Control of Major Accident Hazards Regulations, 2015

L.N. 179 of 2015

OCCUPATIONAL HEALTH AND SAFETY AUTHORITY ACT

(CAP. 424)

Control of Major Accident Hazards Regulations, 2015

IN exercise of the powers conferred by article 12 of the

Occupational Health and Safety Authority Act, the Minister for

Social Dialogue, Consumer Affairs and Civil Liberties, after

consultation with the Occupational Health and Safety Authority, has

made the following regulations:-

(1)

The title of these regulations is the Control of Citation, scope,

applicability and

Major Accident Hazards Regulations, 2015.

coming into

force.

(2) The scope of these regulations is to lay down rules for the

prevention of major accidents which involve dangerous substances,

and the limitation of their consequences for human health and the

environment, with a view to ensuring a high level of protection

throughout the European Union in a consistent and effective manner.

These regulations implement Directive 2012/18/EU of the European

Parliament and of the Council of 4 July 2012 on the control of major-

accident hazards involving dangerous substances, amending and

subsequently repealing Council Directive 96/82/EC.

(3) These regulations shall apply to establishments as defined

in regulation 2.

(4) These regulations shall not apply to any of the following

(a)

military establishments, installations or storage

facilities;

(b)

hazards created by ionising radiation originating

from substances;

(c)

the transport of dangerous substances and directly

related intermediate temporary storage by road, rail, internal

waterways, sea or air, outside the establishments covered by

these regulations, including loading and unloading and transport

to and from another means of transport at docks, wharves or

marshalling yards;

(d)

the transport of dangerous substances in pipelines,

including pumping stations, outside establishments covered by

these regulations;

(e)

the exploitation, namely the exploration, extraction

and processing, of minerals in mines and quarries, including by

means of boreholes;

(f)

the offshore exploration and exploitation of

minerals, including hydrocarbons;

(g)

the storage of gas at underground offshore sites

including both dedicated storage sites and sites where

exploration and exploitation of minerals, including

hydrocarbons are also carried out;

(h)

waste land-fill sites, including underground waste

storage.

(5) Notwithstanding the provisions of sub-regulation (4)(e)

and (h), onshore underground gas storage in natural strata, aquifers,

salt cavities and disused mines and chemical and thermal processing

operations and storage related to those operations which involve

dangerous substances, as well as operational tailings disposal

facilities, including tailing ponds or dams, containing dangerous

substances shall be included within the scope of these regulations.

(6) These regulations shall come into force on the 1st June

2015.

Minimum data and information to be considered in the safety report

referred to in regulation 8

1. Information on the management system and on the

organisation of the establishment with a view to major-accident

prevention.

This information shall contain the elements indicated in

Schedule III.

2. Presentation of the environment of the establishment

(a)

description of the establishment and its

environment

including

the

geographical

location,

meteorological, geological, hydrographic conditions and, if

necessary, its history;

(b)

identification of installations and other activities of

the establishment which could present a major-accident hazard;

(c)

on the basis of available information, identification

of neighbouring establishments, as well as sites that fall outside

the scope of these regulations, areas and developments that

could be the source of, or increase the risk or consequences of a

major accident and of domino effects;

(d)

description of areas where a major accident may

occur.

3. Description of the installation

(a)

description of the main activities and products of

the parts of the establishment which are important from the

point of view of safety, sources of major-accident risks and

conditions under which such a major accident could happen,

together with a description of proposed preventive measures;

(b)

description of processes, in particular the operating

methods; where applicable, taking into account available

information on best practices;

(c)

description of dangerous substances

(i)

inventory of dangerous substances including

- the

identification

of

dangerous

substances: chemical name, CAS number, name

according to IUPAC nomenclature,

- the maximum quantity of dangerous

substances present or likely to be present;

(ii) physical,

chemical,

toxicological

characteristics and indication of the hazards, both

immediate and delayed for human health and the

environment;

(iii) physical and chemical behaviour under

normal conditions of use or under foreseeable accidental

conditions.

4. Identification and accidental risks analysis and prevention

methods

(a)

detailed description of the possible major-accident

scenarios and their probability or the conditions under which

they occur including a summary of the events which may play a

role in triggering each of these scenarios, the causes being

internal or external to the installation; including in particular

(i)

operational causes;

(ii) external causes, such as those related to

domino effects, sites that fall outside the scope of these

regulations, areas and developments that could be the

source of, or increase the risk or consequences of a major

accident;

(iii) natural causes, for example earthquakes or

floods;

(b)

assessment of the extent and severity of the

consequences of identified major accidents including maps,

images or, as appropriate, equivalent descriptions, showing

areas which are likely to be affected by such accidents arising

from the establishment;

(c)

review of past accidents and incidents with the

same substances and processes used, consideration of lessons

learned from these, and explicit reference to specific measures

taken to prevent such accidents;

(d)

description of technical parameters and equipment

used for the safety of installations.

5. Measures of protection and intervention to limit the

consequences of a major accident

(a)

description of the equipment installed in the plant

to limit the consequences of major accidents for human health

and environment, including for example detection/protection

systems, technical devices for limiting the size of accidental

releases, including water spray; vapour screens; emergency

catch pots or collection vessels; shut-off-valves; inerting

systems; fire water retention;

(b)

organisation of alert and intervention;

(c)

description of mobilisable resources, internal or

external;

(d)

description of any technical and non-technical

measures relevant for the reduction of the impact of a major

accident.

(1)

In these regulations, unless the context otherwise

requires -

"Act" means the Occupational Health and Safety Authority Act;

"Authority" means the Occupational Health and Safety

Authority;

"Commission" means the Commission of the European Union;

"competent authority" means -

(a)

the Occupational Health and Safety Authority as

set up by the Act, the Malta Environment and Planning

Authority, established by the Environment and Planning

Authority Act and the Civil Protection Department established

by the Civil Protection Act, acting jointly or separately as

necessary; or

(b)

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;

"dangerous substance" means a substance or mixture covered by

Part 1 or listed in Part 2 of Schedule I, including in the form of a raw

material, product, by-product, residue or intermediate;

"establishment" means the whole location under the control of

an operator where dangerous substances are present in one or more

installations, including common or related infrastructures or

activities; establishments are either lower-tier establishments or

upper-tier establishments;

"existing establishment" means an establishment that on 31 May

2015 falls within the scope of the Control of Major Accident Hazards

Regulations, 2003 * and from 1 June 2015 falls within the scope of L.N. 37 of 2003.

these regulations without changing its classification as a lower-tier

establishment or upper-tier establishment;

"hazard" means the intrinsic property of a dangerous substance

or physical situation, with a potential for creating damage to human

health or the environment;

"inspection" means all actions, including site visits, checks of

internal measures, systems and reports and follow-up documents, and

any necessary follow-up, undertaken by or on behalf of the competent

authority to check and promote compliance of establishments with the

requirements of these regulations;

"installation" means a technical unit within an establishment

and whether at or below ground level, in which dangerous substances

are produced, used, handled or stored; it includes all the equipment,

structures, pipework, machinery, tools, private railway sidings, docks,

unloading quays serving the installation, jetties, warehouses or

similar structures, floating or otherwise, necessary for the operation

of that installation;

"lower-tier establishment" means an establishment where

dangerous substances are present in quantities equal to or in excess of

the quantities listed in Column 2 of Part 1 or in Column 2 of Part 2 of

Schedule I, but less than the quantities listed in Column 3 of Part 1 or

in Column 3 of Part 2 of Schedule I, where applicable using the

summation rule laid down in note 4 to Schedule I;

*revoked by these Regulations.

"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 these

regulations, and leading to serious danger to human health or the

environment, immediate or delayed, inside or outside the

establishment, and involving one or more dangerous substances;

"mixture" means a mixture or solution composed of two or more

substances;

"neighbouring establishment" means an establishment that is

located in such proximity to another establishment so as to increase

the risk or consequences of a major accident;

"new establishment" means -

(a)

an establishment that enters into operation or is

constructed, on or after 1 June 2015; or

(b)

a site of operation that falls within the scope of

these regulations, or a lower-tier establishment that becomes an

upper-tier establishment or vice versa, on or after 1 June 2015

due to modifications to its installations or activities resulting in

a change in its inventory of dangerous substances;

"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;

"other establishment" means a site of operation that falls within

the scope of these regulations, or a lower-tier establishment that

becomes an upper-tier establishment or vice versa, on or after 1 June

2015 for reasons other than those referred to in the definition "new

establishment";

"presence of dangerous substances" means the actual or

anticipated presence of dangerous substances in the establishment, or

of dangerous substances which it is reasonable to foresee may be

generated during loss of control of the processes, including storage

activities, in any installation within the establishment, in quantities

equal to or exceeding the qualifying quantities set out in Part 1 or Part

2 of Schedule I;

"risk" means the likelihood of a specific effect occurring within

a specified period or in specified circumstances;

"storage" means the presence of a quantity of dangerous

substances for the purposes of warehousing, depositing in safe

custody or keeping in stock;

"the public" means one or more natural or legal persons and, in

accordance with national law or practice, their associations,

organisations or groups;

"the public concerned" means the public affected or likely to be

affected by, or having an interest in, the taking of a decision on any

matters covered by the provisions of the Environment and Planning Cap. 504.

Authority Act, the Freedom of Access to Information on the S.L. 504.65

Environment Regulations, and the Plans and Programmes (Public S.L. 504.69

Participation) Regulations; for the purposes of this definition, non-

governmental organisations promoting environmental protection and

meeting any applicable requirements under national law and, or

practice shall be deemed to have an interest;

"upper-tier establishment" means an establishment where

dangerous substances are present in quantities equal to or in excess of

the quantities listed in Column 3 of Part 1 or in Column 3 of Part 2 of

Schedule I, where applicable using the summation rule laid down in

note 4 to Schedule I;

(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 date when the establishment first

becomes so subject.

Information referred to in regulation 6(5) and regulation 8 on the

safety management system and the organisation of the establishment

with a view to the prevention of major accidents

For the purpose of implementing the operator’s safety

management system, account shall be taken of the following

elements

(a)

the safety management system shall be

proportionate to the hazards, industrial activities and

complexity of the organisation in the establishment and be

based on assessment of the risks; it should include the part of

the general management system which includes the

organisational structure, responsibilities, practices, procedures,

processes and resources for determining and implementing the

major-accident prevention policy (MAPP);

(b)

the following issues shall be addressed by the

safety management system

(i) organisation and personnel - the roles and

responsibilities of personnel involved in the management

of major hazards at all levels in the organisation, together

with the measures taken to raise awareness of the need for

continuous improvement. The identification of training

needs of such personnel and the provision of the training

so identified. The involvement of employees and of

subcontracted personnel working in the establishment

which are important from the point of view of safety;

(ii) identification and evaluation of major hazards

- adoption and implementation of procedures for

systematically identifying major hazards arising from

normal and abnormal operation including subcontracted

activities where applicable and the assessment of their

likelihood and severity;

(iii) operational control - adoption and

implementation of procedures and instructions for safe

operation, including maintenance, of plant, processes and

equipment, and for alarm management and temporary

stoppages; taking into account available information on

best practices for monitoring and control, with a view to

reducing the risk of system failure; management and

control of the risks associated with ageing equipment

installed in the establishment and corrosion; inventory of

the establishment’s equipment, strategy and methodology

for monitoring and control of the condition of the

equipment; appropriate follow-up actions and any

necessary countermeasures;

(iv) management of change - adoption and

implementation of procedures for planning modifications

to, or the design of new installations, processes or storage

facilities;

(v) planning for emergencies - adoption and

implementation of procedures to identify foreseeable

emergencies by systematic analysis, to prepare, test and

review emergency plans to respond to such emergencies

and to provide specific training for the staff concerned.

Such training shall be given to all personnel working in the

establishment, including relevant subcontracted personnel;

(vi) monitoring performance - adoption and

implementation of procedures for the ongoing assessment

of compliance with the objectives set by the operator’s

MAPP and safety management system, and the

mechanisms for investigation and taking corrective action

in case of non-compliance. The procedures shall cover the

operator’s system for reporting major accidents or ‘near

misses’, particularly those involving failure of protective

measures, and their investigation and follow-up on the

basis of lessons learnt. The procedures could also include

performance indicators such as safety performance

indicators (SPIs) and/or other relevant indicators;

(vii) audit and review - adoption and

implementation of procedures for periodic systematic

assessment of the MAPP and the effectiveness and

suitability of the safety management system; the

documented review of performance of the policy and

safety management system and its updating by senior

management, including consideration and incorporation of

necessary changes indicated by the audit and review.

(1)

Where the competent authority considers that a Assessment of

dangerous substance does not present a major-accident hazard, based major-accident

hazards for a

on one or more of the following characteristics

particular

dangerous

substance.

(a)

the physical form of the dangerous substance under

normal processing or handling conditions or in an unplanned

loss of containment;

(b)

the inherent properties of the dangerous substance,

in particular those related to dispersive behaviour in a major-

accident scenario, such as molecular mass and saturated vapour

pressure;

(c)

the maximum concentration of the substances in

the case of mixtures;

it shall notify the Commission together with supporting justification,

including the information referred to in sub-regulation (2).

(2) For the purposes of sub-regulation (1), information

necessary for assessing the health, physical and environmental hazard

properties of the dangerous substance concerned shall include

(a)

a comprehensive list of properties necessary to

assess the dangerous substance’s potential for causing physical,

health or environmental harm;

(b)

physical and chemical properties (for instance

molecular mass, saturated vapour pressure, inherent toxicity,

boiling point, reactivity, viscosity, solubility and other relevant

properties);

(c)

health and physical hazard properties (for instance

reactivity, flammability, toxicity together with additional factors

such as mode of attack on the body, injury to fatality ratio, and

long-term effects, and other properties as relevant);

(d)

environmental hazard properties (for instance

ecotoxicity, persistence, bio-accumulation, potential for long-

range environmental transport, and other properties as relevant);

(e)

where available, the European Union classification

of the substance or mixture;

(f)

information about substance-specific operating

conditions (for instance temperature, pressure and other

conditions as relevant) under which the dangerous substance is

stored, used and/or may be present in the event of foreseeable

abnormal operations or an accident such as fire.

Data and information to be included in the emergency plans

referred to in regulation 10

1. Internal emergency plans

(a)

Names or positions of persons authorised 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)

Where necessary, arrangements for training staff in

the duties they will be expected to perform and, as appropriate,

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 authorised to set

emergency procedures in motion and of persons authorised 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,

including responses to major-accident scenarios as set out in the

safety report and considering possible domino effects, including

those having an impact on the environment;

(f)

Arrangements for providing the public and any

neighbouring establishments or sites that fall outside the scope

of these regulations in accordance with regulation 7 with

specific information relating to the accident and the behaviour

which should be adopted;

(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.

(1)

Every operator shall take all necessary measures to

prevent major accidents and to limit their consequences for human

health and the environment.

(2) Every operator shall also, at any time, be in a position to

prove to the satisfaction of the competent authority referred to in

regulation 14, that the measures taken are sufficient to fulfil the

requirements of these regulations and, in particular for the purposes

of inspections and controls referred to in regulation 16.

(3) Every operator shall cooperate fully with the competent

authorities in the exercise of any of their functions under these

regulations.

Items of information to the public as provided for in regulation 11(1)

and in regulation 11(2)(a)

PART 1

For all establishments covered by these regulations

1. Name or trade name of the operator and the full address of

the establishment concerned.

2. Confirmation that the establishment is subject to the

regulations and/or administrative provisions implementing these

regulations and that the notification referred to in regulation 5(1) or

the safety report referred to in regulation 8(1) has been submitted to

the competent authority.

3. An explanation in simple terms of the activity or activities

undertaken at the establishment.

4. The common names or, in the case of dangerous

substances covered by Part 1 of Schedule I, the generic names or the

hazard classification of the relevant dangerous substances involved at

the establishment which could give rise to a major accident, with an

indication of their principal dangerous characteristics in simple terms.

5. General information about how the public concerned will

be warned, if necessary; adequate information about the appropriate

behaviour in the event of a major accident or indication of where that

information can be accessed electronically.

6. The date of the last site visit in accordance with regulation

16(3), or reference to where that information can be accessed

electronically; information on where more detailed information about

the inspection and the related inspection plan can be obtained upon

request, subject to the requirements of regulation 18.

7. Details of where further relevant information can be

obtained, subject to the requirements of regulation 18.

PART 2

For upper-tier establishments, in addition to the information

referred to in Part 1 of this Schedule

1. General information relating to the nature of the major-

accident hazards, including their potential effects on human health

and the environment and summary details of the main types of major-

accident scenarios and the control measures to address them.

2. Confirmation that the operator is required to make

adequate arrangements on site, in particular liaison with the

emergency services, to deal with major accidents and to minimise

their effects.

3. Appropriate information from the external emergency plan

drawn up to cope with any off-site effects from an accident. This

should include advice to cooperate with any instructions or requests

from the emergency services at the time of an accident.

4. Where applicable, indication whether the establishment is

close to the territory of another Member State with the possibility of a

major accident with transboundary effects under the Convention of

the United Nations Economic Commission for Europe on the

Transboundary Effects of Industrial Accidents.

(1)

Every operator shall send a notification to the Notification.

competent authority containing the following information

(a)

the name and, 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 and position of the person in charge of the

establishment, if different from paragraph (a);

(d)

information sufficient to identify the dangerous

substances and category of substances involved or likely to be

present;

(e)

the quantity and physical form of the dangerous

substance or substances concerned;

(f)

the activity or proposed activity of the installation

or storage facility;

(g)

the immediate environment of the establishment,

and factors likely to cause a major accident or to aggravate the

consequences thereof including, where available, details of

neighbouring establishments, of sites that fall outside the scope

of these regulations, areas and developments that could be the

source of, or increase the risk or consequences of a major

accident and of domino effects.

(2) The notification or its update shall be sent to the competent

authority within the following time-limits

(a)

for new establishments, a reasonable period of

time, or other period as may be agreed in writing by the

competent authority, prior to the start of construction or

operation, or prior to the modifications leading to a change in

the inventory of dangerous substances;

(b)

for all other cases, one year from the date from

which these regulations apply to the establishment concerned.

(3) Sub-regulations (1) and (2) shall not apply if the operator

has already sent a notification to the competent authority under the

requirements of the Control of Major Accident Hazards Regulations, L.N. 37 of 2003.

2003 * before 1 June 2015, and the information contained therein

complies with sub-regulation (1) and has remained unchanged.

(4) The operator shall inform the competent authority in

advance of the following events

(a)

any significant increase or decrease in the quantity

or significant change in the nature or physical form of the

dangerous substance present, as indicated in the notification

provided by the operator pursuant to sub-regulation (1), or a

significant change in the processes employing it;

(b)

modification of an establishment or an installation

which could have significant consequences in terms of major-

accident hazards;

(c)

the permanent closure of the establishment or its

de-commissioning; or

(d)

changes in the information referred to in sub-

regulation (1)(a), (b) or (c).

Criteria for the notification of a major accident to the Commission

as provided for in regulation 13(1)

I.

Any major accident covered by paragraph 1 or having at

least one of the consequences described in paragraphs 2, 3, 4 and 5

must be notified to the Commission.

1. Dangerous substances involved

Any fire or explosion or accidental discharge of a

dangerous substance involving a quantity of at least 5% of the

qualifying quantity laid down in Column 3 of Part 1 or in

Column 3 of Part 2 of Schedule I.

2. Injury to persons and damage to real estate

(a)

a death;

(b) six persons injured within the establishment

and hospitalised for at least 24 hours;

(c) one person outside

the

establishment

hospitalised for at least 24 hours;

(d) dwelling(s) outside the establishment

damaged and unusable as a result of the accident;

(e) the evacuation or confinement of persons for

more than 2 hours (persons × hours): the value is at least

(f) the interruption of drinking water, electricity,

gas or telephone services for more than 2 hours (persons ×

hours): the value is at least 1000.

3. Immediate damage to the environment

(a)

permanent or long-term damage to terrestrial

habitats

(i) 0.5 ha or more of a habitat of

environmental or conservation importance

protected by legislation;

(ii) 10 or more hectares of more widespread

habitat, including agricultural land;

(b) significant or long-term damage to freshwater

and marine habitats

(i)

10 km or more of river or canal;

(ii) 1 ha or more of a lake or pond;

(iii) 2 ha or more of delta;

(iv) 2 ha or more of a coastline or open sea;

(c) significant

damage

to

an

aquifer

or

underground water

1 ha or more.

4. Damage to property

(a) damage to property in the establishment: at

least EUR 2,000,000;

(b) damage to property outside the establishment

at least EUR 500,000.

5. Cross-border damage

Any major accident directly involving a dangerous

substance giving rise to effects outside the territory of the

Member State concerned.

II. Accidents or ‘near misses’ which the competent authority

regards as being of particular technical interest for preventing major

accidents and limiting their consequences and which do not meet the

quantitative criteria above should be notified to the Commission.

€4.05

(1)

Every operator shall draw up a document in writing

setting out the major-accident prevention policy (MAPP) and to

ensure that it is properly implemented. The MAPP shall be designed

to ensure a high level of protection of human health and the

environment. It shall be proportionate to the major-accident hazards.

It shall include the operator’s overall aims and principles of action,

the role and responsibility of management, as well as the commitment

towards continuously improving the control of major-accident

hazards, and ensuring a high level of protection.

(2) The MAPP shall be drawn up and sent to the competent

authority within the following time-limits

(a)

for new establishments, a reasonable period of time

or other period as may be agreed in writing by the competent

authority, prior to the start of construction or operation, or prior

to the modifications leading to a change in the inventory of

dangerous substances;

(b)

for all other cases, one year from the date from

which these regulations apply to the establishment concerned.

(3) Sub-regulations (1) and (2) shall not apply if the operator

has already established the MAPP and sent it to the competent

*revoked by these Regulations.

authority before 1 June 2015, and the information contained therein

complies with sub-regulation (1) and has remained unchanged.

(4) Without prejudice to regulation 9, the operator shall

periodically review and where necessary update the MAPP, at least

every five years. The updated MAPP shall be sent to the competent

authority without delay.

(5) The MAPP shall be implemented by appropriate means,

structures and by a safety management system, in accordance with

Schedule III, proportionate to the major-accident hazards, and the

complexity of the organisation or the activities of the establishment.

For lower-tier establishments, the obligation to implement the MAPP

may be fulfilled by other appropriate means, structures and

management systems, proportionate to major-accident hazards, taking

into account the principles set out in Schedule III.

(1)

The competent authority shall, using the Domino effects.

information received from the operators in accordance with

regulations 5 and 8, or following a request for additional information

from the competent authority, or through inspections pursuant to

regulation 16, identify all lower-tier and upper-tier establishments or

groups of establishments where the risk or consequences of a major

accident may be increased because of the geographical position and

the proximity of such establishments, and their inventories of

dangerous substances.

(2) Where the competent authority has additional information

to that provided by the operator pursuant to regulation 5(1)(g), it shall

make this information available to that operator, if it is necessary for

the application of this regulation.

(3) The operators of the establishments identified in

accordance with sub-regulation (1) shall

(a)

exchange suitable information to enable those

establishments to take account of the nature and extent of the

overall hazard of a major accident in their MAPP, safety

management systems, safety reports and internal emergency

plans, as appropriate;

(b)

cooperate in informing the public and neighbouring

sites that fall outside the scope of these regulations, and in

supplying information to the Civil Protection Department.

(1)

Every operator of an upper-tier establishment shall Safety report.

produce a safety report for the purposes of

(a)

demonstrating that a MAPP and a safety

management system for implementing it have been put into

effect in accordance with the information set out in Schedule

III;

(b)

demonstrating that major-accident hazards and

possible major-accident scenarios have been identified and that

the necessary measures have been taken to prevent such

accidents and to limit their consequences for human health and

the environment;

(c)

demonstrating that adequate safety and reliability

have been taken into account in the design, construction,

operation and maintenance of any installation, storage facility,

equipment and infrastructure connected with its operation which

are linked to major-accident hazards inside the establishment;

(d)

demonstrating that internal emergency plans have

been drawn up and supplying information to enable the external

emergency plan to be drawn up;

(e)

providing sufficient information to the competent

authority to enable decisions to be made regarding 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 II. It shall name the relevant

organisations involved in the drawing up of the report.

(3) The safety report shall be sent to the competent authority

within the following time-limits

(a)

for new establishments, a reasonable period of time

or other period as may be agreed in writing by the competent

authority, prior to the start of construction or operation, or prior

to the modifications leading to a change in the inventory of

dangerous substances;

(b)

for existing upper-tier establishments, 1 June 2016;

(c)

for other establishments, two years from the date

from which these regulations apply to the establishment

concerned.

(4) Sub-regulations (1), (2) and (3) shall not apply if the

operator has already sent the safety report to the competent authority

under the requirements of the Control of Major Accident Hazards

Regulations, 2003 * before the 1 June 2015, and the information

contained therein complies with sub-regulations (1) and (2) and has

remained unchanged. In order to comply with sub-regulations (1) and

(2), the operator shall submit any changed parts of the safety report in

the format agreed by the competent authority, subject to the time-

limits referred to in sub-regulation (3).

(5) Without prejudice to regulation 9, the operator shall

periodically review and where necessary update the safety report at

least every five years.

The operator shall also review and where necessary update

the safety report following a major accident at its establishment, and

at any other time at the initiative of the operator or at the request of

the competent authority, where justified by new facts or by new

technological knowledge about safety matters, including knowledge

arising from analysis of accidents or, as far as possible, ‘near misses’,

and by developments in knowledge concerning the assessment of

hazards.

The updated safety report or updated parts thereof shall be

sent to the competent authority without delay.

(6) Before the operator commences construction or operation,

or in the cases referred to in sub-regulation (3)(b) and (c) and in sub-

regulation (5), the competent authority shall within a reasonable

period of receipt of the report communicate the conclusions of its

examination of the safety report to the operator and, where

appropriate, in accordance with regulation 15, prohibit the bringing

into use, or the continued use, of the establishment concerned.

In the event of the modification of an installation, Modification of

establishment, storage facility, or process or of the nature or physical an

an establishment

form or quantity of dangerous substances which could have or

facility.

significant consequences for major-accident hazards, or could result

in a lower-tier establishment becoming an upper-tier establishment or

vice versa, every operator shall review, and where necessary updates

the notification, the MAPP, the safety management system and the

safety report and informs the competent authority of the details of

those updates in advance of that modification.

(1)

Every operator shall ensure that, for all upper-tier Emergency

plans.

establishments

(a)

an internal emergency plan for the measures to be

taken inside the establishment is drawn up;

*revoked by these Regulations.

(b)

the necessary information is supplied to the

competent authority, to enable the Civil Protection Department

to draw up external emergency plans.

(2) Operators shall comply with the obligations set out in sub-

regulation (1)(a) and (b) within the following time- limits

(a)

for new establishments, a reasonable period of time

or other period as may be agreed in writing by the competent

authority, prior to the start of operation, or prior to the

modifications leading to a change in the inventory of dangerous

substances;

(b)

for existing upper-tier establishments, by 1 June

2016 unless the internal emergency plan drawn up under the

requirements of the Control of Major Accident Hazards

Regulations, 2003 * before that date, and the information

contained therein, and the information referred to in sub-

regulation (1)(b) complies with this regulation and has remained

unchanged;

(c)

for other establishments, two years from the date

from which these regulations apply to the establishment

concerned.

(3) The emergency plans shall be established with the

following objectives

(a)

containing and controlling incidents so as to

minimise the effects, and to limit damage to human health, the

environment and property;

(b)

implementing the necessary measures to protect

human health and the environment from the effects of major

accidents;

(c)

communicating the necessary information to the

public and to the services or authorities concerned in the area;

(d)

providing for the restoration and clean-up of the

environment following a major accident.

Emergency plans shall contain the information set out in

Schedule IV.

(4) The operator shall ensure that the internal emergency plans

*revoked by these Regulations.

provided for in these regulations are drawn up in consultation with

the personnel working inside the establishment, including long-term

relevant subcontracted personnel.

(5) The Civil Protection Department shall ensure that the

public concerned is given early opportunity to give its opinion on

external emergency plans when they are being established or

substantially modified. The Civil Protection Department, in terms of

article 4 of the Civil Protection Act, relating to the preparation of Cap. 411.

contingency plans, shall draw up an external emergency plan as

specified in Schedule IV for the measures to be taken outside the

establishment within two years following receipt of the necessary

information from the operator pursuant to sub-regulation (1)(b).

(6) A person or entity who has prepared an emergency plan

pursuant to a duty imposed by these regulations shall ensure that

internal and external emergency plans are reviewed, tested, and where

necessary updated at suitable intervals of 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.

With regard to external emergency plans, the Civil

Protection Department shall take into account the need to facilitate

enhanced cooperation in civil protection assistance in major

emergencies.

(7) The operator and, if necessary, the competent authority

shall ensure that emergency plans are put into effect without delay

when a major accident occurs, or when an uncontrolled event occurs

which by its nature could reasonably be expected to lead to a major

accident.

(8) The competent authority may decide, giving reasons for its

decision, in view of the information contained in the safety report,

that the requirement to produce an external emergency plan under

sub-regulation (1) shall not apply.

(9) Where an exemption has been given under sub-regulation

(8), 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)

Every operator shall ensure that the information Information to

referred to in Schedule V is permanently available to the public, the public.

including electronically. The information shall be kept updated,

where necessary, including in the event of modifications covered by

regulation 9.

(2) Every operator of an upper-tier establishment shall also

ensure that

(a)

all persons likely to be affected by a major accident

receive regularly and in the most appropriate form, without

having to request it, clear and intelligible information on safety

measures and requisite behaviour in the event of a major

accident;

(b)

the safety report is made available to the public

upon request subject to regulation 18(3); where regulation 18(3)

applies, an amended report, for instance in the form of a non-

technical summary, which shall include at least general

information on major-accident hazards and on potential effects

on human health and the environment in the event of a major

accident, shall be made available;

(c)

the inventory of dangerous substances is made

available to the public upon request subject to regulation 18(3).

The information to be supplied under sub-regulation (2)(a)

shall include at least the information referred to in Schedule V. That

information shall likewise be supplied to all buildings and areas of

public use, including schools and hospitals, and to all neighbouring

establishments in the case of establishments covered by regulation 7.

Every operator shall ensure that the information is supplied at least

every five years and periodically reviewed and where necessary,

updated, including in the event of modifications covered by

regulation 9.

(3) The competent authority shall, with respect to the

possibility of a major accident with transboundary effects originating

in an upper-tier establishment, provide sufficient information to the

potentially affected Member States so that all relevant provisions

contained in regulation 10, in the Supplementary Planning Policy

Guidance on Major Accident Hazards and Hazardous Substances and

in this regulation can be applied, where applicable, by the potentially

affected Member States.

(4) Where the competent authority has decided that an

establishment close to the territory of another Member State is

incapable of creating a major-accident hazard beyond its boundary for

the purposes of regulation 10(8) and is not therefore required to

produce an external emergency plan under regulation 10(1), it shall

inform the other Member State of its reasoned decision.

Every operator shall, as soon as practicable following a Information to

be supplied by

major accident, using the most appropriate means

the operator and

actions to be

taken following

(a)

inform the competent authority;

a major

accident.

(b)

provide the competent authority with 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 human health, the environment and

property;

(iv) the emergency measures taken;

(c)

inform the competent authority of the steps

envisaged to

(i) mitigate the medium-term and long-term

effects of the accident;

(ii) prevent any recurrence of such an accident;

(d)

update the information provided if further

investigation reveals additional facts which alter that

information or the conclusions drawn.

The competent authority shall inform the Provision of

Commission as soon as practicable of major accidents meeting the information

following a

criteria of Schedule VI which have occurred on Maltese territory for major accident.

the purpose of prevention and mitigation of major accidents. The

information provided shall include the following details

(a)

the name and address of the authority responsible

for the report;

(b)

the date, time and place of the 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 human health and the environment;

(d)

a brief description of the emergency measures

taken and of the immediate precautions necessary to prevent

recurrence;

(e)

the results of their analysis and recommendations.

(2) The information referred to in sub-regulation (1) shall be

provided as soon as practicable and at the latest within one year of the

date of the accident, using the database set up by the Commission.

Where only preliminary information under sub-regulation (1)(e) can

be provided within this time-limit for inclusion in the database, the

information shall be updated once the results of further analysis and

recommendations are available.

Reporting of the information referred to in sub-regulation

(1)(e) by the competent authority may be delayed to allow for the

completion of judicial proceedings where such reporting may affect

those proceedings.

(3) The competent authority shall inform the Commission of

the name and address of any person and, or entity 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.

(1)

It shall be the 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

Provided that the Occupational Health and 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 15.

(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 operator’s 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 -

(a)

the Civil Protection Department shall take the lead,

as provided in the Civil Protection Act, to ensure that any Cap. 411.

immediate, urgent, medium and long-term measures which may

prove necessary are taken by whosoever has such an obligation;

(b)

the competent authority shall jointly

(i) ensure that any urgent, medium-term and

long-term measures which may prove necessary are taken;

(ii) collect, by inspection, investigation or other

appropriate means, the information necessary for a full

analysis of the technical, organisational and managerial

aspects of the accident;

(iii) take appropriate action to ensure that the

operator takes any necessary remedial measures;

(iv) make recommendations on future preventive

measures; and

(v) inform the persons likely to be affected, of the

accident which has occurred and, where relevant, of the

measures undertaken to mitigate its consequences.

(6) The competent authority shall charge the operator a fee for

performing its functions under these regulations according to

regulation 8, provided that such 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.

(7) 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.

(8) The competent authority may also charge the operator

other fees under such provisions as specified in sub-regulations (6)

and (7), for performing any other functions under these regulations.

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.

(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.

To this end, the competent authority shall, inter alia, take into account

serious failures to take the necessary actions identified in the

inspection report.

(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) in accordance with the relevant provisions of the Occupational

Health and Safety Authority Act or of the Environment and Planning

Authority Act.

The competent authority shall organise a system of Inspections.

inspections which shall be appropriate to the type of establishment

Provided that these inspections shall not be dependent

upon receipt of the safety report or any other report submitted 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 that

(a)

the operator can demonstrate that he has taken

appropriate measures, in connection with the various activities

of the establishment, to prevent major accidents;

(b)

the operator can demonstrate that he has provided

appropriate means for limiting the consequences of major

accidents, on-site and off-site;

(c)

the data and information contained in the safety

report, or any other report submitted, adequately reflects the

conditions in the establishment;

(d)

information has been supplied to the public

pursuant to regulation 11.

(2) The competent authority shall ensure that all

establishments are covered by an inspection plan and shall ensure that

this plan is regularly reviewed and, where appropriate, updated.

Each inspection plan shall include the following

(a)

a general assessment of relevant safety issues;

(b)

the geographical area covered by the inspection

(c)

a list of the establishments covered by the plan;

(d)

a list of groups of establishments with possible

domino effects pursuant to regulation 7;

(e)

a list of establishments where particular external

risks or hazard sources could increase the risk or consequences

of a major accident;

(f)

procedures for routine inspections, including the

programmes for such inspections pursuant to sub-regulation (3);

(g)

procedures for non-routine inspections pursuant to

sub-regulation (5);

(h)

provisions on the co-operation between different

inspection authorities.

(3) Based on the inspection plans referred to in sub-regulation

(2), the competent authority shall regularly draw up programmes for

routine inspections for all establishments including the frequency of

site visits for different types of establishments.

The period between two consecutive site visits shall not

exceed one year for upper-tier establishments and three years for

lower-tier establishments, unless the competent authority has drawn

up an inspection programme based on a systematic appraisal of

major-accident hazards of the establishments concerned.

(4) The systematic appraisal of the hazards of the

establishments concerned shall be based on at least the following

criteria

(a)

the potential impacts of the establishments

concerned on human health and the environment;

(b)

the record of compliance with the requirements of

these regulations.

Where appropriate, relevant findings of inspections carried

out under other regulations shall also be taken into account.

(5) Non-routine inspections shall be carried out to investigate

serious complaints, serious accidents and ‘near misses’, incidents and

occurrences of non-compliance as soon as possible.

(6) Within four months after each inspection, the competent

authority shall communicate the conclusions of the inspection and all

the necessary actions identified to the operator. The competent

authority shall ensure that the operator takes all those necessary

actions within a reasonable period after receipt of the communication.

(7) If an inspection has identified an important case of non-

compliance with these regulations, an additional inspection shall be

carried out within six months.

(8) Inspections shall, where possible, be coordinated with

inspections under other regulations and combined, where appropriate.

(9) Every operator shall provide the competent authorities

with all necessary assistance to enable those authorities to carry out

any inspection and to gather any information necessary for the

performance of their duties for the purposes of these regulations, in

particular to allow the authorities to fully assess the possibility of a

major accident and to determine the scope of possible increased

probability or aggravation of major accidents, to prepare an external

emergency plan and to take into account substances which, due to

their physical form, particular conditions or location, may require

additional consideration.

(1)

L-awtorità kompetenti għandha torganizza sistema Spezzjonijiet.

adegwata ta’ spezzjonijiet, li jkunu xierqa għat-tip ta’ stabbilimenti

kkonċernati

Iżda dawn ma għandhomx jiddependu mir-rapport tas-

sigurtà li jkunu rċevew jew minn kwalunkwe rapport ieħor li jiġi

ppreżentat. Dawn għandhom ikunu suffiċjenti biex is-sistemi li jkunu

qed jiġu mħaddma fl-istabbiliment jiġu eżaminati b’mod ippjanat u

sistematiku, kemm jekk ikunu ta’ natura teknika, organizzattiva jew

maniġerjali, sabiex jiġi żgurat b’mod partikolari li

(a)

l-operatur jista’ juri li huwa ħa l-miżuri meħtieġa,

fir-rigward tal-attivitajiet differenti tal-istabbiliment, sabiex

jevita inċidenti kbar;

(b)

l-operatur jista’ jipprova li huwa pprovda l-mezzi

biex jiġu limitati l-konsegwenzi ta’ inċidenti kbar, fil-post u

barra minnu;

id-data u l-informazzjoni li jkun hemm fir-rapport

tas-sigurtà, jew fi kwalunkwe rapport ieħor li jiġi ppreżentat,

ikunu jirriflettu b’mod adegwat il-kundizzjonijiet fl-

istabbiliment;

(d)

l-informazzjoni tkun ġiet ipprovduta lill-pubbliku

skont ir-regolament 11.

(2) L-awtorità kompetenti għandha tiżgura li l-istabbilimenti

kollha jkunu koperti bi pjan ta’ spezzjoni u għandha tiżgura li dan il-

pjan jiġi rivedut regolarment u, fejn ikun xieraq, jiġi aġġornat.

Kull pjan ta’ spezzjoni għandu jinkludi dawn li ġejjin

(a)

evalwazzjoni ġenerali dwar il-kwistjonijiet ta’

sigurtà rilevanti;

(b)

iż-żona ġeografika koperta mill-pjan ta’ spezzjoni;

lista tal-istabbilimenti koperti bil-pjan;

(d)

lista ta’ gruppi ta’ stabbiliment b’effetti domino

possibbli skont ir-regolament 7;

(e)

lista ta’ stabbilimenti fejn sorsi partikolari ta’ riskji

jew perikli esterni jistgħu jżidu ir-riskju jew il-konsegwenzi ta’

inċident kbir;

(f)

proċeduri għall-ispezzjonijiet ta’ rutina inklużi l-

programmi għal spezzjonijiet bħal dawn skont is-subregolament

(g)

proċeduri għal spezzjonijiet mhux ta’ rutina skont

is-subregolament (5);

(h)

dispożizzjonijiet dwar

il-kooperazzjoni

bejn

awtoritajiet ta’ spezzjoni differenti.

(3) Fuq il-bażi tal-pjanijiet ta’ spezzjoni msemmija fis-

subregolament (2), l-awtorità kompetenti għandha tfassal b’mod

regolari programm għal spezzjonijiet ta’ rutina fl-istabbilimenti

kollha, inkluża l-frekwenza taż-żjajjar fuq il-post għal tipi differenti

ta’ stabbilimenti.

Il-perjodu bejn żewġ żjajjar konsekuttivi fuq il-post ma

għandux jaqbeż sena għall-istabbilimenti tal-livell ogħla u tliet snin

għall-istabbilimenti tal-livell aktar baxx, sakemm l-awtorità

kompetenti ma tkunx fasslet programm ta’ spezzjoni bbażat fuq

evalwazzjoni sistematika tal-perikli ta’ inċidenti kbar relatati mal-

istabbilimenti konċernati.

(4) L-evalwazzjoni sistematika tal-perikli tal-istabbilimenti

konċernati għandha tiġi bbażata fuq tal-anqas il-kriterji li ġejjin

(a)

l-impatti potenzjali tal-istabbilimenti konċernati

fuq is-saħħa tal-bniedem u l-ambjent;

(b)

ir-rekord tal-konformità mar-rekwiżiti ta’ dawn ir-

regolamenti.

Fejn ikun xieraq, għandhom jiġu kkunsidrati s-sejbiet

rilevanti tal-ispezzjonijiet imwettqa skont regolamenti oħra.

(5) L-ispezzjonijiet mhux ta’ rutina għandhom isiru biex jiġu

investigati kemm jista’ jkun malajr ilmenti serji, inċidenti serji u

inċidenti oħrajn li kważi seħħew, kif ukoll inċidenti u okkorrenzi ta’

nuqqas ta’ konformità.

(6) Fi żmien erba’ xhur minn kull spezzjoni, l-awtorità

kompetenti għandha tikkomunika lill-operatur il-konklużjonijiet taż-

żjara u l-azzjonijiet kollha meħtieġa li jkunu ġew identifikati. L-

awtorità kompetenti għandha tiżgura li l-operatur jieħu dawk l-

azzjonijiet kollha meħtieġa f’perjodu raġonevoli wara li jkun irċieva

l-komunikazzjoni.

(7) Jekk waqt spezzjoni jkun ġie identifikat każ gravi ta’

nuqqas ta’ konformità ma’ dawn ir-regolamenti, għandha ssir

spezzjoni supplementari fi żmien sitt xhur.

(8) Meta jkun possibbli, l-ispezzjonijiet għandhom jiġu

kkoordinati mal-ispezzjonijiet li jsiru skont regolamenti oħra u, fejn

xieraq, dawn għandhom ikunu kkombinati.

(9) Kull operatur għandu jipprovdi lill-awtoritajiet kompetenti

bl-għajnuna kollha meħtieġa sabiex jippermettu lil dawk l-

awtoritajiet iwettqu kwalunkwe spezzjoni u jiġbru kwalunkwe

informazzjoni meħtieġa għat-twettiq tal-obbligi tagħhom għall-

finijiet ta’ dawn ir-regolamenti, b’mod partikolari biex jippermettu

lill-awtoritajiet sabiex jevalwaw b’mod sħiħ il-possibbiltà ta’

inċidenti kbar u jiddeterminaw l-għan ta’ probabbiltà akbar jew

aggravazzjoni ta’ inċidenti kbar possibbli, jippreparaw pjan estern ta’

emerġenza u jikkunsidraw is-sustanzi li, minħabba l-forma fiżika, il-

kundizzjonijiet jew il-post partikolari tagħhom, jistgħu jeħtieġu aktar

attenzjoni.

(1)

The competent authority and the Commission shall Information

exchange information on the experience acquired with regard to the system

exchanges.

prevention of major accidents and the limitation of their

consequences. This information shall concern, in particular, the

functioning of the measures provided for in these regulations.

(2) By 30 September 2019, and every four years thereafter, the

competent authority shall provide the Commission with a report on

the implementation of these regulations.

(3) For establishments covered by these regulations, the

competent authority shall supply the Commission with at least the

following information

(a)

the name or trade name of the operator and the full

address of the establishment concerned;

(b)

the activity or activities of the establishment.

(1)

The competent authority shall ensure, in the Access to

interests of transparency, that any information held pursuant to these information

confidentiality.

regulations is made available to any natural or legal person who so

requests in accordance with Directive 2003/4/EC.

(2) Disclosure of any information required under these

regulations, including under regulation 11, may be refused or

restricted by the competent authority where the conditions laid down

in Article 4 of Directive 2003/4/EC are fulfilled.

(3) Disclosure of the complete information referred to in

regulation 11(2)(b) and (c) held by the competent authority may be

refused by that competent authority, without prejudice to sub-

regulation (2) of this regulation, if the operator has requested not to

disclose certain parts of the safety report or the inventory of

dangerous substances for the reasons provided for in Article 4 of

Directive 2003/4/EC.

The competent authority may also decide for the same

reasons that certain parts of the report or inventory shall not be

disclosed. In such cases, and on approval of the competent authority,

the operator shall supply to the competent authority an amended

report or inventory excluding those parts.

(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 requirement or duty, or that there was no better practicable means

than was in fact used to satisfy the duty or requirement.

(3) (a)

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.

(b)

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.

(c)

Without prejudice to the preceding sub-regulations,

no proceedings shall be taken against any person who after receiving

an intimation from the competent authority for the payment of an

administrative fine for having contravened the provisions of these

regulations, pays such a penalty and provides sufficient proof that all

remedial action has been taken to the satisfaction of the competent

authority, within fifteen days of the date of such intimation.

The Control of Major Accident Hazards Regulations, 2003

are hereby revoked.

2003. SCHEDULE I

DANGEROUS SUBSTANCES TO WHICH

THE REGULATIONS APPLY

Dangerous substances covered by the hazard categories listed in

Column 1 of Part 1 of this Schedule are subject to the qualifying

quantities set out in Columns 2 and 3 of Part 1.

Where a dangerous substance is covered by Part 1 of this

Schedule and is also listed in Part 2, the qualifying quantities set out

in Columns 2 and 3 of Part 2 apply.

PART 1

Categories of dangerous substances

This Part covers all dangerous substances falling under the

hazard categories listed in Column 1

Column 1

Column 2

Column 3

Qualifying quantity (tonnes)

of dangerous substances as

Hazard categories in accordance with

referred to in regulation 2 for

Regulation (EC) No 1272/2008

the application of

Lower-tier

Upper-tier

requirements requirements

Section ‘H’ - HEALTH HAZARDS

H1 ACUTE TOXIC Category 1, all

exposure routes

H2 ACUTE TOXIC

- Category 2, all exposure routes

- Category 3, inhalation exposure route

(see note 7)

H3 STOT SPECIFIC TARGET ORGAN

TOXICITY – SINGLE EXPOSURE STOT

SE Category 1

Section ‘P’ - PHYSICAL HAZARDS

P1(a) EXPLOSIVES (see note 8)

- Unstable explosives or

- Explosives, Division 1.1, 1.2, 1.3, 1.5 or

1.6, or

- Substances

or

mixtures

having

explosive properties according to method

A.14 of Regulation (EC) No 440/2008 (see

note 9) and do not belong to the hazard

classes Organic peroxides or Self-reactive

substances and mixtures

P1(b) EXPLOSIVES (see note 8)

Explosives, Division 1.4 (see note 10)

P2 FLAMMABLE GASES

Flammable gases, Category 1 or 2

P3(a) FLAMMABLE AEROSOLS (see

note 11.1)

‘Flammable’ aerosols Category 1 or 2,

150 (net)

500 (net)

containing flammable gases Category 1 or 2

or flammable liquids Category 1

Column 1

Column 2

Column 3

Qualifying quantity (tonnes)

of dangerous substances as

Hazard categories in accordance with

referred to in regulation 2 for

Regulation (EC) No 1272/2008

the application of

Lower-tier

Upper-tier

requirements requirements

P3(b) FLAMMABLE AEROSOLS (see

note 11.1)

‘Flammable’ aerosols Category 1 or 2, not

5000 (net)

50000 (net)

containing flammable gases Category 1 or 2

nor flammable liquids category 1 (see note

11.2)

P4 OXIDISING GASES

Oxidising gases, Category 1

P5(a) FLAMMABLE LIQUIDS

- Flammable liquids, Category 1, or

- Flammable liquids Category 2 or 3

maintained at a temperature above their

boiling point, or

- Other liquids with a flash point ≤ 60°C,

maintained at a temperature above their

boiling point (see note 12)

P5(b) FLAMMABLE LIQUIDS

- Flammable liquids Category 2 or 3

where particular processing conditions,

such as high pressure or high temperature,

may create major-accident hazards, or

- Other liquids with a flash point ≤ 60°C

where particular processing conditions,

such as high pressure or high temperature,

may create major-accident hazards (see note

12)

P5(c) FLAMMABLE LIQUIDS

Flammable liquids, Categories 2 or 3 not

50000

covered by P5(a) and P5(b)

P6(a) SELF-REACTIVE SUBSTANCES

AND

MIXTURES

and

ORGANIC

PEROXIDES

Self-reactive substances and mixtures, Type

A or B or organic peroxides, Type A or B

P6(b) SELF-REACTIVE SUBSTANCES

AND

MIXTURES

and

ORGANIC

PEROXIDES

Self-reactive substances and mixtures, Type

C, D, E or F or organic peroxides, Type C,

D, E, or F

Column 1

Column 2

Column 3

Qualifying quantity (tonnes)

of dangerous substances as

Hazard categories in accordance with

referred to in regulation 2 for

Regulation (EC) No 1272/2008

the application of

Lower-tier

Upper-tier

requirements requirements

P7 PYROPHORIC LIQUIDS AND

SOLIDS

Pyrophoric liquids, Category 1

Pyrophoric solids, Category 1

P8 OXIDISING LIQUIDS AND SOLIDS

Oxidising Liquids, Category 1, 2 or 3, or

Oxidising Solids, Category 1, 2 or 3

Section

‘E’

-

ENVIRONMENTAL

HAZARDS

E1 Hazardous to the Aquatic Environment

in Category Acute 1 or Chronic 1

E2 Hazardous to the Aquatic Environment

in Category Chronic 2

Section ‘O’ - OTHER HAZARDS

O1 Substances or mixtures with hazard

statement EUH014

O2 Substances and mixtures which in

contact with water emit flammable gases,

Category 1

O3 Substances or mixtures with hazard

statement EUH029

Part 2

Named Dangerous Substances

Column 1

Column 2

Column 3

Qualifying quantity

CAS number (tonnes) for the application

( 1 )

Dangerous substances

of

Lower-tier

Upper-tier

requirements requirements

1. Ammonium nitrate (see

-

10000

note 13)

2. Ammonium nitrate (see

-

note 14)

3. Ammonium nitrate (see

-

note 15)

4. Ammonium nitrate (see

-

note 16)

5. Potassium nitrate (see note

-

10000

17)

Column 1

Column 2

Column 3

Qualifying quantity

CAS number (tonnes) for the application

( 1 )

Dangerous substances

of

Lower-tier

Upper-tier

requirements requirements

6. Potassium nitrate (see note

-

18)

7. Arsenic pentoxide, arsenic

1303-28-2

(V) acid and/or salts

8. Arsenic trioxide, arsenious

1327-53-3

-

0.1

(III) acid and/or salts

9. Bromine

7726-95-6

10. Chlorine

7782-50-5

11. Nickel

compounds

in

inhalable powder form

nickel monoxide, nickel

-

-

dioxide, nickel sulphide,

trinickel

disulphide,

dinickel trioxide

12. Ethyleneimine

151-56-4

13. Fluorine

7782-41-4

14. Formaldehyde

50-00-0

(concentration ≥ 90%)

15. Hydrogen

1333-74-0

16. Hydrogen

chloride

7647-01-0

(liquefied gas)

17. Lead alkyls

-

18. Liquefied

flammable

gases, Category 1 or 2

-

(including

LPG)

and

natural gas (see note 19)

19. Acetylene

74-86-2

20. Ethylene oxide

75-21-8

Propylene oxide

75-56-9

22. Methanol 67-56-1

4, 4′-Methylene bis (2-

chloraniline) and/or salts,

101-14-4

-

0.01

in powder form

24. Methylisocyanate 624-83-9 - 0.15

25. Oxygen 7782-44-7

Ossiġenu

7782-44-7

Kolonna 1

Kolonna 2

Kolonna 3

Kwantità li tikkwalifika

(tunnellati) għall-

Numru tal-

applikazzjoni ta’

CAS ( 1 )

Sustanzi perikolużi

Rekwiżiti

Rekwiżiti

tal-livell

tal-livell

aktar baxx

ogħla

2,4 -Toluene diisocyanate

584-84-9

2,6 -Toluene diisocyanate

91-08-7

Carbonyl

dichloride

75-44-5

0.3

0.75

(phosgene)

Arsine (arsenic trihydride)

7784-42-1

0.2

Phosphine

(phosphorus

7803-51-2

0.2

trihydride)

Sulphur dichloride

10545-99-0

-

Sulphur trioxide

7446-11-9

Column 1

Column 2

Column 3

Qualifying quantity

CAS number (tonnes) for the application

( 1 )

Dangerous substances

of

Lower-tier

Upper-tier

requirements requirements

Polychlorodibenzofurans

and

polychlorodibenzodioxins

-

-

0.001

(including

TCDD),

calculated

in

TCDD

equivalent (see note 20)

The

following

CARCINOGENS or the

mixtures containing the

following carcinogens at

concentrations above 5 %

by weight

4-Aminobiphenyl and/or

its salts, Benzotrichloride,

Benzidine and/or salts, Bis

(chloromethyl)

ether,

Chloromethyl methyl ether,

1,2-Dibromoethane,

-

0.5

Diethyl sulphate, Dimethyl

sulphate,

Dimethylcarbamoyl

chloride, 1,2-Dibromo-3-

chloropropane,

1,2-

Dimethylhydrazine,

Dimethylnitrosamine,

Hexamethylphosphoric

triamide, Hydrazine, 2-

Naphthylamine

and/or

salts, 4-Nitrodiphenyl, and

1,3 Propanesultone

Column 1

Column 2

Column 3

Qualifying quantity

CAS number (tonnes) for the application

( 1 )

Dangerous substances

of

Lower-tier

Upper-tier

requirements requirements

Petroleum products and

alternative fuels

(a) gasolines

and

naphthas,

(b) kerosenes (including

jet fuels),

(c) gas oils (including

diesel fuels, home heating

oils and gas oil blending

-

25000

streams)

(d) heavy fuel oils

(e) alternative fuels serving

the same purposes and with

similar

properties

as

regards flammability and

environmental hazards as

the products referred to in

points (a) to (d)

Anhydrous Ammonia

7664-41-7

Boron trifluoride

7637-07-2

Hydrogen sulphide

7783-06-4

38. Piperidine 110-89-4

Bis(2-dimethylaminoethyl)

3030-47-5

(methyl)amin

3-(2-Ethylhexyloxy)

5397-31-9

propylamin

Mixtures (*) of sodium

hypochlorite classified as

Aquatic Acute Category 1

[H400] containing less than

5% active chlorine and not

classified under any of the

other hazard categories in

-

Part 1 of Schedule I.

(*) Provided that the

mixture in the absence of

sodium hypochlorite would

not be classified as Aquatic

Acute Category 1 [H400].

Propylamine (see note 21)

107-10-8

Tert-butyl acrylate (see

1663-39-4

note 21)

Column 1

Column 2

Column 3

Qualifying quantity

CAS number (tonnes) for the application

( 1 )

Dangerous substances

of

Lower-tier

Upper-tier

requirements requirements

2-Methyl-3-butenenitrile

16529-56-9

(see note 21)

Tetrahydro-3,5-dimethyl-

1,3,5,-thiadiazine-2- thione

533-74-4

(Dazomet) (see note 21)

Methyl acrylate (see note

96-33-3

21)

3-Methylpyridine (see note

108-99-6

21)

1-Bromo-3-chloropropane

109-70-6

(see note 21)

( 1 ) The CAS number is shown only for indication.

Notes to Schedule I

1. Substances and mixtures are classified in accordance with

Regulation (EC) No 1272/2008.

2. Mixtures shall be treated in the same way as pure

substances provided they remain within concentration limits set

according to their properties under Regulation (EC) No 1272/2008, or

its latest adaptation to technical progress, unless a percentage

composition or other description is specifically given.

3. The qualifying quantities set out above relate to each

establishment.

The quantities to be considered for the application of the

relevant regulations are the maximum quantities which are present or

are likely to be present at any one time. Dangerous substances present

at an establishment only in quantities equal to or less than 2% of the

relevant qualifying quantity shall be ignored for the purposes of

calculating the total quantity present if their location within an

establishment is such that it cannot act as an initiator of a major

accident elsewhere at that establishment.

4. The following rules governing the addition of dangerous

substances, or categories of dangerous substances, shall apply where

appropriate

In the case of an establishment where no individual dangerous

substance is present in a quantity above or equal to the relevant

qualifying quantities, the following rule shall be applied to determine

whether the establishment is covered by the relevant requirements of

these regulations.

These regulations shall apply to upper-tier establishments if the

sum

q 1 /Q U1 + q 2 /Q U2 + q 3 /Q U3 + q 4 /Q U4 + q 5 / Q U5 + ........ is

greater than or equal to 1,

where q x = the quantity of dangerous substance x (or category of

dangerous substances) falling within Part 1 or Part 2 of this Schedule,

and Q UX = the relevant qualifying quantity for dangerous

substance or category x from Column 3 of Part 1 or from Column 3 of

Part 2 of this Schedule.

These regulations shall apply to lower-tier establishments if the

sum

q 1 /Q L1 + q 2 /Q L2 + q 3 /Q L3 + q 4 /QL 4 + q 5 /Q L5 + ......... is

greater than or equal to 1,

where q x = the quantity of dangerous substance x (or category of

dangerous substances) falling within Part 1 or Part 2 of this Schedule,

and Q LX = the relevant qualifying quantity for dangerous

substance or category x from Column 2 of Part 1 or from Column 2 of

Part 2 of this Schedule.

This rule shall be used to assess the health hazards, physical

hazards and environmental hazards. It must therefore be applied three

times

(a)

for the addition of dangerous substances listed in

Part 2 that fall within acute toxicity category 1, 2 or 3

(inhalation route) or STOT SE category 1, together with

dangerous substances falling within section H, entries H1 to H3

of Part 1;

(b)

for the addition of dangerous substances listed in

Part 2 that are explosives, flammable gases, flammable aerosols,

oxidising gases, flammable liquids, self-reactive substances and

mixtures, organic peroxides, pyrophoric liquids and solids,

oxidising liquids and solids, together with dangerous substances

falling within section P, entries P1 to P8 of Part 1;

(c)

for the addition of dangerous substances listed in

Part 2 that fall within hazardous to the aquatic environment

acute category 1, chronic category 1 or chronic category 2,

together with dangerous substances falling within section E,

entries E1 and E2 of Part 1.

The relevant provisions of these regulations apply where any of

the sums obtained by (a), (b) or (c) is greater than or equal to 1.

5. In the case of dangerous substances which are not covered

by Regulation (EC) No 1272/2008, including waste, but which

nevertheless are present, or are likely to be present, in an

establishment and which possess or are likely to possess, under the

conditions found at the establishment, equivalent properties in terms

of major-accident potential, these shall be provisionally assigned to

the most analogous category or named dangerous substance falling

within the scope of these regulations.

6. In the case of dangerous substances with properties giving

rise to more than one classification, for the purposes of these

regulations the lowest qualifying quantities shall apply. However, for

the application of the rule in Note 4, the lowest qualifying quantity

for each group of categories in Notes 4(a), 4(b) and 4(c)

corresponding to the classification concerned shall be used.

7. Dangerous substances that fall within Acute Toxic

Category 3 via the oral route (H 301) shall fall under entry H2

ACUTE TOXIC in those cases where neither acute inhalation toxicity

classification nor acute dermal toxicity classification can be derived,

for example due to lack of conclusive inhalation and dermal toxicity

data.

8. The hazard class Explosives includes explosive articles

(see Section 2.1 of Annex I to Regulation (EC) No 1272/2008). If the

quantity of the explosive substance or mixture contained in the article

is known, that quantity shall be considered for the purposes of these

regulations. If the quantity of the explosive substance or mixture

contained in the article is not known, then, for the purposes of these

regulations, the whole article shall be treated as explosive.

9. Testing for explosive properties of substances and mixtures

is only necessary if the screening procedure according to Appendix 6,

Part 3 of the UN Recommendations on the Transport of Dangerous

Goods, Manual of Tests and Criteria (UN Manual of Tests and

Criteria) * identifies the substance or mixture as potentially having

explosive properties.

10. If Explosives of Division 1.4 are unpacked or repacked,

they shall be assigned to the entry P1(a), unless the hazard is shown

to still correspond to Division 1.4, in accordance with Regulation

(EC) No 1272/2008.

11.1. Flammable aerosols are classified in accordance with the

Council Directive 75/324/EEC of 20 May 1975 on the approximation

of the laws of the Member States relating to aerosol dispensers

(Aerosol Dispensers Directive). ‘Extremely flammable’ and

‘Flammable’ aerosols of Directive 75/324/EEC correspond to

Flammable Aerosols Category 1 or 2 respectively of Regulation (EC)

No 1272/2008.

11.2. In order to use this entry, it must be documented that the

aerosol dispenser does not contain Flammable Gas Category 1 or 2

nor Flammable Liquid Category 1.

12. According to paragraph 2.6.4.5 in Annex I to Regulation

(EC) No 1272/2008, liquids with a flash point of more than 35°C

need not be classified in Category 3 if negative results have been

obtained in the sustained combustibility test L.2, Part III, section 32

of the UN Manual of Tests and Criteria. This is however not valid

under elevated conditions such as high temperature or pressure, and

therefore such liquids are included in this entry.

13. Ammonium nitrate (5000 / 10000): fertilisers capable of

self-sustaining decomposition

This applies to ammonium nitrate-based compound/composite

fertilisers (compound/composite fertilisers contain ammonium nitrate

with phosphate and/or potash) which are capable of self-sustaining

decomposition according to the UN Trough Test (see UN Manual of

Tests and Criteria, Part III, subsection 38.2), and in which the

nitrogen content as a result of ammonium nitrate is

between 15.75% * and 24.5% ** by weight, and

-

either with not more than 0.4% total combustible/organic

materials or which fulfil the requirements of Annex III-2 to

Regulation (EC) No 2003/2003 of the European Parliament and

of the Council of 13 October 2003 relating to fertilisers

* More guidance on waiving of the test can be found in the A.14 method description, see Commission

Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No

1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and

Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1).

* 15.75% nitrogen content by weight as a result of ammonium nitrate corresponds to 45% ammonium

nitrate.

** 24.5% nitrogen content by weight as a result of ammonium nitrate corresponds to 70% ammonium

nitrate.

-

15.75% by weight or less and unrestricted

combustible materials.

14. Ammonium nitrate (1250 / 5000): fertiliser grade

This applies to straight ammonium nitrate-based fertilisers and

to ammonium nitrate-based compound/composite fertilisers which

fulfil the requirements of Annex III-2 to Regulation (EC) No 2003/

2003 and in which the nitrogen content as a result of ammonium

nitrate is

-

more than 24.5% by weight, except for mixtures of

straight ammonium nitrate-based fertilisers with dolomite,

limestone and/or calcium carbonate with a purity of at least

90%,

-

more than 15.75% by weight for mixtures of

ammonium nitrate and ammonium sulphate,

more than 28% * by weight for mixtures of straight

-

ammonium nitrate-based fertilisers with dolomite, limestone

and/or calcium carbonate with a purity of at least 90%.

15. Ammonium nitrate (350 / 2500): technical grade

This applies to ammonium nitrate and mixtures of ammonium

nitrate in which the nitrogen content as a result of the ammonium

nitrate is

-

between 24.5% and 28% by weight, and which

contain not more than 0.4% combustible substances,

-

more than 28% by weight, and which contain not

more than 0.2% combustible substances.

It also applies to aqueous ammonium nitrate solutions in which

the concentration of ammonium nitrate is more than 80% by weight.

16. Ammonium nitrate (10 / 50): ‘off-specs’ material and

fertilisers not fulfilling the detonation test

This applies to

-

material rejected during the manufacturing process

and to ammonium nitrate and mixtures of ammonium nitrate,

straight ammonium nitrate-based fertilisers and ammonium

* 28% nitrogen content by weight as a result of ammonium nitrate corresponds to 80% ammonium nitrate.

nitrate-based compound/composite fertilisers referred to in

Notes 14 and 15, that are being or have been returned from the

final user to a manufacturer, temporary storage or reprocessing

plant for reworking, recycling or treatment for safe use, because

they no longer comply with the specifications of Notes 14 and

15,

-

fertilisers referred to in first indent of Note 13, and

Note 14 to this Schedule which do not fulfil the requirements of

Annex III-2 to Regulation (EC) No 2003/2003.

17. Potassium nitrate (5000 / 10000)

This applies to those composite potassium-nitrate based

fertilisers (in prilled/granular form) which have the same hazardous

properties as pure potassium nitrate.

18. Potassium nitrate (1250 / 5000)

This applies to those composite potassium-nitrate based

fertilisers (in crystalline form) which have the same hazardous

properties as pure potassium nitrate.

19. Upgraded biogas

For the purpose of the implementation of these regulations,

upgraded biogas may be classified under entry 18 of Part 2 of

Schedule I where it has been processed in accordance with applicable

standards for purified and upgraded biogas ensuring a quality

equivalent to that of natural gas, including the content of Methane,

and which has a maximum of 1% Oxygen.

20. Polychlorodibenzofurans and polychlorodibenzodioxins

The

quantities

of

polychlorodibenzofurans

and

polychlorodibenzodioxins are calculated using the following factors

WHO 2005 TEF

2, 3, 7, 8-TCDD

2, 3, 7, 8-TCDF

0.1

1, 2, 3, 7, 8-PeCDD

2, 3, 4, 7, 8-PeCDF

0.3

1, 2, 3, 7, 8-PeCDF

0.03

1,2,3,4,7,8-HxCDD

0.1

1,2,3,6,7,8-HxCDD

0.1

1, 2, 3, 4, 7, 8-HxCDF

0.1

1,2,3,7,8,9-HxCDD

0.1

1, 2, 3, 7, 8, 9-HxCDF

0.1

1, 2, 3, 6, 7, 8-HxCDF

0.1

1, 2, 3, 4, 6, 7, 8-HpCDD

0.01

2, 3, 4, 6, 7, 8-HxCDF

0.1

OCDD

0.0003 1, 2, 3, 4, 6, 7, 8-HpCDF

0.01

1, 2, 3, 4, 7, 8, 9-HpCDF

0.01

OCDF

0.0003

(T = tetra, P = penta, Hx = hexa, Hp = hepta, O = octa)

Reference - Van den Berg et al: The 2005 World Health Organisation Re-

evaluation of Human and Mammalian Toxic Equivalency Factors for

Dioxins and Dioxin-like Compounds

21. In cases where this dangerous substance falls within

category P5(a) Flammable liquids or P5(b) Flammable liquids, then

for the purposes of these regulations the lowest qualifying quantities

shall apply.