Directive 2012/18 - Control of major-accident hazards involving dangerous substances, amending and subsequently - Main contents

EN

Official Journal of the European Union

L 197/1

Council Directive 96/82/EC of 9 December 1996 on the control of major-accident hazards involving dangerous substances (3) lays down rules for the prevention of major accidents which might result from certain industrial activities and the limitation of their consequences for human health and the environment.

Major accidents often have serious consequences, as evidenced by accidents like Seveso, Bhopal, Schweizerhalle, Enschede, Toulouse and Buncefield. Moreover the impact can extend beyond national borders. This underlines the need to ensure that appropriate precautionary action is taken to ensure a high level of protection throughout the Union for citizens, communities and the environment. There is therefore a need to ensure that the existing high level of protection remains at least the same or increases.

Directive 96/82/EC has been instrumental in reducing the likelihood and consequences of such accidents thereby leading to a better level of protection throughout the Union. A review of that Directive has confirmed that the rate of major accidents has remained stable. While overall the existing provisions are fit for purpose, some changes are required in order to further strengthen the level of protection, in particular with regard to the prevention of major accidents. At the same time the system established by Directive 96/82/EC should be adapted to changes to the Union system of classification of substances and mixtures to which that Directive refers. In addition, a number of other provisions should be clarified and updated.

It is therefore appropriate to replace Directive 96/82/EC in order to ensure that the existing level of protection is maintained and further improved, by making the provisions more effective and efficient, and where possible by reducing unnecessary administrative burdens by streamlining or simplification, provided that safety and environmental and human health protection are not compromised. At the same time, the new provisions should be clear, coherent and easy to understand to help improve implementation and enforceability, while the level of protection of human health and the environment remains at least the same or increases. The Commission should cooperate with the Member States on the practical implementation of this Directive. That cooperation should, inter alia, address the issue of self-classification of substances and mixtures. As appropriate, stakeholders such as representatives of industry, workers and non-governmental organisations promoting the protection of human health or the environment should be involved in the implementation of this Directive.

The Convention of the United Nations Economic Commission for Europe on the Transboundary Effects of Industrial Accidents, which was approved on behalf of the Union by Council Decision 98/685/EC of 23 March 1998 concerning the conclusion of the Convention on the Transboundary Effects of Industrial Accidents (4), provides for measures regarding the prevention of, preparedness for, and response to industrial accidents capable of causing transboundary effects as well as for international cooperation in this field. Directive 96/82/EC implements the Convention within Union law.

Major accidents can have consequences beyond frontiers, and the ecological and economic costs of an accident are borne not only by the establishment affected, but also by the Member States concerned. It is therefore necessary to establish and apply safety and risk-reduction measures to prevent possible accidents, to reduce the risk of accidents occurring and to minimise the effects if they do occur, thereby making it possible to ensure a high level of protection throughout the Union.

The provisions of this Directive should apply without prejudice to the provisions of Union law relating to health and safety at work and the working environment, and, in particular, without prejudice 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 at work (5).

Certain industrial activities should be excluded from the scope of this Directive provided they are subject to other legislation at Union or national level providing for an equivalent level of safety. The Commission should continue to examine whether there are significant gaps in the existing regulatory framework, in particular as regards new and emerging risks from other activities as well as from specific dangerous substances and, if appropriate, present a legislative proposal to address those gaps.

Annex I to Directive 96/82/EC lists the dangerous substances falling within its scope, inter alia, by reference to certain provisions of Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (6) as well as 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 (7). Directives 67/548/EEC and 1999/45/EC have been replaced by 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 (8), which implements within the Union the Globally Harmonised System of Classification and Labelling of Chemicals that has been adopted at international level, within the structure of the United Nations (UN). That Regulation introduces new hazard classes and categories only partially corresponding to those used under those repealed Directives. Certain substances or mixtures would, however, not be classified under that system due to an absence of criteria within that framework. Annex I to Directive 96/82/EC therefore needs to be amended to align it to that Regulation while maintaining the existing level, or further increasing the level, of protection provided for in that Directive.

For the purpose of classifying upgraded biogas, any developments on standards under the European Committee for Standardisation (CEN) should be taken into account.

Unwanted effects from the alignment to Regulation (EC) No 1272/2008 and subsequent adaptations to that Regulation having an impact on the classification of substances and mixtures may occur. On the basis of criteria included in this Directive, the Commission should assess whether, notwithstanding their hazard classification, there are dangerous substances which do not present a major-accident hazard and, where appropriate, submit a legislative proposal to exclude the dangerous substance concerned from the scope of this Directive. The assessment should start swiftly, in particular after the change of classification of a substance or mixture, in order to avoid unnecessary burdens for operators and competent authorities in the Member States. Exclusions from the scope of this Directive should not prevent any Member State from maintaining or introducing more stringent protective measures.

Operators should have a general obligation to take all necessary measures to prevent major accidents, to mitigate their consequences and to take recovery measures. Where dangerous substances are present in establishments above certain quantities the operator should provide the competent authority with sufficient information to enable it to identify the establishment, the dangerous substances present and the potential dangers. The operator should also draw up and, where required by national law, send to the competent authority a major-accident prevention policy (MAPP) setting out the operator’s overall approach and measures, including appropriate safety management systems, for controlling major-accident hazards. When the operators identify and evaluate the major-accident hazards, consideration should also be given to the dangerous substances which may be generated during a severe accident within the establishment.

Directive 2004/35/EC of the European Parliament and of the Council of 21 April 2004 on environmental liability with regard to the prevention and remedying of environmental damage (9) is normally relevant for environmental damage caused by a major accident.

In order to reduce the risk of domino effects, where establishments are sited in such a way or so close together as to increase the likelihood of major accidents, or aggravate their consequences, operators should cooperate in the exchange of appropriate information and in informing the public, including neighbouring establishments that could be affected.

In order to demonstrate that all that is necessary has been done to prevent major accidents, and to prepare emergency plans and response measures, the operator should, in the case of establishments where dangerous substances are present in significant quantities, provide the competent authority with information in the form of a safety report. That safety report should contain details of the establishment, the dangerous substances present, the installation or storage facilities, possible major-accident scenarios and risk analysis, prevention and intervention measures and the management systems available, in order to prevent and reduce the risk of major accidents and to enable the necessary steps to be taken to limit the consequences thereof. The risk of a major accident could be increased by the probability of natural disasters associated with the location of the establishment. This should be considered during the preparation of major-accident scenarios.

To prepare for emergencies, in the case of establishments where dangerous substances are present in significant quantities, it is necessary to establish internal and external emergency plans and to establish procedures to ensure that those plans are tested and revised as necessary and implemented in the event of a major accident or the likelihood thereof. The staff of an establishment should be consulted on the internal emergency plan and the public concerned should have the opportunity to give its opinion on the external emergency plan. Sub-contracting may have an impact on the safety of an establishment. Member States should require operators to take this into account when drafting a MAPP, a safety report or an internal emergency plan.

When considering the choice of appropriate operating methods, including those for monitoring and control, operators should take into account available information on best practices.

In order to provide greater protection for residential areas, areas of substantial public use and the environment, including areas of particular natural interest or sensitivity, it is necessary for land-use or other relevant policies applied in the Member States to ensure appropriate distances between such areas and establishments presenting such hazards and, where existing establishments are concerned, to implement, if necessary, additional technical measures so that the risk to persons or the environment is maintained at an acceptable level. Sufficient information about the risks and technical advice on these risks should be taken into account when decisions are taken. Where possible, to reduce administrative burdens, especially for small and medium-sized enterprises, procedures and measures should be integrated with those under other relevant Union legislation.

In order to promote access to environmental information under the Convention of the United Nations Economic Commission for Europe on access to information, public participation in decision-making and access to justice in environmental matters (the Aarhus Convention), which was approved on behalf of the Union by Council Decision 2005/370/EC of 17 February 2005 on the conclusion, on behalf of the European Community, of the Convention on access to information, public participation in decision-making and access to justice in environmental matters (10), the level and quality of information to the public should be improved. In particular, persons likely to be affected by a major accident should be given sufficient information on the correct action to be taken in that event. Member States should make information available on where to find information on the rights of persons affected by a major accident. Information disseminated to the public should be worded clearly and intelligibly. In addition to providing information in an active way, without the public having to submit a request, and without precluding other forms of dissemination, it should also be made available permanently and kept up to date electronically. At the same time there should be appropriate confidentiality safeguards, to address security-related concerns, among others.

The way information is managed should be in line with the Shared Environmental Information System (SEIS) initiative introduced by the Commission Communication of 1 February 2008 entitled ‘Towards a Shared Environmental Information System (SEIS)’. It should also be in line with Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (11) and its implementing rules, aimed at enabling the sharing of environmental spatial information among public sector organisations and better facilitating public access to spatial information across the Union. Information should be held on a publicly available database at Union level, which will also facilitate monitoring and reporting on implementation.

In line with the Aarhus Convention, effective public participation in decision-making is necessary to enable the public concerned to express, and the decision-maker to take account of, opinions and concerns that may be relevant to those decisions, thereby increasing the accountability and transparency of the decision-making process and contributing to public awareness of environmental issues and support for the decisions taken.

In order to ensure that adequate response measures are taken if a major accident occurs, the operator should immediately inform the competent authority and communicate the information necessary to enable it to assess the effects of that accident on human health and on the environment.

Local authorities have an interest in the prevention of major accidents and mitigation of their consequences and can have an important role to play. This should be taken into account by the Member States in the implementation of this Directive.

In order to facilitate the exchange of information and to prevent future accidents of a similar nature, Member States should forward information to the Commission regarding major accidents occurring on their territory, so that the Commission can analyse the hazards involved, and operate a system for the distribution of information concerning, in particular, major accidents and lessons learned from them. That exchange of information should also cover ‘near misses’ which Member States regard as being of particular technical interest for preventing major accidents and limiting their consequences. Member States and the Commission should strive to ensure the completeness of the information held on information systems established to facilitate the exchange of information on major accidents.

Member States should determine the competent authorities responsible for ensuring that operators fulfil their obligations. The competent authorities and the Commission should cooperate in activities in support of implementation such as the development of appropriate guidance and exchanges of best practice. To avoid unnecessary administrative burden, information obligations should be integrated, where appropriate, with those under other relevant Union legislation.

Member States should ensure that competent authorities take the necessary measures in the event of non-compliance with this Directive. In order to ensure effective implementation and enforcement, there should be a system of inspections, including a programme of routine inspections at regular intervals and non-routine inspections. Where possible, inspections should be coordinated with those under other Union legislation, including Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (12), where appropriate. Member States should ensure that sufficient staff is available with the skills and qualifications needed to carry out inspections effectively. Competent authorities should provide appropriate support using tools and mechanisms for exchanging experience and consolidating knowledge, including at Union level.

In order to take into account technical developments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending Annexes II to VI to adapt them to technical progress. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (13).

Member States should lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive.

Since the objective of this Directive, namely to ensure a high level of protection of human health and the environment, cannot be sufficiently achieved by Member States and can, therefore, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

In accordance with the Joint Political Declaration of Member States and the Commission of 28 September 2011 on explanatory documents (14), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified.

Directive 96/82/EC should therefore be amended and subsequently repealed,

military establishments, installations or storage facilities;

hazards created by ionising radiation originating from substances;

the transport of dangerous substances and directly related intermediate temporary storage by road, rail, internal waterways, sea or air, outside the establishments covered by this Directive, including loading and unloading and transport to and from another means of transport at docks, wharves or marshalling yards;

the transport of dangerous substances in pipelines, including pumping stations, outside establishments covered by this Directive;

the exploitation, namely the exploration, extraction and processing, of minerals in mines and quarries, including by means of boreholes;

the offshore exploration and exploitation of minerals, including hydrocarbons;

the storage of gas at underground offshore sites including both dedicated storage sites and sites where exploration and exploitation of minerals, including hydrocarbons are also carried out;

waste land-fill sites, including underground waste storage.

‘establishment’ means the whole location under the control of an operator where dangerous substances are present in one or more installations, including common or related infrastructures or activities; establishments are either lower-tier establishments or upper-tier establishments;

‘lower-tier establishment’ means an establishment where dangerous substances are present in quantities equal to or in excess of the quantities listed in Column 2 of Part 1 or in Column 2 of Part 2 of Annex I, but less than the quantities listed in Column 3 of Part 1 or in Column 3 of Part 2 of Annex I, where applicable using the summation rule laid down in note 4 to Annex I;

‘upper-tier establishment’ means an establishment where dangerous substances are present in quantities equal to or in excess of the quantities listed in Column 3 of Part 1 or in Column 3 of Part 2 of Annex I, where applicable using the summation rule laid down in note 4 to Annex I;

‘neighbouring establishment’ means an establishment that is located in such proximity to another establishment so as to increase the risk or consequences of a major accident;

‘new establishment’ means

‘existing establishment’ means an establishment that on 31 May 2015 falls within the scope of Directive 96/82/EC and from 1 June 2015 falls within the scope of this Directive without changing its classification as a lower-tier establishment or upper-tier establishment;

‘other establishment’ means a site of operation that falls within the scope of this Directive, or a lower-tier establishment that becomes an upper-tier establishment or vice versa, on or after 1 June 2015 for reasons other than those referred to in point 5;

‘installation’ means a technical unit within an establishment and whether at or below ground level, in which dangerous substances are produced, used, handled or stored; it includes all the equipment, structures, pipework, machinery, tools, private railway sidings, docks, unloading quays serving the installation, jetties, warehouses or similar structures, floating or otherwise, necessary for the operation of that installation;

‘operator’ means any natural or legal person who operates or controls an establishment or installation or, where provided for by national legislation, to whom the decisive economic or decision-making power over the technical functioning of the establishment or installation has been delegated;

‘dangerous substance’ means a substance or mixture covered by Part 1 or listed in Part 2 of Annex I, including in the form of a raw material, product, by-product, residue or intermediate;

‘mixture’ means a mixture or solution composed of two or more substances;

‘presence of dangerous substances’ means the actual or anticipated presence of dangerous substances in the establishment, or of dangerous substances which it is reasonable to foresee may be generated during loss of control of the processes, including storage activities, in any installation within the establishment, in quantities equal to or exceeding the qualifying quantities set out in Part 1 or Part 2 of Annex I;

‘major accident’ means an occurrence such as a major emission, fire, or explosion resulting from uncontrolled developments in the course of the operation of any establishment covered by this Directive, and leading to serious danger to human health or the environment, immediate or delayed, inside or outside the establishment, and involving one or more dangerous substances;

‘hazard’ means the intrinsic property of a dangerous substance or physical situation, with a potential for creating damage to human health or the environment;

‘risk’ means the likelihood of a specific effect occurring within a specified period or in specified circumstances;

‘storage’ means the presence of a quantity of dangerous substances for the purposes of warehousing, depositing in safe custody or keeping in stock;

‘the public’ means one or more natural or legal persons and, in accordance with national law or practice, their associations, organisations or groups;

‘the public concerned’ means the public affected or likely to be affected by, or having an interest in, the taking of a decision on any of the matters covered by Article 15(1); for the purposes of this definition, non-governmental organisations promoting environmental protection and meeting any applicable requirements under national law shall be deemed to have an interest;

‘inspection’ means all actions, including site visits, checks of internal measures, systems and reports and follow-up documents, and any necessary follow-up, undertaken by or on behalf of the competent authority to check and promote compliance of establishments with the requirements of this Directive.

the physical form of the dangerous substance under normal processing or handling conditions or in an unplanned loss of containment;

the inherent properties of the dangerous substance, in particular those related to dispersive behaviour in a major-accident scenario, such as molecular mass and saturated vapour pressure;

the maximum concentration of the substances in the case of mixtures.

a comprehensive list of properties necessary to assess the dangerous substance’s potential for causing physical, health or environmental harm;

physical and chemical properties (for instance molecular mass, saturated vapour pressure, inherent toxicity, boiling point, reactivity, viscosity, solubility and other relevant properties);

health and physical hazard properties (for instance reactivity, flammability, toxicity together with additional factors such as mode of attack on the body, injury to fatality ratio, and long-term effects, and other properties as relevant);

environmental hazard properties (for instance ecotoxicity, persistence, bio-accumulation, potential for long-range environmental transport, and other properties as relevant);

where available, the Union classification of the substance or mixture;

information about substance-specific operating conditions (for instance temperature, pressure and other conditions as relevant) under which the dangerous substance is stored, used and/or may be present in the event of foreseeable abnormal operations or an accident such as fire.

the name and/or trade name of the operator and the full address of the establishment concerned;

the registered place of business of the operator, with the full address;

the name and position of the person in charge of the establishment, if different from point (a);

information sufficient to identify the dangerous substances and category of substances involved or likely to be present;

the quantity and physical form of the dangerous substance or substances concerned;

the activity or proposed activity of the installation or storage facility;

the immediate environment of the establishment, and factors likely to cause a major accident or to aggravate the consequences thereof including, where available, details of neighbouring establishments, of sites that fall outside the scope of this Directive, areas and developments that could be the source of or increase the risk or consequences of a major accident and of domino effects.

for new establishments, a reasonable period of time prior to the start of construction or operation, or prior to the modifications leading to a change in the inventory of dangerous substances;

for all other cases, one year from the date from which this Directive applies to the establishment concerned.

any significant increase or decrease in the quantity or significant change in the nature or physical form of the dangerous substance present, as indicated in the notification provided by the operator pursuant to paragraph 1, or a significant change in the processes employing it;

modification of an establishment or an installation which could have significant consequences in terms of major-accident hazards;

the permanent closure of the establishment or its de-commissioning; or

changes in the information referred to in points (a), (b) or (c) of paragraph 1.

for new establishments, a reasonable period of time prior to the start of construction or operation, or prior to the modifications leading to a change in the inventory of dangerous substances;

for all other cases, one year from the date from which this Directive applies to the establishment concerned.

exchange suitable information to enable those establishments to take account of the nature and extent of the overall hazard of a major accident in their MAPP, safety management systems, safety reports and internal emergency plans, as appropriate;

cooperate in informing the public and neighbouring sites that fall outside the scope of this Directive, and in supplying information to the authority responsible for the preparation of external emergency plans.

demonstrating that a MAPP and a safety management system for implementing it have been put into effect in accordance with the information set out in Annex III;

demonstrating that major-accident hazards and possible major-accident scenarios have been identified and that the necessary measures have been taken to prevent such accidents and to limit their consequences for human health and the environment;

demonstrating that adequate safety and reliability have been taken into account in 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 and supplying information to enable the external emergency plan to be drawn up;

providing sufficient information to the competent authority to enable decisions to be made regarding the siting of new activities or developments around existing establishments.

for new establishments, a reasonable period of time prior to the start of construction or operation, or prior to the modifications leading to a change in the inventory of dangerous substances;

for existing upper-tier establishments, 1 June 2016;

for other establishments, two years from the date from which this Directive applies to the establishment concerned.

the operator draws up an internal emergency plan for the measures to be taken inside the establishment;

the operator supplies the necessary information to the competent authority, to enable the latter to draw up external emergency plans;

the authorities designated for that purpose by the Member State draw up an external emergency plan for the measures to be taken outside the establishment within two years following receipt of the necessary information from the operator pursuant to point (b).

for new establishments, a reasonable period of time prior to the start of operation, or prior to the modifications leading to a change in the inventory of dangerous substances;

for existing upper-tier establishments, by 1 June 2016 unless the internal emergency plan drawn up under the requirements of national law before that date, and the information contained therein, and the information referred to in point (b) of paragraph 1, complies with this Article and has remained unchanged;

for other establishments, two years from the date from which this Directive applies to the establishment concerned.

containing and controlling incidents so as to minimise the effects, and to limit damage to human health, the environment and property;

implementing the necessary measures to protect human health and the environment from the effects of major accidents;

communicating the necessary information to the public and to the services or authorities concerned in the area;

providing for the restoration and clean-up of the environment following a major accident.

the siting of new establishments;

modifications to establishments covered by Article 11;

new developments including transport routes, locations of public use and residential areas in the vicinity of establishments, where the siting or developments may be the source of or increase the risk or consequences of a major accident.

to maintain appropriate safety distances between establishments covered by this Directive and residential areas, buildings and areas of public use, recreational areas, and, as far as possible, major transport routes;

to protect areas of particular natural sensitivity or interest in the vicinity of establishments, where appropriate through appropriate safety distances or other relevant measures;

in the case of existing establishments, to take additional technical measures in accordance with Article 5 so as not to increase the risks to human health and the environment.

all persons likely to be affected by a major accident receive regularly and in the most appropriate form, without having to request it, clear and intelligible information on safety measures and requisite behaviour in the event of a major accident;

the safety report is made available to the public upon request subject to Article 22(3); where Article 22(3) applies, an amended report, for instance in the form of a non-technical summary, which shall include at least general information on major-accident hazards and on potential effects on human health and the environment in the event of a major accident, shall be made available;

the inventory of dangerous substances is made available to the public upon request subject to Article 22(3).

planning for new establishments pursuant to Article 13;

significant modifications to establishments under Article 11, where such modifications are subject to obligations provided for in Article 13;

new developments around establishments where the siting or developments may increase the risk or consequences of a major accident pursuant to Article 13.

the subject of the specific project;

where applicable, the fact that a project is subject to a national or transboundary environmental impact assessment or to consultations between Member States in accordance with Article 14(3);

details of the competent authority responsible for taking the decision, from which relevant information can be obtained and to which comments or questions can be submitted, and details of the time schedule for transmitting comments or questions;

the nature of possible decisions or, where there is one, the draft decision;

an indication of the times and places where, or means by which, the relevant information will be made available;

details of the arrangements for public participation and consultation made pursuant to paragraph 7 of this Article.

in accordance with national legislation, the main reports and advice issued to the competent authority at the time when the public concerned was informed pursuant to paragraph 2;

in accordance with the provisions of Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information (17), information other than that referred to in paragraph 2 of this Article which is relevant for the decision in question and which only becomes available after the public concerned was informed in accordance with that paragraph.

the content of the decision and the reasons on which it is based, including any subsequent updates;

the results of the consultations held before the decision was taken and an explanation of how they were taken into account in that decision.

inform the competent authority;

provide the competent authority with the following information as soon as it becomes available:

inform the competent authority of the steps envisaged to:

update the information provided if further investigation reveals additional facts which alter that information or the conclusions drawn.

ensure that any urgent, medium-term and long-term measures which may prove necessary are taken;

collect, by inspection, investigation or other appropriate means, the information necessary for a full analysis of the technical, organisational and managerial aspects of the accident;

take appropriate action to ensure that the operator takes any necessary remedial measures;

make recommendations on future preventive measures; and

inform the persons likely to be affected, of the accident which has occurred and, where relevant, of the measures undertaken to mitigate its consequences.

the Member State, the name and address of the authority responsible for the report;

the date, time and place of the accident, including the full name of the operator and the address of the establishment involved;

a brief description of the circumstances of the accident, including the dangerous substances involved, and the immediate effects on human health and the environment;

a brief description of the emergency measures taken and of the immediate precautions necessary to prevent recurrence;

the results of their analysis and recommendations.

the operator can demonstrate that he has taken appropriate measures, in connection with the various activities of the establishment, to prevent major accidents;

the operator can demonstrate that he has provided appropriate means for limiting the consequences of major accidents, on-site and off-site;

the data and information contained in the safety report, or any other report submitted, adequately reflects the conditions in the establishment;

information has been supplied to the public pursuant to Article 14.

a general assessment of relevant safety issues;

the geographical area covered by the inspection plan;

a list of the establishments covered by the plan;

a list of groups of establishments with possible domino effects pursuant to Article 9;

a list of establishments where particular external risks or hazard sources could increase the risk or consequences of a major accident;

procedures for routine inspections, including the programmes for such inspections pursuant to paragraph 4;

procedures for non-routine inspections pursuant to paragraph 6;

provisions on the co-operation between different inspection authorities.

the potential impacts of the establishments concerned on human health and the environment;

the record of compliance with the requirements of this Directive.

the name or trade name of the operator and the full address of the establishment concerned;

the activity or activities of the establishment.

the rapid dissemination of the information supplied by Member States pursuant to Article 18(1) and (2) among all competent authorities;

distribution to competent authorities of an analysis of the causes of major accidents and the lessons learned from them;

supply of information to competent authorities on preventive measures;

provision of information on organisations able to provide advice or relevant information on the occurrence, prevention and mitigation of major accidents.

the information supplied by Member States in accordance with Article 18(1) and (2);

an analysis of the causes of the accidents;

the lessons learned from the accidents;

the preventive measures necessary to prevent a recurrence.

any applicant requesting information pursuant to points (b) or (c) of Article 14(2) or Article 22(1) of this Directive is able to seek a review in accordance with Article 6 of Directive 2003/4/EC of the acts or omissions of a competent authority in relation to such a request;

in their respective national legal system, members of the public concerned have access to the review procedures set up in Article 11 of Directive 2011/92/EU for cases subject to Article 15(1) of this Directive.

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Dangerous substances

Substances and mixtures are classified in accordance with Regulation (EC) No 1272/2008.

Mixtures shall be treated in the same way as pure substances provided they remain within concentration limits set according to their properties under Regulation (EC) No 1272/2008, or its latest adaptation to technical progress, unless a percentage composition or other description is specifically given.

The qualifying quantities set out above relate to each establishment.

The quantities to be considered for the application of the relevant Articles are the maximum quantities which are present or are likely to be present at any one time. Dangerous substances present at an establishment only in quantities equal to or less than 2 % of the relevant qualifying quantity shall be ignored for the purposes of calculating the total quantity present if their location within an establishment is such that it cannot act as an initiator of a major accident elsewhere at that establishment.

The following rules governing the addition of dangerous substances, or categories of dangerous substances, shall apply where appropriate:

In the case of an establishment where no individual dangerous substance is present in a quantity above or equal to the relevant qualifying quantities, the following rule shall be applied to determine whether the establishment is covered by the relevant requirements of this Directive.

This Directive shall apply to upper-tier establishments if the sum:

q1/QU1 + q2/QU2 + q3/QU3 + q4/QU4 + q5/QU5 + … is greater than or equal to 1,

where qx = the quantity of dangerous substance x (or category of dangerous substances) falling within Part 1 or Part 2 of this Annex,

and QUX = the relevant qualifying quantity for dangerous substance or category x from Column 3 of Part 1 or from Column 3 of Part 2 of this Annex.

This Directive shall apply to lower-tier establishments if the sum:

q1/QL1 + q2/QL2 + q3/QL3 + q4/QL4 + q5/QL5 + … is greater than or equal to 1,

where qx = the quantity of dangerous substance x (or category of dangerous substances) falling within Part 1 or Part 2 of this Annex,

and QLX = the relevant qualifying quantity for dangerous substance or category x from Column 2 of Part 1 or from Column 2 of Part 2 of this Annex.

This rule shall be used to assess the health hazards, physical hazards and environmental hazards. It must therefore be applied three times:

The relevant provisions of this Directive apply where any of the sums obtained by (a), (b) or (c) is greater than or equal to 1.

In the case of dangerous substances which are not covered by Regulation (EC) No 1272/2008, including waste, but which nevertheless are present, or are likely to be present, in an establishment and which possess or are likely to possess, under the conditions found at the establishment, equivalent properties in terms of major-accident potential, these shall be provisionally assigned to the most analogous category or named dangerous substance falling within the scope of this Directive.

In the case of dangerous substances with properties giving rise to more than one classification, for the purposes of this Directive the lowest qualifying quantities shall apply. However, for the application of the rule in Note 4, the lowest qualifying quantity for each group of categories in Notes 4(a), 4(b) and 4(c) corresponding to the classification concerned shall be used.

Dangerous substances that fall within Acute Toxic Category 3 via the oral route (H 301) shall fall under entry H2 ACUTE TOXIC in those cases where neither acute inhalation toxicity classification nor acute dermal toxicity classification can be derived, for example due to lack of conclusive inhalation and dermal toxicity data.

The hazard class Explosives includes explosive articles (see Section 2.1 of Annex I to Regulation (EC) No 1272/2008). If the quantity of the explosive substance or mixture contained in the article is known, that quantity shall be considered for the purposes of this Directive. If the quantity of the explosive substance or mixture contained in the article is not known, then, for the purposes of this Directive, the whole article shall be treated as explosive.

Testing for explosive properties of substances and mixtures is only necessary if the screening procedure according to Appendix 6, Part 3 of the UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria (UN Manual of Tests and Criteria) (3) identifies the substance or mixture as potentially having explosive properties.

If Explosives of Division 1.4 are unpacked or repacked, they shall be assigned to the entry P1a, unless the hazard is shown to still correspond to Division 1.4, in accordance with Regulation (EC) No 1272/2008.

Flammable aerosols are classified in accordance with the Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (4) (Aerosol Dispensers Directive). ‘Extremely flammable’ and ‘Flammable’ aerosols of Directive 75/324/EEC correspond to Flammable Aerosols Category 1 or 2 respectively of Regulation (EC) No 1272/2008.

In order to use this entry, it must be documented that the aerosol dispenser does not contain Flammable Gas Category 1 or 2 nor Flammable Liquid Category 1.

According to paragraph 2.6.4.5 in Annex I to Regulation (EC) No 1272/2008, liquids with a flash point of more than 35 °C need not be classified in Category 3 if negative results have been obtained in the sustained combustibility test L.2, Part III, section 32 of the UN Manual of Tests and Criteria. This is however not valid under elevated conditions such as high temperature or pressure, and therefore such liquids are included in this entry.

Ammonium nitrate (5 000 / 10 000): fertilisers capable of self-sustaining decomposition

This applies to ammonium nitrate-based compound/composite fertilisers (compound/composite fertilisers contain ammonium nitrate with phosphate and/or potash) which are capable of self-sustaining decomposition according to the UN Trough Test (see UN Manual of Tests and Criteria, Part III, subsection 38.2), and in which the nitrogen content as a result of ammonium nitrate is

Ammonium nitrate (1 250 / 5 000): fertiliser grade

This applies to straight ammonium nitrate-based fertilisers and to ammonium nitrate-based compound/composite fertilisers which fulfil the requirements of Annex III-2 to Regulation (EC) No 2003/2003 and in which the nitrogen content as a result of ammonium nitrate is

Ammonium nitrate (350 / 2 500): technical grade

This applies to ammonium nitrate and mixtures of ammonium nitrate in which the nitrogen content as a result of the ammonium nitrate is

It also applies to aqueous ammonium nitrate solutions in which the concentration of ammonium nitrate is more than 80 % by weight.

Ammonium nitrate (10 / 50): ‘off-specs’ material and fertilisers not fulfilling the detonation test

This applies to

In cases where this dangerous substance falls within category P5a Flammable liquids or P5b Flammable liquids, then for the purposes of this Directive the lowest qualifying quantities shall apply.

Information on the management system and on the organisation of the establishment with a view to major-accident prevention.

This information shall contain the elements indicated in Annex III.

Presentation of the environment of the establishment:

Description of the installation:

Identification and accidental risks analysis and prevention methods:

Measures of protection and intervention to limit the consequences of a major accident:

the safety management system shall be proportionate to the hazards, industrial activities and complexity of the organisation in the establishment and be based on assessment of the risks; it should include the part of the general management system which includes the organisational structure, responsibilities, practices, procedures, processes and resources for determining and implementing the major-accident prevention policy (MAPP);

the following issues shall be addressed by the safety management system:

Internal emergency plans:

External emergency plans:

Name or trade name of the operator and the full address of the establishment concerned.

Confirmation that the establishment is subject to the regulations and/or administrative provisions implementing this Directive and that the notification referred to in Article 7(1) or the safety report referred to in Article 10(1) has been submitted to the competent authority.

An explanation in simple terms of the activity or activities undertaken at the establishment.

The common names or, in the case of dangerous substances covered by Part 1 of Annex I, the generic names or the hazard classification of the relevant dangerous substances involved at the establishment which could give rise to a major accident, with an indication of their principal dangerous characteristics in simple terms.

General information about how the public concerned will be warned, if necessary; adequate information about the appropriate behaviour in the event of a major accident or indication of where that information can be accessed electronically.

The date of the last site visit in accordance with Article 20(4), or reference to where that information can be accessed electronically; information on where more detailed information about the inspection and the related inspection plan can be obtained upon request, subject to the requirements of Article 22.

Details of where further relevant information can be obtained, subject to the requirements of Article 22.

General information relating to the nature of the major-accident hazards, including their potential effects on human health and the environment and summary details of the main types of major-accident scenarios and the control measures to address them.

Confirmation that the operator is required to make adequate arrangements on site, in particular liaison with the emergency services, to deal with major accidents and to minimise their effects.

Appropriate information from the external emergency plan drawn up to cope with any off-site effects from an accident. This should include advice to cooperate with any instructions or requests from the emergency services at the time of an accident.

Where applicable, indication whether the establishment is close to the territory of another Member State with the possibility of a major accident with transboundary effects under the Convention of the United Nations Economic Commission for Europe on the Transboundary Effects of Industrial Accidents.

a death;

six persons injured within the establishment and hospitalised for at least 24 hours;

one person outside the establishment hospitalised for at least 24 hours;

dwelling(s) outside the establishment damaged and unusable as a result of the accident;

the evacuation or confinement of persons for more than 2 hours (persons × hours): the value is at least 500;

the interruption of drinking water, electricity, gas or telephone services for more than 2 hours (persons × hours): the value is at least 1 000.

permanent or long-term damage to terrestrial habitats:

significant or long-term damage to freshwater and marine habitats:

significant damage to an aquifer or underground water:

1 ha or more.

damage to property in the establishment: at least EUR 2 000 000;

damage to property outside the establishment: at least EUR 500 000.