51994PC0004

Proposal for a Council Directive on the control of major-accident hazards involving dangerous substances (Comah) (94/C 106/04) (Text with EEA relevance) COM(94) 4 final - 94/0014(SYN)

(Submitted by the Commission on 4 March 1994)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 130s (1) thereof,

Having regard to the proposal from the Commission,

In cooperation with the European Parliament,

Having regard to the opinion of the Economic and Social Committee,

Whereas Council Directive 82/501/EEC of 24 June 1982 on the major-accident hazards of certain industrial activities (1), as last amended by Directive 91/692/EEC (2), is concerned with the prevention of major accidents which might result from certain industrial activities and with the limitation of their consequences for man and the environment;

Whereas the objectives and principles of the Community's environment policy, as set out in Article 130r (1) and (2) of the Treaty and detailed in the European Community's action programmes on the environment (3), aim, in particular, at preserving and protecting the quality of the environment, and protecting human health, through preventive action;

Whereas the Council in its accompanying resolution concerning the fourth action programme on the environment (4) highlighted the need for more effective implementation of Directive 82/501/EEC, and called for the review of the Directive, if neccessary, to include inter alia a possible widening of its scope, and a greater exchange of information on the matter between Member States;

Whereas the Council resolution of 16 October 1989 (5) invited the Commission to consider ways of including in the Directive planning controls on land use, taking into account, in particular, the consequences of the accident at Bhopal, and the means of seeking mutual understanding and harmonization of national principles and practices regarding safety reports;

Whereas Directive 82/501/EEC constitutes a first stage in the harmonization process; whereas the measures taken by the Member States to implement that Directive have resulted in differing levels of protection of man and the environment;

Whereas major accidents can have repercussions beyond frontiers; whereas the environmental and economic cost of an accident is borne not only by the establishment affected but also by the competent authorities of the Member States concerned; whereas it is therefore necessary to take measures ensuring a high level of protection throughout the Community;

Whereas action at Community level is necessary in order to modify and to supplement Directive 82/501/EEC; whereas the present harmonization is limited to the measures which are necessary to put in place a more effective system for preventing major accidents having widespread effects and for limiting their consequences by improving safety management, land-use policies, the provision of information to the public and inspection systems in order to ensure a high level of protection for man and the environment throughout the Community;

Whereas in order to take account of the significant changes that have occurred in industrial practice regarding risk management and the prevention of major accidents, Directive 82/501/EEC should be replaced by more extensive provisions seeking to ensure that those in control of major-hazard plants throughout the Community provide a high level of safety;

Whereas the use of a list specifying certain undertakings and excluding others with identical hazards is inflexible and technically unsound, and allow potential sources of major accidents to escape regulation; whereas the scope of the Directive should be altered in order to make the provisions applicable to all establishments where dangerous substances are present in sufficiently large quantitites to create a major-accident hazard;

Whereas analysis of the major accidents reported in the Community indicates that the majority of them are the result of managerial and/or organizational shortcomings; whereas it is therefore necessary to lay down at Community level essential requirements for management systems, which must be suitable for controlling major-accident hazards;

Whereas differences in the arrangements for the inspection of establishments by the competent authorities may give rise to differing levels of protection; whereas it is necessary to lay down at Community level the essential requirements with which the control systems established by the Member States must comply;

Whereas in order to prevent major accidents, the operator must, for every establishment at which dangerous substances are present and where, in the event of a major accident, there may be serious consequences for man and the environment, take all measures necessary to prevent such accidents and to limit the consequences thereof;

Whereas, in order to improve management systems and reduce human error, in the case of establishments where dangerous substances are present in certain quantities it is necessary for the operator to introduce a major-accident prevention policy and systems to improve the management of safety in the establishment and to provide the competent authority with information sufficient to enable it to identify the establishment, the dangerous substances present and the potential dangers, in order that it may manage its resources and responsibilities adequately;

Whereas, in order to demonstrate the preventive measures, contingency plans and response measures taken, 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 containing details of the establishment, the dangerous substances present, the installation or storage facilities, possible major accidents and the management systems available, in order to reduce the risk of major accidents and to enable the necessary steps to be taken to reduce the consequences thereof;

Whereas in order to reduce the risk of domino effects, the operators should, in the case of establishments which are so close together that the probability of a major accident may be increased, or its consequences aggravated, cooperate in devising measures to prevent, prepare for and respond to major accidents;

Whereas, in order to provide against emergencies, in the case of establishments where dangerous substances are present in significant quantities it is necessary to establish external and internal emergency plans in response to major accidents and to create systems to ensure those plans are tested and revised as necessary and implemented in the event of a major accident or threat thereof;

Whereas, where an external emergency plan is not prepared within the period fixed, it is necessary to make authorities responsible for the creation of the external emergency plan liable for any costs incurred by the operator owing to his being unable to operate his establishment;

Whereas, in order to promote access to information on the environment the public should have access to the safety report produced by the operator, and persons liable to be affected by a major accident should be given information sufficient to inform them of the correct action to be taken in the event of a major accident;

Whereas, in order to provide greater protection from major-accident hazards for centres of population and natural areas of particular interest or sensitivity, it is necessary for Member States' land-use policies to take account of the need for adequate separation between such areas and establishments presenting such hazards. Such policies should include consultation procedures between competent authorities and planning authorities;

Whereas, in order to ensure that adequate response measures are taken if a major accident occurs, the operator must immediately inform the competent authorities and communicate the information necessary for assessing the impact of that accident;

Whereas, in order to provide for an information exchange and to prevent future accidents of a similar nature, Member States should forward information to the Commission regarding major accidents occurring in their territory, so that the Commission can analyse the hazards from major accidents, and operate an information system for the distribution of information on any particular major accident, and the lessons learned from it;

Whereas in the establishment of management systems in the field of preventing, preparing against and responding to major accidents involving dangerous substances it is necessary to ensure appropriate participation by workers in the establishment, in order to contribute to the prevention of occupational risks and to promote protection of the health and safety of workers;

Whereas the requirements of this Directive should not prejudice Community requirements concerning the working environment as regards the health and safety of workers,

HAS ADOPTED THIS DIRECTIVE:

Article 1

This Directive is aimed at the prevention of major accidents which involve dangerous substances, and the limitation of their consequences for man and the environment, with a view to ensuring high levels of protection throughout the Community.

Article 2

1. The Directive will apply 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 Annex I, Parts 1 and 2, column 2, with the exception of Article 9, which will apply 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 Annex I, Parts 1 and 2, column 3.

2. The requirements of the Directive shall apply without prejudice to Community requirements concerning the working environment, and, in particular, without prejudice to Council Directive 89/391/EEC (6).

Article 3

For the purposes of this Directive:

(a) establishment:

means the whole area under the control of an operator where dangerous substances are present in any installation or any storage facility and all the remaining area under the control of the operator at that place, including administrative buildings, ancillary epuipment, pipework, storage, process and production equipment, marshalling yards, docks, piers, jetties, depots, or similar structures, whether floating or not;

(b) installation:

means the equipment, building, pipework, machinery, tools and all other appliances, whether fixed or not, at an establishment for the chemical, physical or biological processing of a dangerous substance;

(c) operator:

means any person (including individuals and corporate bodies), responsible for the control of an establishment covered by this Directive;

(d) dangerous substance:

means a substance, mixture or preparation listed in Annex I, Part 1, or fulfilling the criteria laid down in Annex I, Part 2, and present as a raw material, product, by-product, residue, or intermediary, including those substances produced in the course of an accident;

(e) 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 man and/or the environment, immediate or delayed, inside or outside the establishment, and involving one or more dangerous substances;

(f) hazard:

means the intrinsic property of a dangerous substance or physical situation at an establishment, with a potential for creating damage;

(g) risk:

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

(h) storage:

means the presence of a quantity of dangerous substances for the purposes of warehousing, depositing in safe custody or keeping in stock for trading purposes.

Article 4

This Directive shall not apply to the following:

(a) military installations or storage facilities;

(b) hazards created by ionizing radiation;

(c) the transport of dangerous substances by road, rail, water, or air, outside the establishments covered by this Directive;

(d) the transmission of dangerous substances in pipelines outside the establishment covered by this Directive;

(e) The activities of the extractive industries concerned with exploration for, and the exploitation of, minerals in mines and quarries or by means of boreholes, including the preparation of boreholes, including the preparation of extracted materials for sale.

Article 5

1. Member States shall ensure that the operator is obliged to take all measures necessary to prevent major accidents and to limit their consequences for man and the enivronment.

2. In the case of establishments where there is more than one operator, owing to the mixed ownership or control of the establishment concerned, Member States shall ensure that all the operators are collectively responsible for compliance with this Directive and in particular the production of the safety report required by Article 9 (1).

Article 6

1. Without prejudice to Article 5, Member States shall require operators to draw up a document setting out their major-accident prevention policy and in particular a management system and procedures. That document shall cover the following elements:

(a) the overall aims, approach and specific objectives of the operator in the control of major accidents;

(b) the principles and criteria on which action to prevent, and respond to major accidents is based;

(c) the identification of major-accident hazards;

(d) the measures identified as necessary to prevent major accidents;

(e) the measures identified as necessary to limit the consequences of major accidents for man and the environment;

(f) the organization and procedures necessary for implementing and managing the major-accident prevention policy including the appointment of suitably qualified and trained personnel;

(g) the programme for implementation, assessment of effectiveness and introduction of improvements;

(h) the periodic review of the major-accident prevention policy and management system by senior management of the establishment, in order to check performance against relevant standards.

2. Member States shall require the operator to send the competent authority specified in Article 16 a notification in writing within the following time limits:

- for new establishments, between four and eight months before commencing construction or operation,

- for existing establishments, a period of time between eight and 12 months after the date referred to in Article 24 (1).

3. The notification required by paragraph 2 shall contain the following details:

(a) the name or trade name of the operator and complete address of the establishment concerned;

(b) the registered place of business of the operator and complete address;

(c) the name of a director or person in charge of the establishment, if different from (a);

(d) information sufficient to identify the dangerous substance or category of substances involved;

(e) the quantity and physical form of the dangerous substance or substances involved;

(f) the activity or proposed activity of the installation or storage.

4. In the case of existing establishments for which the operator has already provided all the information under paragraph 3 to the competent authority under the requirements of national law at the date of entry into force of this Directive, notification pursuant to paragraph 2 is not required.

5. In the event of any significant change to the maximum quantity or physical form of the dangerous substance present, as indicated in the notification provided by the operator pursuant to paragraph 2, or in the event of the permanent closure of the installation the operator shall immediately inform the competent authority of the change.

Article 7

Member States shall ensure that all operators are required to prove to the competent authority at any time, in particular for the purposes of the inspections and controls referred to in Article 18, that they have taken all the measures necessary as specified in this Directive.

Article 8

1. Member States shall ensure that the competent authority using the information received from operators in compliance with this Directive and taking into account inter alia the location, proximity and total quantities of dangerous substances present, identifies groups of establishments where the likelihood of a major accident may be increased.

For the purposes of this Article the competent authority shall identify those groups of establishments where the total quantity of dangerous substances is equal to or in excess of the relevant quantity listed in Annex I, Parts 1 and 2, column 3.

2. Member States shall ensure that, whenever an increased likelihood or an aggravation of major accidents is identified under paragraph 1 in a group of establishments:

(a) the provisions of Article 9 are extended to all the establishments thus identified;

(b) the operators of all the establishments identified shall exchange such information as is necessary to enable them all to take account of the overall major-accident hazard;

- in their major-accident prevention policy,

- in their management systems,

- in the safety report;

(c) the operators of all the establishments identified are required to cooperate in the preparation of emergency plans and the provision of information to the public.

3. Member States shall inform the Commission of the criteria which they apply in determining the conditions under which the provisions of Article 9 are to be applied to all the establishments of a group. The Commission shall, if necessary, establish harmonized criteria, in accordance with the procedure laid down in Article 22.

Article 9

1. Without prejudice to Articles 5, 6 and 7, Member States shall require the operator to produce a safety report for the purposes of:

(a) demonstrating the establishment and implementation of the major-accident prevention policy and management systems and procedures, as specified in Article 6 (1);

(b) demonstrating the safety and reliability incorporated into the design, construction, and covering, where appropriate, the abandonment of the installation, storage or establishment;

(c) demonstrating the safe operation and maintenance of the installation or storage facility;

(d) detailing the operational requirements and limitations of the establishment with respect to technical, organizational and managerial matters used to prevent major accidents;

(e) providing for continuing safety assurance by means of regular review;

(f) providing for emergency preparedness and for the response in the event of a major accident;

(g) providing sufficient information to the relevant authorities to enable decisions to be made in terms of the siting and land use for new establishments and developments around existing establishments.

The safety report, as an integral part of the safety management systems of the establishment, shall contain the data and information listed in Annex II.

Internal safety audits shall be carried out as an integral part of the management system of the establishment. The results of these shall be made available to the competent authorities at the time at which inspections are carried out pursuant to Article 18.

2. The report presented to the competent authority shall provide a clear description of the installation or storage concerned, and meet the objectives outlined in this Article. Safety reports, or parts of reports, or any other equivalent reports produced in response to other legislation, may be combined to form a single safety report for the purposes of this Article, where such a format obviates the unnecessary duplication of information and the repetition of work by the operator or competent authority, on condition that all the requirements of this Article are complied with.

3. The safety report or details of the content, conclusions and any changes resulting from the review specified in paragraph 5, shall be sent to the competent authority within the following time limits:

- for new establishments, between four and eight months before commencing construction or operation,

- for existing establishments, within two years of the date referred to in Article 24 (1),

- without delay following periodic review under paragraph 5.

4. Before the operator commences construction or operation, or, in the cases referred to in the second and third indents of paragraph 3, within one year of the submission of the safety report, the competent authority shall:

- write to the operator expressing satisfaction with the report, or

- ask for further information, to be supplied within three months, or

- prohibit the bringing into use, or the continued use, of the establishment concerned, in accordance with the powers and procedures laid down in Article 17.

Where the competent authority requests further information, the conclusions of its examination of the report must be communicated to the operator within six months of submission of the information required.

5. The safety report shall be reviewed and where necessary updated periodically, as follows:

- at least every five years,

- at any time, at the explicit request of the competent authority,

- at any other time to take account as necessary of new technical knowledge about safety matters and of developments in knowledge concerning the assessment of hazards.

6. Where it is demonstrated to the satisfaction of the competent authority that particular substances present at the establishment, or on any part thereof, are in a state incapable of creating a major-accident hazard, then the Member State may limit the information required in safety reports to those matters which are relevant to the prevention of those residual major-accident hazards and the limitation of their consequences for man and the environment.

7. Member States shall ensure that the competent authority publishes the criteria it intends to use in reaching a decision that a substance or establishment are in a state incapable of creating a major-accident hazard under paragraph 6 and that it communicates a copy of the said criteria to the Commission. The Commission shall, if necessary, establish harmonized criteria in accordance with the procedure laid down in Article 22.

8. Member States shall inform the Commission of the criteria they use for:

- risk analysis and risk evaluation methods and procedures;

- safety management systems, including safety audit methods and procedures;

- assessing the reliability of technical systems and arrangements for accident prevention.

The Commission shall if necessary, establish harmonized criteria in accordance with the procedure laid down in Article 22.

Article 10

In the event of the modification of an installation, storage facility or establishment which could have significant repercussions on major-accident hazards, the Member States shall ensure that the operator:

- reviews and where necessary revises the major-accident prevention policy, and management systems and procedures referred to in Article 6 (1),

- reviews, and where necessary revises, the safety report and informs the competent authority of the details of such revision in advance of such modification.

Article 11

1. Member States shall ensure that, for all establishments to which Article 9 applies:

(a) an internal emergency plan is drawn up by the operator for action inside the establishment, as follows:

- for new establishments, prior to commencing operation,

- for existing establishments not previously covered by Directive 82/501/EEC, one year from the date referred to in Article 24 (1),

- for other establishments, by the date referred to in Article 24 (1);

(b) the necessary information is supplied by the operator to the authorities designated by the Member State for establishing external emergency plans, so as to enable external emergency plans to be produced, as follows:

- for new establishments, between four and eight months before commencing construction or operation,

- for existing establishments not previously covered by Directive 82/501/EEC, two years from the date referred to in Article 24 (1),

- for other establishments, by the date referred to in Article 24 (1);

(c) an external emergency plan is drawn up by the authorities designated for that purpose by the Member State for implementation outside the establishment, as follows:

- for new establishments, prior to commencing operation,

- for existing establishments not previously covered by Directive 82/501/EEC, not more than six months from receipt of the information deemed necessary by the competent authority pursuant to this Article,

- for other establishments, by the date referred to in Article 24 (1).

2. The emergency plans must be established with the objectives of:

- containing and controlling incidents so as to minimize the effects, and to limit damage to man and the environment,

- implementing response measures to protect man and the environment from the effects of major accidents,

- communicating relevant information to the public and other services or authorities concerned in the area,

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

Emergency plans shall contain the information set out in Annex III.

3. Member States shall ensure that, without prejudice to the obligations of the competent authorities, the opportunity of contributing to the preparation of emergency plans pursuant to this Directive is afforded:

- in the case of internal and external emergency plans, to personnel inside the establishment, and,

- in the case of external emergency plans, to the public liable to be affected.

4. Member States shall ensure that internal and external emergency plans as reviewed, tested, and where necessary revised and updated by the operators and designated authorities at suitable intervals no longer than three years. The review shall take into account changes occurring in the establishments concerned or within the emergency services concerned, new technical knowledge, and knowledge concerning the response to major accidents.

5. Member States shall ensure that emergency plans are put into effect without delay by the person nominated or by the designated authority, whenever:

- a major accident occurs, or

- an uncontrolled event occurs which by its nature could reasonably be expected to lead to a major accident.

6. Where a safety report demonstrates to the satisfaction of the competent authority that the establishment is incapable of creating a major-accident hazard beyond its boundary, the requirements to produce an external emergency plan in terms of Article 11 (1) shall not apply.

7. Member States shall ensure that the competent authority publishes the criteria which it intends to use in reaching a decision that an establishment is incapable of creating a major-accident hazard beyond its boundary under of paragraph 6 and that it communicates a copy of the said criteria to the Commission. The Commission shall, if necessary, establish harmonized criteria, in accordance with the procedure laid down in Article 22.

Article 12

1. Member States shall ensure that their land-use policy includes among its objectives the prevention of major accidents and the limitation of their consequences. They shall accomplish this objective through controls on:

(a) the siting of new estabishments;

(b) modifications to existing establishments covered by Article 10;

(c) new developments surrounding such existing establishments where the siting or developments may be liable to increase the risk or consequences of a major accident.

Member States shall ensure that their land-use policy, and the procedures for implementing it, take account of the need, in the long term, to separate establishments covered by this Directive from residential areas, areas of substantial public use, and areas of particular natural sensitivity or interest, and also of the need to facilitate emergency planning in the event of a major accident.

2. Member States shall ensure that all competent authorities and planning authorities responsible for decisions on siting and land use set up appropriate consultation procedures to facilitate the implementation of the policy established pursuant to paragraph 1. The procedures shall be designed to ensure that technical advice on the risks arising from the establishment is available, either on a case-by-case or on a generic basis, when decisions are taken.

3. Member States shall inform the Commission of the siting and land-use planning criteria which they apply for the purpose of paragraph 1. The Commission shall, if necessary establish guidelines on such criteria in accordance with the procedure laid down in Article 22.

Article 13

1. Member States shall 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 originating in an establishment covered by Article 9. The information shall be reviewed every two years, and where necessary repeated and updated, at least if there is any modification within the meaning of Article 10. It shall also be made permanently available to the public. The maximum period between the repetition of the information to the public shall, in any case, be no longer than four years.

Such information shall contain, at least, the information listed in Annex IV.

2. The Member States concerned shall, at the same time, make available to the other Member States liable to be affected in the event of a major accident originating in an establishment pursuant to Article 9 sufficient information to enable emergency plans to be prepared where necessary, and the same information as is disseminated at national level.

Such information shall be reviewed, repeated and updated at the same intervals as are laid down under paragraph 1.

3. Where the Member State concerned has decided that an establishment close to a border with another Member State is incapable of creating a major-accident hazard beyond its boundary for the purposes of Article 11 (6) and is not therefore required to produce an external emergency plan pursuant to Article 11 (1), it shall so inform the other Member State.

4. Member States shall ensure that the safety report is made available to the public. The operator may ask the competent authority not to disclose to the public certain parts of the report, for reasons of industrial, commercial or personal confidentiality, public security or national defence. In such cases, on the approval of the competent authority, the operator shall supply to the authority, and make available to the public, an amended report excluding those matters.

5. Member States shall ensure that the public is able to participate in relevant procedures and debates, relating to:

- planning for new establishments covered by Article 9, modifications to existing establishments pursuant to Article 10, where such modifications are subject to obligations provided for in this Directive as to planning, and developments around such existing establishments,

- the major-accident hazard control policies and criteria of the competent authority and development policies and procedures regarding siting and land-use, developed to implement this Directive.

6. In the case of establishments subject to the provisions of Article 9, Member States shall ensure that the operator provides the competent authority with an inventory of all dangerous substances present which attain or exceed the quantity listed in Annex I, Parts 1 and 2, column 3, at the establishment; the operator shall give the following details:

- information sufficient to identify either the dangerous substance or the category of dangerous substance,

- an indication of the total quantity present, and

- the source of any additional information.

This inventory shall be updated annually and shall be made available to the public, on the premises of the establishment.

Article 14

1. Member States shall take the necessary measures to ensure that, as soon as practicable following a major accident, the operator shall be required, using the most appropriate means:

(a) to inform the competent authorities;

(b) to provide them with the following information as soon as it becomes available:

- the circumstances of the accident,

- the dangerous substances involved,

- the data available for assessing the effects of the accident on man and the environment, and

- the emergency measures taken;

(c) to inform them of the steps envisaged:

- to alleviate the medium and long-term effects of the accident,

- to prevent any recurrence of such an accident;

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

2. The Member States shall require the competent authorities:

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

(b) to collect, by inspection, investigation or other appropriate means, the information necessary for a full analysis of the technical, organizational and managerial aspects of the major accident;

(c) to take appropriate action to ensure that the operator takes any necessary remedial measures; and

(d) to make recommendations on future preventive measures.

3. Member States shall inform the Commission of the criteria they apply for the reporting of major accidents pursuant to Articles 14 and 15. The Commission shall, if necessary establish guidelines concerning such criteria in accordance with the procedure laid down in Article 22.

Article 15

1. For the purposes of prevention and mitigation of major accidents, Member States shall inform the Commission as soon as practicable of major accidents which have occurred within their territory and shall provide it with the following details:

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

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

(c) a brief description of the circumstances of the accident, including the dangerous substances involved, and the immediate effects on man and the environment;

(d) a brief description of the emergency measures taken and of the immediate precautions necessary to prevent recurrence.

2. Member States shall, as soon as the information is collected in accordance with Article 14, inform the Commission of the result of their analysis and recommendations using a report form established and kept under review through the procedure referred to in Article 22.

Reporting of this information by Member States may be delayed only to allow for the completion of legal proceedings where such reporting is liable to affect those proceedings.

3. Member States shall inform the Commission of the name and address of any organization which might have relevant information on major accidents and which is able to advise the competent authorities of other Member States which have to intervene in the event of such an accident.

Article 16

Member States shall set up or appoint the competent authority or authorities responsible for planning, organizing, authorizing and supervising the activities of establishments covered by this Directive.

Article 17

1. Member States shall prohibit the use or bringing into use of any establishment installation or storage facility, or any part thereof if its or their continued use will involve an imminent risk of a major accident.

Member States may prohibit the use or bringing into use of any establishment, installation or storage facility, or any part thereof pursuant to this Article if:

- the operator has not submitted the notification, reports or other information required by the Directive within the specified period,

- an external emergency plan has not been prepared within the specified period.

In accordance with their own legal systems Member States shall ensure that if the competent authority prohibits the use or bringing into use of any establishment, installation or storage facility, or any part thereof because an external emergency plan has not been prepared within the specified period, the operator is entitled to seek compensation from the authorities responsible for the preparation of such plans for any costs incurred due to the prohibition.

2. Member States shall ensure that operators may appeal against the prohibition by a competent authority mentioned in paragraph 1, according to national law and procedures, to an appropriate body. On such an appeal the prohibition may be cancelled, amended or confirmed. During such appeal the prohibition imposed by the competent authority shall remain in force.

Article 18

1. Member States shall ensure that the competent authorities organize a system of inspections, or other measures of control proper to the type of establishment concerned. Those inspections or control measures shall not be dependent upon receipt of the safety report or any other report submitted. Such inspections or other control measures shall be sufficient for a planned and systematic examination of the systems being employed at the establishment, whether of a technical, organizational or managerial nature, so as to ensure in particular:

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

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

- that the data and information contained in the safety report specified in Article 9 (1), or any other report submitted, adequately reflects the conditions in the establishment,

- that information has been supplied to the public pursuant to Article 13 (1).

2. The system of inspection specified in paragraph 1 shall comply with the following conditions:

(a) it shall be conducted by a suitably qualified and trained person employed by the competent authority;

(b) inspections shall be undertaken by suitably qualified and trained persons;

(c) a programme of inspections for all establishments. Unless the competent authority has established a programme of inspection which provides for a longer period between inspections based upon a systematic appraisal of the major-accident hazards of the particular establishment concerned, the programme shall entail at least one on-site inspection made by the competent authority every 12 months to each establishment covered by Article 9;

(d) following each inspection a report, including conclusions and follow-up action, shall be prepared by the person carrying out the inspection, for submission to and consideration by the manager appointed by the competent authority;

(e) every inspection carried out by the competent authority shall be followed up with the management of the establishment, no later than three months following the inspection.

3. The competent authority may require the operator to provide any additional information necessary to allow the authority fully to assess the possibility of a major accident and to determine the scope of possible increased probability and/or aggravation of major accidents, to permit the preparation of an external emergency plan, to provide information concerning siting and land use, and to take substances into account which, due to their physical form, particular conditions or location, may require additional consideration.

4. Member States shall ensure that sufficient and appropriate resources, including financial, technical and human resources, are put at the disposal of the competent authority, the authority designated for the establishment of the external emergency plans and any other authority designated by the Member State to achieve the objectives of, and to carry out an activity required by, this Directive.

5. Member States shall inform the Commission of the criteria they apply for the establishment and management of inspection programmes and procedures. The Commission shall adopt, if necessary, harmonized criteria under the procedure laid down in Article 22.

Article 19

1. The Commission shall set up and keep at the disposal of Member States a register and information system containing, in particular, details of the major accidents which have occurred within the territory of Member States, for the purpose of:

(a) the rapid dissemination of the information supplied by Member States pursuant to Article 15 (1) among all competent authorities;

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

(c) supply of information to competent authorities on preventive measures;

(d) provision of information on organizations able to provide advice or relevant information on the occurrence, prevention and mitigation of major accidents.

The register and information system shall contain, at least:

(a) the information supplied by Member States in compliance with Article 15 (1);

(b) an analysis of the causes of the accidents;

(c) the lessons learned from the accidents;

(d) the preventive measures necessary to prevent a recurrence.

2. Access to the register and information system shall be open to government departments of the Member States, industry or trade associations, trade unions, non-governmental organizations in the field of the protection of the environment, and other international or research organizations working in the field.

3. Member States shall provide the Commission with an annual report on the numbers and types of establishments covered by Articles 6 and 9, the number of safety reports received, the number of internal and external emergency plans produced, and the number of inspections made. The Commission shall publish a summary of this information every year.

Article 20

1. Information obtained by the competent authorities and by the Commission in pursuance of this Directive is confidential only so far as it affects:

- the confidentiality of the proceedings of competent authorities and of the Commission,

- the confidentiality of international relations and national defence,

- public security or other security aspects,

- matters which are or have been sub judice, or under investigation (including disciplinary inquiries), or which are the subject of preliminary investigation proceedings,

- commercial and industrial confidentiality, including intellectual property,

- the confidentiality of personal data and/or files,

- material supplied by a third party without that party's being under a legal obligation to do so.

2. This Directive shall not preclude the conclusion by a Member State of agreements with third countries on the exchange of information to which it is privy at internal level other than that obtained through the Community procedures for the exchange of information set up by this Directive.

Article 21

The procedure specified in Article 22 shall be used for the adaptation of the Annexes to technical progress and for establishing: the harmonized Community criteria referred to in Article 8 (3), 9 (8), 11 (7), 14 (3) and 18 (5); the guidelines referred to in Article 12 (3) and the report form referred to in Article 15 (2).

Article 22

Wherever reference is made to this Article, the following procedure shall be applied:

- the Commission shall be assisted by a committee of an advisory nature composed of the representatives of the Member States and chaired by the representative of the Commission;

- the representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote;

- the opinion shall be recorded in the minutes; in addition, each Member States shall have the right to ask to have its position recorded in the minutes;

- the Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account.

Article 23

Directive 82/501/EEC is hereby repealed with effect from 1 January 1996.

Article 24

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 1 January 1996. They shall forthwith notify the Commission thereof.

When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.

Article 25

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.

Article 26

This Directive is addressed to the Member States.

(1) OJ No L 230, 5. 8. 1982, p. 1.

(2) OJ No L 377, 31. 12. 1991, p. 48.

(3) OJ No C 112, 20. 12. 1973, p. 1.

OJ No C 139, 13. 6. 1977, p. 1.

OJ No C 46, 17. 2. 1983, p. 1.

OJ No C 70, 18. 3. 1987, p. 1.

OJ No C 138, 17. 5. 1993, p. 1.

(4) OJ No C 328, 7. 12. 1987, p. 3.

(5) OJ No C 273, 26. 10. 1989, p. 1.

(6) OJ No L 183, 29. 6. 1989, p. 1.

ANNEX I

APPLICATION OF THE DIRECTIVE

This Annex applies to the presence of dangerous substances at any establishment as defined by this Directive, and determines the application of the relevant articles.

The presence of dangerous substances in the context of this Directive includes where their presence, above the relevant threshold quantity, is provided for or when dangerous substances are likely to be present above threshold quantities as a result of an accident.

Mixtures and preparations shall be treated in the same way as pure substances provided they remain within concentration limits set according to their properties under the relevant directive or latest adaptation to technical progress given in note 1, unless a percentage composition or other description is specifically given.

The qualifying quantities set out below 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 liable to be present at any one time. Dangerous substances present at an establishment solely in an isolated quantity equal to or less than 2 % of the relevant qualifying quantity shall be ignored for the purposes of calculating the total quantity present. An isolated quantity refers to a quantity of dangerous substance itself incapable of causing a major accident, and located within an establishment such that it cannot act as an initiator of a major accident elsewhere on the site.

The rules given in note 4 governing the addition of dangerous substances, or categories of dangerous substance shall apply where appropriate.

PART 1

Named substances

Where a substance or group of substances listed in Part 1 also falls within a category of Part 2, the qualifying quantities set out in Part 1 must be used.

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PART 2

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NOTES

1. Substances and preparations are classified according to the following Directives (as amended) and their current Adaptation to technical progress:

- Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances,

- Council Directive 88/379/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations,

- Council Directive 78/631/EEC on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations (pesticides).

In the case of substances and preparations which are not classified according to any of the above Directives but which nevertheless are present, or are liable to be present, in an establishment and which possess or are liable to possess, under the conditions found at the establishment, equivalent properties in terms of major accident potential, the procedures for provisional classification shall be followed according to the relevante Article of the appropriate directive.

In the case of substances and preparations with properties giving rise to more than one classification, for the purposes of this Directive, the lower thresholds shall apply.

For the purposes of this Directive a list providing information on substances and preparations shall be established, kept up to date, and approved by the procedure set up pursuant to Article 22.

2. An EXPLOSIVE means:

(a) a solid or liquid substance or mixture of solid or liquid substances or both, which is capable of detonation, that is the production of a large volume of gas at supersonic velocity from a small volume of solid or liquid; or

a solid or liquid substance or mixture of solid or liquid substances or both which is designed to produce a propellant effect by releasing a large quantity of gas at subsonic velocity from a small volume of solid or liquid;

(b) notwithstanding substances or preparations covered by the definition given in 2 (a), those substances and preparations classified as EXPLOSIVE according to note 1 in combination with risk phrase R3 'Extreme risk of explosion by shock, friction, fire or other sources of ignition`, and all other substances and preparations which can produce an effect by explosion.

3. FLAMMABLE, HIGHLY FLAMMABLE and EXTREMELY FLAMMABLE in categories 6, 7 and 8 mean:

(a) FLAMMABLE liquids:

- substances and preparations having a flash point equal to or greater than 21 °C and less than or equal to 55 °C, supporting combustion;

(b) HIGHLY FLAMMABLE liquids:

- substances and preparations which may become hot and finally catch fire in contact with air at ambient temperature without any input of energy, and substances which have a flash point lower than 55 °C and which remain liquid under pressure, where particular processing conditions, such as high pressure and high temperature, may create major accident hazards;

(c) EXTREMELY FLAMMABLE gases and liquids:

- liquid substances and preparations which have a flash point lower than 0 °C and the boiling point (or in the case of a boiling range the initial boiling point) of which at normal pressure is less than or equal to 35 °C, EXCLUDING gasoline and petroleum spirits which shall be covered by category 7b, and

- gaseous substances and preparations which are flammable in contact with air at ambient temperature and pressure whether or not kept in the gaseous or liquid state under pressure, EXCLUDING Liquedfied petroleum gas (including propane and butane) which shall be treated according to their listing in Part 1.

4. The addition of dangerous substances to determine the quantity present at an establishment shall be carried out according to the following rule:

if the sum:

q1/Q + q2/Q + q3/Q + q4/Q + q5/Q + . . . = ≥ 1

where qx = the quantity of dangerous substance or category of dangerous substance falling within Parts 1 or 2 of this Annex, x present

Q = the relevant threshold quantity from Part 1 or 2.

then the establishment is covered by the relevant requirements of the Directive.

This rule will apply for the following circumstances:

(a) for substances and preparations appearing in Part 1 at quantities less than their individual qualifying quantity present with substances having the same classification from Part 2, and the addition of substances and preparations with the same classification form Part 2;

(b) for the addition of categories 1, 2 and 10 present at an establishment together;

(c) for the addition of categories 3, 4, 5, 6, 7a, 7b, and 8, present at an establishment together.

ANNEX II

DATA AND INFORMATION TO BE CONSIDERED IN THE SAFETY REPORT SPECIFIED IN ARTICLE 9

1. Information relating to the establishment including:

(a) the geographical location of the establishment and predominant meteorological conditions and sources of danger arising from its location;

(b) the maximum number of persons working at the establishment and particularly those persons exposed to the major-accident hazard, and an indication of the maximum number of persons likely to be present at the establishment at any one time;

(c) a general description of the technological processes for each installation;

(d) a description of the sections of the establishment which are important from the safety point of view, the sources of major-accident hazard and the conditions under which a major accident could occur, together with a description of the preventative measures planned;

2. Information relating to the dangerous substances at each installation or storage or present elsewhere at the establishment and liable to be significant in creating a major-accident hazard:

(a) composition of the dangerous substances present in significant quantities, including, chemical name, CAS number, name according to IUPAC nomenclature, other names, empirical formula, degree of purity and the main impurities and their relative percentages;

(b) the quantity (order of magnitude), of the dangerous substance, or substances, present;

(c) methods and precautions laid down by the operator in connection with handling, storage and fire;

(d) methods available to the operator for rendering the substance harmless;

(e) an indication of the hazards, both immediate and delayed for man and the environment;

(f) the chemical and/or physical behaviour under normal conditions of use during the process;

(g) the forms in which the substances may occur or into which they may be transformed in the case of abnormal conditions which can be foreseen.

3. Information relating to the installation or storage:

(a) detection and determination methods available, including a description of the methods used or the references in the scientific literature;

(b) the stage at which the dangerous substances are or may be involved in the installation;

(c) if necessary, other dangerous substances whose presence could have an effect on the potential major-accident hazard presented;

(d) the arrangements made to ensure that the technical means necessary for the safe operation of the installation or storage and to deal with any malfunctions that arise are available at all times.

4. Information relating to possible major accidents:

(a) details of the main possible major accident scenarios including consideration of knock-on effects involving adjacent installations, storage, or establishments and an assessment, in general terms, of the likelihood of its happening, taking into account the preventative and mitigatory actions taken;

(b) a summary of the events which could be significant in bringing about each of these scenarios together with an assessment of the extent and severity of the consequences;

(c) emergency measures laid down by the operator in the event of accidental dispersion, including the internal emergency plan prepared in compliance with Article 11.

5. Information relating to the management system and organization of the establishment, as it relates to major-accident prevention, preparedness and response:

(a) a summary of the operator's major-accident prevention policy as required by Article 6;

(b) a summary of the organizational structure for implementing the aims and objectives of the major-accident prevention policy, including the position and names of those persons with significant responsibilities and their relevant duties;

(c) the management systems used to monitor, audit and review the content and implementation of the major-accident prevention policy, including the evaluation of safety performance;

(d) analysis of the training needs of the individuals responsible for the implementation and monitoring of the major-accident prevention policy;

(e) a summary of the safety critical procedures, including an assessment of possible human error, for the operation, maintenance, and emergency preparedness of the establishment and individual installations or storage;

(f) the procedures adopted for planning modifications to the existing installations or storage or the design of a new installation or storage;

(g) the involvement of the workforce, including that of any contractors, in the major-accident prevention policy, its implementation and assessment;

(h) the internal system for reporting major accidents or near misses, particularly those involving failure of protective measures, and their investigation and follow up.

ANNEX III

DATA AND INFORMATION TO BE INCLUDED IN THE EMERGENCY PLANS SPECIFIED UNDER ARTICLE 11

1. Internal emergency plans

(a) Names or positions of persons authorized to set emergency procedures in motion and the person in charge of and coordinating the on site mitigatory action.

(b) Name or position of the person with responsibility for liaising with the authority responsible for the external emergency plan.

(c) For foreseeable conditions or events which could be significant in bringing about a major accident, a description of the action which should be taken to control the conditions or events and to limit their consequences, including a description of the safety equipment and the resources available.

(d) Arrangements for limiting the risks to persons on site including how warnings are to be given and the actions persons are expected to take on receipt of a warning.

(e) Arrangements for providing early warning of the incident to the authority responsible for setting the external emergency plan in motion, the type of information which should be contained in an initial warning and the arrangements for the provision of more detailed information as it becomes available.

(f) Arrangements for training staff in the duties they will be expected to perform, and where necessary coordinating this with off-site emergency services.

(g) Arrangements for providing assistance with off-site mitigatory action.

2. External emergency plans

(a) Names or positions of persons authorized to set emergency procedures in motion and of persons authorized to take charge of and coordinate off-site action.

(b) Arrangements for receiving early warning of incidents, and alert and call out procedures.

(c) Arrangements for coordinating resources necessary to implement the external emergency plan.

(d) Arrangements for providing assistance with on site mitigatory action.

(e) Arrangements for off-site mitigatory action.

(f) Arrangements for providing the public with specific information relating to the incident and the behaviour which it should adopt.

(g) Arrangements for the provision of information to the emergency services of other Member States in the event of a major accident with possible transboundary consequences.

ANNEX IV

ITEMS OF INFORMATION TO BE COMMUNICATED TO THE PUBLIC IN APPLICATION OF ARTICLE 13 (1)

1. Name of occupier and address of the establishment.

2. Identification, by position held, of the person giving the information.

3. Confirmation that the establishment is subject to the regulations and/or administrative provisions implementing the Directive and that the notification referred to in Article 6 (3), or the safety report referred to in Article 9 (1) has been submitted to the competent authority.

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

5. The common names or, in the case of dangerous substances covered by Part 2 of Annex I, the generic names or the general danger classification of the substances and preparations involved at the establishment which could give rise to a major accident, with an indication of their principal dangerous characteristics.

6. General information relating to the nature of the major-accident hazards, including their potential effects on the population, and the environment.

7. Adequate information on how the population concerned will be warned and kept informed in the event of a major accident.

8. Adequate information on the actions the population concerned should take, and on the behaviour they should adopt, in the event of a major accident.

9. Conformation that the operator is required to make adequate arrangements on site, including liaison with the emergency services, to deal with major accidents to minimize their effects.

10. A reference to 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.

11. Details of where further relevant information can be obtained, subject to the requirements of confidentiality laid down in national legislation.