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Occupational Health And Safety Authority Act (Cap. 424) Control Of Major Acident Hazard Regulations, 2003 (L.N. 37 Of 2003 )

OCCUPATIONAL HEALTH & SAFETY AUTHORITY ACT (CAP.424)
Control of Major Accident Hazard Regulations, 2003
Arrangement of Regulations
1. Citation and commencement
2. Aim
3. Interpretation
4. Application
5. General duty
6. Notifications
7. Major accident prevention policy
8. Safety Report
9. Review and revision of safety report
10. Emergency plans
11. Review and testing of emergency plans
12. Provision of information to the public
13. Provision of information to the competent authority
14. Provision of information to other establishments
15. Provision of information by competent authority
16. Competent authority

Schedule 1
Schedule 2
Schedule 3
Schedule 4
Schedule 5
Schedule 6
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L.N. 37 of 2003

OCCUPATIONAL HEALTH AND SAFETY AUTHORITY ACT
(CAP.424)
Control of Major Accident Hazards Regulations, 2003
IN exercise of the powers conferred by article 12 of the Act providing for the establishment of an Occupational Health and Safety Authority, the Deputy Prime Minister and Minister for Social Policy, after consultation with Minister for Home Affairs and the Environment and the Occupational Health and Safety Authority, has made the following regulations>
1. The title of these regulations is the Control of Major Accident Hazards Regulations, 2003 and they shall come into force on such a date as the Minister responsible for Social Policy may appoint by notice in the Gazette, and different dates may be so appointed for different provisions of these regulations.
2. These regulations are aimed at the prevention of major accidents that involve dangerous substances, and the limitation of their consequences for humans and the environment, with a view to ensuring high levels of protection.
3. (1) In these regulations, unless the context otherwise requires –
“Act” means Act XXVII of 2000 providing for the establishment of the Occupational Health and Safety Authority<
“Authority” means the Occupational Health and Safety
Authority<
“competent authority” means -
(i) the Occupational Health and Safety Authority as set up by the Act, Cap.435, the Environment Protection Directorate within the Malta Environment and Planning Authority in terms of the Environment Protection Act, and the Civil Protection Department established by article 3 of

Citation and commencement.

Aim.

Interpretation.

B 440
the Civil Protection Act, Cap.411, acting jointly or separately as necessary, or
(ii) any other agency or authority to which the Minister responsible for occupational health and safety, civil protection or the environment may from time to time, assign any of the responsibilities of the competent authority under these regulations>
Provided that the Minister shall issue a notice of any such assignment of responsibilities in the Gazette<
“control” in relation to a person means control in the course of a trade, business or other undertaking or work activity carried on by him<
“dangerous substance” means a substance, mixture or preparation listed in Schedule 1, Part 2, or fulfilling the criteria laid down in Schedule 1 Part 3 and present as a raw material, product, by-product, residue or intermediate<
“the Directive” means Council Directive 96#82#EC on the control of major accident hazards involving dangerous substances<
“establishment” means the whole area under the control of the same person where dangerous substances are present in one or more installations, including common or related infrastructures or activities, and for this purpose two or more areas under the control of the same person and separated only by a road, shall be treated as one whole area<
“existing establishment” means an establishment whose operation commenced before the date of implementation of these regulations<
“hazard” means the intrinsic property of a dangerous substance or physical situation which has a potential to cause damage to human health and, or of the environment<
“installation” means a technical unit within an establishment in which dangerous substances are, or are intended to be, produced, used, handled or stored, and it includes –
(a) any equipment, structures, pipework, machinery and tools,
(b) private railway sidings, docks and unloading quays serving the installation, and
(c) jetties, warehouses or similar structures, whether floating or not,
which are necessary for the operation of the installation< “international body” means any appropriate international body
that the Minister by order shall designate in the Gazette<
“major accident” means an occurrence (including in particular, but not limited to, a major emission, fire or explosion) resulting from uncontrolled developments in the course of the operation of any establishment and leading to serious danger to human health or the environment, immediate or delayed, inside or outside the establishment, and involving dangerous substances<
“new establishment” means an establishment which commenced operation on or after the date of implementation of these regulations<
“notify” means notify in writing and “notification” shall be construed accordingly<
“operator” means an “employer”, as defined in the Act, who is in control of the operation of an establishment or installation (or in relation to an establishment or installation which is to be constructed or operated, the person who proposes to control its operation or, if that person is not known, the person who in the course of a trade, business or other undertaking carried on by him has commissioned its design and construction)< and any duty imposed by these regulations on him shall extend only in relation to that establishment or installation<
“presence of dangerous substances” includes the actual and anticipated presence of such substances and the presence of those which it is reasonable to believe may be generated during the loss of control of an industrial chemical process<
“risk” means the likelihood of a specific effect occurring within a specific period or in specified circumstances<
“safety report” means a report sent to the competent authority pursuant to regulation 8<
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Application.

“state” means any country, or group of countries which the
Minister may designate in the Gazette<
“storage” of dangerous substances includes the presence of dangerous substances for the purposes of warehousing, depositing in safe custody or keeping in stock.
(2) Where after the coming into force of these regulations an establishment becomes subject to any of these regulations by reason of any increase in the quantity of dangerous substances present there, any reference in that regulation to the start of operation of the establishment, is a reference to the time when the establishment first becomes so subject.
(3) The columns in Parts 2 and 3 of Schedule 1 shall be applied in accordance with the provisions of Part 1 of that Schedule and notes set out in each of those Parts.
(4) Any reference in these regulations to -
(a) a numbered regulation or Schedule is a reference to the regulation in or Schedule to these regulations so numbered, and
(b) a numbered sub-regulation is a reference to the sub- regulation so numbered in the regulation or Schedule in which the reference appears.
4. (1) These regulations shall apply to an establishment where a dangerous substance listed in Parts 2 and 3 of Schedule 1, is present in a quantity equal to or exceeding the quantity listed in the entry for that substance in column 2 of those Parts>
Provided that regulations 8 to 12 shall apply only to an establishment where such a dangerous substance is present in a quantity equal to or exceeding the quantity listed in the entry for that substance in column 3 of Parts 2 and 3 of Schedule 1.
(2) The reference in sub-regulation (1) to the presence of dangerous substances shall not include the presence of dangerous substances in the following activities -
(a) military establishments, installations or storage facilities< (b) hazards created by ionizing radiation<
(c) the transport of those substances and their intermediate temporary storage by road, rail, inland waterways, sea or air, outside the establishments covered by this regulation, including their loading and unloading and transport to and from another means of transport at docks, wharves and marshalling yards<
(d) the transport of those substances in a pipeline or pumping station outside establishments covered by these regulations<
(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<
(f) waste land-fill sites.
(3) Where, by reason of any change in -
(a) the classification of a substance (as referred to in note 1 of Part 3 of Schedule 1), or
(b) knowledge of what dangerous substances may be generated during the loss of control of an industrial chemical process<
(c) the area of land on which the substance is present becomes an establishment after the coming into force of these regulations, any requirement imposed by these regulations on an operator which is to be performed by him before an establishment starts to operate shall apply to the operator of the new establishment as if that requirement had to be performed within 12 months after the change in classification takes effect or the change in knowledge occurs.
(4) The provisions of these regulations shall apply without prejudice to the fulfilment of any other measures, which may be required to encourage improvements in safety and health of workers at risk.
5. (1) Every operator shall take all measures necessary to prevent major accidents and limit their consequences to persons and the environment.
(2) Every operator shall also, at any time, be in a position to prove to the satisfaction of the competent authority that the measures referred to in regulation (5) (1) are sufficient to fulfill the requirements of these regulations and, in particular for the purposes of inspection and controls referred to in regulation 18.
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General Duty.

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Notifications.

(3) Every operator shall cooperate fully with the competent authorities in the exercise of any of their functions under these regulations.
6. (1) (a) Within six months, or other period as may be agreed in writing by the Authority, prior to the start of construction of an establishment the operator of the establishment shall send to the competent authority a notification containing the information specified in sub-regulation (2).
(b) Within six months, or other period as may be agreed in writing by the Authority, prior to the start of the operation of an establishment, or in the case of an existing establishment within three months of the date of implementation of these regulations, the operator of the establishment shall send to the competent authority a notification containing the information specified in sub- regulation (2).
(2) The notification required by sub-regulation (1) shall contain the following details>
(a) the name or trade name of the operator and the full address of the establishment concerned<
(b) the registered place of business of the operator, with the full address<
(c) the name or position of the person in charge of the establishment, if different from paragraph (a)<
(d) information sufficient to identify the dangerous substances 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 facility<
(g) the immediate environment of the establishment (elements liable to cause a major accident or to aggravate the consequences thereof).
(3) Every operator shall notify the competent authority forthwith if there is -
(a) any significant increase in the quantity of dangerous substances notified under this regulation, or
(b) any significant change in -
(i) the nature or physical form of the dangerous substances so notified,
(ii) the processes employing them, or
(iii) any other information notified to the competent authority in respect of the establishment<
(c) permanent closure of an installation in the establishment. (4) This regulation shall not require the notification of any
information, which has been included in a safety report, which has been
submitted to the competent authority.
7. (1) Every operator shall prepare and keep a document setting out his policy with respect to the prevention of major accidents (in these regulations referred to as a “major accident prevention policy document”) within the following time limits>
(a) for new establishments, within four months prior to the start of construction or of operation, or other period as may be agreed in writing by the Authority,
(b) for existing establishments within nine months of the date of implementation of these regulations,
(2) The policy referred to in sub-regulation (1) shall be designed to guarantee a high level of protection for persons and the environment by appropriate means, structures and management systems.
(3) The major accident prevention policy document shall -
B 445

Major Accident

Prevention Policy.

and
(a) take account of the principles specified in Schedule 2<
(b) include sufficient particulars and be made available to the competent authority for the purposes of amongst others, demonstrating implementation of regulations 5 (2) and 18.
(4) In the event of the modification of the establishment or installation, the process carried on there, or the nature or quantity of
B 446

Safety Report.

dangerous substances present there which could (in each case) have significant repercussions with respect to the prevention of major accidents, the operator shall review and where necessary revise the major accident prevention policy document.
(5) Every operator shall implement the policy set out in his major accident prevention policy document.
(6) Subject to paragraph 1 of Schedule 3, this regulation shall not apply to an establishment to which regulation 8 applies.
8. (1) Every operator shall produce a safety report for the purposes of>
(a) demonstrating that a major-accident prevention policy and a safety management system for implementing it have been put into effect in accordance with the information set out in Schedule 2<
(b) demonstrating that major-accident hazards have been identified and that the necessary measures have been taken to prevent such accidents and to limit their consequences for man and the environment<
(c) demonstrating that adequate safety and reliability have been incorporated into the design, construction, operation and maintenance, of any installation, storage facility, equipment and infrastructure connected with its operation which are linked to major-accident hazards inside the establishment<
(d) demonstrating that internal emergency plans referred to in regulation 10 have been drawn up and that the necessary information to enable the external emergency plan referred to in regulation 10 (4) to be drawn up in order to take the necessary measures in the event of a major accident have been supplied<
(e) providing sufficient information to the competent authority to enable decisions to be made in terms of the siting of new activities or developments around existing establishments.
(2) The safety report shall contain at least the data and information listed in Schedule 3. It shall also contain an updated inventory of the dangerous substances present in the establishment.
(3) Every operator shall send the safety report provided for in sub-regulation (1) to the competent authority within the following time limits>
(a) for new establishments, within four months prior to the start of construction or of operation, or other period as may be agreed in writing by the Authority,
(b) for existing establishments within twelve months of the date of implementation of these regulations,
(c) in the case of the periodic reviews provided for in sub- regulation (5), without delay.
(4) Before the operator commences construction or operation, or in the cases referred to in sub-regulation (3) (b) and (c), the competent authority shall within a reasonable period of receipt of the report>
(a) communicate the conclusions of its examination of the safety report to the operator, if necessary after requesting further information, or
(b) prohibit the bringing into use, or the continued use, of the establishment concerned, in accordance with the powers and procedures laid down in regulation 17.
(5) The competent authority may limit the information required in the safety reports to those matters which are relevant to the prevention of residual major-accident hazards and the limitation of their consequences for man and the environment, if it is demonstrated to itís satisfaction that particular substances present at the establishment, or any part thereof, are in a state incapable of creating a major accident hazard>
Provided that such a dispensation shall be made in writing in accordance with the criteria listed in sub-regulation (6).
(6) The competent authority may grant a dispensation, in terms of the preceding paragraph, if at least one of the following criteria is fulfilled>
(a) Physical form of substance>
Substances in solid form, such that, under both normal conditions and any abnormal conditions which can reasonably
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Review and revision of safety report.

be foreseen, a release, of matter or of energy, which could create a major accident, is not possible.
(b) Containment and quantities>
Substances packaged or contained in such a fashion and in such quantities that the maximum release possible under any circumstance cannot create a major accident.
(c) Location and quantities>
Substances present in such quantities and at such distances from other dangerous substances (at the establishment or elsewhere) that they can neither create a major accident hazard by themselves nor initiate a major accident involving other dangerous substances.
(d) Classification>
Substances which are defined as dangerous substances by virtue of their generic classification in Schedule 1, but which cannot create a major accident hazard, and for which therefore, the generic classification is inappropriate for this purpose.
9. (1) Where a safety report has been sent to the competent authority the operator shall, subject to sub-regulation (3), review it -
(a) at least every 5 years<
(b) whenever such a review is necessary because of new facts or to take account of new technical knowledge about safety matters and of developments in knowledge concerning the assessment of hazards<
(c) whenever the operator makes a change to the safety management system (referred to in paragraph 1 of Schedule 3) which could have significant repercussions with respect to the prevention of major accidents or the limitation of consequences of major accidents to persons and the environment< and
(d) whenever so requested by the competent authority<
and where in consequence of that review it is necessary to revise the report, the operator shall do so forthwith and inform the competent authority of the details of such revision.
(2) Where a safety report has been reviewed pursuant to sub-regulation (1)(a) but not revised, the operator shall inform the competent authority of that fact.
(3) Where an operator proposes to modify the establishment or installation in it, the process carried on there, or the nature or quantity of dangerous substances present there, and that modification could have significant repercussions with respect to the prevention of major accidents or the limitation of consequences of major accidents to persons and the environment, he shall in advance of such modification -
(a) review, and where necessary revise, the major accident prevention policy or safety report prepared in respect of the establishment, installation, process or dangerous substances as the case may be< and
(b) inform the competent authority of the details of such revision.
10. (1) Every operator shall ensure that, for all establishments to which regulation 8 applies>
(a) an emergency plan for the measures to be taken inside the establishment, henceforth referred to as internal emergency plan, is prepared to meet the objectives set out in sub-regulation (2) and shall contain the information set out in Schedule 4<
(b) the necessary information is supplied to the competent authority to enable them to draw up external emergency plans>
Provided that this obligation is fulfilled within the following periods of time>
(i) for new establishments, four months prior to the start of operation,
(ii) for existing establishments within fifteen months of the date of implementation of these regulations.
(2) Emergency plans shall have the following objectives > (a) containing and controlling incidents so as to minimise
the effects, and to limit damage to man, the environment and
property,
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Emergency plans.

B 450

Review and testing of emergency plans.

(b) implementing the measures necessary to protect man and the environment from the effects of major accidents,
(c) communicating the necessary information to the public and to the services or authority concerned in the area,
(d) providing for the restoration and clean-up of the environment following a major accident.
(3) The operator shall ensure that the internal emergency plans provided for in these regulations are drawn up in consultation with personnel employed inside the establishment.
(4) The competent authority shall, within three months of receipt of information required under sub-regulation (1), and its acceptance thereof, consult the public and other interested parties as it considers appropriate. The Civil Protection Department, in terms of article 4 of the Civil Protection Act, relating to the preparation of contingency plans, shall draw up an emergency plan as specified in Schedule 4 Part 2, for the measures to be taken outside the establishment, henceforth referred to as the external emergency plan.
(5) The operator and, if necessary the competent authority shall ensure that emergency plans are put into effect without delay>
(a) when a major accident occurs, or
(b) when an uncontrolled event occurs which by its nature could reasonably be expected to lead to a major accident.
(6) The competent authority may, in view of the information contained in the safety report, decide that the requirement to produce an external emergency plan under sub-regulation (2) shall not apply. Any such exemption, which shall be in writing, shall include the reasons for such decision.
(7) Where an exemption has been given under sub- regulation (6), the competent authority shall, for the purposes of these regulations and while the exemption is in force, have no function in relation to the preparation, review, testing and putting into effect of an off-site emergency plan for the establishment concerned.
11. (1) A person who has prepared an emergency plan pursuant to a duty imposed on him by these regulations shall at suitable intervals not exceeding three years -
(a) review and where necessary revise the plan< and
(b) test the plan and take reasonable steps to arrange for the emergency services to participate in the test to such extent as is necessary,
(c) and any such review shall take into account changes occurring in the establishment to which the plan relates and within the emergency services concerned, new technical knowledge, and knowledge concerning the response to major accidents.
(2) The operator shall co-operate fully with the competent authority in the implementation of the testing of external emergency plans.
12. (1) The operator of an establishment shall -
(a) ensure that persons who are likely to be affected by a major accident originating in an establishment covered by regulation 8 are supplied with information on safety measures at the establishment and on the requisite behaviour in the event of a major accident at the establishment, without their having to request it<
(b) make that information permanently available to the public, after approval has been obtained from the Civil Protection Department.
(2) The information referred to in sub-regulation (1) shall contain at least the information specified in Schedule 5.
(3) In preparing the information required to be supplied in accordance with sub-regulation (1), the operator may consult any other persons who appear to him to be appropriate, but the operator shall remain responsible for the accuracy, completeness and form of the information so supplied.
(4) The operator shall review and where necessary revise the information referred to in sub-regulation (1) -
(a) at intervals not exceeding three years< or
(b) in the event of a modification referred to in regulations
6(3) or 9(3).
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Provision of information to the public.

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Provision of information to the competent authority.

(5) The operator shall ensure that the information referred to in sub-regulation (1) is supplied in accordance with that sub-regulation within 2 months after the off-site emergency plan has been prepared for the establishment and that the information is so supplied again -
(a) at intervals not exceeding 5 years< or
(b) if it is revised pursuant to paragraph (4).
(6) Every operator shall take the necessary measures to ensure that the safety report is available to the public>
Provided that the operator may ask the competent authority for authorisation 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 competent authority, and make available to the public, an amended report excluding those matters>
Provided further that where information is provided to the competent authority pursuant to a requirement imposed by or under these Regulations then, if the person providing it applies to the competent authority to have the information excluded from the register on the ground that it is commercially or personally confidential (as regards himself or another person), the competent authority shall determine whether the information is or is not commercially or personally confidential.
(7) In the case of establishments subject to the provisions of regulation 8, the operator shall ensure that the inventory of dangerous substances provided for in Regulation 8 (2) is made available to the public.
13. (1) Every operator of an establishment shall, when requested to do so by the competent authority provide sufficient information to the competent authority to demonstrate that he has taken all measures necessary to comply with these Regulations, and the information shall be so provided within such period as the competent authority specifies in the request.
(2) Without prejudice to the generality of sub-regulation (1), the operator shall when requested to do so by the competent authority, provide the competent authority with any information necessary to enable the competent authority to -
(a) fully assess the possibility of a major accident and to determine the scope of possible increased probability or aggravation of a major accident<
(b) take substances into account which, due to their physical form, particular conditions or location, may require additional consideration<
(c) perform its functions of obtaining or collecting information<
(d) enable the preparation of external emergency plans<
(e) and the information shall be so provided within such period as the competent authority specifies in the request.
(3) Where a major accident has occurred at an establishment the operator shall forthwith, by the quickest and most appropriate means, inform the Civil Protection Department of that accident.
(4) Without prejudice to paragraph 3, every operator shall, as soon as practicable following a major accident, and using the most appropriate means supply the competent authority with suitable details of the incident and in particular>
(a) provide the following information as soon as it becomes available>
- (i) the circumstances of the accident,
- (ii) the dangerous substances involved,
- (iii) the data available for assessing the effects of the accident on man and the environment, and
- (iv) the emergency measures taken< (b) the steps envisaged>
(i) to alleviate the medium- and long-term effects of the accident,
(ii) to prevent any recurrence of such an accident<
(c) update the information provided if further investigation reveals additional facts which alter that information or the conclusions drawn.
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Provision of information to other establishments.

Provision of information to the competent authority.

14. (1) The competent authority shall, using the information received from operators in notifications sent pursuant to regulation 6 and in safety reports, designate groups of establishments where the likelihood or consequences of a major accident may be increased because of the location and proximity of establishments in the group and the dangerous substances present there.
(2) The competent authority shall notify each operator of an establishment in a group designated pursuant to sub-regulation (1) of the names and addresses of other establishments within the same group.
(3) The operator of any establishment in a group designated pursuant to paragraph (1) shall -
(a) pass appropriate information about the establishment to other establishments in the group to enable them to take account of the nature and extent of the overall hazard of a major accident in their major accident prevention policy documents, safety reports and on-site emergency plans< and
(b) co-operate with those other establishments to enable them to carry out any obligations they have under regulations 10(2),
12(1) and 13(2).
15. (1) The competent authority shall inform any appropriate international body as soon as practicable of major accidents meeting the criteria of Schedule 6 which have occurred on Maltese territory for the purpose of prevention and mitigation of major accidents. The information provided shall include the following details>
(a) the name and address of the competent authority responsible for the report<
(b) the date, time and place of the major accident, including the full name of the operator and the 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) The competent authority shall provide the international body with all relevant information including<
(a) the results of their analysis and recommendations> Provided that the reporting of this information may be delayed to
allow for the completion of legal proceedings where such reporting is
liable to affect those proceedings<
(b) of the name and address of any body which might have relevant information on major accidents and which is able to advise the competent authority of another State which have to intervene in the event of such an accident.
(3) The competent authority shall keep records of relevant information as prescribed in Schedule 6.
(4) The competent authority shall provide any appropriate international body with regular reports for establishments covered by regulations 6 and 8, and shall exchange information as necessary with the international body on the experience acquired with regard to the prevention of major accidents and the limitation of their consequences, and in particular on the functioning of the measures taken pursuant to these regulations.
(5) The competent authority shall provide sufficient information to potentially affected States in cases where the possibility exists of a major accident with transboundary effects occurring in establishments falling under regulation 8. Such information shall include information on emergency plans, land-use planning, and safety measures>
Provided that if the competent authority decides that an establishment is incapable of creating a major accident hazard beyond its boundary for the purposes of regulation 10(6), and is therefore not required to produce an external emergency plan under regulation 10(1), it shall so inform the relevant state.
(6) The competent authority shall communicate a list of establishments falling under regulation 8(5) to the International body, giving reasons for its decisions.
16. (1) It shall be the joint duty of the agencies of which the competent authority is composed to ensure that the overall functions of the competent authority as set out in these regulations are carried out in close collaboration and as efficiently as possible>
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Competent authority.

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Provided that the Occupational Health & Safety Authority shall take the lead in co-ordinating the administrative actions of the competent authority>
Provided further that anything required to be sent by an operator of an establishment to the competent authority pursuant to these Regulations shall be sent to the competent authority at an office of the Occupational Health and Safety Authority, and any information thus supplied and acknowledged, shall be considered to have been sent to all the agencies comprising the competent authority.
(2) The competent authority shall within a reasonable period of receiving a safety report -
(a) communicate the conclusions of its examination of the report to the operator of the establishment concerned< or
(b) prohibit the operation or bringing into operation of the establishment or installation concerned or any part thereof in accordance with regulation 18.
(3) Without prejudice to sub-regulation (1), any additional information requested by a competent authority and supplied separately and in writing to any of the agencies comprising the competent authority shall, for the purpose of these regulations, be considered to have been supplied to all the other agencies.
(4) Without prejudice to the operatorís responsibilities, the competent authority shall, if necessary, appoint individuals or set-up bodies to assist the competent authority at technical level.
(5) In the case of the occurrence of a major accident-
(i) the Civil Protection Department shall take the lead, as provided in the Civil Protection Act, to ensure that any immediate, urgent, medium and long-term measures which may prove necessary are taken by whosoever has such an obligation<
(ii) the competent authority shall jointly>
(a) make a full analysis of the technical, organisational and managerial aspects of the major accident and collect, by inspection, investigation or other appropriate means, the information necessary for that purpose<
(b) take appropriate action to ensure that the operator takes any necessary remedial measures< and
(c) make recommendations on future preventive measures.
(6) The competent authority may charge the operator a fee for performing any of its functions under these regulations and in particular regulations 11 and 12.
(7) (i) The fee shall not exceed the sum of the costs reasonably incurred by the competent authority in performing the functions referred to in sub-regulation (1) in relation to the establishment concerned.
(ii) Without prejudice to the preceding paragraph, this may include, but shall not be limited to, any costs reasonably incurred by the competent authority in arranging for any emergency services to participate in the testing of the off-site emergency plan.
(8) When requiring payment the competent authority shall send or give to the operator a detailed statement of the work done and costs incurred including the dates of any visits to the establishment and the period to which the statement relates< and the fee, which shall be recoverable only as a civil debt, shall become payable one month after the statement has been sent or given.
17. (1) The competent authority shall prohibit the use or bringing into use of any establishment, installation or storage facility, or any part thereof where the measures taken by the operator for the prevention and mitigation of major accidents are seriously deficient.
(2) The competent authority may prohibit the use or bringing into use of any establishment, installation or storage facility, or any part thereof if the operator has not submitted the notification, reports or other information required by these regulations within the specified period.
(3) Where the competent authority proposes to prohibit an operation or the bringing into operation of an establishment or installation or any part thereof pursuant to this regulation, it may serve on the operator a notice giving reasons for the prohibition and specifying the date when it is to take effect, and any such notice may be withdrawn in writing by the competent authority.
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Prohibition of use.

B 458

Inspections.

(4) A notice served pursuant to sub-regulation (3) may specify measures which, if taken, would cause the competent authority to withdraw the notice.
(5) Where a notice has been served on an operator in accordance with sub-regulation (3) the operator shall comply with it (including any such notice as modified on appeal).
(6) The operators may appeal against a prohibition order issued by the competent authority made under sub-regulations (1) and (2) of this regulation in accordance with the provisions in the Occupational Health & Safety Authority Act or the Environment Protection Act as relevant.
18. (1) The competent authority shall organise an adequate system of inspections, or other actions or procedures appropriate to the type of establishment concerned, to ascertain the levels of compliance with these regulations>
Provided that these shall not be dependent solely upon receipt of the safety report or any other report submitted to the competent authority but shall be sufficient for a planned and systematic examination of the systems being employed at the establishment, whether of a technical, organisational or managerial nature, so as to ensure in particular>
(a) 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,
(b) that the operator can demonstrate that he has provided appropriate means for limiting the consequences of major accidents, on site and off site,
(c) that the data and information contained in the safety report, or any other report submitted, adequately reflects the conditions in the establishment,
(d) that information has been supplied to the public pursuant to regulation 12.
(2) The system of inspection specified in sub-regulation (1)
shall comply with the following conditions>
(a) there shall be a programme of inspections for all establishments. Unless the competent authority has established a programme of inspections based upon a systematic appraisal of
major-accident hazards of the particular establishment concerned, the programme shall entail at least one on-site inspection made by the competent authority every twelve months of each establishment covered by regulation 8<
(b) following each inspection, a report shall be prepared by the competent authority<
(c) where necessary, every inspection carried out by the competent authority shall be followed up with the management of the establishment, within a reasonable period following the inspection.
19. (1) The competent authority shall make any information received pursuant to these regulations available to any natural or legal person who so requests>
Provided that information obtained by the competent authority may be kept confidential if it calls into question>
(i) the confidentiality of the deliberations of the competent authority,
(ii) the confidentiality of international relations and national defence, or public security,
(iii) the confidentiality of preliminary investigation proceedings or of current legal proceedings,
(iv) commercial and industrial secrets, including intellectual property, personal data and#or files,
(v) data supplied by a third party if that party asks for them to be kept confidential.
(2) Nothing in these regulations shall preclude the conclusion by Government of agreements with third countries on the exchange of information to which it is privy at internal level.
20. (1) Any breach of any of these regulations shall be deemed an offence.
(2) In any proceedings for an offence under these regulations consisting of a failure to comply with a duty or requirement to do something, it shall be for the accused to prove (as the case may be) that it was not practicable to do more than was in fact done to satisfy the
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Confidentiality.

Enforcement.

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requirement or duty, or that there was no better practicable means than was in fact used to satisfy the duty or requirement.
(3) (i) The Occupational Health and Safety Authority shall be the enforcing authority for provisions relating to health and safety at an establishment to which any of these regulations apply.
(ii) The Malta Environment and Planning Authority shall be the enforcing authority for the provisions relating to the environment at an establishment to which any of these regulations apply.
(iii) Without prejudice to the preceding sub-regulations, no proceedings shall be taken against any person who after receiving intimation from the competent authority for the payment of an administrative fine for having contravened the provisions of these Regulations, pays such a penalty within fifteen days of the date of such intimation.

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Ippubblikat mid-Dipartiment ta’ l-Informazzjoni — 3, Pjazza Kastilja — Published by the Department of Information — 3, Castille Place

Mitbug] fl-Istamperija tal-Gvern — Printed at the Government Printing Press

Prezz 72` - Price 72c