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Occupational Health And Safety Authority Act (Cap. 424) Protection Of The Health And Safety Of Workers From The Risks Related To Chemical Agents At Work Regulations, 2003. (L.N. 227 Of 2003 )

concerned, the provisions of these regulations shall apply without prejudice to more stringent and/or specific provisions contained in any other law or regulation.
2. In these regulations, unless the context otherwise requires: Interpretation
‘Act’ means the Occupational Health and Safety Authority Act ; Cap. 424
‘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 article 8 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:
(i) any chemical agent which meets the criteria for classification as a dangerous substance listed in Schedule IV;
(ii) any chemical agent which meets the criteria for classification as a dangerous preparation within the meaning of Directive
88/379/EEC, whether or not that preparation is classified under that Directive, other than those preparations which only
meet the criteria for classification as dangerous for the environment;
(iii) any chemical agent which, whilst not meeting the criteria for classification as dangerous in accordance with (i) may, because of its physicochemical, chemical or toxicological properties and the way it is used or is present in the workplace, present a risk to the health and safety of workers, including any chemical agent assigned an 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.
3. The occupational exposure limit values for chemical agents shall be those listed in Schedule V to these regulations, and others which may be prescribed from time to time.

Occupational exposure limits and biological limit

values

4. (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,

Determination and assessment of risk of hazardous chemical agents

- 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:
(i) their hazardous properties;
(ii) information on health and safety provided by the supplier, 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, 2003 (L.N.
36 of 2003);
(iii) the level, type and duration and frequency of exposure;
(iv) the circumstances of work involving such agents, including their amount;
(v) any occupational exposure limit values or biological limit values established on the territory of Malta;
(vi) the effect of preventive measures taken or to be taken,
(vii) 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) paragraphs (e) to (h) of this regulation, and shall identify which measures have been taken in accordance with regulations 5 and 6 of these regulations. The risk assessment shall be documented in a suitable form according to national law and practice, and may include 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 kept 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.
5. (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.

General principles for the prevention of risks

(2) An employer shall implement the measures referred to in the first paragraph of subregulation (1) on the basis of the requirements of subarticle 6 (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 subregulations (1) and (2) of this regulation are sufficient to reduce that
risk, the provisions of Regulations 6, 7 and 10 shall not apply.
6. (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.

Specific measures

(2) (a) In applying paragraph 1, substitution shall by preference be undertaken, whereby the employer shall avoid the use of a hazardous chemical agent by 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 subregulation (2) of this regulation 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 subregulation (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 subregulation (4) of this regulation 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 control of plant, equipment and machinery or provision of explosion suppression equipment or explosion pressure relief arrangements.
7. (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 take place in accordance with the Work Place (First Aid) Regulations 2002), the Work Place (Minimum Health and Safety Requirements) Regulations, 2002 and the
Work Place (Provision of Health and/or Safety Signs) Regulations 2002.

Arrangements to deal with accidents, incidents and emergencies

(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 paragraph, 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 signal 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 external 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.
8. (1) Without prejudice to the General Provisions for Health and
Safety at Work Places Regulations, 2003 concerning the information and training of workers, the employer shall ensure that:

Information and training for workers

(i) workers and, or their representatives are provided with:
a) the data obtained pursuant to Regulation 4 of these Regulations, and further informed whenever a major alteration at the workplace leads to a change in these data,
b) 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,
c) training and information on appropriate precautions and actions to be taken in order to safeguard themselves and other workers at the workplace,
d) access to any safety data sheet provided by the supplier;
and
(ii) the information is:
(a) provided in a manner appropriate to the outcome of the risk assessment pursuant to Regulation 4 of these Regulations. 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,
(b) 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 2002, 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.
9. (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.

Prohibitions

(2) (a) The Minister may permit derogations from requirements of subregulation (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 subregulation (1) for use as intermediates, and for such use.
(b) The exposure of workers to chemical agents referred to in subregulation (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 paragraph 2 may be permitted, after the employer submits to the Authority the 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,
f) the technical and organisational measures taken to prevent the exposure of workers.
(4) The Minister may amend the list of prohibitions under subregulation
(1) of this regulation, 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 of these Regulations reveal a risk to health, and such health and exposure
records shall be made available to the Authority.

Health surveillance

(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 subregulation (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.
11. 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, 2002.

Consultation and participation of workers

12. 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.

Onus of proof

13. 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.

Technical guidance

( 1 ) EINECS: European Inventory of Existing Commercial Chemical Substances.

( 2 ) CAS: Chemical Abstracts Service.

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

( 4 ) A limit value above which exposure should not occur, and which is related to a 15 minute

period unless otherwise specified.

( 5 ) mg/m 3 = milligrams per cubic metre of air at 20 HC and 101,3 kPa.

( 6 ) ppm = parts per million by volume in air (ml/m 3 ).

1. Lead and its ionic compounds
1.1. Biological monitoring must include measuring the blood-lead level (PbB) using absorption spectrometry or a method giving equivalent results. The binding biological limit value is:
70 µg Pb/100 ml blood
1.2 Medical surveillance is carried out if:
- exposure to a concentration of lead in air is greater than 0,075 mg/m 3 , calculated as a time-weighted average over 40 hours per week, or
- a blood-lead level greater than 40 lg Pb/100 ml blood is measured in individual workers.
1.3 Practical guidelines for biological monitoring and medical surveillance must be developed in accordance with regulation 13. These must include recommendations of biological indicators (e.g. ALAU, ZPP, ALAD) and biological monitoring strategies.

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

(b) Work activities
None.

The following are 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 preparations 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.