Tag Archives: Dangerous substance

Protection of the aquatic environment against discharges of dangerous substances

Protection of the aquatic environment against discharges of dangerous substances

Outline of the Community (European Union) legislation about Protection of the aquatic environment against discharges of dangerous substances

Topics

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

Environment > Water protection and management

Protection of the aquatic environment against discharges of dangerous substances (until 2013)

Document or Iniciative

Directive 2006/11/EC of the European Parliament and of the Council of 15 February 2006 on pollution caused by certain dangerous substances discharged into the aquatic environment of the Community (Codified version).

Summary

This Directive lays down rules for protection against, and prevention of, pollution resulting from the discharge of certain substances into the aquatic environment. It applies to inland surface water, territorial waters and internal coastal waters.

Two lists of dangerous substances have been compiled to combat pollution:

  • discharge of substances in list I must be eliminated; while
  • discharge of substances in list II must be reduced.

Pursuant to Annex IX of the Water Framework Directive (Directive 2000/60/EC), quality objectives and emission limit values are established by the “daughter directives” of Directive 2006/11/EC. Moreover, emission limit values for pollutants must be based on the best available techniques in line with Article 10 of Framework Directive 2000/60/EC.

All discharges of substances included in list I require prior authorisation by the competent authority in the Member State concerned. The authorisation is granted for a limited period and lays down emission standards which may be more stringent than the thresholds set by Community legislation, particularly to take account of the toxicity or persistence of the substance in the environment into which it is discharged. It is up to the Member States to ensure compliance with the emission standards.

For the substances on list II, the Member States adopt and implement programmes to preserve and improve water quality. All discharges are subject to prior authorisation by the competent authority in the Member State concerned that lays down the emission standards.

The Member States draw up an inventory of the discharges into the waters covered by this Directive and may take more severe measures than those laid down by Community legislation to reduce or eliminate pollution caused by dangerous substances.

The Directive lays down a procedure for revising and adding to the lists or transferring specific substances from list II to list I.

Before 22 December 2012, Member States may carry out surveillance and notification pursuant to Articles 5, 8 and 15 of the Water Framework Directive.

Background

This Directive codifies and replaces Directive 76/464/EEC and its subsequent amendments. This codification leads to the clarification and rationalisation of legislation. It takes into account the adoption of the water framework Directive and the international conventions on the protection of water courses and the marine environment.

The Directive is repealed by the Water Framework Directive as from 22 December 2013.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 2006/11/EC

24.4.2006

OJ L 64 of 4.4.2006

Related Acts

Environmental quality standards

Council Directive 82/176/EEC [Official Journal L 81 of 27.3.1982].

This Directive sets limit values and quality objectives for mercury discharges by the chlor-alkali electrolysis industry].
See consolidated version .

Council Directive 83/513/EEC [Official Journal L 291 of 24.10.1983]
This Directive sets limit values and quality objectives for cadmium discharges in the aquatic environment.
See consolidated version .

Council Directive 84/156/EEC [Official Journal L 74 of 17.3.1984]

This Directive sets limit values and quality objectives for mercury discharges in sectors other than the chlor-alkali electrolysis industry.
See consolidated version .

Council Directive [Official Journal L 274 of 17.10.1984].
This Directive sets limit values and quality objectives for discharges of hexachlorocyclohexane in the aquatic environment.

See consolidated version .

Council Directive 86/280/EEC [Official Journal L 181 of 4.7.1986]. This Directive sets limit values and quality objectives for discharges of certain dangerous substances included in List I of the Annex to Directive 2006/11/EC.

See consolidated version .

Directive 2008/105/CE of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water, amending and repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive [Official Journal L 348 of 24.12.2008].
This Directive establishes environmental quality standards (EQS) in the field of water. These quality standards aim to combat surface water pollution by 33 priority chemical substances (Annex II). This Directive provides in particular for:

  • an amendment of the list of priority substances and the corresponding EQS;
  • transparent criteria to designate so-called “mixing” zones, within which standards may be exceeded under certain conditions;
  • the preparation of an inventory of emissions, discharges and losses. This inventory will be used to prepare the Commission Report which will check progress achieved in reducing or ceasing emissions of pollutant substances by 2018.

The Directive supplements the legislative framework introduced by the Water Framework Directive. It allows decisions to be made at all levels of governance. Member States have until December 2009 to prepare plans for the management of hydrographical districts and programmes of measures relating thereto.

Improvement of information

Directive 91/692/EEC [Official Journal L 377 of 31.12.1991].

This Directive aims at rationalizing and improving on a sectoral basis the provisions on the transmission of information and the publication of reports concerning certain Community Directives on the protection of the environment.

Decision 92/446/EEC [Official Journal L 247 of 27.8.1992].

This Decision draws up the outlines of questionnaires needed to monitor the implementation of and compliance with the provisions of all Directives in the water sector, including Directives 76/464/EEC, 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC and 86/280/EEC.

Transfer Register

Regulation (EC) No 166/2006 [Official Journal OJ L 33 of 4.2.2006].
The EU introduces a European Pollutant Release and Transfer Register to improve access by the public to information and, in the long term, contribute to preventing and reducing pollution.

Substances affecting the ozone layer

Substances affecting the ozone layer

Outline of the Community (European Union) legislation about Substances affecting the ozone layer

Topics

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

Environment > Air pollution

Substances affecting the ozone layer

Document or Iniciative

Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer.

Summary

This Regulation replaces Regulation (EC) No 2037/2000. It brings the Community rules into line with technical developments and changes made to the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer. It therefore enables the European Union (EU) to continue its worldwide action to protect the ozone layer and guarantee its recovery.

Scope

This Regulation covers:

  • controlled substances such as chlorofluorocarbons (CFCs), halons, carbon tetrachloride, methyl bromide, hydrochlorofluorocarbons (HCFCs), etc. (see Annex I);
  • new substances (see Annex II);
  • products and equipment containing or relying on such substances.

Prohibitions

The production, placing on the market and use of controlled substances or products and equipment containing these substances shall be prohibited, with the exception of certain uses as feedstock * or process agents *, or laboratory and analytical uses.

The placing on the market and use of fire protection systems and fire extinguishers containing controlled substances, particularly halons, shall be prohibited.

Derogations

Controlled substances may be produced, placed on the market and used as feedstock or as process agents. These substances may also be used for laboratory or analytical uses. The quantity annually authorised shall be restricted by a system of quotas. Producers and importers must have a licence which is granted for a limited period by the competent authority of the Member State concerned.

Hydrochlorofluorocarbons (HCFCs) shall be phased out. No HCFCs may be produced after 31 December 2019.

The use of methyl bromide has been prohibited since 18 March 2010, except in an emergency, to prevent the spread of pests or disease. However, this derogation applies only for a period not exceeding 120 days and a quantity not exceeding 20 tonnes.

Halons may be placed on the market and used for critical uses (see Annex VI).

Any producer or importer authorised to use or place controlled substances on the market may transfer those rights to other producers or importers of such substances within the Community. Any transfer shall be notified in advance to the Commission.

A producer may also be authorised to exceed established levels of production, on condition that the maximum level of national production is not exceeded.

Trade

Imports and exports of controlled substances and of products and equipment containing such substances shall be prohibited.

Nevertheless, derogations exist for certain uses of controlled substances or for their destruction according to appropriate methods.

Imports and exports shall be subject to the issue of a licence. Such licences shall be issued by the Commission using an electronic licensing system.

Control of substances

Undertakings must put in place systems for the recovery of controlled substances contained in:

  • refrigeration, air-conditioning and heat pump equipment;
  • equipment containing solvents;
  • fire protection systems and fire extinguishers.

Once recovered, these substances must be recycled, reclaimed or destroyed in an environmentally acceptable manner in order to prevent their release into the atmosphere.

Undertakings must also take measures to avoid any risk of leakage or release of controlled substances. Any undertaking which operates equipment containing such substances must carry out regular checks for leakage. If leakage is detected, the undertaking must repair it as soon as possible and in any case within 14 days after detection.

Context

The ozone layer protects organisms living on Earth from ultraviolet (UV) radiation. In the 1980s, scientists observed a thinning of the stratospheric ozone layer due to emissions of man-made chemical substances. This depletion of the ozone layer is causing an increase in UV radiation which is dangerous for man, in whom it causes skin cancers in particular, and for ecosystems. The international community took rapid action by first of all adopting the Vienna Convention in 1985 and then the Montreal Protocol in 1987.

The Montreal Protocol requires signatories to phase out ozone-depleting substances according to a pre-established schedule. Twenty years after its adoption, the Montreal Protocol represents a model multilateral environmental agreement.

Key terms of the Act
  • Feedstock: any controlled substance or new substance that undergoes chemical transformation in a process in which it is entirely converted from its original composition and whose emissions are insignificant.
  • Process agents: controlled substances used as chemical process agents in the applications listed in Annex III.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1005/2009

1.1.2010

30.6.2011

OJ L 286 of 31.10.2009

Subsequent amendments and corrections to Regulation (EC) No 1005/2009 have been incorporated in the basic text. This consolidated version  has a purely documentary value”.

Related Acts

Commission Decision 2010/209/EU of 26 March 2010 on the allocation of import quotas for controlled substances for the period 1 January to 31 December 2010 under Regulation (EC) No 1005/2009 of the European Parliament and of the Council [Official Journal L 89 of 9.4.2010].

Materials and articles in regenerated cellulose film

Materials and articles in regenerated cellulose film

Outline of the Community (European Union) legislation about Materials and articles in regenerated cellulose film

Topics

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

Food safety > Contamination and environmental factors

Materials and articles in regenerated cellulose film

Document or Iniciative

Commission Directive 2007/42/EC of 29 June 2007 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs.

Summary

This Directive is a specific directive provided for by Regulation (EC) No 1935/2004 concerning materials and articles intended to come into contact with food.

Scope

It applies to regenerated cellulose film which constitutes a finished product in itself, or forms part of a finished product containing other materials and which are intended to come into contact or are placed in contact with foodstuffs.

It does not apply to synthetic casings of regenerated cellulose.

Description

Regenerated cellulose film is defined as a thin sheet obtained from a refined cellulose derived from unrecycled wood or cotton. To meet technical requirements, suitable substances may be added either in the mass or on the surface. Regenerated cellulose film may be coated on one or both sides.

The regenerated cellulose films covered by this Directive belong to one of the following categories:

  • uncoated regenerated cellulose film;
  • coated regenerated cellulose film with coating derived from cellulose; or
  • coated regenerated cellulose film with coating consisting of plastics.

Authorised substances and restrictions

The Directive lays down a positive list of substances authorised in the manufacture of regenerated cellulose film with restrictions of use (see Annex II).

Regenerated cellulose films which are uncoated or coated with plastics may be manufactured with substances other than those specified in Annex II if they are employed as colouring matter or as adhesives, provided that there is no trace of migration of the substances into or onto foodstuffs.

Regenerated cellulose films which are coated with plastics shall comply with the provisions laid down by Regulation (EU) No 10/2011 concerning plastic materials and articles intended to come into contact with foodstuffs.

Printed surfaces of regenerated cellulose film shall not come into contact with the foodstuffs.

Marketing and labelling

At the marketing stages other than the retail stages, materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs shall be accompanied by a written declaration in accordance with Regulation (EC) No 1935/2004. However, materials and articles which, by their nature, are clearly intended to come into contact with foodstuffs are not subject to this obligation.

Where special conditions of use are indicated, the material or article made of regenerated cellulose film shall be labelled accordingly.

Context

This Directive codifies and repeals Commission Directive 93/10/EEC of 15 March 1993 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs and its amendments.

REFERENCES

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

Directive 2007/42/EC

20.7.2007

OJ L 172 of 30.6.2007

Exposure to asbestos

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).

 

Classification, packaging and labelling of dangerous preparations

Classification, packaging and labelling of dangerous preparations

Outline of the Community (European Union) legislation about Classification, packaging and labelling of dangerous preparations

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 > Chemical products

Classification, packaging and labelling of dangerous preparations

Document or Iniciative

Directive 1999/45/EC of the European Parliament and of 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 [See amending acts].

Summary

Scope

This Directive applies to dangerous preparations which contain at least one dangerous substance within the meaning of Article 2 or which are considered dangerous within the meaning of Articles 5, 6 or 7. The term “preparation” covers mixtures or solutions composed of two or more substances.

This Directive provides specific provisions for preparations which are not considered dangerous (within the meaning of Articles 5, 6 or 7), but which may nevertheless present a specific hazard.

This Directive shall not apply to the following preparations in the finished state, intended for the final user:

  • medicinal products for human or veterinary use;
  • cosmetic products;
  • mixtures of substances in the form of waste covered by Directive 2006/12/EC on waste disposal);
  • foodstuffs;
  • animal feedingstuffs;
  • preparations containing radioactive substances;
  • medical devices which are invasive or used in direct physical contact with the human body;
  • the carriage of dangerous preparations by rail, road, inland waterway, sea or air;
  • ,preparations in transit which are under customs supervision, provided they do not undergo any treatment or processing.

Classification

The classification of dangerous preparations shall be based on the definitions of categories of danger laid down in Article 2 of the Directive. These categories take into account the degree and specific nature of the hazards involved. They include preparations considered dangerous due to:

  • physico-chemical properties (for example, explosive, oxidising, or flammable); and/or
  • the health hazards it presents (for example, toxic, carcinogenic or harmful); and/or
  • the environmental hazards it presents.

The general principles of classification and labelling of dangerous substances applies to the methods specified in Regulation (EC) No 440/2008 and the criteria laid down in Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances, save where alternative criteria in the Directive are applied.

Packaging

The main requirements relating to packaging are as follows:

  • it shall be so designed and constructed that its contents cannot escape;
  • the materials constituting the packaging and fastenings must not be susceptible to adverse attack by the contents, or liable to form dangerous compounds with the contents;
  • packaging and fastenings must be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling;
  • the shape and/or graphic decoration of packaging shall not arouse the curiosity of children nor mislead consumers;
  • it shall be designed so that it cannot be confused with foodstuffs, animal feedingstuffs, medicinal products or cosmetics;
  • containers for preparations must be fitted with child-resistant fastenings and/or carrying a tactile warning of danger.

Labelling

Any package must be clearly and indelibly marked with certain specific information such as:

  • the trade name of the preparation;
  • the name and contact details of the person responsible for placing it on the market;
  • in general the chemical name of the substance or substances present in the preparation which have given rise to the classification of the preparation with regard to health hazards;
  • the danger symbols and indications of danger, the risk phrases and the safety advice. Specific provisions concerning the presentation, format and wording of this information are laid down in Annexes II and VI to the Directive 67/548/EEC.

Member States may require the labelling of a preparation to be produced in their official language(s).

Under certain very restricted conditions specified in Article 12 of the Directive, some dangerous preparations may be exempt from the general requirements on packaging and labelling. Henceforth, the labelling of these preparations may be optional or may differ from the requirements laid down if the quantities present are so low that they do not present any hazard to users.

Obligations and duties of the Member States

The Member States appoint a national authority who shall inform the Commission on the application of this Directive. Those responsible for placing dangerous preparations on the market must hold at the disposal of that authority all information relating to the classification of the preparation (safety data, etc.).

Member States are required to designate the bodies responsible for receiving information on the health effects of preparations. This information can be used only in response to requests of a medical nature.

Confidentiality

The person responsible for placing a dangerous preparation on the market may make a request for confidentiality. This request is addressed to the competent authority of the Member States in which the preparation is to be first placed on the market. This procedure prevents the disclosure of the chemical identity of a certain substance on the label and does not risk the confidential nature of intellectual property. When the authority has made its decision, it shall inform the person responsible for placing the preparation on the market.

Free movement clause

Member States may not prohibit, restrict or impede the placing on the market of dangerous preparations which satisfy the requirements of this Directive.

Safeguard clause

A Member State may provisionally prohibit the placing on the market of a dangerous preparation or subject it to special conditions in its territory, even if it complies with the provisions of this Directive.

The Member States shall inform the Commission and the other Member States immediately of the adoption of such a measure and the reasons for its decision. The Commission shall consult Member States as soon as possible before making its decision.

Procedure for adaptation to technical progress

The amendments required to adapt the nine annexes to technical progress are adopted by the Commission with the assistance of a regulatory committee made up of representatives of the Member States and chaired by a representative of the Commission.

Context

This Directive shall be repealed with effect on 1 June 2015 by Regulation (EC) No 1272/2008 on the classification, labelling and packaging of chemicals and their mixtures.

References

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

Directive 1999/45/EC

30.7.1999

30.7.2002

O.J. L 200 of 30.7.1999

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

Regulation (EC) No 1882/2003

20.11.2003

OJ L 284 of 31.10.2003

Regulation (EC) No 1907/2006

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

OJ L 396 of 30.12.2006

Regulation (EC) No 1137/2008

11.12.2008

OJ L 311 of 21.11.2008

Regulation (EC) No 1272/2008

20.1.2009

OJ L 353 of 31.12.2008

The successive amendments and corrections to Directive 1999/45/EC have been incorporated in the original text. This consolidated version is of documentary value only.

The Rotterdam Convention on the international trade in hazardous chemicals

The Rotterdam Convention on the international trade in hazardous chemicals

Outline of the Community (European Union) legislation about The Rotterdam Convention on the international trade in hazardous chemicals

Topics

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

Environment > Environment: cooperation with third countries

The Rotterdam Convention on the international trade in hazardous chemicals

Document or Iniciative

Council Decision 2006/730/EC of 25 September 2006 on the conclusion, on behalf of the European Community, of the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade.

Regulation(EC) n° 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals.

Summary

The Rotterdam Convention was signed by the European Community on 11 September 1998. This Decision, approving the Rotterdam Convention on behalf of the European Community, is accompanied by a Council Regulation to implement the Convention’s provisions within the European Union (EU).

DECISION APPROVING THE ROTTERDAM CONVENTION

Fundamental principle

The Convention regulates the import and the export of certain hazardous chemicals and pesticides. It is based on the fundamental principle of Prior Informed Consent (PIC), meaning that under the Convention, a chemical listed in the Convention may only be exported with the importer’s prior consent. The Convention establishes a procedure to disseminate the decisions taken by the importing countries, thus implementing the PIC principle in the international trade in chemicals. It contains provisions requesting detailed information on the chemicals so that these decisions may be taken once data are available on the properties and the incidence of these products in particular on human health and the environment.

Products concerned

The Convention applies to banned or severely restricted chemicals and to extremely hazardous pesticide formulations. Over 30 chemicals are currently subject to the PIC procedure.

However, certain products are excluded from the scope of the Convention, namely:

  • narcotic drugs and psychotropic substances;
  • radioactive materials;
  • waste;
  • pharmaceuticals;
  • chemical weapons;
  • chemicals used as food additives;
  • food;
  • chemicals imported in quantities not likely to involve a risk provided they are imported for the purpose of research or analysis or by an individual for his or her own personal use.

Implementation of the Convention

Each Party must designate a national authority to ensure implementation at national and regional level. The Convention establishes a conference of the Parties which ensures implementation at international level and the evaluation of the Convention, including the approval of amendments. There is also a subsidiary body called the Chemical Review Committee (the Committee), which is responsible for analysing and assessing chemicals. The Secretariat is mainly responsible for coordination and administrative tasks.

Listing of hazardous chemicals and pesticides

Each Party must inform the Secretariat of any regulatory action adopted in respect of one or more chemicals or pesticides on its territory. Such notification must include information on the properties, identification and use of the chemical and its regulatory action. Where there are two notifications for the same chemical from at least two different regions, the Committee will review the information provided and, where appropriate, will recommend that the chemical in question be included in the list of chemicals subject to the Convention. Severely hazardous pesticides are subject to specific provisions. The Convention takes into consideration the fact that developing countries or countries with economies in transition have more limited means, and allows these countries to draw upon technical expertise from any source if they wish to include a pesticide in the list. The Committee will then review the information provided and may recommend the pesticide for listing.

The Conference of the Parties reviews the Committee’s recommendation and may take the final decision. It can also decide to remove a chemical from the Convention.

Imports

Each Party must specify whether or not it consents to the import into its territory of the hazardous chemicals or pesticides listed in the Convention. Parties may also decide to consent to import only subject to specified conditions. Interim decisions are also accepted. A Party that does not consent to the import of a chemical or that only consents under specified conditions must ensure that the import of the chemical from any source and the domestic production of the chemical for domestic use are made subject to the same conditions.

Exports

Each exporting Party must, of course, comply with the decisions of the other Parties relating to import authorisations. A chemical may not be exported to any Party that has failed to transmit a response or has transmitted an interim response. However, there are exceptions, for example where the importing Party has given its explicit consent to the import of the chemical in question.

In addition, the exporting Parties should assist importing Parties, upon request, to obtain further information and to strengthen their capacities to manage chemicals during their life-cycle.

Any exported chemical that is banned or severely restricted under the Convention must be accompanied by an export notification, and the importing Party must also acknowledge receipt of the chemical. The Convention contains provisions on the information that must accompany the chemicals, such as labelling requirements.

Exchange of information

The aim is to facilitate the exchange of scientific, technical, economic and legal information concerning the chemicals within the scope of the Convention, and to provide information on domestic regulatory actions in this area.

Technical assistance

Developing countries and countries with economies in transition may receive technical assistance from Parties which are more advanced in the area of chemical regulation.

Settlement of disputes

The Conference of the Parties draws up provisions on non-compliance with the Convention. With respect to dispute settlement, the Parties may resort to an arbitration procedure. A Party which is not a regional economic integration organisation may also submit the dispute to the International Court of Justice.

Withdrawal from the Convention

A Party may withdraw from the Convention three years after the date on which it came into force. This will take effect upon expiry of at least one year from the date of receipt of the notification of withdrawal.

REGULATION CONCERNING EXPORTS AND IMPORTS

The purpose of the Regulation is to implement the provisions of the Rotterdam Convention within the European Community. It will ensure that the measures laid down in the Convention are adopted; at the same time, some of the provisions contained in the Regulation will go beyond what is required in the Convention.

Chemicals concerned

The scope of the Regulation is wider than that of the Convention. It covers certain hazardous chemicals, which are banned or severely restricted within the Community or a Member State. It also covers the classification, packaging and labelling of all exported chemicals.

Export procedure

The Regulation establishes the deadlines and obligations which will apply to the notification procedure. The system requires that each exporter submit one export notification each year before the first export of a chemical. The notifications will be entered in a centralised register.

The Regulation contains certain measures that are more stringent than those of the Convention. Under the Regulation, any chemical or pesticide that is banned or severely restricted within the Community, and any articles containing these chemicals, must be accompanied by a notification. In addition, explicit consent for export is required for any dangerous chemical or pesticide which is banned or severely restricted within the Community, where it qualifies for PIC notification, even if that chemical or pesticide is not subject to the provisions of the Convention and is not included in the list of products already subject to the PIC procedure. The Regulation also imposes minimum standards concerning, for instance, the useful life of exported chemicals or pesticides, and storage conditions. The measures on labelling and packaging are also more stringent.

Export measures will apply to exports to all countries and not just to those that have signed the Convention.

The Regulation provides for the possibility of completely banning the export of certain specific chemicals or pesticides.

Penalties

The penalties applicable to infringements of the provisions of this Regulation is determined by the Member States. These must be effective, proportional and dissuasive.

Exchange of information

The provisions are extended to all countries and the Regulation refers to European Community participation in an information network on capacity building set up by the Intergovernmental Forum on Chemical Safety.

Monitoring and evaluation

The Regulation requires regular reports to be drawn up on the quantities of exported chemicals and pesticides concerned. As regards the monitoring and evaluation of the functioning of the Regulation, Member States must regularly submit information to the Commission, which in turn will draw up regular reports on the subject.

Implementation

The implementing conditions are mostly laid down by the Convention. Each Member States must designate one or several national authorities to ensure that the Regulation is implemented at national level. The European Commission will be responsible for implementation at Community level; it will also play a coordinating role between the Member States and between the European Community and the institutions of the Convention. The Commission will also be responsible for amending the annexes. It will be assisted by a committee.

References

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

Decision 2006/730/EC

19.2.2002

OJ L 299 of 28.10.2006

Regulation (EC) No 689/2008

1.8.2008

OJ L 204 of 31.7.2008

The successive amendments and corrections to Regulation (EC) No 689/2008 have been incorporated in the original text. This consolidated versionis of documentary value only.

Basel Convention

Basel Convention

Outline of the Community (European Union) legislation about Basel Convention

Topics

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

Environment > Environment: cooperation with third countries

Basel Convention

Document or Iniciative

Council Decision 93/98/EEC of 1 February 1993 on the conclusion, on behalf of the Community, of the Convention on the control of transboundary movements of hazardous wastes and their disposal (Basel Convention).

Council Decision 97/640/EC of 22 September 1997 on the approval, on behalf of the Community, of the amendment to the Convention on the control of transboundary movements of hazardous wastes and their disposal (Basel Convention), as laid down in Decision III/1 of the Conference of the Parties.

Summary

The EEC approves the Convention on the control of transboundary movements of hazardous wastes and their disposal. The Convention came into force for the EEC on 7 February 1994.

The Convention (text attached as annex) aims, in introducing a system for controlling the export, import and disposal of hazardous wastes and their disposal, to reduce the volume of such exchanges so as to protect human health and the environment.

It defines hazardous wastes. Each party may add to the list other wastes listed as hazardous in its national legislation.

A transboundary movement is any movement of hazardous wastes or other wastes from an area under the national jurisdiction of one State to or through an area under the national jurisdiction of another State, or to or through an area not under the national jurisdiction of any State, provided at least two States are involved in the movement.

General obligations:

  • it is prohibited to export or import hazardous wastes or other wastes to or from a non-party State;
  • no wastes may be exported if the State of import has not given its consent in writing to the specific import;
  • information about proposed transboundary movements must be communicated to the States concerned, by means of a notification form, so that they may evaluate the effects of the proposed movements on human health and the environment;
  • transboundary movements of wastes must only be authorised where there is no danger attaching to their movement and disposal;
  • wastes which are to be the subject of a transboundary movement must be packaged, labelled and transported in conformity with international rules, and must be accompanied by a movement document from the point at which a movement commences to the point of disposal;
  • any party may impose additional requirements that are consistent with the provisions of the Convention.

The Convention establishes notification procedures regarding:

  • transboundary movements between parties;
  • transboundary movements from a party through the territory of States which are not parties.

It sets out those cases where there is a duty to re-import hazardous wastes, especially if they have been the subject of illegal trafficking.

Parties to the Convention must cooperate with each other in order to improve and achieve environmentally sound management of hazardous wastes and other wastes. The aim is to implement all practical measures to ensure that wastes covered by the Convention are handled in such a way that protection of human health and the environment from their harmful effects is guaranteed.

Parties may enter into bilateral, multilateral or regional agreements or arrangements regarding transboundary movements of hazardous wastes, with parties or non-parties, provided that these do not derogate from the principles defined by the Convention.

A Conference of the Parties is established and is charged with overseeing the effective implementation of the Convention.

Provisions on the settlement of disputes between Parties.

Under Decision II/1 the Parties provided for an amendment to the Convention to immediately prohibit transboundary movements of hazardous wastes destined for final disposal and prohibit as from 01.01.1998 transboundary movements of hazardous wastes destined for recovery operations from States listed in Annex VII to the Convention, namely, “Members of the European Organisation for Cooperation and Development (OECD), the European Community and Liechtenstein”, to States not listed in Annex VII to the Convention. This amendment to the Convention and Annex VII have not yet entered into force for lack of sufficient ratification.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Decision 93/98/EEC 1.2.1993 OJ L 39 of 16.2.1993
Decision 97/640/EC 22.9.1997 OJ L 272 of 4.10.1997

Related Acts


Regulation (EC) No 1013/2006

of the European Parliament and of the Council of 14 June 2006 on shipments of waste [Official Journal L 190, 12.7.2006].
This Regulation will replace Regulation (EEC) No 259/93 from 12 July 2007. It is designed to strengthen, simplify and spell out the current control procedures for waste shipments, thus reducing the risk of shipments of uncontrolled waste. It also incorporates into Community legislation the amendments to the waste lists annexed to the Basel Convention and the revision adopted by the Organisation for Economic Cooperation and Development (OECD) in 2001.

International trade in hazardous chemicals

International trade in hazardous chemicals

Outline of the Community (European Union) legislation about International trade in hazardous chemicals

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 > Chemical products

International trade in hazardous chemicals

Document or Iniciative

Regulation (EU) No. 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals.

Summary

The Regulation provides rules concerning the import of chemicals that are banned or severely restricted for use in the European Union (EU). Exporters shall be required to notify the export of chemicals subject to this Regulation before export can take place. Furthermore, the chemicals covered by the Rotterdam Convention, and chemicals that are banned or severely restricted in the European Union, cannot be exported without the consent of the importing countries.

This Regulation aims at ensuring that the provisions of the Regulation on the classification, labelling and packaging of chemical substances shall also apply to all chemicals when they are exported from Member States to other Parties to the Convention or to other countries, except if these provisions are incompatible with the specific requirements of these Parties or other countries.

Chemicals concerned:

This Regulation covers:

  • certain hazardous chemicals that are subject to the prior informed consent procedure (the ‘PIC procedure’) under the Rotterdam Convention;
  • certain hazardous chemicals that are banned or severely restricted within the Union or a Member State; and
  • all chemicals when exported in so far as their classification, labelling and packaging are concerned.

Certain products are excluded from the scope of the Regulation, specifically:

  • narcotic drugs and psychotropic substances;
  • radioactive materials;
  • wastes;
  • chemical weapons;
  • food and food additives;
  • feedingstuffs;
  • genetically modified organisms;
  • medicinal products;
  • chemicals exported for the purpose of research or analysis in low quantities which do not present a risk to health or the environment.

National authorities

Each Member State shall designate one or more authority to carry out the administrative functions required by this Regulation.

European Chemicals Agency

The European Chemicals Agency (ECHA) shall assist the Commission by managing the technical, scientific and administrative aspects relating to the import and export of said products. It shall send, in particular, manufacturers’ notifications to non-EU importing countries, manage all related communications, and maintain a database of the notifications which shall be accessible on its website.

Notification and explicit consent procedure

This Regulation sets the time periods and obligations concerning the notification procedure and the explicit consent procedure depending on the category to which the chemical product belongs.

Imports

The Commission shall adopt a decision in the form of a final or interim response regarding the import of the chemical in question. Where a chemical is subject to additional or amended restrictions, the Commission shall adopt a revised import decision.

In the case of a chemical being banned or severely restricted, the Commission shall take this information into account in its import decision.

Exports

Exporters must comply with the decisions of other Parties concerning import. Export of a chemical to a Party which has not provided a response concerning the import of the chemical concerned is prohibited. However, the chemical may be exported if the importing Party has given explicit consent for the chemical in question.

Any export of a chemical which is banned or severely restricted by European Union legislation must be notified to the importing country and said country must acknowledge receipt of the notification in accordance with the Convention.

Exchange of information

The Commission, assisted by ECHA and the Member States, shall facilitate the provision of scientific, technical, economic and legal information concerning the chemicals covered by this Regulation.

Technical assistance

The Commission, the designated national authorities of the Member States and ECHA shall cooperate in promoting technical assistance for the development of the infrastructure, the capacity and the expertise necessary to manage chemicals properly throughout their lifecycles, depending on the needs of developing countries and countries with economies in transition.

Penalties

The rules on penalties applicable to infringements of the provisions of this Regulation shall be determined by Member States. The penalties provided for must be effective, proportionate and dissuasive.

Repeal

This Regulation repeals Regulation (EC) No. 689/2008 with effect from 1 March 2014.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EU) No. 649/2012

16.8.2012

OJ L 201 of 27.7.2012

Major accidents involving dangerous substances

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].