the European Parliament and of the Council of 14 December 2005 on the establishment of a Community list of air carriers subject to an operating ban within the Community and on informing air transport passengers of the identity of the operating air carrier, and repealing Article 9 of Directive 2004/36/EC [See amending act(s)].

Summary

This new Regulation is designed to give passengers the right to be informed of the identity of the carrier operating the flight they have booked, while at the same time reinforcing the obligation on European Union (EU) countries to pass on safety-related information. Companies considered to be unsafe will find their aircraft banned from flying and will have their names published on a universally accessible blacklist. This list will be published both on the Internet and in the Official Journal.

These provisions apply to flights:

departing from an airport in the territory of an EU country to which the Treaty applies;
departing from an airport in a third country and arriving at an airport in the territory of an EU country, provided that the contracting carrier is based in the EU;
departing from an airport in a third country, where the flight is part of a contract of carriage entered into in the EU, and provided that the journey started in the EU.

A blacklist of unsafe airlines

The Annex sets out common criteria for considering an EU-wide operating ban for safety reasons. Air carriers will be included on the blacklist on the basis of the following criteria:

evidence of serious safety deficiencies on the part of a carrier;
a lack of ability (or willingness) on the part of a carrier to address safety deficiencies (lack of transparency or insufficient action);
a lack of ability (or willingness) on the part of the authorities responsible for overseeing a carrier to address safety deficiencies (lack of cooperation, insufficient ability, etc.).

EU countries publish a list of all air carriers banned from their airspace or subject to traffic rights restrictions for safety reasons. This list is made available to other EU countries and to the Commission. The Commission publishes a consolidated list of these air carriers. Furthermore, at least once every three months, the Commission must assess whether the blacklist needs to be updated to include or exclude certain carriers. To update the list, both the EU country concerned and the European Aviation Safety Agency (EASA) must notify the Commission of all the relevant information.

Passengers’ rights to information and reimbursement

To enable airline passengers to be better informed about the operating carrier when choosing a flight, passengers must be able to know which carrier will be operating the flight when they make the booking. The contracting carrier is required to inform passengers of the identity of the operating air carrier or carriers when making a reservation, whatever the means used to make the booking. The passenger must also be kept informed of any change of operating carrier, either at check-in or, at the latest, when boarding.

The Regulation also gives passengers the right to reimbursement or re-routing if a carrier with which a booking has been made is subsequently added to the blacklist, resulting in cancellation of the flight concerned.

Background

Safety oversight is regulated worldwide within the framework of the 1944 Chicago Convention on International Civil Aviation and is based on standards developed by the International Civil Aviation Organisation (ICAO). Under the Convention, air carriers, and in particular their compliance with safety requirements, must be supervised by their home country.

At European level, safety procedures are based on EU legislation and specifically on the European Aviation Safety Agency.

However, outside the EU, safety levels depend on the effectiveness of oversight procedures applicable in third countries. In this context, Directive 2004/36/EC ensures a high level of aviation safety for aircraft flying into, out of or within the EU by providing for a harmonised inspection system for third-country aircraft using European airports.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 2111/2005	16.1.2006	–	OJ L 344 of 27.12.2005

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 596/2009	9.9.2010	–	OJ L 237 of 8.9.2010

Successive amendments and corrections to Regulation (EC) No 2111/2005 have been incorporated in the basic text. This consolidated versionis for reference purposes only.

Related Acts

Blacklist of high-risk companies.

Commission Regulation (EC) No 474/2006 of 22 March 2006 establishing the Community list of air carriers which are subject to an operating ban within the Community referred to in Chapter II of Regulation (EC) No 2111/2005 of the European Parliament and of the Council [Official Journal L 84 of 23.3.2006].

Self-employed workers: health and safety at work

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Self-employed workers: health and safety at work

Outline of the Community (European Union) legislation about Self-employed workers: health and safety at work

Topics

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

Employment and social policy > Health hygiene and safety at work

Self-employed workers: health and safety at work

Document or Iniciative

Council Recommendation 2003/134/EC of 18 February 2003 concerning the improvement of the protection of the health and safety at work of self-employed workers.

Summary

This recommendation concerns workers who exercise their occupational activity in a manner which does not involve an employment relationship with an employer or, more generally, does not make them subordinate to a third person.

Although self-employed workers are not covered by the Directives on health and safety at work, notably Directive 89/391/EEC, they are very often subject to health and safety risks similar to those experienced by employees.
Moreover, there are a large number of self-employed workers in certain “high-risk” sectors such as agriculture, fishing, construction, and transport.

For this reason the Council recommends that Member States promote prevention policies as well as health and safety at work measures, notably via awareness-raising campaigns, as well as access to training and health surveillance.
More specifically, Member States are recommended:

to promote, in the context of their policies on preventing occupational accidents and diseases, the safety and health of self-employed workers, while taking account of the special risks existing in specific sectors and the specific nature of the relationship between contracting undertakings and self-employed workers;
when promoting health and safety for self-employed workers, to choose the measures they consider most appropriate, such as one or more of the following: legislation, incentives, information campaigns and encouragement of relevant stakeholders;
to implement awareness-raising campaigns, so that self-employed workers can obtain from the competent services and/or bodies, as well as from their own representative organisations, useful information and advice on the prevention of occupational accidents and diseases;
to take the measures necessary so that self-employed workers can have access to sufficient training to acquire appropriate safety and health skills;
to facilitate easy access to this information and training without involving excessive expense for self-employed workers;
to allow self-employed workers who so wish to have access to health surveillance appropriate to the risks to which they are exposed;
to take account of available information on experience in other Member States;
to examine, between now and 2007, the effectiveness of existing national measures or measures taken subsequent to the adoption of this recommendation and to duly inform the Commission.

This recommendation does not affect existing or future national provisions providing for a higher degree of protection and Member States should choose the means they consider to be most appropriate to meet its objectives.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Council Recommendation 2003/134/EC	18.02.03	–	OJ L 53 of 28.02.2003

European Agency for Safety and Health at Work

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European Agency for Safety and Health at Work

Outline of the Community (European Union) legislation about European Agency for Safety and Health at Work

Topics

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

Institutional affairs > The institutions bodies and agencies of the union

European Agency for Safety and Health at Work

Document or Iniciative

Council Regulation (EC) No 2062/94 of 18 July 1994 establishing a European Agency for Safety and Health at Work [See amending acts].

Summary

The Agency’s role is to:

collect and analyse technical, scientific and economic information on health and safety at work in the Member States and to pass it on to the Community bodies, other Member States and interested parties;
collect and analyse technical, scientific and economic information on research into safety and health at work and disseminate the results of this research;
promote and support cooperation and exchange of information and experience amongst the Member States in the field of safety and health at work, including information on training programmes;
organise conferences and seminars (such as the European Health and Safety at Work Week) and exchanges of national experts in the field of safety and health at work;
supply the Community bodies and the Member States with the technical, scientific and economic information they require to formulate and implement judicious and effective policies designed to protect the safety and health of workers;
establish an information network in cooperation with the Member States, and coordinate it, including national, Community (the European Foundation for the Improvement of Living and Working Conditions) and international bodies and organisations which provide this type of information and services;
collect and make available information on safety and health matters from and to third countries and international organisations: the World Health Organisation (WHO), the International Labour Organisation (ILO), the Pan American Health Organisation (PAHO), the International Migration Office (IMO), etc.;
provide technical, scientific and economic information on methods and tools for implementing preventive activities, especially for small and medium-sized enterprises, and identify good practices;
contribute to the development of Community action programmes and strategies relating to the protection of safety and health at work, without prejudice to the Commission’s sphere of competence;
ensure that the information disseminated is easily understood by the end-users.

The Agency collaborates as closely as possible with institutions, foundations, specialist bodies and programmes at Community level in order to avoid any duplication. For example, it works together with the European Foundation for the Improvement of Living and Working Conditions.

The Agency will set up a network comprising:

the main component elements of the national information networks, including the national social partner organisations in accordance with national legislation;
the national focal points;
European topic centres.

Member States regularly inform the Agency of the main component elements of their information networks on health and safety at work. The relevant national authorities coordinate and forward the information to be provided to the Agency at national level.

The Agency has legal personality. Its steering and management structure comprises a Governing Board, a Bureau and a Director.
Its Governing Board comprises 78 members, of whom 25 members represent the governments of the Member States, 25 members represent employer organisations, 25 members represent employee organisations and three members represent the Commission. The Members of the Governing Board have a three-year term of office which is renewable. The Board’s headquarters is in Bilbao, Spain.

The Governing Board determines the Agency’s strategic objectives and adopts its budget, the rolling four-year programme and the annual work programme on the basis of a draft drawn up by the Director after consultation of the Commission and of the Advisory Committee on Safety, Hygiene and Health Protection at Work. By 31 January each year at the latest, the Governing Board adopts an annual general report on the Agency’s activities.

The Bureau comprises 11 members: the chairman and the three vice-chairmen of the Governing Board, one coordinator for each of the three groups of representatives (employers, workers and government), an additional representative for each of these three groups, and a Commission representative. The Bureau monitors the implementation of the Governing Board’s decisions and takes all necessary steps to ensure that the Foundation is managed properly between meetings of the Governing Board

The Agency is headed by a Director appointed by the Governing Board.

Since November 2003, the Regulation establishing the Bilbao Agency has been in line with the new Financial Regulation applicable to the General Budget of the European Communities (June 2002) and the Regulation on public access to documents (May 2001).

Establishment of the Agency

The inaugural meeting of the Governing Board took place at the Agency’s headquarters in Bilbao (Spain) on 25 and 26 October 1995.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 2062/94	18.07.1994	–	Official Journal L 216 of 20.08.1994

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 1643/95	29.06.1995	–	Official Journal L 156 of 07.07.1995
Regulation (EC) No 1654/2003	30.10.2003	–	Official Journal L 245 of 29.09.2003
Regulation (EC) No 1112/2005	04.07.2005	–	Official Journal L 184 of 15.07.2005

Related Acts

Communication from the Commission to the Council regarding the Commission’s report on the European Agency for Safety and Health at Work (progress report 1996-2000) [COM(2001)163 final – Not published in the Official Journal].

Exposure to carcinogens and mutagens

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Exposure to carcinogens and mutagens

Outline of the Community (European Union) legislation about Exposure to carcinogens and mutagens

Topics

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

Employment and social policy > Health hygiene and safety at work

Exposure to carcinogens and mutagens

Document or Iniciative

Directive 2004/37/EC of the European Parliament and the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC).

Summary

This Directive does not apply to workers exposed only to the forms of radiation covered by the Treaty establishing the European Atomic Energy Community (Euratom Treaty). It applies to workers exposed to asbestos when its provisions are more favourable than those of Directive 83/477/EEC (as last amended by Directive 2003/18/EC).
Directive 89/391/EEC applies in full, without prejudice to more binding and/or more specific provisions contained in this Directive.

In the case of any activity likely to carry the risk of exposure to carcinogens or mutagens, the nature, degree and duration of workers’ exposure must be determined on a regular basis in order to assess any risk to workers’ health or safety and decide the steps to be taken. All routes of exposure must be taken into account, including absorption into and/or through the skin. Particular attention must be paid to workers who are especially at risk.

EMPLOYERS’ OBLIGATIONS

Reduction and replacement

Employers must reduce the use of a carcinogen or mutagen, particularly by replacing it, as far as is technically possible, with a substance, preparation or process that is not dangerous or is less dangerous.

Prevention and reduction of exposure

Employers must ensure that the carcinogen or mutagen is manufactured and used in a closed system. If this is not technically possible, employers must ensure that the level of exposure is as low as is technically possible.
Exposure must not exceed the limits set out in Annex III.

Information for the competent authority

Employers must provide the competent authority, on request, with information relating to such matters as the reasons for using carcinogens or mutagens, the preventive measures taken and the number of workers exposed.

Unforeseeable exposure

In the event of unforeseeable incidents or accidents likely to lead to workers being abnormally exposed, employers must inform their workers. Protective clothing and respiratory personal protective equipment must be worn, and exposure must be kept to the strict minimum necessary.

Foreseeable exposure

For certain activities, such as maintenance work, for which the likelihood of a significant increase in exposure is foreseeable and against which all preventive measures have been taken, employers must decide the measures necessary to reduce as far as possible the amount of time workers are exposed and to ensure that they are protected during these activities. Protective clothing and respiratory personal protective equipment must be worn, and exposure must be kept to the strict minimum necessary. Moreover, the areas used for such activities must be clearly demarked and indicated.

Access to risk areas

Employers must restrict access to risk areas to workers who, by virtue of their work or duties, are required to enter such areas.

Measures regarding hygiene and personal protection

Employers are required to take the following measures regarding hygiene and personal protection for all activities that carry a risk of contamination:

ensure that workers do no eat, drink or smoke in work areas where there is a risk of contamination;
supply workers with the appropriate clothes and provide separate storage places for work clothes and street clothes;
provide washing and toilet facilities;
properly store, check and clean protective equipment before and after every use.

Workers must not bear the cost of these measures.

Informing, training and consulting workers

Employers must take appropriate steps to ensure that workers and/or their representatives receive sufficient and suitable training about:

potential and additional health risks (smoking);
precautions for preventing exposure;
hygiene requirements;
protective clothing;
measures to be taken in the event of an incident.

Employers must ensure that containers, packages and installations containing carcinogens or mutagens are clearly and legibly labelled, and that warning signs are clearly displayed.

Appropriate measures must be taken to ensure that workers are able to assess whether the Directive is being applied correctly. They must be informed as quickly as possible in the event of abnormal exposure.

Employers must have an updated list of workers undertaking activities that carry a risk to their health and safety in terms of exposure to carcinogens and mutagens.

Workers and/or their representatives must be consulted about and involved in all matters related to exposure to carcinogens and mutagens.

MISCELLANEOUS PROVISIONS

Health monitoring

Member States must take steps to ensure that the health of every exposed worker can be adequately monitored. These must be such that it is possible to apply individual and work-related health measures. When a worker’s health is monitored, an individual medical file is to be created.
Practical recommendations relating to the monitoring of workers’ health can be found in Annex II.
All cases of cancer identified as resulting from exposure at work must be notified to the competent authority.

Record-keeping

The up-to-date list of workers who have been exposed, which the employer is required to keep, and individual medical files are to be kept for at least 40 years after the end of exposure.

Limit values

The Council sets out in directives, where possible, limit values for all carcinogens or mutagens and, where necessary, other directly related provisions. Annex III contains the limit values for benzene, vinyl chloride monomer and hardwood dusts.

Annexes I (list of substances, preparations and processes) and III (limit values) can be amended only by the Council (Article 137 of the EC Treaty).
Technical amendments to Annex II (practical recommendations relating to the monitoring of workers’ health) are adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC.

Context

This Directive is a consolidation Directive that replaces Directive 90/394/EEC and its subsequent amendments (Directive 90/394/EEC, Directive 97/42/EC and Directive 1999/38/EC). It makes no substantive changes and merely consolidates the body of texts which it replaces. The deadlines for the transposition of Directives 90/394/EEC, 97/42/EC and 1999/38/EC into national law continue to apply.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 2004/37/EC	20.05.2004	Directive 90/394/EEC: 31.12.92 Directive 97/42/EC: 27.06.00 Directive 1999/38/EC: 29.04.03	OJ L 158 of 30.04.2004

Related Acts

Council Directive 1967/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances [Official Journal L 196 of 16.08.1967]

Directive of the European Parliament and the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations [Official Journal L 200 of 30.07.1999]

Advisory Committee on Safety and Health at Work

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Advisory Committee on Safety and Health at Work

Outline of the Community (European Union) legislation about Advisory Committee on Safety and Health at Work

Topics

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

Employment and social policy > Health hygiene and safety at work

Advisory Committee on Safety and Health at Work (ACSHW)

Document or Iniciative

Council Decision 2003/C 218/01 of 22 July 2003 setting up an Advisory Committee on Safety and Health at Work and repealing Decisions 74/325/EEC and 74/326/EEC.

Summary

This new committee takes over the activities of the two former committees which now no longer exist:

the Advisory Committee for Safety, Hygiene and Health Protection at Work, set up in 1974, for all economic activities except for the extractive industries and the protection of the health of workers against the dangers arising from ionising radiation;
the Safety and Health Commission for the Mining and Other Extractive Industries, set up in 1957, whose remit was extended to all extractive industries.

This Committee has the task of assisting the Commission in the preparation, implementation and evaluation of all initiatives related to safety and health at work, in particular:

defining, within the framework of Community action programmes, the criteria and aims for preventing accidents at work and health hazards within the undertaking;
defining methods enabling undertakings and their employees to evaluate and improve the level of protection;
contributing, alongside the European Agency for Safety and Health at Work, to keeping national administrations, trades unions and employers’ organisations informed of Community measures in order to facilitate cooperation and to encourage exchanges of experience and establish codes of practice.

In order to accomplish the above tasks, the Committee cooperates with the other committees involved in safety and health at work, inter alia with the Senior Labour Inspectors Committee and the Scientific Committee for Occupational Exposure Limits to Chemical Agents.

The Committee consists of three full members from each Member State: one government representative, one trade union representative and one employers’ representative. They are appointed by the Council for a three-year term, which is renewable.

It is chaired by a Commission official.

The Committee’s opinions are delivered by an absolute majority of the votes validly cast, and reasons are given for these opinions.

Context

Given the radical changes in working life over the past few years, the opportunities opened up by enlargement and the implementation of a new Community strategy on safety and health (2002-2006), it had become necessary to streamline the operation of the two existing advisory committees. The creation of the new Committee should allow the following objectives to be achieved:

extending this Committee’s role to all aspects related to safety, hygiene and health protection at work;
integrating the activities of the various bodies involved in defining and implementing Community policy on health and safety at work (cooperation with other advisory committees and with the European Agency for Safety and Health at Work).

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Decision 2003/C 218/01	01.01.2004	–	Official Journal [C 218 of 13.9.2003]

Communication on the practical implementation of directives on health and safety at work

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Communication on the practical implementation of directives on health and safety at work

Outline of the Community (European Union) legislation about Communication on the practical implementation of directives on health and safety at work

Topics

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

Employment and social policy > Health hygiene and safety at work

Communication on the practical implementation of directives on health and safety at work

Document or Iniciative

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of Regions on the practical implementation of the provisions of the Health and Safety at Work Directives 89/391 (Framework), 89/654 (Workplaces), 89/655 (Work Equipment), 89/656 (Personal Protective Equipment), 90/269 (Manual Handling of Loads) and 90/270 (Display Screen Equipment) [COM(2004) 62 – Not published in the Official Journal].

Summary

LEGAL IMPACT IN THE MEMBER STATES

Directive 89/391/EEC changed the practical perspective of the protection of the health and safety of workers by introducing an integrated preventive approach and by making ongoing improvement of health and safety conditions at work a requirement. This new approach is based on the fundamental principles which the framework Directive 89/391/EEC introduced, namely, employer responsibility, prevention, information, training, consultation and participation of workers. Directive 89/391/EEC and Directives 89/654/EEC, 89/655/EEC, 89/656/EEC, 90/269/EEC and 90/270/EEC led to the rationalisation and simplification of the National legislative corpora. Transposal of the directives obliged the Member States to switch from legislation often based on remedial principles to a preventive approach based on individual behaviour and organisational structures.

MONITORING TRANSPOSAL

Analysis of the transposal of the framework directive has made it possible to highlight shortcomings in nearly all the Member States, particularly as regards scope, employer responsibility, the principles of prevention, the extent of the obligation to evaluate risks to the health and safety of workers, protection and prevention services, the obligation to keep records of risk assessment in all types of companies and, lastly, information, consultation, participation and training of workers.
As far as individual directives are concerned, the situation as regards transposal is more positive and most of the shortcomings observed have been rectified without the need for infringement proceedings, which have, however, been necessary in certain cases.

ACTION ON THE GROUND: PRACTICAL IMPLEMENTATION

Substantial heterogeneousness continues to exist in the practical implementation of the various directives, depending on the countries, the different sectors of activity and the size of company. Nevertheless, the primary aims of guaranteeing common minimum standards of protection through harmonisation of the recommendations on safety and health, reducing the number of accidents at work and the number of cases of occupational diseases, have been attained.

Publicity and supporting measures

Although National (action plans and awareness-raising campaigns) and European (role of the European Agency for Health and Safety at Work) measures have contributed greatly to better understanding of the new legislation and better awareness by employers and workers alike of their rights and obligations, the impact of these measures varies depending on the economic players to whom they apply. While things run smoothly from this point of view in the bigger companies, this is not the case in the small and medium-sized enterprises (SMEs), where a big effort is needed.

Awareness raising

Despite the huge volume of information available, the level of information among employers and workers, particularly in the SMEs, is insufficient. Employers point to problems in understanding the legislation. This stems from the nature of the provisions, which involve establishing a general objective, and from the fact that there is no information at National level to help employers establish prevention plans tailored to the risks detected in the risk assessment.

Risk assessment, documentation and supervision

The points to be improved concerning the practical implementation of the provisions related to the risk assessment are:

superficial, schematic procedures place tend to focus on obvious risks, while long-term effects (e.g. psychological and psycho-social factors) as well as the more insidious risks, e.g. those caused by chemical substances, are neglected;
as a result, there is no overall or integrated approach to risks and measures are taken in isolation;
risk assessment is often considered as a one-off obligation and lacks continuity;
the effectiveness of steps taken is not sufficiently monitored by employers.

Protective and preventive services

Not all companies comply with their obligation to set up departments to protect against and prevent occupational risks, either by designating a worker to carry out such activities or, if this is not possible, by calling in an external service. This is particularly the case of the SMEs.
The introduction of such services is held up by the lack of qualified personnel, the low quality of the services delivered (unilateral importance attached to the technical aspects, few multi-disciplinary services) and by the tendency for employers to use the cheapest possible services.

Information, consultation, participation and training

Few data are available on information flow but it is clear that the practical implementation of the obligation to inform workers leaves a lot to be desired by comparison with the other obligations which employers have to comply with. This is the case of nearly all the industrial sectors in all the Member Stakes irrespective of size of company. The problem is particularly manifest among temporary workers. Nor is the participation of workers organised satisfactorily despite the range of options proposed by the directives.

Organisation and management of health and safety at work

The growing complexity of work processes, trends in working conditions and changes in the types of risks encountered as a result, call for a transparent and systematic approach to health and safety at work. Yet, with the exception of the bigger companies, safety and health are seldom an integral part of companies’ overall management process.

Enforcement

Enforcement of health and safety at work legislation is primarily a matter for the labour inspectorates, often working in conjunction with other specialised monitoring agencies in certain sectors of activity. The progress made with implementation by the Member States is generally measured taking the ratio between the number of labour inspectors in each Member State and the number of inspections performed every year. 1 400 000 inspections are carried out every year in the European Union by approximately 12 000 inspectors.

The entry into force of the new EU health and safety legislation and does not appear to have boosted the number of inspections. In their reports, the Member States point to a chronic lack of resources in their labour inspectorates to cover all aspects of the new legislation, particularly in the SMEs.

The analysis carried out shows that the action of the EU labour inspectorates actively contributes to bringing down the rate of absenteeism due to occupational accidents and diseases and also to changing the approaches of those involved in prevention at workplace level. Further progress is needed in order to improve checks in the SMEs and the high-risk sectors and in order to make warnings and sanctions more dissuasive.

Analysis of two specific cases: SMEs and the public sector

SMEs

The analysis shows that there are major shortcomings in complying with essential elements of EU health and safety legislation in SMEs, in particular as regards risk assessment, workers’ participation and training, and in the traditionally high-risk sectors of agriculture and construction. These shortcomings stem primarily from:

the lack of information and specific (targeted information distributed locally) and comprehensible guidelines;
poor capacity and skills in terms of health and safety;
lack of resources to ensure appropriate basic training of workforce and managers;
poor access to effective, specific and specialised technical assistance.

The public sector

The inclusion of the public sector within the scope of the health and safety legislation is a groundbreaking development in most Member States.

Despite problems in certain countries (particularly in the military sector), the transposal of European legislation in the public sector can all in all be considered to be satisfactory. The degree to which it is implemented nonetheless poses certain problems because:

it is widely held in public administration that the risk levels are negligible by comparison with the private sector;
it is not generally for labour inspectorates to intervene in public administration or the in-house departments responsible for this function do not have enough hierarchical autonomy;
the budgets allocated are often limited.

EVALUATION OF THE EFFECTIVENESS OF THE LEGISLATION

The National reports show that the majority of Member States consider that it is as yet too early to make a proper and full evaluation of effectiveness. Although nearly all Member States believe there has been a positive impact, they do not have the data or statistical results available yet to substantiate that impact. Nevertheless, the evaluation that the legislation has contributed to making the workplace safer is supported by general statistical data on occupational health and safety.

Effects on accidents at work and occupational diseases

The most up-to-date statistics (for the year 2000) show that the accident rate per 100 000 workers had fallen from 4513 to 4016 since 1994. Also by comparison with 1994, there was a marked improvement in the rate of fatal accidents in Europe, which fell back from 6423 to 5237 in 2000.

The 1999 labour force survey and those conducted by the European Foundation for Living and Working Conditions, for their part, show that the active population feels that working conditions have not improved overall. A great deal remains to be done with regard to monitoring and organising work in order to head off intensive working patterns, problems stemming from working on screen, repetitive movements and psychological damage.

Costs and benefits in the enterprises

Member States have indicated in their National reports that due to the lack of indicators they consider that it is not possible to make a full evaluation, but acknowledge that a reduction in accidents at work and worker absenteeism brings about a clear reduction in business costs, which should in turn boost productivity.

General economic effects

In the European Union the costs for accidents at work and work-related illnesses are estimated between 2.6 and 3.8% of the gross National product (GNP). 158 million days of work were lost in the Union in 2000. Around 350 000 workers were obliged to change their job as a result of an accident. Nearly 350 000 workers have various degrees of permanent disability and 15 000 have been forced out of the labour market. However, the fall in the number of accidents at work since the entry into force of Community legislation is estimated to have generated savings of 25 million days of work.
So, while the implementation of this legislation may not be totally satisfactory, it has definitely produced economic benefits.

Effects on employment and competitiveness

The beneficial effects of investment in health and safety at work take some time to filter through. This makes it very difficult for the time being to draw conclusions on the impact of the legislation in question on the competitiveness of the business sector. Cost/benefit analyses will have to be carried out in order to evaluate the short and longer term effects. As an overall conclusion, Member States in their National reports generally indicate that health and safety at work measures contribute towards improved working conditions, boosting productivity, employment and competitiveness.

OVERALL EVALUATION OF IMPLEMENTATION

Positive effects, problems with implementation and suggestions for improving the various Directives

Framework Directive 89/391/EEC

-This downward trend in the number of accidents at work and the aforementioned increase in employers’ awareness are considered by the Member States to be the great achievement of Directive 89/391/EEC. The following positive points were also mentioned:

emphasis on a prevention philosophy;
broadness of scope;
obligation for the employers to perform risk assessments and provide documentation;
obligation for the employer to inform and train workers;
rights and obligations of the workers;
the opportunity to consolidate, rationalise and simplify the National regulations in force.

The main problems pointed to by the Member States arose in the SME context and concerned the administrative obligations and formalities, the financial burden and at the time needed to prepare appropriate measures. Other difficulties were:

the lack of participation by the workers in the operational processes;
the absence of evaluation criteria for National labour inspectorates;
the lack of harmonised European statistical information system on occupational accidents and diseases;
problems in implementing certain provisions in the SMEs.

– If the degree of implementation of the directive is to be improved then there is a need to:

increase the level of application of the Directives in SMEs;
ensure the availability of comprehensive and harmonised statistics on occupational accidents;
provide easy access to information and assistance for employers and workers to make them aware of their rights and obligations;
step up action and allocate the resources necessary to guarantee uniform, effective and equivalent implementation;
identify any provisions of the Directives that have been outdated by technological development and need to be reviewed;
focus greater attention on the specific situation of temporary workers.

Directive 89/654/EEC on workplaces

– The positive aspects:

regulation of various situations which would not have received the required attention had they not been dealt with by the European Directive, e.g. windows, translucent partitions, doors or gates opening upwards, emergency routes and exits, etc.;
reinforcing regulations on the employers’ obligations relating to workplaces used for the first time, and workplaces already in use.

Implementation difficulties:

excessive detail concerning certain aspects, this being detrimental to the proper transposal of the directive ;
unclear distinction made by the Directive between workplaces used for the first time and those already in use ;
the investment required to adopt the new provisions in SMEs.

– Suggestions for improvement:

the need for a co-ordinated approach to the problems regarding environmental conditions, e.g. by exchange of relevant experience among Member States;
the establishment of guidelines and recommendations (with up-to-date data, charts and figures) in order to clarify certain aspects (ventilation, lighting, temperature, dimensions of the workplace, etc.);
examining the provisions which are applicable to teleworking.

Directive 89/655/EEC on the use of work equipment by workers at work

-The positive points:

minimum safety level for work equipment defined;
National regulations unified and harmonised, which has contributed towards simplification;
scope extended to a greater number of items of work equipment;
standards generally clearer and more specific;
employer awareness raised with regard to the safety level of work equipment;
adaptation, official approval and modernisation of work equipment in use;
more active prevention of risks associated with the use of work equipment;
better analysis of factors to be taken into account when acquiring new equipment.

– Implementation difficulties:

excessive cost for SMEs which do not have the necessary financial resources;
the need for long-term investment to adapt work equipment;
the practical distinction between the Directive on safety in the use of work equipment and the machinery Directive has not been made sufficiently clear;
the definition of various safety levels for a machine already in use and for a new machine makes it difficult to adapt it to the requirements of the Directive.

-Suggestions for improvement:

clarification of the various safety levels for a machine in use and for a new machine;
support measures to smooth over the implementation of the directive, particularly for the SMEs: financial aid, loans, etc;
publication of guidelines on the practical part of the provisions.

Directive 89/656/EEC on the use by workers of personal protective equipment

– The positive points:

National legislation has been standardised, simplified and co-ordinated;
extension of the regulations to new sectors and new equipment ;
obligation on the employer to assess risks before selecting individual protection equipment and a widespread increase in awareness as regards the conditions to be met by this equipment;
greater detail in the regulations, which entail, for instance, knowing the exact type of activities in which certain individual protection equipment is mandatory.

– Implementation difficulties:

lack of assistance for SMEs, which have difficulty in selecting suitable protection equipment by themselves;
cost of new equipment for small companies;
workers insufficiently familiar with the use of personal protective equipment.

– Suggestions for improvement:

the Commission should publish specific guidelines and codes of good practice, which would include selection criteria for personal protective equipment;
supplement the annexes to the directive in order to make it easier for companies to choose equipment;
synchronisation and simplification of implementation reports.

Directive 90/269/EEC on the manual handling of loads

– The positive points:

support for existing regulations on manual handling of loads in some Member States;
regulations which are clear and have been generally applied without problems;
improvements in the level of awareness of employers (taking on board the ergonomics aspects in risk assesment);
these obligations have been put into practice in nearly all sectors of industry.

– Implementation difficulties:

job losses could result from a high level of mechanisation and costs;
some aspects of the Directive are considered too detailed (although this is considered a positive aspect in some Member States);
the possibility that a series of workplaces may cease to be considered as suitable for women;
the absence of standards other than those of load weight and distance, regarding rest periods and rest intervals.

– Suggestions for improvement:

several Member States are of the opinion that limit values should be set, since the margin for interpretation allowed as regards manual handling of loads is excessive;
the Commission should give details concerning evaluation models and guidelines;
the application of ergonomics principles to the handling of materials should be given closer attention.

Directive 90/270/EEC on work with visual display equipment

– The positive points:

further support for control and improvement of the ergonomics aspects of workstations using visual display equipment;
introduction of rest periods and the workers’ right to better health surveillance, in particular eye tests;
these obligations have been put into practice in nearly all sectors of the industry.

– Implementation difficulties

a number of problems are difficult to solve (use of natural light, the ergonomics aspects of seating, the inability to neutralise certain electromagnetic fields);
confusion as to who is authorised to or should carry out eye tests;
problems stemming from teleworking and supervision of working conditions within that framework.

– Suggestions for improvement:

it would be advisable to specify the provisions on changes of activity or rest periods, as well as the persons to whom they should apply;
the problems caused by electromagnetic radiation from terminals, lasers and magnetic fields should be examined;
various Member States consider a review of the Directive to be appropriate, in order to adapt it to technological development.

BACKGROUND

The analysis concerns the transposition and application of the framework directive 89/391 on the introduction of measures to encourage improvements in the safety and health of workers at work as well as of the first five individual directives, addressing particular workplace environments or risks. The individual directives concern in particular:

minimum requirements for the workplace (Directive 89/654/EEC)
the use of work equipment (Directive 89/655/EEC)
personal protective equipment (Directive 89/656/EEC)
manual handling of loads (Directive 90/269/EEC)
display screen equipment (Directive 90/270/EEC)

This report is the Commission’s response to the call made in the framework directive and in the five individual directives to “submit a report on the implementation of the various directives at regular intervals to the European Parliament, the Council and the Economic and Social Committee”

A major input to this Communication are the National reports provided by the Member States in accordance with the directives which state that “Member States shall report to the Commission every five years (every four years for Directives 90/269 and 90/270) on the practical implementation of the provisions of this Directive, indicating the points of view of employers and workers”. It is also based on a report by independent experts.

Key figures of the act (for the year 2000)
Number of accidents (having resulted in absence from work of over three days): for 100.000 workers, 4016 cases (4539 in 1994); Fatal accident rate: 5237 cases (643 in 1994); Cost of accidents at work and of occupational diseases: between 2.6 and 3.8% of GDP Days of work lost as a result of accidents at work: 158 million; 7% of accident victims are forced to change jobs; 4% of accident victims have to reduce their working hours or suffer varying degrees of permanent disability; 15.000 workers were forced out of the employment market for good following an accident at work; 14% of workers have more than one accident per year.

Key figures of the act (for the year 2000)

Number of accidents (having resulted in absence from work of over three days): for 100.000 workers, 4016 cases (4539 in 1994);
Fatal accident rate: 5237 cases (643 in 1994);
Cost of accidents at work and of occupational diseases: between 2.6 and 3.8% of GDP
Days of work lost as a result of accidents at work: 158 million;
7% of accident victims are forced to change jobs;
4% of accident victims have to reduce their working hours or suffer varying degrees of permanent disability;
15.000 workers were forced out of the employment market for good following an accident at work;
14% of workers have more than one accident per year.

Protection of young people at work

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Protection of young people at work

Outline of the Community (European Union) legislation about Protection of young people at work

Topics

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

Employment and social policy > Health hygiene and safety at work

Protection of young people at work

Document or Iniciative

Council Directive 94/33/EC of 22 June 1994 on the protection of young people at work.

Summary

The Directive applies to all young people under the age of 18 who have an employment contract or an employment relationship defined by the law in force in a Member State and/or subject to the law in force in a Member State.

The Member States may stipulate that the Directive shall not be applicable to occasional work or work carried out for a limited period in domestic service in a private household or to work in a family business which is not considered likely to harm, injure or endanger young people.

The Directive provides that the Member States shall take the necessary measures to prohibit the employment of children and shall ensure that the employment of adolescents is strictly controlled and protected under the conditions provided for in the Directive.

The Directive defines categories of young people as follows:

young people: young people under the age of 18;
children: young people under the age of 15 or who are still in full-time compulsory education in accordance with national legislation;
adolescents: young people between the ages of 15 and 18 who are no longer in full-time compulsory education in accordance with national legislation.

The Directive’s main objective is to prohibit the employment of children.

However, the Directive allows the Member States to stipulate, subject to certain conditions, that the ban on the employment of children is not applicable to:

children employed for the purposes of cultural, artistic, sporting or advertising activities, subject to prior authorisation by the competent authority in each specific case;
children aged 14 years or over who work in an undertaking as part of a work/training scheme or traineeship, provided that this work is carried out in accordance with the requirements laid down by the competent authority;
children aged 14 years or over performing light work other than that referred to in the first point above ; however, children over 13 may perform light work for a limited number of hours per week in categories of employment defined in national legislation.

The Directive includes provisions relating to:

the employer’s general obligations, such as protection of the health and safety of young people, assessment of the risks to young people associated with their work, assessment and monitoring of the health of young people, information about young people and children’s legal representatives on the possible risks to their health and safety;
types of employment which must not be carried out by young people, such as work which exceeds the mental or physical capacities of young people, work involving harmful exposure to dangerous substances.

In addition, the Directive contains provisions relating to working hours, night work, rest periods, annual leave and rest breaks.

Each Member State is responsible for defining the measures to be taken in the event of infringement of the provisions of this Directive. These measures must be effective and proportionate to the offence.

The Directive contains a non-regression clause concerning the level of protection for young people.

The Directive provides for transition periods of varying lengths for Member States for which the application of this Directive poses significant problems. This is the case for the United Kingdom, which has a transition period of four years to apply some of the most important provisions of the Directive, i.e. until 22 June 2000.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Council Directive 94/33/EC	22.06.1996	–	Official Journal L 216 of 20.08.1994

Related Acts

Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of Regions on the application of Directive 94/33/EC on the protection of young people at work [COM(2004) 105 final].

The report concludes that in most Member States the legislation already made provision for the protection of young workers and the prohibition of child labour before the Directive was adopted. There were therefore no significant problems in transposing the Directive.

Report from the Commission on the effects of the transitional period granted to the United Kingdom concerning certain provisions of Council Directive 94/33/EC on the protection of young people at work [COM(2000)457 final].

Protection of workers from exposure to biological agents

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Protection of workers from exposure to biological agents

Outline of the Community (European Union) legislation about Protection of workers from exposure to biological agents

Topics

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

Employment and social policy > Health hygiene and safety at work

Protection of workers from exposure to biological agents

Document or Iniciative

Directive 2000/54/EC of the European Parliament and the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC).

Summary

This Directive protects the health and safety of workers exposed to biological agents * whilst undertaking their work.

Biological agents are classified into four risk groups, according to the risk of infection involved:

group 1 includes agents that are unlikely to cause human disease;
group 2 concerns agents that can cause human disease but are unlikely to spread to the community, for which effective treatment is available;
group 3 includes agents that can cause human disease and may spread to the community, although prevention or treatment is possible;
group 4 concerns agents that can cause severe human disease. They present a high risk of spreading to the community, for which there is no effective treatment.

Risk assessment

Risk assessment must be carried out for all professional activities that may expose workers to biological agents. The nature, degree and duration of exposure shall be determined in order to plan preventive measures.

The employer shall participate in regular risk assessments.

Employers’ obligations

If the activity so permits, the employer must replace the harmful agents with agents that are not dangerous or are less dangerous, considering their conditions of use and the level of scientific knowledge thereof.

Moreover, if there is a risk to the safety or health of workers, the employer shall ensure that such risk is reduced to a sufficiently low level. The employer may:

limit the number of workers exposed to a minimum;
control the release of agents into the workplace, using technical procedures;
organise collective and/or individual protection measures;
prevent or reduce accidental release outside the workplace, using hygiene measures;
install risk warning signs;
draw up plans to deal with accidents;
provide for the collection, storage and disposal of waste;
arrange for safe handling conditions and transport of biological agents.

The employer is obliged to keep a list of workers exposed to group 3 and/or group 4 agents. This list may be kept for up to 40 years in some cases. Furthermore, the employer shall inform the competent national authority when group 2, group 3 or group 4 biological agents are used for the first time.

Lastly, the employer shall ensure that workers and/or their representatives are sufficiently informed and trained, concerning:

potential risks to health;
precautions to be taken to prevent exposure;
hygiene rules;
use of protective equipment and clothing;
measures to be taken in the case of incidents.

If there is an accident or incident, the employer shall inform workers and/or their representatives as soon as possible of the causes, risks and measures to be taken.

Health surveillance

The Member States shall establish arrangements to carry out the health surveillance of workers, prior to and following exposure to biological agents.

Context

Directive 90/679/EEC on the risks related to exposure of workers to biological agents is repealed.

Key terms
Biological agents: micro-organisms, including those which have been genetically modified, cell cultures and human endoparasites, which may be able to provoke any infection, allergy or toxicity. Micro-organism: a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material. Cell culture: the in-vitro growth of cells derived from multicellular organisms.

Key terms

Biological agents: micro-organisms, including those which have been genetically modified, cell cultures and human endoparasites, which may be able to provoke any infection, allergy or toxicity.
Micro-organism: a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material.
Cell culture: the in-vitro growth of cells derived from multicellular organisms.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 2000/54/EC	18.9.2000	6.11.2000	OJ L 262 of 17.10.2000