Tag Archives: Risk prevention

Risk of explosive atmospheres

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Risk of explosive atmospheres

Outline of the Community (European Union) legislation about Risk of explosive atmospheres

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

Risk of explosive atmospheres

Document or Iniciative

Directive 1999/92/EC of the European Parliament and of the Council of 16 December 1999 on minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres (15th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC).

Summary

An “explosive atmosphere” is a mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture.

The employer must take technical and/or organisational measures to prevent the formation of explosive atmospheres, prevent the ignition of explosive atmospheres, and reduce the effects of an explosion in such a way that workers are not at risk.

The employer must ensure that a health and safety protection document, describing explosion protection measures and satisfying the requirements of Directive 89/391/EEC, is prepared and kept up to date.

Workers and/or their representatives must be informed of all the measures to be taken for their safety and health at work.

The employer must take the necessary steps to ensure that workers potentially at risk from explosive atmospheres receive appropriate training.

Work equipment for use in places where explosive atmospheres may occur must comply with the minimum requirements laid down in the Annex to the Directive.

Where workplaces which contain places in which explosive atmospheres may occur are already in use before the entry into force of the proposed Directive, they must comply with its minimum requirements no later than three years after its entry into force.

After consulting the Advisory Committee on Safety, Hygiene and Health Protection at Work, the Commission must draw up practical guidelines in a guide to good practice of a non-binding nature.

Member States must, on request, endeavour to make relevant information available to employers, with particular reference to the guide to good practice.

Member States must report to the Commission every five years on the practical implementation of the Directive, indicating the points of view of employers and workers. The Commission must inform the European Parliament, the Council, the Economic and Social Committee and the Advisory Committee on Safety, Hygiene and Health Protection at Work.

Annex I contains the classification of places where explosive atmospheres may occur. Annex II describes the minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres and criteria for the selection of equipment and protective systems. Annex III presents the warning sign for places where explosive atmospheres may occur.

References

Act

Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 1999/92/EC of 16 December 1999 from the European Parliament and the Council

–

–

OJ L 23 of 28.01.2000

Related Acts

Communication from the Commission regarding the non-mandatory guide to good practice in order to implement Directive 1999/92/EC on minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres [COM(2003) 515]

The present guide is be used alongside Directive 94/9/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres.

European system for registration of carriers of radioactive materials

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European system for registration of carriers of radioactive materials

Outline of the Community (European Union) legislation about European system for registration of carriers of radioactive materials

Topics

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

Transport > Road transport

European system for registration of carriers of radioactive materials (Proposal)

Proposal

Proposal for a Council Regulation of 30 August 2011 establishing a Community system for registration of carriers of radioactive materials [COM(2011) 518 final – Not published in the Official Journal].

Summary

This Proposal for a Regulation aims at putting in place a European system for registration of carriers of radioactive materials *. Workers and the general public must be protected against the dangers arising from ionising radiation.

The Proposal concerns any carrier transporting radioactive materials within the European Union (EU), from third countries into the EU and from the EU into third countries. It does not concern carriers transporting radioactive materials by air or sea.

Registration of carriers

Carriers must register with the Electronic System for Carrier Registration (ESCReg). The system offers restricted and secure access to the competent authorities of the Member States, to the registered carriers and to the applicants, in accordance with the provisions of the Data Protection Directive.

If an applicant is established in one or more Member States, its application is processed by the competent authority * of the Member State where its head office is located. If the applicant is established in a third country, its application is processed by the competent authority of the Member State where the carrier intends to first enter EU territory.

Member States shall designate a competent authority and a national contact point for the transport of radioactive materials.

If the competent authority refuses to grant the carrier a certificate of registration, the applicant may lodge an appeal.

The certificate of registration is recognised by all Member States and is valid for a period of five years. It may be renewed.

Conditions of transport for radioactive materials

Once registered, the carrier is authorised to carry out transport operations throughout the EU. Carriers must have a copy of their registration certificate during such transport operations.

National reporting and authorisation requirements in addition to those of this Proposal for a Regulation may only apply for the following materials:

  • fissile materials;
  • high consequence radioactive materials.

However, holders of a licence or registration issued pursuant to the Directive on the dangers arising from ionising radiation may transport radioactive materials without registration if their transport is included in licences or registrations for all Member States where the transport takes place.

If carriers do not comply with the requirements of this Proposal for a Regulation, the authorities of the Member State where the offence is recorded may suspend, revoke or modify the carrier’s registration. The carrier may also be prosecuted.

Context

In 2008, the Council and the Parliament adopted the Directive on the transport of dangerous goods grouping together all modes of inland transport. Pursuant to Directive 96/29/Euratom, which lays down basic safety standards for the protection of the health of workers and the general public against dangers arising from ionising radiation, Member States must put in place a system for the registration of companies and institutions processing radioactive materials, including carriers. Under this Proposal for a Regulation, registration will be centralised in order to facilitate transport within the EU.

Key terms of the Act
  • Radioactive material: any material containing radionuclides where both the activity concentration and the total activity in the consignment exceed the values specified in the Regulation on shipments of radioactive substances.
  • Competent authority: any authority designated by the Member State to carry out tasks in accordance with this Regulation.

Reference

Proposal Official Journal Procedure

COM(2011) 518 final

–

2011/0225/NLE

The precautionary principle

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The precautionary principle

Outline of the Community (European Union) legislation about The precautionary principle

Topics

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

Food safety > Food safety: general provisions

The precautionary principle

Document or Iniciative

Communication from the Commission of 2 February 2000 on the precautionary principle [COM(2000) 1 final – Not published in the Official Journal].

Summary

The precautionary principle is detailed in Article 191 of the Treaty on the Functioning of the European Union (EU). It aims at ensuring a higher level of environmental protection through preventative decision-taking in the case of risk. However, in practice, the scope of this principle is far wider and also covers consumer policy, European legislation concerning food and human, animal and plant health.

This Communication establishes common guidelines on the application of the precautionary principle.

The definition of the principle shall also have a positive impact at international level, so as to ensure an appropriate level of environmental and health protection in international negotiations. It has been recognised by various international agreements, notably in the Sanitary and Phytosanitary Agreement (SPS) concluded in the framework of the World Trade Organisation (WTO).

Recourse to the precautionary principle

According to the Commission the precautionary principle may be invoked when a phenomenon, product or process may have a dangerous effect, identified by a scientific and objective evaluation, if this evaluation does not allow the risk to be determined with sufficient certainty.

Recourse to the principle belongs in the general framework of risk analysis (which, besides risk evaluation, includes risk management and risk communication), and more particularly in the context of risk management which corresponds to the decision-making phase.

The Commission stresses that the precautionary principle may only be invoked in the event of a potential risk and that it can never justify arbitrary decisions.

The precautionary principle may only be invoked when the three preliminary conditions are met:

  • identification of potentially adverse effects;
  • evaluation of the scientific data available;
  • the extent of scientific uncertainty.

Precautionary measures

The authorities responsible for risk management may decide to act or not to act, depending on the level of risk. If the risk is high, several categories of measures can be adopted. This may involve proportionate legal acts, financing of research programmes, public information measures, etc.

Common guidelines

The precautionary principle shall be informed by three specific principles:

  • the fullest possible scientific evaluation, the determination, as far as possible, of the degree of scientific uncertainty;
  • a risk evaluation and an evaluation of the potential consequences of inaction;
  • the participation of all interested parties in the study of precautionary measures, once the results of the scientific evaluation and/or the risk evaluation are available.

In addition, the general principles of risk management remain applicable when the precautionary principle is invoked. These are the following five principles:

  • proportionality between the measures taken and the chosen level of protection;
  • non-discrimination in application of the measures;
  • consistency of the measures with similar measures already taken in similar situations or using similar approaches;
  • examination of the benefits and costs of action or lack of action;
  • review of the measures in the light of scientific developments.

The burden of proof

In most cases, European consumers and the associations which represent them must demonstrate the danger associated with a procedure or a product placed on the market, except for medicines, pesticides and food additives.

However, in the case of an action being taken under the precautionary principle, the producer, manufacturer or importer may be required to prove the absence of danger. This possibility shall be examined on a case-by-case basis. It cannot be extended generally to all products and procedures placed on the market.

Contained use of genetically modified micro-organisms

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Contained use of genetically modified micro-organisms

Outline of the Community (European Union) legislation about Contained use of genetically modified micro-organisms

Topics

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

Food safety > Specific themes

Contained use of genetically modified micro-organisms (GMMs)

Document or Iniciative

2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms.

Summary

Member States are required to take all measures necessary in order to avoid the contained use * of genetically modified micro-organisms * (GMMs) having negative consequences on human health and the environment.

The Directive does not cover:

  • genetic modifications resulting from the use of certain techniques or methods listed in Annex II, part A;
  • contained uses involving the GMMs listed in Annex II, part C. GMMs on this list meet the criteria laid down in Annex II, part B, establishing their safety for human health and the environment;
  • the transport of GMMs by road, rail, inland waterway, sea or air;
  • the storage, culture, transport, destruction, disposal or use of GMMs which have been placed on the market in accordance with Directive 2001/18/EC on the release of GMOs or pursuant to other Community legislation which provides for a specific environmental risk assessment similar to that laid down in the said Directive, provided that the contained use is in accordance with the conditions, if any, of the consent for placing on the market.

The assessment of GMM records shall result in a risk hierarchy of the contained uses consisting of four classes. The containment measures to be applied shall also be classified in a four-level hierarchy.

  • Class 1: No or negligible risk, level 1 containment;
  • Class 2: Low risk, level 2 containment;
  • Class 3: Moderate risk, level 3 containment;
  • Class 4: High risk, level 4 containment.

The contained use of GMMs requires an examination of the containment and protection measures taken, in order to avoid a release.

When contained uses are to be carried out in premises for the first time, the user shall be required, before commencing such use, to submit to the competent authorities a notification containing at least the information listed in Annex V, Part A, B or C, as appropriate. Following notification to the competent authorities of a class 1 contained use, subsequent class 1 contained use may proceed without further notification. Users of GMMs in class 1 contained uses shall be required to keep a record of each assessment, which shall be made available to the competent authority on request.

If the premises have been the subject of a previous notification to carry out class 2 or a higher class of contained uses and any associated consent requirements have been satisfied, the class 2 contained use may proceed immediately following the new notification. However, the applicant may himself request from the competent authority a decision on the grant of a formal authorisation. The decision must be made within a maximum of 45 days from the notification.

If the premises have not been the subject of a previous notification to carry out class 2 or a higher class of contained uses, the class 2 contained use may, in the absence of any indication to the contrary from the competent authority, proceed 45 days after submission of the notification or earlier with the agreement of the competent authority.

A class 3 or higher class of contained use may not proceed without the prior consent of the competent authority, which shall communicate its decision in writing:

  • at the latest 45 days after submission of the new notification, in the case of premises which have been the subject of a previous notification to carry out class 3 or a higher class of contained uses and where any associated consent requirements have been satisfied for the same or a higher class than the contained use with which it is intended to proceed;
  • at the latest 90 days after submission of the notification, in other cases.

The Annexes to the Directive detail the criteria for assessing the risks of GMMs to health and the environment, as well as the protective measures for each of the four levels of containment.

If they so wish, Member States may provide for groups or the public to be consulted on any aspect of proposed contained use.

Before a contained use commences, Member States shall ensure that:

  • an emergency plan is drawn up in order to react effectively in the case of an accident *; and
  • persons at risk of being affected by an accident are informed of all aspects related to their safety.

If an accident occurs, the user should immediately inform the competent authority and communicate the information necessary for assessing the impact of that accident and for taking the appropriate action. The Member State shall also inform the Commission and any Member State which may be affected by the accident.

The Commission shall create a register of accidents including an analysis of the causes of the accidents, the experience gained and measures taken to avoid similar accidents.

The Commission shall be assisted by a Committee which is to rule on matters related to the application of the Directive and adapting it in light of technical progress.

Context

This Directive replaces and repeals Directive 90/219/EEC. It is a formal amendment aimed at bringing together the original Directive and its successive amendments into a single act, without any changes to the fundamental provisions nor any new transposition into national law being made.

Finally, this Directive lays down the minimal standards applicable to the contained use of genetically modified micro-organisms. Member States are permitted to take more stringent measures. They may also extend the scope of the Directive to contained uses involving genetically modified plants, animals or fish.

Key terms of the Act
  • Genetically modified micro-organism: a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination; within the terms of this definition:
    1. genetic modification occurs at least through the use of the techniques listed in Annex I, Part A;
    2. the techniques listed in Annex I, Part B, are not considered to result in genetic modification.
  • Contained use : any activity in which micro-organisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment.
  • Accident: any incident involving a significant and unintended release of GMMs in the course of their contained use which could present an immediate or delayed hazard to human health or the environment.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 2009/41/EC

10.6.2009

–

OJ L 125 of 21.5.2009

Exposure to asbestos

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Exposure to asbestos

Outline of the Community (European Union) legislation about Exposure to asbestos

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 asbestos

Asbestos is a dangerous product which can cause serious diseases. The exposure of workers to this product is monitored and harmonised at European level. The different degrees of exposure are adjusted in line with the development of scientific knowledge on the subject.

Document or Iniciative

Council Directive 83/477/EEC of 19 September 1983 on the protection of workers from the risks related to exposure to asbestos at work (second individual Directive within the meaning of Article 8 of Directive 80/1107/EEC) [See amending acts].

Summary

Directive 83/477/EEC and Directive 91/382/EEC

The Directives do not apply to sea or air transport.

“Asbestos” is taken to mean six fibrous silicates (actinolite, asbestos gruenerite, anthophyllite, chrysotile, crocidolite, and tremolite). The limit values pertaining to in-air concentrations are:

  • for chrysotile: 0.60 fibres per cm3 calculated or measured for an eight-hour reference period;
  • for all other forms of asbestos: 0.30 fibres per cm3 calculated or measured for an eight-hour reference period.

Any activity likely to entail risk of exposure to dust arising from asbestos or materials containing asbestos must be assessed in such a way as to determine the degree and nature of the workers’ exposure.

These activities are to be notified by the employer to the responsible authority of the Member State. The notification must include at least a description of the types and quantities of asbestos used, the activities and processes involved, and the products manufactured. Workers or their representatives are entitled to see the documents concerned.

The application of asbestos by means of the spraying process and working procedures that involve the use of low-density (less than 1g/cm3) insulating or soundproofing materials are prohibited.

Exposure to asbestos is reduced by limiting its use as far as possible, keeping to a minimum the number of persons exposed, and taking adequate measures to maintain buildings and ensure that materials are properly stored, transported and labelled.

In order to ensure compliance with the limit values, asbestos-in-air concentrations are to be measured regularly.

If these values are exceeded, the reasons must be identified and appropriate measures to remedy the situation must be taken before work is resumed.

The places in which activities giving rise to exposure risks are carried out must be clearly marked and indicated by warning signs. They are to be out of bounds to smokers and workers other than those who, by reason of work or duties, are required to enter such areas. Areas are to be set aside where workers can eat and drink without risking being contaminated by asbestos dust. Workers are to be provided with appropriate working or protective clothing.

Workers and/or their representatives must receive adequate information on health risks; the existence of limit values; the need for monitoring of the atmosphere; hygiene requirements and specific precautions to be taken.

Each worker’s state of health must be assessed, including a specific chest examination, prior to exposure to dust arising from asbestos or materials containing asbestos and subsequently at least once every three years for the duration of the exposure. The employer is required to keep a register indicating the nature and duration of the activity and the exposure to which the worker is subjected; both the worker concerned and doctors must have access to the information in the register.

A plan of work setting out the necessary health and safety measures is to be drawn up before the commencement of any demolition work or work involving removal of asbestos.

Member States must keep a register of cases of asbestosis and mesothelioma.

The employer will not be required to notify the authority, take atmospheric measurements, put up warning signs, carry out health assessment or inform workers if the assessment of the exposure risks shows that the asbestos-in-air concentration is as follows:

  • for chrysotile, lower than 0.20 fibres per cm3 for an eight-hour reference period or lower than a cumulative dose of 12.00 fibres over a three-month period,
  • for all other forms of asbestos, lower than 0.10 fibres per cm3 for an eight-hour reference period or lower than a cumulative dose of 6.00 fibres over a three-month period.

Directive 98/24/EC

Adapts the provisions of the above-mentioned Directives to Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers in the workplace. This Directive now applies to the exposure of workers to chemical agents

Directive 2003/18/EC

  • reduces the limit value for occupational exposure of workers to asbestos. It repeals the two limit values established by Directive 83/477, setting a single maximum limit value for airborne concentration of asbestos of 0.1 fibres per cm3 as an eight-hour time-weighted average (TWA);
  • abolishes the derogations applicable to the sea and air transport sectors;
  • prohibits activities exposing workers to asbestos fibres, with the exception of the treatment and disposal of products resulting from demolition and asbestos removal;
  • updates the practical recommendations on the clinical surveillance of exposed workers in the light of the latest medical expertise, with a view to the early detection of pathologies linked to asbestos.

References

Act Date of entry into force Deadline for transposition in the Member States Official Journal
Directive 83/477/EEC

22.9.1983

1.1.1987

1.1.1990 in the case of asbestos-mining activities

OJ L 263 of 24.9.1983
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Directive 91/382/EEC

4.7.1991

1.1.1993

1.1.1996 in the case of asbestos-mining activities

1.1.1999 for Greece

OJ L 206 of 29.7.1991
Directive 98/24/EC

25.5.1998

5.5.2001

OJ L 131 of 5.5.1998
Directive 2003/18/EC

15.4.2003

14.4.2006

OJ L 97 of 15.4.2003
Directive 2007/30/EC

28.6.2007

31.12.2007

OJ L 165 of 27.6.2007

Related Acts

Directive 2009/148/EC of the European Parliament and of the Council of 30 November 2009 on the protection of workers from the risks related to exposure to asbestos at work (Text with EEA relevance).

Directive of the European Parliament and of the Council of 20 June 2007 amending Council Directive 89/391/EEC, its individual Directives and Council Directives 83/477/EEC, 91/383/EEC, 92/29/EEC and 94/33/EC with a view to simplifying and rationalising the reports on practical implementation (Text with EEA relevance)
Member States must present a report every five years on the application of the Directive. The first report must cover the period from 2007 to 2012.

Directive 2004/37/EC of the European Parliament and of 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) [OJ L 158 of 30.04.2004; corrigendum OJ L 229 of 29.06.2004].
This Directive applies to asbestos. It includes provisions which are more favourable to health and safety in the workplace than those set out in Directive 83/477/EEC.

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).

 

Another Normative about Exposure to asbestos

Topics

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

Internal market > Single Market for Goods > Construction

Exposure to asbestos

Asbestos is a dangerous product which can cause serious diseases. The exposure of workers to this product is monitored and harmonised at European level. The different degrees of exposure are adjusted in line with the development of scientific knowledge on the subject.

Document or Iniciative

Council Directive 83/477/EEC of 19 September 1983 on the protection of workers from the risks related to exposure to asbestos at work (second individual Directive within the meaning of Article 8 of Directive 80/1107/EEC) [See amending acts].

Summary

Directive 83/477/EEC and Directive 91/382/EEC

The Directives do not apply to sea or air transport.

“Asbestos” is taken to mean six fibrous silicates (actinolite, asbestos gruenerite, anthophyllite, chrysotile, crocidolite, and tremolite). The limit values pertaining to in-air concentrations are:

  • for chrysotile: 0.60 fibres per cm3 calculated or measured for an eight-hour reference period;
  • for all other forms of asbestos: 0.30 fibres per cm3 calculated or measured for an eight-hour reference period.

Any activity likely to entail risk of exposure to dust arising from asbestos or materials containing asbestos must be assessed in such a way as to determine the degree and nature of the workers’ exposure.

These activities are to be notified by the employer to the responsible authority of the Member State. The notification must include at least a description of the types and quantities of asbestos used, the activities and processes involved, and the products manufactured. Workers or their representatives are entitled to see the documents concerned.

The application of asbestos by means of the spraying process and working procedures that involve the use of low-density (less than 1g/cm3) insulating or soundproofing materials are prohibited.

Exposure to asbestos is reduced by limiting its use as far as possible, keeping to a minimum the number of persons exposed, and taking adequate measures to maintain buildings and ensure that materials are properly stored, transported and labelled.

In order to ensure compliance with the limit values, asbestos-in-air concentrations are to be measured regularly.

If these values are exceeded, the reasons must be identified and appropriate measures to remedy the situation must be taken before work is resumed.

The places in which activities giving rise to exposure risks are carried out must be clearly marked and indicated by warning signs. They are to be out of bounds to smokers and workers other than those who, by reason of work or duties, are required to enter such areas. Areas are to be set aside where workers can eat and drink without risking being contaminated by asbestos dust. Workers are to be provided with appropriate working or protective clothing.

Workers and/or their representatives must receive adequate information on health risks; the existence of limit values; the need for monitoring of the atmosphere; hygiene requirements and specific precautions to be taken.

Each worker’s state of health must be assessed, including a specific chest examination, prior to exposure to dust arising from asbestos or materials containing asbestos and subsequently at least once every three years for the duration of the exposure. The employer is required to keep a register indicating the nature and duration of the activity and the exposure to which the worker is subjected; both the worker concerned and doctors must have access to the information in the register.

A plan of work setting out the necessary health and safety measures is to be drawn up before the commencement of any demolition work or work involving removal of asbestos.

Member States must keep a register of cases of asbestosis and mesothelioma.

The employer will not be required to notify the authority, take atmospheric measurements, put up warning signs, carry out health assessment or inform workers if the assessment of the exposure risks shows that the asbestos-in-air concentration is as follows:

  • for chrysotile, lower than 0.20 fibres per cm3 for an eight-hour reference period or lower than a cumulative dose of 12.00 fibres over a three-month period,
  • for all other forms of asbestos, lower than 0.10 fibres per cm3 for an eight-hour reference period or lower than a cumulative dose of 6.00 fibres over a three-month period.

Directive 98/24/EC

Adapts the provisions of the above-mentioned Directives to Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers in the workplace. This Directive now applies to the exposure of workers to chemical agents

Directive 2003/18/EC

  • reduces the limit value for occupational exposure of workers to asbestos. It repeals the two limit values established by Directive 83/477, setting a single maximum limit value for airborne concentration of asbestos of 0.1 fibres per cm3 as an eight-hour time-weighted average (TWA);
  • abolishes the derogations applicable to the sea and air transport sectors;
  • prohibits activities exposing workers to asbestos fibres, with the exception of the treatment and disposal of products resulting from demolition and asbestos removal;
  • updates the practical recommendations on the clinical surveillance of exposed workers in the light of the latest medical expertise, with a view to the early detection of pathologies linked to asbestos.

References

Act Date of entry into force Deadline for transposition in the Member States Official Journal
Directive 83/477/EEC

22.9.1983

1.1.1987

1.1.1990 in the case of asbestos-mining activities

OJ L 263 of 24.9.1983

Amending act(s) 		Entry into force Deadline for transposition in the Member States Official Journal
Directive 91/382/EEC

4.7.1991

1.1.1993

1.1.1996 in the case of asbestos-mining activities

1.1.1999 for Greece

OJ L 206 of 29.7.1991
Directive 98/24/EC

25.5.1998

5.5.2001

OJ L 131 of 5.5.1998
Directive 2003/18/EC

15.4.2003

14.4.2006

OJ L 97 of 15.4.2003
Directive 2007/30/EC

28.6.2007

31.12.2007

OJ L 165 of 27.6.2007

Related Acts

Directive 2009/148/EC of the European Parliament and of the Council of 30 November 2009 on the protection of workers from the risks related to exposure to asbestos at work (Text with EEA relevance).

Directive

2007/30/EC

of the European Parliament and of the Council of 20 June 2007 amending Council Directive 89/391/EEC, its individual Directives and Council Directives 83/477/EEC, 91/383/EEC, 92/29/EEC and 94/33/EC with a view to simplifying and rationalising the reports on practical implementation (Text with EEA relevance)
Member States must present a report every five years on the application of the Directive. The first report must cover the period from 2007 to 2012.

Directive 2004/37/EC of the European Parliament and of 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) [OJ L 158 of 30.04.2004; corrigendum OJ L 229 of 29.06.2004].
This Directive applies to asbestos. It includes provisions which are more favourable to health and safety in the workplace than those set out in Directive 83/477/EEC.


Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).

 

Prevention of natural or man-made disasters in the European Union

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Prevention of natural or man-made disasters in the European Union

Outline of the Community (European Union) legislation about Prevention of natural or man-made disasters in the European Union

Topics

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

Environment > Civil protection

Prevention of natural or man-made disasters in the European Union

Document or Iniciative

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 23 February 2009 – A Community approach on the prevention of natural and man made disasters [COM(2009) 82 final – Not published in the Official Journal].

Summary

Community territory is affected by natural or man-made disasters, the number and impact of which is rising. This increasing vulnerability is caused in particular by the effects of climate change and by urban and industrial development.

The strategy is part of a set of instruments with both an external and an internal dimension. It does not cover emergencies related to conflicts or acts of terrorism.

The measures taken regarding disaster prevention are mainly at national level. Disaster prevention should nevertheless be approached at European level, since hazards often have cross-border impact and effects on the growth and competitiveness of the European Union (EU).

A Community approach should enhance the effectiveness of prevention action by adding to national actions in certain areas. This strategy is therefore based on three main themes:

  • Developing existing knowledge, so as to improve the effectiveness of prevention policies.

The Commission should facilitate the production of information and its comparability with regard to disaster factors. It will carry out an inventory of information sources and best practices, and dissemination of best practices in risk management procedures (land use planning, emergency plans, etc.). Risk areas should be mapped according to guidelines prepared at European level.

The 7th Research and Development Framework Programme (RDFP) supports the coordination of research activities and the dissemination of information on disaster risks.

  • Extending cooperation of actors involved in disaster management.

Prevention, preparedness, response and recovery activities should be based on coordinated mechanisms involving public and private actors. The creation of a network of those responsible at national level and specialists should serve to improve the coordination of Community, national and regional measures.

Links between detection and early warning systems should be developed, including in cooperation with Mediterranean third countries. The Commission must further develop the evaluation of the Civil Protection Mechanismand training will be carried out within the framework of the civil protection programme. Citizens should be better informed about prevention measures, as well as the existence of the emergency number 112 (pdf ).

  • Targeting legislative and financial instruments for prevention action.

Within the framework of the 2007-2013 budget, the Commission should identify the Community instruments which could finance prevention measures (for example in the areas of rural development, civil protection, environmental protection, research and information and communication technologies). If necessary, the Commission shall make recommendations for the integration of these measures in national operational programmes.

When certain legislative provisions are amended, the constraints related to disaster risk management should be better addressed. The following are particularly concerned: the SEA Directiveon the environmental impact of public and private projects, the SEVESO Directive on technological risks and the provisions concerning technical standards of anti-seismic construction. European legislation also coversflood management and oil spills.

International cooperation

This strategy should be implemented in cooperation with Candidate countries or potential Candidates for accession, with Neighbourhood Policy (ENP) partner countries and as part of the programme for prevention, preparedness and response to natural and man-made disasters (PPRD) within the Euro-Mediterranean Partnership.

The Commission will coordinate these actions with the European strategy for the reduction of risks in developing countries. This is to be in line with the international Hyogo Framework for Action 2005 – 2015 for disaster prevention.

Response to natural or man-made disasters

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Response to natural or man-made disasters

Outline of the Community (European Union) legislation about Response to natural or man-made disasters

Topics

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

Environment > Civil protection

Response to natural or man-made disasters

Document or Iniciative

Communication from the Commission to the European Parliament and the Council of 5 March 2008 on “Reinforcing the Union’s Disaster Response Capacity” [COM(2008) 130 final – Not published in the Official Journal].

Summary

The Commission has put forward proposals which aim to reinforce the European Union’s

disaster response capacity. The notion of ‘disaster’ is used in a broad sense to cover natural or man-made disasters and conflict-related emergencies taking place within the European Union (EU) and also outside its borders.

In order to react effectively to these disasters, a comprehensive approach including risk assessment, forecast, prevention, preparedness and rehabilitation is required. This also requires the mobilisation of all the policies, instruments and services available to the Community and Member States.

Planning, coordination and rapid response

The Commission stresses the need to reinforce the links between civil protection and the environmental policies included in environmental legislation in order to take full advantage of the preventive measures included in the latter. Importance is also placed on developing synergies with international, national and local stakeholders to achieve better coordination.

In particular, the Commission put forward the suggestion to streamline coordination between itself, the Council and Member States for large scale disasters involving both Community instruments and Common Foreign and Security Policy (CFSP) instruments. The Commission referred to the opportunity to establish joint planning and operational teams as well as to develop standard operational procedures adapted to different types of disasters and geographical areas.

The Commission reiterated that it manages many Rapid Alert Systems (RAS) in case of specific sectoral disasters. It also decides on Community humanitarian assistance and coordinates the Community Civil Protection Mechanism. Furthermore, the Commission has at its disposal a number of instruments it can use to finance disaster prevention measures or to alleviate the financial costs incurred by public authorities when undertaking emergency operations. These instruments include the European Regional Development Fund (ERDF), the European Union Solidarity Fund (EUSF), funds allocated for Rural Development, the Civil Protection Financial Instrument (CPFI) and the Instrument for Stability.

The Commission also has at its disposal a number of coordination tools for managing crisis situations more effectively, such as ARGUS, an internal mechanism developed in June 2006 to respond to multidimensional crises, and the RELEX Crisis Platform, established after the 2004 Tsunami, which assists political coordination between the Commission and Member States during external crisis situations.

Improving humanitarian aid

The Commission aims to improve the European Union’s humanitarian aid capacities. In particular this will be achieved by identifying existing gaps in terms of logistics, further strengthening the rapid assessment and response capacity in the field and improving liaison between the different actors involved.

Noting that the majority of disasters taking place in third countries do not trigger an international response and that when an international response is initiated, it often takes days for external assistance to reach the site, the Commission believes it is important to have an active expert presence in the field and to ensure that local authorities have the capacity to react immediately.

Reinforcing civil protection

In the field of civil protection, the Commission proposes to build up the Monitoring and Information Centre so that it can take on the role of the European Union’s operational centre for intervention. It also aims to improve the European Union’s response capacity, whilst keeping in reserve the means to rapidly intervene in the event of a disaster.

The Commission intends to undertake studies and finance diverse projects with the aim of developing a knowledge base on the EU’s capacity to intervene quickly in the event of major disasters in a Member State or third country. This will include studies on scenarios which aim to identify potential shortcomings and trial runs of different methods which would enable rapid intervention capacities to be kept in reserve. On this basis the Commission will put forward appropriate proposals.

The Commission suggests undertaking other measures in parallel, such as the creation of a European Disaster Response Training Network, the development of early warning systems and promoting the use of the single European emergency number (“112”).

The Communication includes an Annex on the subject of forest fires to clearly demonstrate how further prevention, preparedness, response and recovery measures could be combined to deal with such a disaster in a more effective manner.

Context

The increase in major disasters in recent years (the 2004 tsunami in Asia, the war in Lebanon in 2006, forest fires and floods in Europe in 2007) and the risk of increasingly frequent disasters due to climate change makes modernisation and adaptation of the European Union’s means of response essential.

In December 2007 the European Parliament and European Council invited the Council and Commission to make the best use of the Community Civil Protection Mechanism and the Civil Protection Financial Instrument to help prepare for major emergencies. Furthermore, in December 2007 the European Parliament and the European Council signed the European Consensus on Humanitarian Aid, a comprehensive framework for improved delivery of humanitarian aid at the European Union level.

Moreover, the Commission believes that a disaster management policy must include measures aimed at preventing this type of event. The Commission announced its intention to present an integrated approach to disaster prevention in the European Union, as well as a European Strategy for Disaster Risk Reduction in Developing Countries.

Regulatory framework for the management of chemicals , European Chemicals Agency

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Regulatory framework for the management of chemicals , European Chemicals Agency

Outline of the Community (European Union) legislation about Regulatory framework for the management of chemicals , European Chemicals Agency

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

Regulatory framework for the management of chemicals (REACH), European Chemicals Agency

Document or Iniciative

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [See amending act(s)].

Summary

The European Union (EU) has established REACH, an integrated system for the registration, evaluation, authorisation and restriction of chemicals, together with a European Chemicals Agency. REACH requires firms which manufacture and import chemicals to evaluate the risks resulting from the use of those chemicals and to take the necessary steps to manage any identified risk. Industry has the burden of proving that chemicals produced and placed on the market are safe.

The purpose of the regulation is to ensure a high level of protection of human health and the environment, and to strengthen the competitiveness of the chemicals sector and promote innovation.

Scope

The scope of the Regulation covers all substances *, whether manufactured, imported, placed on the market, or used on their own or in mixtures.

The following are excluded from the scope of the Regulation:

  • radioactive substances (covered by Directive 96/29/Euratom);
  • substances under customs supervision which are in temporary storage, in free zones or free warehouses with a view to re-exportation or still in transit;
  • non-isolated intermediates *;
  • the transport of dangerous substances; and
  • waste.

The rules on registration, downstream users, evaluation and authorisation do not apply to substances used in medicinal products for human or veterinary use or in food or feedingstuffs (including additives) provided they fall within the scope of Community legislation on medicinal products or food.

Registration

Registration is the key component of the REACH system. It will be compulsory to register in a central database chemicals which are manufactured or imported in quantities of one tonne or more per annum. The database will be managed by the European Chemicals Agency. If a substance is not registered it cannot be produced or placed on the European market.

Registration will be compulsory from 1 June 2008, but there will be transitional arrangements until 1 June 2018 in some cases for certain substances which must be pre-registered.

Some groups of substances (listed in the Regulation) are, however, exempt from the obligation to register, for instance:

  • polymers (however monomers which make up polymers must still be registered);
  • some substances for which the estimated risk is negligible (water, glucose, etc.);
  • naturally occurring and chemically unaltered substances;
  • substances used in research and development, under certain conditions.

Registration requires the industry (manufacturers and importers) to provide information on the properties and uses of chemicals and the precautionary measures to be taken when using them (technical dossier). The data required are proportional to the production volume of and the risks presented by the substance concerned (for example, extensive toxicity tests for substances manufactured or imported in quantities of more than 1000 tonnes). An application to register a substance which is imported or manufactured in a quantity of 10 tonnes or more per year must include a detailed description of the risks associated with that substance and the different possible exposure scenarios and risk management measures (chemical safety report).

There are “lighter” requirements for isolated intermediates, provided they are manufactured in strictly controlled conditions and for isolated intermediates which are transported and used under strict control in quantities of less than 1 000 tonnes. In these cases, only the classification, risk management measures and information already available on the properties are required. If more than 1 000 tonnes of the substance are being transported, further information is required.

Likewise, there are special arrangements for the registration of substances present in articles: given the millions of articles that are placed on the market in the EU and the potential risk some of them represent to human health and the environment, certain substances incorporated into articles must be registered. Registration is compulsory when the substance in question is normally released when the article is used and is present in those articles in quantities totalling over one tonne per producer or importer per year. For substances that are not normally released but which are particularly hazardous and are contained in a minimum concentration of 0.1% and placed on the market in quantities of over one tonne per producer or importer per year, simple notification is required, on the basis of which the European Chemicals Agency may request a registration.

The European Chemicals Agency is responsible for managing the database, receiving registration dossiers and developing technical guides aimed at helping manufacturers, importers and the competent authorities in implementing these provisions. During the first eleven years of application of the REACH system, around 30 000 substances already on the market should be registered. It is thought that about 80% of all registered substances will not need any further action.

Data sharing

The Regulation lays down a number of rules on data sharing in order to reduce testing on vertebrate animals and to reduce costs to industry. Provision is made for relevant data to be shared between registrants in exchange for payment.

To the same end, the Regulation requires all registrants of the same substance to submit their applications for registration together except in cases where there are grounds for not doing so, to protect confidential information, in case of disagreement with other registrants, or where joint submission of an application for registration involves disproportionate costs.

Information at the centre of the supply chain

Safety data will be passed throughout the supply chain so that those using chemicals in their production process to manufacture other preparations or articles will be able to do so safely and responsibly, without endangering workers’ or consumers’ health and without putting the environment at risk. This requires information to be passed both up and down the supply chain, and between all actors in that supply chain.

The data transmitted concern, inter alia, identification, composition and properties of the substances, the measures to be taken for use and transport without risk, the measures to be taken in case of fire or accidental release, and toxicological and ecological information. Sensitive information of a commercial nature does not have to be transmitted.

Downstream users

Downstream users must consider the safety of substances, based primarily on information from their suppliers, and to take appropriate risk management measures. These provisions also allow authorities to have an overview of the uses of a substance as it moves through the supply chain and, if necessary, to request further information and take appropriate measures.

Evaluation

Evaluation makes it possible for the Agency to check that industry is fulfilling its obligations and avoiding tests on vertebrate animals when unnecessary. Two types of evaluation are provided for: dossier evaluation and substance evaluation.

Dossier evaluation is to be compulsory for any applications to carry out tests specified in Annexes IX and X to the Regulation (these are the most stringent tests, mostly involving the use of vertebrate animals). The aim is essentially to minimise the need for experiments of this kind. Dossier evaluation may also be carried out in order to check the conformity of a registration. The Agency is expected to carry out a thorough review of at least 5% of the dossiers filed.

Substances suspected of posing a risk to human health or the environment may also be evaluated by the competent authorities in the Member States in order to determine whether further information is required. The evaluation programme is developed by the Agency, in cooperation with the competent authorities.

If a substance is suspected of posing a risk to human health or the environment, the Agency will include this substance in a specific list and a designated Member State will carry out an evaluation in order to determine whether further information is required from the registrant.

Evaluation can lead to the following conclusions:

  • the substance must be subject to restriction or authorisation procedures;
  • the classification and labelling of the substance must be harmonised;
  • information must be supplied to the other authorities so that they can adopt appropriate measures. For example, if, while the substance is being evaluated, information on risk management measures become available and could have an impact on the conditions of use of that substance, the information should be transmitted to the authorities responsible for this legislation.

Authorisation

Substances of extremely high concern may be subject to authorisation by the Commission with regard to particular uses. The objective is to ensure that the risks linked with these substances are validly controlled and that these substances are gradually replaced by other appropriate substances or technologies where this is economically and technically viable.

The Agency publishes and regularly updates a list of substances (‘list of candidate substances’) identified as having characteristics of extremely high concern. These may include the following:

  • CMRs (carcinogens, mutagens and reproductive toxins);
  • PBTs (persistent, bioaccumulative and toxic substances);
  • vPvBs (very persistent and very bioaccumulative substances);
  • some substances of concern which have irreversible serious effects on humans and the environment, such as endocrine disruptors.

The inclusion of candidate substances on the list involves, under certain conditions, the requirement of information on the presence of this substance in the articles. After inclusion of this substance in Annexe XIV to the Regulation any placing on the market and use of such chemical substances is subject to authorisation. This is granted if the risks arising from the substance in question can be validly controlled. If they cannot and if no alternative exists, the Commission is to assess the level of risk and the socio-economic advantages of using the substance and decide whether to authorise it or not. Some substances, such as PBTs and vPvBs can be authorised only if the socio-economic advantages override the risks and there are no alternatives.

The burden of proof is placed on the applicant. All authorisations must be reviewed after a certain period of time, determined on a case-by-case basis.

Downstream users may use a substance for an authorised use provided they obtain the substance from a company to which an authorisation has been granted and keep within the conditions of that authorisation. However, such downstream users must inform the Agency so that the authorities are fully aware of how certain substances of extremely high concern are being used.

Restriction

The restriction procedure provides a safety net, making it possible to manage the risks which are not adequately covered by other provisions of the REACH system. Proposed restrictions may relate to the conditions of manufacture, use(s) and/or placing on the market of a substance, or the possible prohibition of such activities, if necessary. They are suggested by Member States or by the Agency (at the Commission’s request) in the form of a structured dossier and decided on by the Commission.

European Chemicals Agency

The Regulation establishes a European Chemicals Agency, responsible for managing the technical, scientific and administrative aspects of REACH and ensuring consistency of decision-making at Community level.

The Agency is also to manage the registration process and play a key role in the evaluation process. It receives applications for authorisation and delivers opinions and issues recommendations in relation to the authorisation and restriction procedures.

The Agency’s headquarters are in Helsinki.

Information

Non-confidential information on chemicals is to be available, for example to allow those exposed to chemicals to take decisions as to the acceptability of the associated risks. Some information is accessible free of charge on the Agency’s website, other information on request. However, the Agency may not disclose confidential company data.

Competent authorities

The Regulation requires there to be authorities in each of the Member States with the competence and resources necessary to carry out the tasks assigned to them. These authorities must cooperate with each other and with the Agency in the performance of their duties.

Context

The previous system often proved itself to be incapable of identifying risks posed by many chemicals and was slow to act when risks were identified.

The REACH system is complemented by Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures. This Directive integrates the classification criteria and rules on labelling of the United Nations’ Globally Harmonized System (GHS) with Community legislation and includes the REACH provisions governing the inventory of classifications and labelling.

Key terms used in the act
  • Substance: a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
  • Intermediate: a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance. There are: non-isolated intermediates (an intermediate that during synthesis is not intentionally removed from the equipment in which the synthesis takes place), on-site isolated intermediates (an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site) and transported isolated intermediates (an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites).

References

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

Regulation (EC) No 1907/2006

1.6.2007
Application:
1.6.2008
1.8.2008 (Art. 135)
1.6.2009 (Title VIII and Annex XVII)

–

OJ L 136 of 29.5.2007
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1354/2007

23.11.2007

–

OJ L 304 of 22.11.2007

Regulation (EC) No 1272/2008

20.1.2009

–

OJ L 353 of 31.12.2008

The successive amendments and corrections to Regulation (EEC) No 1907/2006 have been incorporated into the original text.

AMENDMENTS TO THE ANNEXES

Annex II – Requirements concerning the compilation of safety data sheets
Regulation (EU) No 453/2010 [Official Journal L 133 of 31.5.2010].

Annex IV – Exemptions to the registration requirement in compliance with Article 2, paragraph 7, point a)
Regulation (EC) No 987/2008 [Official Journal L 268 of 9.10.2008].

Annex V – Exemptions to the registration requirement in compliance with Article 2, paragraph 7, point b
Regulation (EC) No 987/2008 [Official Journal L 268 of 9.10.2008].

Annex VI – Information requirements
Regulation (EU) No 453/2010 [Official Journal L 133 of 31.5.2010].

Annex XI – General rules on changes to the standard testing system
Regulation (EC) No 134/2009 [Official Journal L 46 of 17.2.2009].

Annex XIV – List of substances subject to authorisation
Regulation (EU) No 143/2011 [Official Journal L 44 of 18.2.2011].

Annex XV – Dossiers
Regulation (EC) No 1272/2008 [Official Journal L 53 of 31.12.2008].

Annex XVII – Restrictions on the manufacture, placing on the market and use of certain dangerous substances and preparations and certain dangerous articles
Regulation (EC) No 1272/2008 [Official Journal L 53 of 31.12.2008];
Regulation (EC) No 552/2009 [Official Journal L 164 of 26.6.2009];
Regulation (EU) No 276/2010 [Official Journal L 86 of 1.4.2010].

Related Acts

Commission Regulation (EC) No 771/2008 of 1 August 2008 laying down the rules of organisation and procedure of the Board of Appeal of the European Chemicals Agency [Official Journal L 206 of 2.8.2008].

Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) [Official Journal L 142 of 31.5.2008].

Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) [Official Journal L 107 of 17.4.2008].

Commission Regulation (EC) No 1238/2007 of 23 October 2007 on laying down rules on the qualifications of the members of the Board of Appeal of the European Chemicals Agency [Official Journal L 280 of 24.10.2007].

Major accidents involving dangerous substances

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Major accidents involving dangerous substances

Outline of the Community (European Union) legislation about Major accidents involving dangerous substances

Topics

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

Environment > Civil protection

Major accidents involving dangerous substances

Document or Iniciative

Council Directive 96/82/EC of 9 December 1996 on the control of major-accident hazards involving dangerous substances [See amending act(s)].

Summary

This Directive (Seveso II) replaced Directive 82/501/EEC (Seveso I, named after the Italian town which suffered exposure to an accidental release of dioxin in 1976).

Seveso establishments

The Directive’s scope was both broadened and simplified. It is applicable to any establishment where dangerous substances are present, or likely to be produced as a result of an accident, in quantities equal to or in excess of the quantities listed in the Annex. The Directive does not cover:

  • military establishments;
  • hazards created by ionising radiation;
  • the carriage of dangerous substances by road, rail, air and inland waterways;
  • the carriage of dangerous substances in pipelines outside the establishments covered by the Directive;
  • the exploitation of minerals, with the exception of chemical and thermal treatment operations and storage connected with such operations which lead to the presence of dangerous substances;
  • mineral prospecting and offshore exploitation activities;
  • waste landfill sites.

General obligations of the operator

Member States must ensure that the operator:

  • takes all measures necessary to prevent major accidents and to limit their consequences for man and the environment;
  • is required to prove to the competent authority that all the necessary measures provided for by the Directive have been taken.

The burden of proof for the latter obligation rests on the operator.

Notification

The Directive includes an obligation to notify under the principle that it is illegal for enterprises to hold large quantities of dangerous substances without informing the competent authorities within the time-limits specified by the Directive. This notification must contain the following details:

  • the name of the operator and the address of the establishment;
  • the registered place of business of the operator;
  • the name or position of the person in charge of the establishment;
  • information sufficient to identify the dangerous substances or category of substances involved;
  • the quantity and physical form of the dangerous substance or substances involved;
  • the activity or proposed activity of the installation or storage facility;
  • the immediate environment of the establishment.

In the event of a change in the situation (for example, the permanent closure of an establishment), the operator must immediately inform the competent authority.

Prevention policy

Member States must ensure:

  • that the operator draws up a document setting out his major-accident prevention policy;
  • that the policy is properly implemented.

Safety report

Member States must require the operator to produce a safety report for the purposes of:

  • demonstrating that a major-accident prevention policy and a safety management system have been put into effect;
  • demonstrating that major-accident hazards have been identified and that the necessary measures have been taken to prevent such accidents and to limit their consequences;
  • demonstrating that adequate safety and reliability have been incorporated into the design, construction, operation and maintenance of any installation, storage facility, equipment and infrastructure connected with its operation which are linked to major-accident hazards inside the establishment;
  • demonstrating that internal emergency plans have been drawn up;
  • supplying information to enable an external plan to be drawn up;
  • providing sufficient information to the competent authorities.

The safety report must contain certain specific information, including an updated inventory of the dangerous substances present in the establishment.

The report must be reviewed:

  • at least every five years, or
  • at any other time at the initiative of the operator or the request of the competent authority, where justified by new facts, or
  • in the event of a site being modified.

Under certain conditions, the operator may be granted a dispensation by the competent authority from providing certain information in the safety report, without this affecting the obligation to submit the report, however. Member States must notify the Commission of any dispensations, and the reasons why they were granted.

Emergency plans

Member States must ensure that all operators obliged to submit a safety report also draw up an internal emergency plan and supply the competent authorities with the information necessary to draw up an external emergency plan. The emergency plans must be reviewed, tested and where necessary revised and updated at least every three years.

Precautions regarding location

The competent authority must:

  • identify establishments or groups of establishments where the risk or consequences of a major accident could be increased due to the location and the proximity of the establishments and their holdings of dangerous substances;
  • ensure an exchange of information and cooperation between the establishments.

Information on safety measures

Member States must ensure that the objectives of preventing major accidents are taken into account in their land-use policies, notably through controls on the siting of new establishments, modifications to existing establishments and new developments (transport links, residential areas, etc.) in the vicinity of existing establishments. They must take into account the need, in the long term, to ensure that appropriate distances are maintained or created between establishments and residential areas.

Member States must ensure that information on safety measures and on the requisite behaviour in the event of an accident is supplied, without their having to request it, to persons liable to be affected by a major accident. They must also ensure that safety reports are made permanently available to the public.

Information to be provided following a major accident

Following a major accident, the operator must:

  • inform the competent authority;
  • provide them with information on the circumstances of the accident, the dangerous substances involved, the data available for assessing the effects of the accident on people and the environment and the emergency measures taken;
  • inform them of the steps envisaged to alleviate the effects of the accident and to prevent any recurrence of such an accident;
  • update the information provided.

The competent authority must:

  • ensure that emergency measures have been taken;
  • collect the information necessary for a full analysis of the accident;
  • ensure that the operator takes any necessary remedial measures;
  • make recommendations on future preventive measures.

Information to be provided by Member States to the Commission

Member States must inform the Commission of major accidents which have occurred within their territory. The information must initially comprise:

  • the name and address of the authority responsible for the report;
  • the date, time and place of the major accident;
  • the name of the operator and the address of the establishment;
  • a brief description of the circumstances of the accident;
  • a brief description of the emergency measures taken and of the immediate precautions necessary to prevent recurrence.

In order to fulfil its obligations with respect to informing Member States, the Commission must establish a file and an information system to collect all the data on major accidents occurring within the territory of Member States.

Inspection

The competent authorities must organise a system of inspections so as to ensure:

  • that the operator can demonstrate that he has provided appropriate means for preventing major accidents and limiting their consequences;
  • that the safety report is accurate and complete;
  • that information has been supplied to the public.

Prohibition of operations

Member States must prohibit the use or bringing into use of any establishment, installation or storage facility where the measures taken by the operator for the prevention of accidents are inadequate. Member States may also prohibit operations if the operator has not submitted, within the specified period:

  • the notification;
  • the reports;
  • any other information required by the Directive.

References

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

Directive 96/82/EC

3.2.1997

3.2.1999

OJ L 10 of 14.1.1997
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Directive 2003/105/EC

31.12.2003

1.7.2005

OJ L 345 of 31.12.2003

Regulation (EC) No 1882/2003

20.11.2003

–

OJ L 284 of 31.10.2003

Regulation (EC) No 1137/2008

11.12.2008

–

OJ L 311 of 21.11.2008

Successive amendments and corrections to Directive 96/82/EC have been incorporated into the basic text. This consolidated versionis for information only.

Related Acts

Proposal for a Directive of the European Parliament and of the Council on control of major-accident hazards involving dangerous substances [COM(2010) 781 final – Not published in the Official Journal].
On 21 December 2010 the Commission adopted a proposal for a new directive (Seveso III) to follow up the changes made to the EU’s system for the classification of dangerous substances, to which the Directive refers, and to clarify and update certain provisions in order to improve its implementation (strengthened provisions concerning inspections and public access to information).
Codecision procedure 2010/0377/COD

Commission Decision 2009/10/EC of 2 December 2008 establishing a major accident report form pursuant to Council Directive 96/82/EC on the control of major-accident hazards involving dangerous substances [Official Journal L 6 of 10.1.2009].

Commission Decision 98/433/EC of 26 June 1998 on harmonised criteria for dispensations according to Article 9 of Council Directive 96/82/EC on the control of major-accident hazards involving dangerous substances [Official Journal L 192 of 8.7.1998].

Good laboratory practice: tests on chemical substances

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Good laboratory practice: tests on chemical substances

Outline of the Community (European Union) legislation about Good laboratory practice: tests on chemical substances

Topics

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

Internal market > Pharmaceutical and cosmetic products

Good laboratory practice: tests on chemical substances

Document or Iniciative

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) [See amending act(s)].

Summary

This directive substantially amends and repeals Directive 87/18/EEC on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice (GLP) and the verification of their applications for tests on chemical substances.

The Directive requires Member States to take all measures necessary to ensure that laboratories carrying out tests on chemical products, in accordance with Directive 67/548/EEC, comply with the principles of good laboratory practice (GLP) as laid down in Annex I to this Directive.

It also applies where other Community provisions provide for the application of the principles of GLP to tests on chemical products to evaluate their safety for man and/or the environment.

The tests conducted on these different elements seek to obtain data on their properties and their safety with regard to human health and the environment.

When submitting results, laboratories must certify that the tests were carried out in accordance with the principles of good laboratory practice.

Member States must adopt the measures necessary for verification of compliance with the principles of good laboratory practice including, in particular, inspections and checks conducted in accordance with the recommendations of the Organisation for Economic Cooperation and Development (OECD) in this area.

Member States may not, on grounds relating to the principles of GLP, prohibit, restrict or impede the placing on the market of chemical products if the principles applied are in conformity with this directive.

Should a Member State establish that the application of the principles of GLP and the verification of their application for tests on chemical substances show that, although a chemical substance has been examined in accordance with the requirements of this Directive, it presents a danger to man or the environment, the Member State may provisionally prohibit or make subject to special conditions the marketing of that product on its territory.

References

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

Directive 2004/10/EC

11.03.2004 – OJ L 50 of 20.02.2004
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 219/2009

20.4.2009

–

OJ L 87 of 31.3.2009

Related Acts

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [Official Journal L 396 of 30.12.2006].