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PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

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Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

SUBSIDIARY LEGISLATION 646.16

PROTECTION OF THE HEALTH AND SAFETY

OF WORKERS FROM THE RISKS RELATED TO

CHEMICAL AGENTS AT WORK

REGULATIONS

5th September, 2003

LEGAL NOTICE 227 of 2003, as amended by Legal Notices 353 of 2007,

53 of 2012, 198 of 2015, 57 of 2018 and 356 of 2021 and Act XXXIII of

2024 and Legal Notice 164 of 2026.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

(1) The title of these regulations is the Protection of the

Health and Safety of Workers from the Risks related to Chemical

Agents at Work Regulations.

(2) The scope of these regulations is to

(a) lay down minimum requirements for the protection of

workers from risks to their health and safety arising, or

likely to arise, from the effects of chemical agents that

are present at the workplace or as a result of any work

activity involving chemical agents;

(b) implement Directive 2014/27/EU of the European

Parliament and of the Council of 26 February 2014

amending Council Directives 92/58/EEC, 92/85/EEC,

94/33/EC, 98/24/EC and Directive 2004/37/EC of the

European Parliament and of the Council, in order to

align them to Regulation (EC) No 1272/2008 on

classification, labelling and packaging of substances

and mixtures;

(c) implement Commission Directive (EU) 2017/164 of 31

January 2017 establishing a fourth list of indicative

occupational exposure limit values pursuant to Council

Directive 98/24/EC, and amending Commission

Directives 91/222/EC, 2000/39/EC and 2009/161/EU;

(d) implement Commission Directive (EU) 2019/1831 of 24

October 2019 establishing a fifth list of indicative

occupational exposure limit values pursuant to Council

Directive 98/24/EC, and amending Commission

Directive 2000/39/EC;

(e) Directive (EU) 2024/869 of the European Parliament and

of the Council of 13 March 2024 amending Directive

2004/37/EC of the European Parliament and of the

Council and Council Directive 98/24/EC as regards the

limit values for lead and its inorganic compounds and for

diisocyanates.

(3) These regulations apply where hazardous chemical agents

are present or may be present at the workplace, and shall be without

prejudice to the provisions for chemical agents to which measures

for radiation protection apply pursuant to other regulations as may

be prescribed.

(4) These regulations shall apply for carcinogens and mutagens

at work without prejudice to more stringent and, or specific

p ro visi on s con tai ne d in a n y o th e r law or r e gu la t io n o n the

protection of workers from the risks related to exposure to

carcinogens and mutagens.

(5) As far as the transport of hazardous chemical agents is

concerned, the provisions of these regulations shall apply without

prejudice to more stringent and, or specific provisions contained in

any other law or regulation.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

LIST OF BINDING OCCUPATIONAL EXPOSURE LIMIT VALUES

Limit values

8 hours ( 3 )

Short-term ( 4 )

CAS

Transitional

No

Notation

μg/

μg/

measures

ppm f/ml

ppm f/ml

( 2 )

m 3

m 3

( 6 )

( 7 )

( 6 )

( 7 )

( 5 )

( 5 )

A limit value of 10

μg NCO/m 3 in

Skin ( 8 )

relation to a

Dermal and reference period of

respiratory 8 hours and a short-

-

-

-

-

-

sensitisatio term exposure limit

value of 20 μg

n

NCO/m 3 shall

( 9 )

apply until 31

December 2028.

(1)

EC No, i.e., Einecs, ELINCS or NLP, is the official number of the

substance within the European Union, as defined in Annex VI, Part 1, Section

1.1.1.2, to Regulation (EC) No 1272/2008.

(2)

CAS No: Chemical Abstract Service Registry Number.

(3)

Measured or calculated in relation to a reference period of 8-hour

time-weighted average (TWA).

(4)

Short-term exposure limit (STEL). A limit value above which

exposure should not occur and which is related to a 15-minute period unless

otherwise specified.

(5)

μg/m3 = micrograms per cubic metre of air at 20 °C and 101,3 kPa

(760 mm mercury pressure).

(6)

ppm = parts per million by volume in air (ml/m3).

(7)

f/ml = fibres per millilitre.

(8)

Substantial contribution to the total body burden via possible dermal

(9)

The substance may cause sensitisation of the skin and of the

respiratory tract.

(10)

NCO refers to isocyanate functional groups of the diisocyanate

compounds.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

In these regulations, unless the context otherwise requires

"Act" means the Health and Safety at Work Act;

"activity involving chemical agents" means any work in which

chemical agents are used, or are intended to be used, in any

process, including production, handling, storage, transport or

disposal and treatment, or which result from such work;

"Authority" means the Occupational Health and Safety Authority

established by virtue of article 4 of the Act;

"biological limit value" means the limit of the concentration in

the appropriate biological medium of the relevant agent, its

metabolite, or an indicator of effect;

"chemical agent" means any chemical element or compound, on

its own or admixed, as it occurs in the natural state or as produced,

used or released, including release as waste, by any work activity,

whether or not produced intentionally and whether or not placed on

the market;

"hazard" means the intrinsic property of a chemical agent with

the potential to cause harm;

"hazardous chemical agent" means

(a) any chemical agent which meets the criteria for

classification as hazardous within any physical and/or

health hazard classes laid down in Regulation (EC) No

1272/2008 of the European Parliament and of the

Council, whether or not that chemical agent is

classified under that Regulation;

(b) any chemical agent which, whilst not meeting the

criteria for classification as hazardous in accordance

with paragraph (a) may, because of its physic-

chemical, chemical or toxicological properties and the

way it is used or is present in the workplace, present a

risk to the safety and health of workers, including any

chemical agent that is assigned on occupational

exposure limit value under regulation 3;

"health surveillance" means the assessment of an individual

worker to determine the state of health of that individual, as related

to exposure to specific chemical agents at work;

"occupational exposure limit value" means, unless otherwise

specified, the limit of the time-weighted average of the

concentration of a chemical agent in the air within the breathing

zone of a worker in relation to a specified reference period;

"risk" means the likelihood that the potential for harm will be

attained under the conditions of use and, or exposure.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

BINDING BIOLOGICAL LIMIT VALUES AND

HEALTH SURVEILLANCE MEASURES

Repealed by Legal Notice 164 of 2026.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

The occupational exposure limit values for chemical agents

shall be those listed in Schedule V, and others which may be

prescribed from time to time.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

PROHIBITIONS

The production, manufacture or use at work of the chemical agents and activities

involving chemical agents set out below are prohibited. The prohibition does not

apply if the chemical agent is present in another chemical agent, or as a constituent

of waste, provided that its individual concentration therein is less than the limit

specified.

(a)

Chemical Agents

EINECS No ( 1 )

CAS No ( 2 )

Name of agent

Concentration limit

for exemption

202-080-4

91-59-8

2-naphthylamine and its salts

0,1% w/w

202-177-1

92-67-1

4-aminodiphenyl and its salts

0,1% w/w

202-199-1

92-87-5

Benzidine and its salts

0,1% w/w

202-204-7

92-93-3

4-nitrodiphenyl

0,1% w/w

( 1 ) EINECS: European

Inventory of Existing Commercial Chemical

Substances

( 2 ) CAS: Chemical Abstracts Service

(b)

Work activities

None.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

(1) An employer shall determine whether any hazardous

chemical agents are present at the workplace, and shall

(a) evaluate the risks to the health and safety of workers,

inter alia in the choice of work equipment, the

chemical substances or preparations used, and the

fitting-out of work places, and as necessary

-

assuring an improvement in the level of

protection afforded to workers with regard to

health and safety,

-

be integrated into all the activities of the

undertaking and, or establishment and at all

hierarchical levels;

(b) where he entrusts tasks to a worker, take into

consideration the worker’s capabilities as regards

health and safety;

(c) ensure that the planning and introduction of new

technologies are the subject of consultation with the

workers and, or their representatives, as regards the

consequences of the choice of equipment, the working

conditions and the working environment for the health

and safety of workers;

(d) take appropriate steps to ensure that only workers who

have received adequate instructions may have access

to areas where there is serious and specific danger;

(e) be in possession of an assessment of the risks to health

and safety at work, including those facing groups of

workers exposed to particular risks;

(f)

decide on the protective measures to be taken and, if

necessary, the protective equipment to be used;

(g) keep a list of occupational accidents resulting in a

worker being unfit for work for more than three

working days;

(h) draw up reports on occupational accidents suffered by

his workers, which shall be forwarded to the Authority

without undue delay.

(2) Where chemical agents are present at a workplace, the

employer shall assess any risk to the health and safety of workers

arising from the presence of those chemical agents, taking into

consideration the following

(a) their hazardous properties;

(b) information on safety and health shall be provided by

the supplier (e.g. the relevant safety data sheet in

accordance with Regulation (EC) No 1907/2006 of the

European Parliament and of the Council, including the

relevant Material Safety Data Sheet, a copy of which

shall be kept at the place of work and made available

to the workers and, or the Workers’ Health and Safety

Representatives, and to the persons designated by the

employer in terms of regulation 9 of the General

Provisions for Health and Safety at Work Places

Regulations;

(c) the level, type and duration and frequency of exposure;

(d) the circumstances of work involving such agents,

including their amount;

(e) any occupational exposure limit values or biological

limit values established on the territory of Malta;

(f)

the effect of preventive measures taken or to be taken;

(g) where available, the conclusions to be drawn from any

health surveillance already undertaken.

(3) The employer shall obtain additional information which is

needed for the risk assessment from the supplier or from other

readily available sources. Where appropriate, this information shall

comprise the specific assessment concerning the risk to users

established on the basis of national legislation on chemical agents.

(4) The employer must be in possession of an assessment of the

risks mentioned in sub-regulation (1)(e) to (h), and shall identify

which measures have been taken in accordance with regulations 5

and 6. The risk assessment shall be documented in a suitable form

a c c o r d i n g t o n a t i o n a l l a w an d p r a c t i c e , a n d m a y i n c l u d e a

justification by the employer that the nature and extent of the risks

related to chemical agents make a further detailed risk assessment

unnecessary. The risk assessment shall be k ep t up-to-date,

particularly if there have been significant changes which could

render it out-of-date, or when the results of health surveillance

show it to be necessary.

(5) Certain activities within the undertaking or establishment,

such as maintenance, in respect of which it is foreseeable that there

is a potential for significant exposure, or which may result in

deleterious effects to health and safety for other reasons, even after

all technical measures have been taken, shall be included in the risk

assessment.

(6) In the case of activities involving exposure to several

hazardous chemical agents, the risk shall be assessed on the basis

of the risk presented by all such chemical agents in combination.

(7) In the case of a new activity involving hazardous chemical

agents, work shall only commence after an assessment of the risk of

that activity has been made and any preventive measures identified

have been implemented.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

DANGEROUS SUBSTANCES

The following chemical agents are to be considered dangerous within the meaning

of these regulations

(a) explosive substances and preparations: solid, liquid, pasty or gelatinous

substances and p reparations which may also react exothermically without

atmospheric oxygen thereby quickly evolving gases, and which, under defined test

conditions, detonate, quickly deflagrate or upon heating explode when partially

confined;

(b) oxidising substances and preparations: substances and preparations which

give rise to a highly exothermic reaction in contact with other substances,

particularly flammable substances;

(c) extremely flammable substances and preparations: liquid substances and

preparations having an extremely low flash-point and a low boiling-point and

gaseous substances and preparations which are flammable in contact with air at

ambient temperature and pressure.

(d)

highly flammable substances and preparations

-

substances and preparations which may become hot and finally catch

fire in contact with air at ambient temperature without any application

of energy, or

-

solid substances and preparations which may readily catch fire after

brief contact with a source of ignition and which continue to burn or to

be consumed after removal of the source of ignition, or

-

liquid substances and preparations having a very low flash-point, or

-

substances and preparations which, in contact with water or damp air,

evolve extremely flammable gases in dangerous quantities;

(e) flammable substances and preparations: liquid substances and preparations

having a low flash-point;

(f)

very toxic substances and preparations: substances and preparations which

in very low quantities cause death or acute or chronic damage to health when

inhaled, swallowed or absorbed via the skin;

(g) toxic substances and preparations: substances and preparations which in low

quantities cause death or acute or chronic damage to health when inhaled, swallowed

or absorbed via the skin;

(h) harmful substances and preparations: substances and preparations which

may cause death or acute or chronic damage to health when inhaled, swallowed or

absorbed via the skin;

(i)

corrosive substances and preparations: substances and preparations which

may, on contact with living tissues, destroy them;

(j)

irritant substances and preparations: non-corrosive substances and

preparations which, through immediate, prolonged or repeated contact with the skin

or mucous membrane, may cause inflammation;

(k) sensitising substances and preparations: substances and preparations which,

if they are inhaled or if they penetrate the skin, are capable of eliciting a reaction of

hypersensitisation such that on further exposure to the substance of preparation,

characteristic adverse effects are produced;

(l)

carcinogenic substances and preparations: substances or preparations which,

if they are inhaled or ingested or if they penetrate the skin, may induce cancer or

increase its incidence;

(m) mutagenic substances and preparations: substances and preparations which,

if they are inhaled or ingested or if they penetrate the skin, may induce heritable

genetic defects or increase their incidence;

(n) substances and preparations which are toxic for reproduction: substances

and preparations which, if they are inhaled or ingested or if they penetrate the skin,

may produce, or increase the incidence of, non-heritable adverse effects in the

progeny and/or an impairment of male or female reproductive functions or capacity.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

(1) In carrying out his obligation to ensure the health and

safety of workers in any activity involving hazardous chemical

agents, the employer shall, apart from the measures set out in these

regulations, take, within the context of his responsibilities, the

measures necessary for the health and safety protection of workers,

including prevention of occupational risks and provision of

information and training, as well as provision of the necessary

organization and means. The employer shall be alert to the need to

adjust these measures to take account of changing circumstances

and aim to improve existing situations.

(2) An employer shall implement the measures referred to in the

first part of sub-regulation (1) on the basis of the requirements of

article 12(2) of the Act.

(3) Risks to the health and safety of workers at work involving

hazardous chemical agents shall be eliminated or reduced to a

minimum by

(a) the design and organisation of systems of work at the

workplace,

(b) the provision of suitable equipment for work with

chemical agents and maintenance procedures which

ensure the health and safety of workers at work,

(c) reducing to a minimum the number of workers exposed

or likely to be exposed,

(d) reducing to a minimum the duration and intensity of

exposure,

(e) appropriate hygiene measures,

(f)

reducing the quantity of chemical agents present at the

workplace to the minimum required for the type of

work concerned,

(g) suitable working procedures including arrangements

for the safe handling, storage and transport within the

workplace of hazardous chemical agents and waste

containing such chemical agents.

(4) Where the results of the assessment referred to in regulation

4(1) reveal a risk to the health and safety of workers, the specific

protection, prevention and monitoring measures laid down in

regulations 6, 7 and 10 shall be applied.

(5) Where the results of the risk assessment referred to in

regulation 4(1) show that, because of the quantities of a hazardous

chemical agent present in the workplace, there is only a slight risk

to the health and safety of workers, and the measures taken in

accordance with sub-regulations (1) and (2) are sufficient to reduce

that risk, the provisions of regulations 6, 7 and 10 shall not apply.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

Substituted by

L.N. 353 of 2007;

L.N. 53 of 2012;

L.N.57 of 2018;

L.N. 356 of 2021.

OCCUPATIONAL EXPOSURE LIMIT VALUES

Name of agent

Limit values

EC No (1)

CAS No (2)

Notation (3)

Eight hours (4)

Short-term (5)

mg/

ppm

mg/

pp

m

m3

(7)

m3

(7)

(6)

(6)

200-193-3

54-11-5

Nicotine

0.5

-

-

-

skin

200-240-8

55-63-0

Glycerol trinitrate

0.095

0.01

0.19

0.02

skin

Carbon tetrachloride;

200-262-8

56-23-5

Tetrachloromethane

6.4

skin

200-467-2

60-29-7

Diethylether

-

200-521-5

61-82-5

Amitrole

0.2

-

-

-

-

200-539-3

62-53-3

Aniline ( )

7.74

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

(1) The employer shall ensure that the risk from a

hazardous chemical agent to the health and safety of workers at

work is eliminated or reduced to a minimum.

(2)

(a) In applying sub-regulation (1), substitution shall by

preference be undertaken, whereby the employer shall

a v o i d t h e u s e o f a h az a r d o u s c h e m i c a l a g e n t b y

replacing it with a chemical agent or process which,

under its condition of use, is not hazardous or less

hazardous to workers’ health and safety, as the case

may be.

(b) Where the nature of the activity does not permit risk to

be eliminated by substitution, having regard to the

activity and risk assessment referred to in regulation 4,

the employer shall ensure that the risk is reduced to a

minimum by application of protection and prevention

measures, consistent with the assessment of the risk

made pursuant to regulation 4. These will include, in

order of priority

(i)

design of appropriate work processes and

engineering controls and use of adequate

equipment and materials, so as to avoid or

minimise the release of hazardous chemical

agents which may present a risk to workers’

health and safety at the place of work;

(ii) application of collective protection measures at

the source of the risk, such as adequate

ventilation and appropriate organizational

measures;

(iii) where exposure cannot be prevented by other

means, application of individual protection

measures

including

personal

protective

equipment.

(3) The measures referred to in sub-regulation (2) shall be

accompanied by health surveillance in accordance with regulation

10 if it is appropriate to the nature of the risk.

(4) Unless the employer clearly demonstrates by other means

of evaluation that, in accordance with sub-regulation (2), adequate

prevention and protection have been achieved, the employer shall

carry out on a regular basis, and when any change occurs in the

conditions which may affect workers’ exposure to chemical agents,

such measurements of chemical agents which may present a risk to

workers’ health at the workplace as are necessary, in particular in

relation to the occupational exposure limit values.

(5)

(a) The employer shall take into account the results of the

procedures referred to in sub-regulation (4) in carrying

out the obligations laid down in or resulting as a

consequence of regulation 4.

(b) In any event, where an occupational exposure limit

value prescribed by regulations has been exceeded, the

employer shall immediately take steps, taking into

account the nature of that limit, to remedy the situation

by carrying out preventive and protective measures.

(6) On the basis of the overall assessment of and general

principles for the prevention of risks in regulations 4 and 5, the

employer shall take technical and, or organisational measures

appropriate to the nature of the operation, including storage,

handling and segregation of incompatible chemical agents,

providing protection of workers against hazards arising from the

physico-chemical properties of chemical agents. In particular he

shall take measures, in order of priority, to

(a) prevent the presence at the workplace of hazardous

concentrations of inflammable substances or

hazardous quantities of chemically unstable substances

or, where the nature of the work does not allow that,

(b) avoid the presence of ignition sources which could

give rise to fires and explosions, or adverse conditions

which could cause chemically unstable substances or

mixtures of substances to give rise to harmful physical

effects, and

(c) mitigate the detrimental effects to the health and safety

of workers in the event of fire or explosion due to the

ignition of inflammable substances, or harmful

physical effects arising from chemically unstable

substances or mixtures of substances.

(7) Work equipment and protective systems provided by the

employer for the protection of workers shall comply with the

relevant national provisions on design, manufacture and supply

with respect to health and safety.

(8) The employer shall take measures to provide sufficient

c on tr ol of pla nt, e qu ip me n t a nd m a c h in e ry o r pr ov is io n of

explosion suppression equipment or explosion pressure relief

arrangements.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

(1) The first-aid, fire-fighting and evacuation measures as

well as the warning and communication systems related to matters

covered by these regulations including the Schedules hereto shall

t a k e p l a c e i n a c c o r d a n c e w i t h t h e Wo r k P l a c e ( F i r s t A i d )

R eg u l at i o n s, t h e Wo r k P l a c e ( M i n i m u m H e a l t h a n d S af et y

Requirements) Regulations, and the Work Place (Provision of

Health and, or Safety Signs) Regulations.

(2) Without prejudice to the generality of the foregoing, an

employer shall, in order to protect the health and safety of workers

from an accident, incident or emergency related to the presence of

hazardous chemical agents at the workplace, establish procedures

or action plans which can be put into effect when any such event

occurs, so that appropriate action is taken. These arrangements

shall include any relevant safety drills that are to be performed at

regular intervals, as well as the provision of appropriate first aid

facilities.

(3) In the case of the occurrence of an event such as is

mentioned in the preceding sub-regulation, an employer shall

immediately take steps to reduce the effects of the event and to

inform the workers concerned thereof. In order to restore the

situation to normal, the employer shall implement appropriate

measures to remedy the situation as soon as possible, and shall

permit only those workers who are essential to the carrying out of

repairs or to carry out other necessary work in the affected area.

(4) Workers who are permitted to work in the affected area

shall be provided with appropriate protective clothing, personal

protective equipment, specialised safety equipment and plant,

which they must use as long as the situation persists. An employer

shall ensure that such a situation is not allowed to become

permanent.

(5) An employer shall take all appropriate steps to ensure that

no unprotected persons permitted to remain or to enter in the

affected area.

(6) An employer shall take the measures necessary to provide

the warning and other communication systems required to signa1

an increased risk to health and safety whenever such occurs, so as

to enable an appropriate response and to launch remedial actions,

assistance, escape and rescue operations immediately if the need

arises.

(7) An employer shall ensure that information on emergency

arrangements involving hazardous chemical agents is available,

including to the relevant internal and externa1 accident and

emergency services, and for this purpose shall give advance notice

of relevant work hazards, hazard identification arrangements,

precautions and procedures, so that the emergency services can

prepare their own response procedures and precautionary measures.

An employer shall also make available information concerning

specific hazards arising, or likely to rise, at the time of an accident

or emergency, including information on procedures prepared

pursuant to this regulation.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

(1) Without prejudice to the General Provisions for Health

and Safety at Work Places Regulations, concerning the information

and training of workers, the employer shall ensure that

(a) workers and, or their representatives are provided

with

(i)

the data obtained pursuant to regulation 4, and

further informed whenever a major alteration at

the workplace leads to a change in these data,

(ii) information on the hazardous chemical agents

occurring in the workplace, such as the identity

of those agents, the risks to health and safety,

relevant occupational exposure limit values and

other legislative provisions,

(iii) training and information on appropriate

precautions and actions to be taken in order to

safeguard themselves and other workers at the

workplace,

(iv) access to any safety data sheet provided by the

supplier in accordance with Article 31 of

Regulation (EC) No 1907/2006; and

(b) the information is

(i)

provided in a manner appropriate to the outcome

of the risk assessment pursuant to regulation 4.

This may vary from oral communication to

individual instruction and training supported by

information in writing, depending on the nature

and degree of the risk revealed by the

assessment required by the said regulation,

(ii) updated to take account of changing

circumstances.

(2) Where containers and pipes for hazardous chemical agents

used at work are not marked in accordance with Work Place

(Provision of Health and, or Safety Signs) Regulations, the

employer shall, without prejudice to any derogations provided for

in any such regulations, ensure that the contents of the containers

and pipes, together with the nature of those contents and any

associated hazards, are clearly identifiable.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

(1) To prevent the exposure of workers to health risks from

certain chemical agents and, or certain activities involving

chemical agents, the production, manufacture or use at work of the

chemical agents and the activities set out in Schedule III shall be

prohibited to the extent specified therein.

(2)

(a) The Minister may permit derogations from the

requirements of sub-regulation (1) in the following

circumstances

(i)

for the sole purpose of scientific research and

testing, including analysis,

(ii) for activities intended to eliminate chemical

agents that are present in the form of by-

products or waste products,

(iii) for the production of the chemical agents

referred to in sub-regulation (1) for use as

intermediates, and for such use.

(b) The exposure of workers to chemical agents referred to

in sub-regulation (1) must be prevented, in particular

by providing that the production and earliest possible

use of such chemical agents as intermediates must take

place in a single closed system, from which the

aforesaid chemical agents may be removed only to the

extent necessary to monitor the process or service the

system.

(c) The Minister may make regulations providing for

systems of individual authorisations.

(3) Derogations pursuant to sub-regulation (2) may be

per m it ted , af te r th e em p lo yer s u bm i ts to t he Au th or it y th e

following information

(a) the reason for requesting the derogation,

(b) the quantity of the chemical agent to be used annually,

(c) the activities and, or reactions or processes involved,

(d) the number of workers liable to be involved,

(e) the precautions envisaged to protect the health and

safety of workers concerned,

PROTECTION OF THE HEALTH AND SAFETY OF WORKERS

FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

(f)

the technical and organisational measures taken to

prevent the exposure of workers.

(4) The Minister may amend the list of prohibitions under sub-

regulation (1), to include further chemical agents or activities.

10.(1)(a) Without prejudice to each worker’s right, if he so

wishes, to receive health surveillance at regular

intervals, an employer shall make arrangements for

carrying out appropriate health surveillance of workers

for whom the results of the assessment referred to in

regulation 4 reveal a risk to health, and such health and

exposure records shall be m ade available to the

Authority.

(b) Health surveillance, the results of which shall be taken

into account in applying preventive measures in the

specific workplace, shall be appropriate where

(i)

the exposure of the worker to a hazardous

chemical agent is such that an identifiable

disease or adverse health effect may be related

to the exposure, and

(ii) there is a likelihood that the disease or effect

may occur under the particular conditions of the

worker’s work, and

(iii) the technique of investigation is of low risk to

workers.

(c) Furthermore, there shall be valid techniques for

detecting indications of the disease or effect.

(d) Where a prescribed biological limit value has been set

as indicated in Schedule II, health surveillance shall be

a compulsory requirement for work with the hazardous

chemical agent in question, in accordance with the

procedures in that schedule. Workers shall be informed

of this requirement before being assigned to the task

involving risk of exposure to the hazardous chemical

agent indicated.

(2) An employer shall ensure that for each worker who

undergoes health surveillance in accordance with the requirements

of sub-regulation (1), individual health and exposure records are

made and kept up-to-date.

(3)

(a) Health and exposure records shall contain a summary

of the results of health surveillance carried out and of

any monitoring data representative of the exposure of

the individual. Biological monitoring and related

requirements may form part of health surveillance.

(b) Health and exposure records shall be kept in a suitable

form so as to permit consultation at a later date, taking

into account any confidentiality.

(c) Copies of the appropriate records shall be supplied to

the Authority on request. The individual worker shall,

at his request, have access to the health and exposure

records relating to him personally.

(d) Where an undertaking ceases to trade, the health and

exposure records shall be made available to the

Authority, or to the worker concerned as the case may

be.

(4)

Where, as a result of health surveillance -

(a) a worker is found to have an identifiable disease or

adverse health effect which is considered by a doctor

or other competent person to be the result of exposure

at work to a hazardous chemical agent, or

(b) a binding biological limit value is found to have been

exceeded,

the worker shall be informed by the doctor or other competent

person of the result which relates to him personally, including

information and advice regarding any health surveillance which he

should undergo following the end of the exposure. The employer

shall

(i)

review the risk assessment made pursuant to

regulation 4(1),

(ii) review the measures provided to eliminate or

reduce risks pursuant to regulations 5 and 6,

(iii) take into account the advice of the competent

person or the Authority in implementing any

measures required to eliminate or reduce risk in

accordance with regulation 6, including the

possibility of assigning the worker to alternative

work where there is no risk of further exposure,

and

(iv) arrange continued health surveillance and

provide for a review of the health status of any

other worker who has been similarly exposed. In

such cases the doctor or competent person or the

Authority may propose that exposed persons

undergo a medical examination.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

Consultation and participation of workers and, or their

representatives on the matters covered by these regulations,

including the Schedules hereto, shall take place in accordance with

the General Provisions for Health and Safety at Work Places

Regulations.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

In any proceedings for an offence under these regulations

consisting of a failure to comply with a duty or requirement to do

something, or to do something so far as is reasonably practicable, it

shall be for the accused to prove (as the case may be) that it was not

practicable or not reasonably practicable to do more than was in

fact done to satisfy the duty or requirement, or that there was no

better practicable means than was in fact used to satisfy the duty or

requirement.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

The Authority may draw up practical guidelines of a non-

binding nature. These guidelines shall address the topics referred to

in regulations 3, 4, 5 and 6, and Schedule II, section 1.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

Any person who knowingly or recklessly interferes with

the process of providing a safe and healthy place of work shall be

guilty of an offence.

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

35

skin

200-579-1

64-18-6

Formic acid

-

-

-

200-580-7

64-19-7

Acetic acid

-

200-659-6

67-56-1

Methanol

-

-

skin

200-662-2

67-64-1

Acetone

-

-

-

200-663-8

67-66-3

Chloroform

-

-

skin

N,N-

200-679-5

68-12-2

Dimethylformamide

skin

200-756-3

71-55-6

1,1,1-Trichloroethane

-

200-817-4

74-87-3

Chloromethane

-

-

-

Hydrogen cyanide

200-821-6

74-90-8

(as cyanide)

0.9

4.5

skin

200-830-5

75-00-3

Chloroethane

-

-

-

200-834-7

75-04-7

Ethylamine

9.4

-

-

-

200-835-2

75-05-8

Acetonitrile

-

-

skin

Methylene chloride;

200-838-9

75-09-2

Dichloromethane

skin

200-843-6

75-15-0

Carbon disulphide

-

-

skin

200-863-5

75-34-3

1,1-Dichloroethane

-

-

skin

Vinylidene chloride;

200-864-0

75-35-4

1,1- Dichloroethylene

-

200-870-3

75-44-5

Phosgene

0.08

0.02

0.4

0.1

-

Chlorodifluoromethan

200-871-9

75-45-6

e

-

-

-

200-875-0

75-50-3

Trimethylamine

4.9

12.5

-

201-083-8

78-10-4

Tetraethyl orthosilicate

-

-

-

201-142-8

78-78-4

Isopentane

-

-

-

201-159-0

78-93-3

Butanone

-

201-176-3

79-09-4

Propionic acid

-

Acrylic acid; Prop-2-

59( 8 )

20( 8 )

201-177-9

79-10-7

enoic acid

-

201-188-9

79-24-3

Nitroethane

skin

Bisphenol A; 4,4’-

Isopropylidenedipheno

2( 9 )

201-245-8

80-05-7

l

-

-

-

-

201-297-1

80-62-6

Methyl methacrylate

-

-

-

201-865-9

88-89-1

Picric acid

0.1

-

-

-

-

202-049-5

91-20-3

Naphtalene

-

-

-

202-422-2

95-47-6

skin

o-Xylene

202-425-9

95-50-1

1,2-Dichlorobenzene

skin

1,2,4-

202-436-9

95-63-6

Trimethylbenzene

-

-

-

202-500-6

96-33-3

Methyl acrylate

-

2-Phenyl-propane

(Cumene) ( 15 )

202-704-5

98-82-8

skin

202-705-0

98-83-9

2-Phenylpropene

-

202-716-0

98-95-3

Nitrobenzene

0.2

-

-

skin

202-849-4

100-41-4

Ethylbenzene

skin

202-981-2

101-84-8

Diphenyl ether

-

203-234-3

104-76-7

2-Ethylhexan-1-ol

5.4

-

-

-

203-300-1

105-46-4

sec-Butylacetate

-

ε-Caprolactam (dust

203-313-2

105-60-2

and vapour)

-

-

-

203-388-1

106-35-4

Heptan-3-one

-

-

-

203-396-5

106-42-3

p-Xylene

skin

1,4-Dichlorobenzene;

203-400-5

106-46-7

p- Dichlorobenzene

skin

203-403-1

106-49-0

4-aminotoluene

4.46

8.92

skin

Acrolein;

Acrylaldehyde;

203-453-4

107-02-8

Prop-2-enal

0.05

0.02

0.12

0.05

-

203-470-7

107-18-6

Allyl alcohol

4.8

12.1

skin

203-473-3

107-21-1

Ethylene glycol

skin

203-481-7

107-31-3

Methyl formate

skin

203-539-1

107-98-2

1-Methoxy-2-propanol

skin

203-545-4

108-05-4

Vinyl acetate

17.6

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

2

skin

203-550-1

108-10-1

4-Methylpentan-2-one

-

203-576-3

108-38-3

skin

m-Xylene

203-585-2

108-46-3

Resorcinol

-

-

skin

2-Methoxy-1-

203-603-9

108-65-6

methylethyl acetate

skin

Mesitylene

203-604-4

108-67-8

(Trimethylbenzes)

-

-

-

203-625-9

108-88-3

Toluene

skin

203-628-5

108-90-7

Monochlorobenzene

-

203-631-1

108-94-1

Cyclohexanone

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

8

81.6

skin

203-632-7

108-95-2

Phenol

skin

203-692-4

109-66-0

Pentane

-

-

-

203-713-7

109-86-4

2-Methoxyethanol

-

-

-

skin

203-716-3

109-89-7

Diethylamine

-

203-726-8

109-99-9

Tetrahydrofuran

skin

203-737-8

110-12-3

5-Methylhexan-2-one

-

-

-

203-745-1

110-19-0

Isobutyl acetate

-

203-767-1

110-43-0

Heptan-2-one

skin

2-Methoxyethyl

203-772-9

110-49-6

acetate

-

-

-

skin

203-777-6

110-54-3

n-Hexane

-

-

-

203-788-6

110-65-6

But-2-yne-1,4-diol

0.5

-

-

-

-

203-804-1

110-80-5

2-Ethoxyethanol

-

-

skin

203-806-2

110-82-7

Cyclohexane

-

-

-

203-808-3

110-85-0

Piperazine

0.1

-

0.3

-

-

203-809-9

110-86-1

Pyridine

-

-

-

203-815-1

110-91-8

Morpholine

-

203-839-2

111-15-9

2-Ethoxyethyl acetate

-

-

skin

203-905-0

111-76-2

2-Butoxyethanol

skin

2-(2-

Methoxyethoxy)ethan

203-906-6

111-77-3

ol

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

1

-

-

skin

203-933-3

112-07-2

2-Butoxyethyl acetate

skin

2-(2-

203-961-6

112-34-5

Butoxyethoxy)ethanol

Laws of Malta — Subsidiary Legislation 646.16 — PROTECTION OF THE HEALTH AND SAFETY OF WORKERS FROM THE RISKS RELATED TO CHEMICAL AGENTS AT WORK

5

101.2

-

204-065-8

115-10-6

Dimethylether

-

-

-

1,2,4-

204-428-0

120-82-1

Trichlorobenzene

15.1

37.8

skin

204-469-4

121-44-8

Triethylamine

8.4

12.6

skin

204-633-5

123-51-3

Isoamyl alcohol

-

204-658-1

123-86-4

n-Butyl acetate

-

204-661-8

123-91-1

1,4-Dioxane

-

-

-

204-662-3

123-92-2

Isopentylacetate

-

204-696-9

124-38-9

Carbon dioxide

-

-

-

204-697-4

124-40-3

Dimethylamine

3.8

9.4

-

204-825-9

127-18-4

Tetrachloroethylene

skin

N,N-

204-826-4

127-19-5

Dimethylacetamide

skin

205-438-8

140-88-5

Ethyl acrylate

-

205-480-7

141-32-2

n-Butyl acrylate

-

205-483-3

141-43-5

2-Aminoethanol

2.5

7.6

skin

205-500-4

141-78-6

Ethyl acetate

-

205-563-8

142-82-5

-

-

-

n-Heptane

Sodium cyanide (as

205-599-4

143-33-9

cyanide)

-

-

skin

205-634-3

144-62-7

Oxalic acid

-

-

-

-

Potassium cyanide (as

205-792-3

151-50-8

cyanide)

-

-

skin

206-992-3

420-04-2

Cyanamide

0.58

-

-

skin

Diacetyl;

207-069-8

431-03-8

Butanedione

0.07

0.02

0.36

0.1

-

207-343-7

463-82-1

Neopentane

-

-

-

1,2,3-

208-394-8

526-73-8

Trimethylbenzene

-

-

-

5-Methylheptan-3-

208-793-7

541-85-5

one

-

210-866-3

624-83-9

Methyl isocyanate

-

-

-

0.02

-

1-Methylbutyl

210-946-8

626-38-0

acetate

-

211-047-3

628-63-7

Pentyl acetate

-

211-128-3

630-08-0

Carbon monoxide

-

n-Methyl-2-

212-828-1

872-50-4

pyrrolidone

skin

1( 10 )

4( 10 )

215-137-3

1305-62-0

Calcium dihydroxide

-

-

-

215-138-9

1305-78-8

Calcium oxide

1( )

-

4( )

-

-

Diphosphorus

215-236-1

1314-56-3

pentaoxide

-

-

-

-

Diphosphorus

215-242-4

1314-80-3

pentasulphide

-

-

-

-

215-293-2

1319-77-3

Cresols (all isomers)

-

-

-

Xylene, mixed

215-535-7

1330-20-7

isomers, pure

skin

Tert-Butyl methyl

216-653-1

1634-04-4

ether

183.5

-

222-995-2

3689-24-5

Sulphotep

0.1

-

-

-

skin

231-116-1

7440-06-4

Platinum (metallic)

-

-

-

-

231-131-3

7440-22-4

Silver, metallic

0.1

-

-

-

-

Silver (soluble

231-131-3

compounds as Ag)

0.01

-

-

-

-

231-195-2

7446-09-5

Sulphur dioxide

1.3

0.5

2.7

-

231-484-3

7580-67-8

Lithium hydride

-

-

0.02( )

-

-

231-595-7 7647-01-0

Hydrogen chloride

-

231-633-2

7664-38-2

Orthophosphoric acid

-

-

-

231-634-8

7664-39-3

Hydrogen fluoride

1.5

1.8

2.5

-

231-635-3

7664-41-7

Ammonia, anhydrous

-

Sulphuric acid mist

231-639-5

7664-93-9

(11)(12)

0.05

-

-

-

-

231-714-2

7697-37-2

Nitric acid

-

-

2.6

-

231-778-1

7726-95-6

Bromine

0.7

0.1

-

-

-

231-954-8

7782-41-4

Fluorine

1.58

3.16

-

231-959-5

7782-50-5

Chlorine

-

-

1.5

0.5

-

231-977-3

7783-06-4

Hydrogen sulphide

-

231-978-9

7783-07-5

Dihydrogen selenide

0.07

0.02

0.17

0.05

-

232-260-8

7803-51-2

Phosphine

0.14

0.1

0.28

0.2

-

Pyrethrum (purified

of sensitising

232-319-8

8003-34-7

lactones)

-

-

-

-

Phosphoryl

233-046-7

10025-87-3

trichloride

0.064

0.01

0.12

0.02

-

Phosphorus

233-060-3

10026-13-8

pentachloride

-

-

-

-

233-113-0 10035-10-6

Hydrogen bromide

-

-

6.7

-

Nitrogen

monoxide( 13 )

233-271-0 10102-43-9

2.5

-

-

-

233-272-6 10102-44-0

Nitrogen dioxide

0.96

0.5

1.91

-

247-852-1

26628-22-8

Sodium azide

0.1

-

0.3

-

skin

(2-Methoxy-

methylethoxy)-

252-104-2

34590-94-8

propanol

-

-

skin

Terphenyl,

262-967-7

61788-32-7

hydrogenated

-

620-11-1

3-Pentylacetate

-

625-16-1

Amylacetate, tert

-

Fluorides, inorganic

2.5

-

-

-

-

Barium (soluble

compounds as Ba)

0.5

-

-

-

-

Chromium Metal,

Inorganic Chromium

-

-

-

-

(II) Compounds and

Inorganic Chromium

(III) Compounds

(insoluble)

Tin (inorganic

compounds as Sn)

-

-

-

Mercury and divalent

inorganic mercury

compounds including

mercuric oxides and

0.02

mercuric chloride

(measured

as mercury) ( 14 )

Manganese and

inorganic manganese

0.2 ( 9 )

compounds (as

0.05( 10 )

manganese)

( 1 ) EC No: European Community (EC) number, the numerical identifier for substances within the European Union.

( 2 ) CAS No: Chemical Abstract Service Registry Number.

( 3 ) A skin notation assigned to the occupational exposure limit value indicates the possibility of significant uptake

through the skin.

( 4 ) Measured or calculated in relation to a reference period of eight-hours as a time-weighted average.

( 5 ) Short-term exposure limit (STEL). A limit value above which exposure should not occur and is related to a 15-

minute period, unless otherwise specified.

( 6 ) mg/m 3: milligrams per cubic metre of air at 20 °C and 101.3 KPa.

( 7 ) ppm: parts per million by volume in air (ml/m3).

( 8 ) Short-term exposure limit value in relation to a reference period of 1 minute.

( 9 ) Inhalable fraction.

( 10 )Respirable fraction.

( 11 )When selecting an appropriate exposure monitoring method , account should be taken of potential limitations

and interferences that may arise in the presence of other sulphur compounds.

( 12 )The mist is defined as the thoracic fraction.

( 13 )Established in accordance with the Annex to Directive.

( 14 )During exposure monitoring for mercury and its divalent inorganic compounds, account should be taken of

relevant biological monitoring techniques that complement the OELV.

( 15 )During exposure monitoring, account should be taken of relevant biological monitoring values as suggested by

the Scientific Committee on Occupational Exposure Limits for Chemical Agents (SCOEL).

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