CONTROL OF MAJOR ACCIDENT HAZARDS REGULATIONS

SUBSIDIARY LEGISLATION 646.12

CONTROL OF MAJOR ACCIDENT HAZARDS

REGULATIONS

1st June, 2015 *

LEGAL NOTICE 179 of 2015, as amended by Legal Notice 122 of 2020

and Act XXXIII of 2024.

(1) The title of these regulations is the Control of Major

Accident Hazards Regulations.

(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;

*see regulation 1(6) of these Regulations, as originally promulgated.

(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.

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

Hazard categories in accordance with Regulation Qualifying quantity (tonnes) of

(EC) No 1272/2008

dangerous substances as referred

to in regulation 2 for 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)

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)

150 (net)

500 (net)

‘Flammable’ aerosols Category 1 or 2, containing

flammable gases Category 1 or 2 or flammable

liquids Category 1

Column 1

Column 2

Column 3

Hazard categories in accordance with Regulation Qualifying quantity (tonnes) of

(EC) No 1272/2008

dangerous substances as referred

to in regulation 2 for the

application of

Lower-tier

Upper-tier

requirements

requirements

P3(b ) FL AMMABLE AEROSO LS (see note

5000 (net)

50000 (net)

11.1)

‘Flammable’ aerosols Category 1 or 2, not

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

50000

Flammable liquids, Categories 2 or 3 not 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

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

Column 1

Column 2

Column 3

Hazard categories in accordance with Regulation Qualifying quantity (tonnes) of

(EC) No 1272/2008

dangerous substances as referred

to in regulation 2 for the

application of

Lower-tier

Upper-tier

requirements

requirements

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

CAS number

Column 2

Column 3

( 1 )

Qualifying quantity (tonnes)

for the application of

Dangerous substances

Lower-tier

Upper-tier

requirements requirements

1. Ammonium nitrate (see note

-

10000

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)

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

Column 1

CAS number

Column 2

Column 3

( 1 )

Qualifying quantity (tonnes)

for the application of

Dangerous substances

Lower-tier

Upper-tier

requirements requirements

16. Hydrogen chloride (liquefied

7647-01-0

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

(1)

In these regulations, unless the context otherwise

requires -

"Act" means the Health and Safety at Work 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 Environment and Resources Authority,

established by the Environment Protection 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 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;

*revoked by these Regulations.

"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;

"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";

" p r e s e n c e o f d a n g e r o u s su b s t a n c e s " m e a n s t h e a c t u a l o r

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 qu anti ty of dang erou s

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 Protection

Act, the Freedom of Access to Information on the Environment

Regulations, and the Plans and Programmes (Public 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.

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

(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) Where the competent authority considers that a

dangerous substance does not present a major-accident hazard,

based on one or more of the following characteristics

(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.

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) 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.

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 send a notification to the

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;

CONTROL OF MAJOR ACCIDENT HAZARDS

(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 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, 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).

*revoked by 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 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 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

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.

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 500;

(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.

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.

(1) The competent authority shall, using the information

received from the operators in accordance with regulations 5 and 8,

or f o ll o wi ng a r e q ues t fo r a dd it io n a l i nf or m a t io n f r om th e

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

CONTROL OF MAJOR ACCIDENT HAZARDS

(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

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 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,

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

physical form or quantity of dangerous substances which could

have 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

n e c e s s a r y u p d a t e s t h e n o t i f i c a t i o n , t h e M A P P, t h e s a f e t y

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

establishments

(a) an internal emergency plan for the measures to be

taken inside the establishment is drawn up;

(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 prior

*revoked by these Regulations.

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, 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

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 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.

*revoked by these Regulations.

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

referred to in Schedule V is permanently available to 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

p o s s i b i l i t y o f a m aj o r a c c i d e n t w i t h t r a n s b o u n d a r y eff e c t s

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

major accident, using the most appropriate means

(a) inform the competent authority;

(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.

(1) The competent authority shall inform the Commission

as soon as practicable of major accidents meeting the criteria of

Schedule VI 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 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

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.

(9) The competent authority shall accept equivalent

information submitted by operators in accordance with other

relevant Union legislation, which fulfils any of the requirements of

these regulations for the purposes of these regulations. In such

cases the competent authority shall ensure that the requirements of

these regulations are complied with.

(10) The competent authority shall take steps to provide

mechanisms and tools for exchanging experience and consolidating

knowledge, and to participate in such mechanisms at Union level

where appropriate.

(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 Health and Safety

at Work Act or of the Environment Protection Act.

(1) The competent authority shall organise a system of

inspections which shall be appropriate to the type of establishment

concerned

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 plan;

(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 t o 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) The competent authority and the Commission shall

exchange information on the experience acquired with regard to the

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 interests

of transparency, that any information held pursuant to these

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 Environment and Resources 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.

Ethylene oxide

75-21-8

Propylene oxide

75-56-9

22. Methanol 67-56-1

4, 4′-Methylene bis (2-

101-14-4

-

0.01

chloraniline) and/or salts, in

powder form

24. Methylisocyanate 624-83-9 - 0.15

25. Oxygen 7782-44-7

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

Polychlorodibenzofurans and

-

-

0.001

polychlorodibenzodioxins

(including

TCDD),

calculated in TCDD

equivalent (see note 20)

Column 1

CAS number

Column 2

Column 3

( 1 )

Qualifying quantity (tonnes)

for the application of

Dangerous substances

Lower-tier

Upper-tier

requirements requirements

The

following

-

0.5

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)

e t h e r,

Chloromethyl methyl ether,

1,2-Dibromoethane, Diethyl

sulphate, Dimethyl sulphate,

Dimethylcarbamoyl

c h l o r i d e , 1 ,2 - D i b r o m o - 3 -

chloropropane,

1,2-

Dimethylhydrazine,

Dimethylnitrosamine,

Hexamethylphosphoric

triamide, Hydrazine, 2-

Naphthylamine and/or salts,

4-Nitrodiphenyl, and 1,3

Propanesultone

Petroleum products and

-

25000

alternative fuels

(a) gasolines and naphthas,

(b) kerosenes (including jet

fuels),

(c) gas

oils

(including

diesel fuels, home heating

oils and gas oil blending

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

Column 1

CAS number

Column 2

Column 3

( 1 )

Qualifying quantity (tonnes)

for the application of

Dangerous substances

Lower-tier

Upper-tier

requirements requirements

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 note 1663-39-4

21)

2-Methyl-3-butenenitrile

16529-56-9

(see note 21)

Tetrahydro-3,5-dimethyl-

533-74-4

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

(Dazomet) (see note 21)

Methyl acrylate (see note 21)

96-33-3

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). ‘E xtrem ely

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

-

15.75% by weight or less and unrestricted combustible materials.

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

lation (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.

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 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

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

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.