PROTECTION OF WORKERS FROM
THE RISKS RELATED TO EXPOSURE TO 
CARCINOGENS OR MUTAGENS AT WORK [S.L.424.22 1
SUBSIDIARY LEGISLATION 424.22
PROTECTION OF WORKERS FROM THE RISKS 
RELATED TO EXPOSURE  TO CARCINOGENS OR 
MUTAGENS AT WORK REGULATIONS
16th May, 2003
LEGAL NOTICE 122 of 2003, as amended by Legal Notice 197 of 2015 ,
318 of 2019 and 51 of 2021.
Citation, scope and 
application.
Amended by:L.N. 318 of 2019;
L.N. 51 of 2021.1. (1) The title of these regulations is the Protection of
Workers from the Risks related to Exposure to Carcinogens or
Mutagens at Work Regulations.
(2) These regulations aim to protect workers against risks to
their health and safety, including the prevention of such risks ,
arising or likely to arise from exposure to carcinogens or muta gens
at work, and lay down minimum requirements in this area,
including limit values.
(3) These regulations shall apply to activities in which workers
are or are likely to be exposed to carcinogens or mutagens as aresult of their work.
(4) As regards asbestos, insofar as any provisions in these
regulations are more favourable t o safety and health at work th an
any other provision contained in regulations dealing with asbes tos,
these regulations shall apply.
(5) These regulations shall not apply to workers exposed only
to radiation insofar as such issu e is regulated under any other
regulation or legislative provision.
(6) The scope of these regulations is to transpose:
(a) Directive 2014/27/EU of the European Parliament and
of the Council of 26 February 2014 amending CouncilDirectives 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 themto Regulation (EC) No 1272/2008 on classification,
labelling and packaging of  s u b s t a n c e s  a n d  m i x t u r e s ;
and
(b) Directive 2017/2398 of the European Parliament and of
the Council of 12 Decembe r 2017 amending Council
Directive 2004/37/EC on the protection of workersfrom the risks related to exposure to carcinogens or
mutagens at work; and
(c) Directive 2019/130 of the European Parliament and of
the Council of 16 January 2019 amending CouncilDirective 2004/37/EC on the protection of workers
from the risks related to exposure to carcinogens or
mutagens at work; and
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(d) Directive 2019/983 of the European Parliament and of
the Council of 5 June 2019 amending Council Directive2004/37/EC on the protection of workers from the risks
related to exposure to carcinogens or mutagens at work.
Interpretation.
Amended by:
L.N. 197 of 2015.2. In these regulations, unless t he context otherwise requires:
"Act" means the Occupational H ealth and Safety Authority Act;
"Authority" means the Occupational Health and Safety Authority
established by article 8 of the Act;
"carcinogen" means:
(a) a  s u b s t a n c e  o r  m i x t u r e  w h i ch meets the criteria for
classification as a categor y 1A or 1B carcinogen set
out in Annex I to Regulation (EC) No 1272/2008 of
the European Parliament and of the Council;
(b)(deleted by L.N. 197 of 2015 );
(c) a substance, preparation or process referred to in
Annex I as well as a substance or preparation released
by a process referred to in Annex I;
"doctor" means a medical practitioner, specialised in internal or
oncological medicine , who is appointed by an employer to examin e
workers exposed to car cinogens or mutagens;
"limit value" means, unless ot herwise specified, the limit of t he
time-weighted average of the concentration for a carcinogen ormutagen in the air within the br eathing zone of a worker in rel ation
to a specified period as  set out in Schedule III;
"mutagen" means:
(a) a  s u b s t a n c e  o r  m i x t u r e  w h i ch meets the criteria for
classification as a category 1A or 1B germ cell
mutagen set out in Annex I to Regulation (EC) No
1272/2008 of the European Parliament and of theCouncil;
(b)(deleted by L.N. 197 of 2015 ).
Determination of 
risks.3. (1) In the case of any activity likely to involve a risk of
exposure to carcinogens or mutagens the nature degree andduration of workers’ exposure must be determined in order to ma ke
it possible to assess any risk t o the workers’ health or safety  and to
lay down the measures to be taken.
The assessment must be renewe d regularly and in any event
when any change occurs in th e conditions which may affect
workers’ exposure to carcinogens or mutagens.
The employer must supply the Authority at its request with
the information used for  making the assessment.
(2) When assessing the risk, account shall be taken of all other
routes of exposure, such as absorption into and, or through the  skin.
(3) When the assessment referred to in this regulation is carrie d
out, an employer shall give particular attention to any effects
PROTECTION OF WORKERS FROM
THE RISKS RELATED TO EXPOSURE TO 
CARCINOGENS OR MUTAGENS AT WORK [S.L.424.22 3
concerning the health or safety of workers at particular risk a nd
shall, inter alia , take account of the desirability of not employing
such workers in areas where they may come into contact with
carcinogens or mutagens.
Reduction and 
replacement.
Amended by:L.N. 197 of 2015.4. (1) The employer shall reduce the use of a carcinogen or
mutagen at the place of work, in particular by replacing it, in  so far
as is technically possible, by a substance, mixture or process which,
under its conditions of use, is not dangerous or is less danger ous to
workers’ health or safet y, as the case may be.
(2) The employer shall, upon request, submit the findings of
his investigations to the Authority.
Prevention and 
reduction of 
exposure.
Amended by:L.N. 197 of 2015.5. (1) Where the results of the assessment referred to in
regulation 3 reveal a risk to workers’ health or safety, worker s’
exposure must be prevented.
(2) Where it is not technical ly possible to replace the
carcinogen or mutagen by a substa nce, mixture or process which,
under its conditions of use, is not dangerous or is less danger ous to
health or safety, the employer s hall ensure that the carcinogen  or
the mutagen is, in so far as is technically possi ble, manufactu red
and used in a closed system.
(3) Where a closed system is not technically possible, the
employer shall ensure that the level of exposure of workers is
reduced to as low a level a s is technically possible.
(4) Exposure shall not exceed the  limit values as set out in
Schedule III.
(5) Wherever a carcinogen or mutagen is used, the employer
shall apply all the following measures:
(a) limitation of the quantities of a carcinogen or mutagen
at the place of work;
(b) keeping as low as possible the number of workers
exposed or likely to be exposed;
(c) design of work processes and engineering control
measures so as to avoid or minimize the release of
carcinogens or mutagens  into the place of work;
(d) evacuation of carcinogens o r mutagens at source, local
extraction system or general ventilation, all suchmethods to be appropriate and compatible with the
need to protect public health and the environment;
(e) use of existing appropriate procedures for the
measurement of carcinogens or mutagens, in particular
for the early detection of a bnormal exposures resulting
from an unforeseeable event or an accident;
(f) application of suitable working procedures and
methods;
(g) collective protection measures and, or, where exposure
cannot be avoided by other means, individual
protection measures;
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(h) hygiene measures, in particular regular cleaning of
floors, walls and  other surfaces;
(i) information for workers;
(j) demarcation of risk areas and use of adequate warning
and safety signs including ‘no smoking’ signs in areas
where workers are exposed or likely to be exposed to
carcinogens or  mutagens;
(k) drawing up plans to deal with emergencies likely to
result in abnormally high exposure;
(l) means for safe storage, handling and transportation, in
particular by using sealed and clearly and visiblylabelled containers;
(m) means for safe collection, storage and disposal of
waste by workers, including the use of sealed and
clearly and visibly l abelled containers.
Information for the 
Authority.
Amended by:L.N. 197 of 2015.6. Where the results of the assessment referred to in
regulation 3 reveal a risk to workers’ health or safety, an emp loyer
shall, when requested, make available to the Authority appropri ate
information on:
(a) the activities and, or indust rial processes carried out,
including the reasons for which carcinogens or
mutagens are used;
(b) the quantities of substances or mixtures manufactured
or used which contain carcinogens or mutagens;
(c) the number of workers exposed;
(d) the preventive measures taken;
(e) the type of protective equipment used;
(f) the nature and degree of exposure;
(g) the cases of replacement.
Unforeseen 
exposure.7. (1) In the event of an unforeseeable event or an accident
which is likely to result in an abnormal exposure of workers, t he
employer shall inform the workers thereof.
(2) Until the situation has been restored to normal and the
causes of the abnormal exposure have been eliminated:
(a) only those workers who are essential to the carrying
out of repairs and other necessary work shall be
permitted to work in  the affected area;
(b) the workers concerned shall be provided with
protective clothing and individual respiratoryprotection equipment whic h they must wear; the
exposure may not be permanent and shall be kept to
the strict minimum of time  necessary for each worker;
(c) unprotected workers shall not be allowed to work in
the affected area.
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Foreseeable 
exposure.8. (1) For certain activities such  as maintenance, in respect of
which it is foreseeable that ther e is the potential for a signi ficant
increase in exposure of workers, and in respect of which all sc ope
for further technical preventive measures for limiting workers’
exposure has already been exhausted, the employer shall determi ne,
after consultation of the workers  and, or their representatives  in the
undertaking or establishment, without prejudice to the employer ’s
responsibility, the measures necessary to reduce the duration o f
workers’ exposure to the minimum possible and to ensure
protection of workers while they are engaged in such activities .
(2) Pursuant to subregulation (1), the workers concerned shall
be provided with protective clothing and individual respiratory
protection equipment which they must wear as long as theabnormal exposure persists; th at exposure may not be permanent
and shall be kept to the stric t minimum of time necessary for e ach
worker.
(3) Appropriate measures shall be taken to ensure that the areas
in which the activities referred to in subregulation (1) take p lace
are clearly demarcated and indica ted or that unau thorized perso ns
are prevented by oth er means from having access to such areas.
Access to risk 
areas.9. Appropriate measures shall be taken by employers to
ensure that access to areas in which the activities in respect of
which the results of the assessment referred to in regulation 3
reveal a risk to workers’ safety or health take place are acces sible
solely to workers who, by reason  of their work or duties, are
required to enter them.
Personal hygiene 
and individual 
protection.10. (1) Employers shall be obliged, in the case of a ll activities
for which there is a risk of contamination by carcinogens or
mutagens, to take appropriate measures to ensure that:
(a) workers do not eat, drink or smoke in working areas
where there is a risk of c ontamination by carcinogens
or mutagens;
(b) workers are provided w ith appropriate protective
clothing or other appropr iate special clothing;
(c) separate storage places are provided for working or
protective clothing and  for street clothes;
(d) workers are provided w ith appropriate and adequate
washing and toilet facilities;
(e) protective equipment is properly stored in a well-
defined place; it is checked and cleaned if possible
before, and in any case after each use; defective
equipment is repaired or r eplaced before further use.
(2) Workers may not be charged fo r the cost of these measures.
Information and 
training of 
workers.11. (1) Appropriate measures shall be taken by the employer
to ensure that workers and, or workers’ representatives in the
undertaking or establishment receive sufficient and appropriatetraining, on the basis of all available information, in particu lar in
the form of information and instructions, concerning:
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(a) potential risks to health, including the additional risks
due to tobacco  consumption;
(b) precautions to be taken  to prevent exposure;
(c) hygiene requirements;
(d) wearing and use of protectiv e equipment an d clothing;
(e) steps to be taken by wo rkers, including rescue
workers, in the case of incidents and to prevent
incidents.
The training shall be:
- adapted to take account of new or changed risk,
and
- repeated periodically if necessary.
(2) Employers shall inform workers of installations and related
containers containing carcinogens  or mutagens, ensure that all
containers, packages and installa tions containing carcinogens a nd
mutagens are labelled clearly and legibly, and display clearly
visible warning and hazard signs.
Information for 
workers.12. Appropriate measures shall  be taken to ensure that: 
(a) workers and, or any workers’ representatives in the
undertaking or establishm ent can check that these
regulations are applied or can be involved in its
application, in particular with regard to:
(i) the consequences for workers’ safety and health
of the selection, wearing and use of protectiveclothing and equipment, without prejudice to the
employer’s responsibility for determining the
effectiveness of pro tective clothing and
equipment;
(ii) the measures determined by the employer which
are referred to in regulation 8(1), without
prejudice to the employer’s responsibility fordetermining such measures;
(b) workers and, or any workers’ representatives in the
undertaking or establishment are informed as quickly
as possible of abnormal exposures, including thosereferred to in regulation 8,  of the causes thereof and of
the measures taken or to be taken to rectify the
situation;
(c) the employer keeps an up-to-date list of the workers
engaged in the activities in respect of which the results
of the assessment referred to in regulation 3 reveal arisk to workers’ health or safety, indicating, if the
information is available, the exposure to which they
have been subjected;
(d) the doctor and, or the Auth ority as well as all other
persons who have responsibility for health and safety
at work at the employer’s workplace have access to the
PROTECTION OF WORKERS FROM
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list referred to in paragraph ( c);
(e) each worker has access to the information on the list
which relates to him personally;
(f) workers and, or any workers’ representatives in the
undertaking or establishment have access to
anonymous collective information.
Consultation and 
participation of 
workers.13. (1) Employers shall consult workers and, or their
representatives and allow them to take part in discussions on a ll
questions relating to safety and health at work. This presuppos es:
- the consultation of workers,
- the right of workers and, or their representatives to
make proposals,
S.L. 424.18 - balanced participation in accordance with the General
Provisions for Health and  Safety at Work Places
Regulations.
(2) Workers or workers’ rep resentatives with specific
responsibility for the safety an d health of workers shall take part in
a balanced way, in accordance with applicable laws and, orpractices, and shall be consulted in advance and in good time b y the
employer with regard to:
(a) any measure which may substantially affect safety and
health;
(b) the designation of worker or workers which the
employer is obliged to designate to carry out activities
related to the protection and prevention of
occupational risks for the undertaking and, orestablishment and the work ers which the employer is
obliged to designate to implement measures inter alia ,
for first aid, fire-figh ting and the evacuation of
workers, and the activities related to the protection and
prevention of occupational risks;
(c) the following information:
(i) an assessment of the risks to safety and health at
work, including those facing groups of workersexposed to particular risks;
(ii) the protective measur es to be taken and, if
necessary, the protective equipment to be used;
(iii) a list of occupational accidents resulting in a
worker being unfit for work for more than threeworking days;
(iv) reports on occupational accidents suffered by his
workers;
(v) the safety and health r isks and protective and
preventive measures and act ivities in respect of
both the undertaking and, or establishment in
general and each type of workstation and, or job;
(vi) the measures taken in re lation to first aid, fire-
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fighting and the evacuation of workers;
(vii) the appropriate measures taken so that
employers of workers from any outsideundertakings and, or establishments engaged in
work in his undertaking and, or establishment
receive adequate information concerning thepoints referred to  in subparagraphs (v) and (vi);
(viii) the appropriate measur es taken so that workers
with specific functions in protecting the safety
and health of workers, or workers’
representatives with specific responsibility for
the safety and health of workers may be able tohave access, to car ry out their functions and to:
- the risk assessment and protective measures
referred to in subparagraphs (v) and (vi);
- the list and reports referred to in
subparagraphs (iii) and (iv);
- the information yielded by protective and
preventive measures, inspection agencies
and bodies responsible for safety and
health;
(d) the enlistment, where appropriate, of the competent
services or persons outside the undertaking and, or
establishment, where such protective and preventive
measures cannot be organized for lack of competentpersonnel in the undertaking and, or establishment;
(e) the planning and organization of the training to each
worker regarding adequate s afety and health training,
in particular in the form of information andinstructions specific to his workstation or job:
- on recruitment,
- in the event of a transfer or a change of job,- in the event of the introduction of new work
equipment or a change in equipment,
- in the event of the introduction of any new
technology.
(3) Workers’ representatives with specific responsibility for th e
safety and health of workers shall have the right to ask theemployer to take appropriate measures and to submit proposals t o
him to that end to mitigate hazards for workers and, or to remo ve
sources of danger.
(4) The workers referred to in subregulation (2) and the
workers’ representatives referred to in subregulations (2) and (3)
may not be placed at a disadvantage because of their respective
activities referred to in su bregulations (2) and (3).
(5) Employers must allow work ers’ representatives with
specific responsibility for the safety and health of workers ad equate
time off work, without loss of pay, and provide them with the
PROTECTION OF WORKERS FROM
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necessary means to enable such rep resentatives to exercise thei r
rights and functions.
(6) Workers and, or their representatives are entitled to appeal
to the Authority if they consider that the measures taken and t he
means employed by the employer are inadequate for the purposes
of ensuring safety and health at work. Workers’ representatives
must be given the opportunity to submit their observations duri ng
inspection visits by the Authority.
Health 
surveillance.
Amended by:
L.N. 318 of 2019.14. (1) The employer shall make arrangements for carrying out
relevant health surveillance of workers for whom the results of  the
assessment referred to in regulation 3 reveal a risk to health or safety.
The doctor or Authority may indi cate that health surveillance m ust
continue after the end of exposure for as long as they consider  it to be
necessary to safeguard the health of the worker concerned.
(2) ( a) The arrangements referred to in subregulation (1) shall
be such that each worker shall be able to undergo, if
appropriate, relevant health surveillance:
- prior to exposure,
- at regular intervals thereafter.
(b) Those arrangements shall be such that it is directly
possible to implement individual and occupationalhygiene measures.
(3) If a worker is found to be suffering from an abnormality
which is suspected to be the res ult of exposure to carcinogens or
mutagens, the doctor or the Authority may require other workers
who have been similarly exposed t o undergo health surveillance.  In
that event, a reassessment of th e risk of exposure shall be car ried
out in accordance wi th regulation 3.
(4) In cases where health surveillance is carried out, an
individual medical record shall be kept and the doctor or the
Authority shall propose any prot ective or preventive measures t o be
taken in respect of any individual workers.
(5) Information and advice must be given to workers regarding
any health surveillance which they may undergo following the en d
of exposure.
(6) Workers shall have access to the results of the health
surveillance which con cern them, and the workers co ncerned or t he
employer may request a review of the results of the health
surveillance.
(7) Practical recommendations fo r the health surveillance of
workers are given in Schedule II.
(8) All cases of cancer identifie d in accordance with applicable
laws and, or practice as resulting from occupational exposure t o a
carcinogen or mutagen shall be  notified to the Authority.
Record keeping. 15. (1) The list referred to in regulation 12( c) and the medical
records referred to in regulation 14(4) shall be kept for at le ast forty
years following the end of exposure.
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(2) Those documents shall be made available to the Authority
in cases where the unde rtaking ceases activity.
Limit values. 16. Limit values and other direc t l y  r e l a t e d  p r o v i s i o n s  a r e  s e t
out in Schedule III.
Onus of proof. 17. 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 practicab le, 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 i n
fact done to satisfy the duty or r equirement, or that there was  no
better practicable means than was  in fact used to satisfy the d uty or
requirement.
Offences. 18. Any person who knowingly or recklessly interferes with
the process of providing a safe and healthy place of work, shal l be
guilty of an offence.
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List of substances, mixtures and processes
1. Manufacture of auramine.2. Work involving exposure to polycyclic aromatic hydrocarbons p resent in
coal soots, coal tar or coal pitch.
3. Work involving exposure to dusts, fumes and sprays produced d uring the
roasting and electro-refini ng of cupro-nickel mattes.
4. Strong acid process in the manufacture of isopropyl alcohol.5. Work involving exposure to hardwood dust.
6. Work involving exposure to respirable crystalline silica dust  generated by work
process
SCHEDULE II
(Regulation 14 (7))
Practical recommendati ons for the health surveillance of worker s 
1. The doctor must be familiar with the exposure conditions or c ircumstances
of each worker.
2. Health monitoring of workers must be carried out in accordanc e with the
principles and practi ces of occupational medicine; it must incl ude at least the
following measures:
- keeping records of a worker’s medical and occupational history ,
- a personal interview,- where appropriate, biological m onitoring, as well as detection  of early
and reversible effects.
Further tests may be decided upon  for each worker when he is th e subject of
health monitoring, in the light of the most recent knowledge av ailable to
occupational medicine.Amended by:
L.N. 197 of 2015;
L.N. 318 of 2019.SCHEDULE I
[Regulation 2( c)]
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Amended by:
L.N. 197 of 2015;
L.N. 318 of 2019.
Substituted by:L.N. 51 of 2021.SCHEDULE III
(Regulation 16)
Limit values and other directly related provisions 
Limit values for occupational exposure

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