37 tal-2003 - Regolamenti tal-2003 dwar il-Kontroll ta’ Perikli ta’ Inċidenti Kbar Arranġament tar-Regolamenti

L.N. 37 of 2003

OCCUPATIONAL HEALTH & SAFETY AUTHORITY ACT

(CAP.424)

Control of Major Accident Hazard Regulations, 2003

The title of these regulations is the Control of Major Accident Citation and

commencement.

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.

These regulations are aimed at the prevention of major Aim.

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.

In these regulations, unless the context otherwise Interpretation.

(1)

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

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<

“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.

(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.

(1) Every operator shall take all measures necessary to General Duty.

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.

(3) Every operator shall cooperate fully with the competent

authorities in the exercise of any of their functions under these

regulations.

(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.

(1) Every operator shall prepare and keep a document setting Major Accident

Prevention Policy.

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 -

(a)

take account of the principles specified in Schedule 2<

and

(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

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.

(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

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

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.

(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.

(1) Every operator shall ensure that, for all establishments Emergency plans.

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

(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,

(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.

(1) A person who has prepared an emergency plan pursuant

of emergency plans.

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

Provision of

(1) The operator of an establishment shall -

information to the

public.

(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

(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).

(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.

(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.

(1) The competent authority shall, using the information

information to other

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).

(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.

(1) It shall be the joint duty of the agencies of which the Competent

authority.

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>

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.

(1) The competent authority shall prohibit the use or Prohibition of use.

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.

(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.

(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.

(1) The competent authority shall make any information Confidentiality.

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.

Any breach of any of these regulations shall be deemed Enforcement.

(1)

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

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.

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