PROTECTION OF WORKERS FROM THE RISKS RELATED TO EXPOSURE TO CARCINOGENS, MUTAGENS OR REPROTOXIC SUBSTANCES AT

P R O T E C T I O N O F W O R K E R S THE RISKS RELATED

TO EXPOSURE TO CARCINOGENS, MUTAGENS OR

REPROTOXIC SUBSTANCES AT W O RK

SUBSIDIARY LEGISLATION 424.22

PROTECTION OF WORKERS FROM THE RISKS

RELATED TO EXPOSURE TO CARCINOGENS,

MUTAGENS OR REPROTOXIC SUBSTANCES AT

WORK REGULATIONS *

16th May, 2003

LEGAL NOTICE 122 of 2003, as amended by Legal Notice 197 of 2015 ,

318 of 2019, 51 of 2021 and 102 of 2024 and Act XXXIII of 2024.

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

Wor ker s f r om the Risks related to Exposure to Carcinogens,

Mutagens or Reprotoxic Substances at Work Regulations.

(2) These regulations have as their objective the protection of

workers against risks to their health and safety, arising from or are

likely to result from exposure to carcinogens, mutagens or reprotoxic

substances at the workplace, including prevention of such risks.

(3) These regulations shall apply to activities in which workers

are or are likely to be exposed to carcinogens, mutagens or reprotoxic

substances as a result of their work.

(4) As regards asbestos, insofar as any provisions in these

regulations are more favourable to safety and health at work than

any other provision contained in regulations dealing with asbestos,

these regulations shall apply.

(5) These regulations shall not apply to workers exposed only

to radiation insofar as such issue is regulated under any other

regulation or legislative provision.

(6)

The purpose of these regulations is to transpose

(a) Directive 2004/37/EC of the European Parliament and

of the Council of 29 April 2004 on the protection of

workers from the risks related to exposure to

carcinogens, mutagens or reprotoxic substances at

work (Sixth individual Directive within the meaning of

Article 16(1) of Council Directive 89/391/EEC); and

(b) 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

with Regulation (EC) No 1272/2008 on classification,

labelling and packaging of substances and mixtures;

and

(c) Directive (EU) 2017/2398 of the European Parliament

and of the Council of 12 December 2017 amending

Directive 2004/37/EC on the protection of workers

*These regulations have been transferred to Cap. 646. Vide S.L. 646.14 and Act

XXXIII of 2024.

REPROTOXIC SUBSTANCES AT W O R K

from the risks related to exposure to carcinogens or

mutagens at work; and

(d) Directive (EU) 2019/130 of the European Parliament

and of the Council of 16 January 2019 amending

Council Directive 2004/37/EC on the protection of

workers from the risks related to exposure to

carcinogens or mutagens at work; and

(e) Directive (EU) 2019/983 of the European Parliament

and of the Council of 5 June 2019 amending Directive

2004/37/EC on the protection of workers from the

risks related to exposure to carcinogens or mutagens at

work; and

(f)

Directive (EU) 2022/431 of the European Parliament and

of the Council of 9 March 2022 amending Directive 2004/

37/EC on the protection of workers from the risks related

to exposure to carcinogens or mutagens at work.

Amended by

L.N. 197 of 2015;

[Regulation 2(c)]

L.N. 318 of 2019.

List of substances, mixtures and processes

1. Manufacture of auramine.

2. Work involving exposure to polycyclic aromatic hydrocarbons present in

coal soots, coal tar or coal pitch.

3. Work involving exposure to dusts, fumes and sprays produced during the

roasting and electro-refining 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

In these regulations, unless the context otherwise requires

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

"Authority" means the Occupational Health and Safety Authority

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

"carcinogen" means

(a) a substance or mixture which meets the criteria for

classification as a category 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);

(ba) "reprotoxic substance" means a substance or mixture,

which meets the criteria for classification as a category

1A or 1B reproductive toxicant set out in Annex I to

Regulation (EC) No 1272/2008 of the European

Parliament and of the Council of 16 December 2008 on

classification, labelling and packaging of substances

and mixtures, amending and repealing Directives 67/

548/EEC and 1999/45/EC, and amending Regulation

(EC) No 1907/2006;

(bb) "non-threshold reprotoxic substance" means a

reprotoxic substance to which there is no safe level of

exposure for workers’ health and which is identified as

such in the notation column of Schedule III;

(bc) "threshold reprotoxic substance" means a reprotoxic

substance for which a safe level of exposure exists below

which there is no risk to workers’ health and which is

identified as such in the notation column of Schedule III;

(c) a substance, preparation or process referred to in

P R O T E C T I O N O F W O R K E R S THE RISKS RELATED

TO EXPOSURE TO CARCINOGENS, MUTAGENS OR

REPROTOXIC SUBSTANCES AT W O RK

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 examine

workers exposed to carcinogens or mutagens;

"health surveillance" means the assessment of an individual worker

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

exposure to specific carcinogens, mutagens or reprotoxic substances at

work.

"limit value" means, unless otherwise specified, the limit of the

time-weighted average of the concentration for a carcinogen, mutagen

or reprotoxic substance in the air within the breathing zone of a worker

in relation to a specified reference period as set out in Schedule III;

"mutagen" means

(a) a substance or mixture which 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 the

Council;

(b) (deleted by L.N. 197 of 2015).

Amended by

L.N. 102 of 2024.

(Regulation 14 (7))

Practical recommendations for the health surveillance of workers

1. The doctor and, or authority responsible for the health surveillance of workers

exposed to carcinogens, mutagens or reprotoxic substances shall be familiar with the

exposure conditions or circumstances of each worker.

2. Health monitoring of workers must be carried out in accordance with the

principles and practices of occupational medicine; it must include at least the

following measures

-

keeping records of a worker’s medical and occupational history,

-

a personal interview,

-

where appropriate, biological monitoring, as well as detection of early

and reversible effects.

Further tests may be decided upon for each worker when he is the subject of

hea lt h m on it ori ng , i n th e li gh t o f th e m ost rece nt k no wl ed ge av ailable to

occupational medicine.

REPROTOXIC SUBSTANCES AT W O R K

(1)

In the case of any activity likely to involve a risk of

exposure to carcinogens, mutagens or reprotoxic substances, the

nature, degree and duration of workers’ exposure shall be determined

in order to make it possible to assess any risk to the workers’ health or

safety and to lay down the measures to be taken. The assessment shall

be renewed regularly and in any event when any change occurs in the

conditions which may affect workers’ exposure to carcinogens,

mutagens or reprotoxic substances. 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 risk assessment is carried out, employers shall give

particular attention to any effects concerning the health or safety of

workers at particular risk and shall, inter alia, take account of the

desirability of not employing such workers in areas where they may

come into contact with carcinogens, mutagens or reprotoxic

substances.

Amended by

L.N. 197 of 2015;

(Regulation 16)

L.N. 318 of 2019.

Limit values and other directly related provisions

Substituted by

L.N. 51 of 2021;

Limit values for occupational exposure

L.N. 102 of 2024.

Name of agent

EC No CAS No

Limit values

Notation

Transitional

measures

( 1 )

( 2 )

8 hours ( 3 )

Short-term ( 4 )

mg/m 3 ( 5 ) ppm f/ml mg/ ppm f/ml

( 6 ) ( 7 ) m3 ( 6) ( 7 )

( 5 )

Hardwood dusts -

-

-

-

-

-

-

-

Limit value

2 ( )

3 mg/m3 until

17 January

Chromium (VI) -

-

0.005

-

-

-

-

-

-

Limit value

compounds

0.010 mg/m3

which are car-

until 17 Janu-

cinogens within

ary 2025

the meaning of

paragraph (a) of

Limit value

the defenition

0.025 mg/m3

"carcinogen" in

for welding

regulation 2

or plasma

(as chromium)

cutting pro-

cesses or sim-

ilar work

processes that

generate

fume until 17

January 2025

Refractory

-

-

-

-

0.3 -

-

-

-

-

ceramic fibres

which are car-

cinogens within

the meaning of

paragraph (a) of

definition "car-

cinogen" in reg-

ulation 2

Respirable crys- -

-

-

-

-

-

-

-

-

0.1 ( 9 )

talline silica dust

P R O T E C T I O N O F W O R K E R S THE RISKS RELATED

TO EXPOSURE TO CARCINOGENS, MUTAGENS OR

REPROTOXIC SUBSTANCES AT W O RK

Benzene

200-

71-43-2

0.66

0.2

-

-

-

-

Limit value

skin (10)

753-7

of 1ppm

(3.25 mg/m3)

until 5 April

2024. Limit

value of 0,5

ppm

(1.65 mg/m 3 )

from 5 April

2024 until 5

April 2026.

Vinyl chloride 200-

75-01-4

2.6

-

-

-

-

-

-

monomer

831-0

Ethylene oxide 200-

75-21-8

1.8

-

-

-

-

-

skin (10)

849-9

1,2- Epoxypro- 200-

75-56-9

2.4

-

-

-

-

-

-

pane

879-2

Trichloroethyl- 201-

79-01-6

54.7

-

164. 30

-

-

skin (10)

ene

167-4

Acrylamide

201-

79-06-1

0.1

-

-

-

-

-

-

skin (10)

173-7

2-Nitropropane 201-

79-46-9

-

-

-

-

-

-

209-1

o-Toluidine

202-

95-53-4

0.5

0.1

-

-

-

-

-

skin (10)

429-0

4,4’-Methylene- 202-

101-77-9

0.08

-

-

-

-

-

-

skin (10)

dianiline

974-4

Epichlorohy-

203-

106-89-8

1.9

-

-

-

-

-

-

skin (10)

drine

439-8

Ethylene dibro- 203-

106-93-4

0.8

0.1

-

-

-

-

-

skin (10)

mide

444-5

1,3-Butadiene 203-

106-99-0

2.2

-

-

-

-

-

-

450-8

Ethylene dichlo- 203-

107-06-2

8.2

-

-

-

-

-

skin (10)

ride

458-1

Hydrazine

206-

302-01-2

0.013

0.01 -

-

-

-

-

skin (10)

114-9

Bromoethylene 209-

593-60-2

4.4

-

-

-

-

-

-

800-6

REPROTOXIC SUBSTANCES AT W O R K

Diesel engine

-

-

-

-

-

-

-

-

The limit

0.05( * )

exhaust emis-

value shall

sions

apply from 21

February

2023. For

underground

mining and

tunnel con-

struction the

limit value

shall apply

from 21 Feb-

ruary 2026.

Polycyclic aro- -

-

-

-

-

-

-

-

-

skin (10)

matic hydrocar-

bons mixtures,

particularly

those containing

benzo[a]pyrene,

which are car-

cinogens within

the meaning of

these regulations

Mineral oils that -

-

-

-

-

-

-

-

-

skin (10)

have been used

before in internal

combustion

engines to lubri-

cate and cool the

moving parts

within the

engine

Cadmium and its -

-

0.001( 11 ) -

-

-

-

-

-

Limit value

inorganic com-

0.004 mg/m 3

pounds

( 12 ) until 11

July 2027

Beryllium and -

-

0.0002 ( 11 ) -

-

-

-

-

dermal and Limit value

inorganic beryl-

respiratory 0.0006 mg/

lium compounds

sensitisa- m 3 until 11

tion ( 13 ) July 2026

Arsenic acid and -

-

-

-

-

-

-

-

For the cop-

0.01 ( 11 )

its salts, as well

per smelting

as inorganic

sector, the

arsenic com-

limit value

pounds

shall apply

from 11 July

P R O T E C T I O N O F W O R K E R S THE RISKS RELATED

TO EXPOSURE TO CARCINOGENS, MUTAGENS OR

REPROTOXIC SUBSTANCES AT W O RK

Formaldehyde

200-

50-00-0

0.37

0.3

-

0.74 0.6 -

dermal sen- Limit value

001-8

sitisation 0.62 mg/m 3

( 14 )

or 0.5 ppm ( 3 )

for the health

care, funeral

and embalm-

ing sectors

until 11 July

4,4’-Methylene- 202-

101-14-4

0.01

-

-

-

-

-

skin ( 10 )

bis(2-chloroani- 918-9

line)

Acrylonitrile

203-

107-13-1

0.45 -

1.8 -

Skin ( 10 ) The limit val-

466-5

ues shall

Dermal

sensitisa- apply from 5

April 2026.

tion ( 14 )

Nickel com-

-

-

-

-

-

-

-

Dermal and The limit

0.01 ( 15 )

pounds

respiratory value ( 15 )

0.05 ( 16 )

sensitisa- shall apply

tion ( 13 ) from 18 Janu-

ary 2025.

The limit

value ( 16 )

shall apply

from 18 Janu-

ary 2025.

Until then a

limit value of

0.1 mg/m 3

( 16 ) shall

apply.

Inorganic lead

-

-

0.15

-

-

-

-

-

-

-

and its com-

pounds

N,N-dimethy-

204-

127-19-5

-

-

-

Skin ( 10 )

lacetamide

826-4

Nitrobenzene

202-

98-95-3

0.2

-

-

-

-

-

Skin ( 10 )

716-0

REPROTOXIC SUBSTANCES AT W O R K

N,N-Dimethyl- 200-

68-12-2

-

-

-

Skin ( 10 )

formamide

679-5

2-Methoxyetha- 203-

109-86-4

-

-

-

-

-

-

Skin ( 10 )

nol

713-7

2-Methoxyethyl 203-

110-49-6

-

-

-

-

-

-

Skin ( 10 )

acetate

772-9

2-Ethoxyethanol 203-

110-80-5

-

-

-

-

-

Skin ( 10 )

804-1

2-Ethoxyethyl

203-

111-15-9

-

-

-

-

-

Skin ( 10 )

acetate

839-2

1-Methyl-2-

212-

872-50-4

-

-

-

Skin ( 10 )

pyrrolidone

828-1

Mercury and

-

-

0.02

-

-

-

-

-

-

-

divalent inor-

ganic mercury

compounds

including mer-

cury oxide and

mercury chlo-

ride (measured

as mercury)

Bisphenol A;

201-

80-05-7

-

-

-

-

-

-

-

2 ( 11 )

4,4'-Isopro-

245-8

pylidenediphe-

nol

Carbon monox- 211-

630-08-0

-

117 100 -

-

-

ide

128-3

P R O T E C T I O N O F W O R K E R S THE RISKS RELATED

TO EXPOSURE TO CARCINOGENS, MUTAGENS OR

REPROTOXIC SUBSTANCES AT W O RK

(1) EC No, i.e. EINECS, ELINCS or NLP, is the official number of the substance within the European

Union, as defined in Section 1.1.1.2 in Annex VI, Part 1, of Regulation (EC) No 1272/2008.

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

(3) Measured or calculated in relation to a reference period of eight (8) hours 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) mg/m3 = milligrams 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) Inhalable fraction: if hardwood dusts are mixed with other wood dusts, the limit value shall apply

to all wood dusts present in that mixture.

(9) Respirable fraction.

(10) Substantial contribution to the total body burden via possible dermal exposure

(11) Inhalable fraction

(12) Inhalable fraction. Respirable fraction in those Member States that implement, on the date of the

entry into force of this Directive, a monitoring system with a biological limit value not exceeding

0.002

mg Cd/g creatinine in urine.

(13) The substance can cause sensitisation of the skin and of the respiratory tract.

(14) The substance can cause sensitisation of the skin.

(15) Respirable fraction, measured as nickel.

(16) Inhalable fraction, measured as nickel.

(*) Measured as elemental carbon.

REPROTOXIC SUBSTANCES AT W O R K

(1)

The employer shall reduce the use of a carcinogen,

mutagen or reprotoxic substance 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 dangerous to workers’ health or safety, as the case may be.

(2) The employer shall, upon request, submit the findings of

his investigations to the Authority.

REPROTOXIC SUBSTANCES AT W O R K

Added by

L.N. 102 of 2024.

BIOLOGICAL LIMIT VALUES AND HEALTH

SURVEILLANCE MEASURES

(Regulation 16(3))

1. Lead and its ionic compounds

Biological monitoring shall 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

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 forty (40)

hours per week, or a blood-lead level greater than 40 μg Pb/100 ml blood is

measured in individual workers.".

(1) Where the results of the assessment referred to in

regulation 3 reveal a risk to workers’ health or safety, workers’

exposure must be prevented.

(2) Where it is not technically possible to replace the carcinogen,

mutagen or reprotoxic substance by a substance, mixture or process

which, under its conditions of use, is not dangerous or is less

dangerous to health or safety, the employer shall ensure that the

carcinogen, mutagen or reprotoxic substance is, in so far as is

technically possible, manufactured 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 to the

carcinogen, mutagen or non-threshold reprotoxic substance is reduced

to as low a level as is technically possible.

(3A) Where it is not technically possible to use or manufacture a

threshold reprotoxic substance in a closed system, the employer

shall ensure that the risk related to the exposure of workers to that

threshold reprotoxic substance is reduced to a minimum.

(3B) The employer shall, with regard to reprotoxic substances

other than non-threshold reprotoxic substances and threshold

reprotoxic substances, apply sub-regulation (3A). In such a case,

when carrying out the risk assessment referred to in regulation 3,

the employer shall duly take into account the possibility that a safe

level of exposure for workers’ health for such a reprotoxic

substance might not exist and shall lay down appropriate measures

in that regard.

(4) Exposure shall not exceed the limit value of a carcinogen,

mutagen or a reprotoxic substance as set out in Schedule III.

(5) Wherever a carcinogen, mutagen or reprotoxic substance is

used, the employer shall apply all the following measures

(a) limitation of the quantities of a carcinogen, mutagen or

reprotoxic substance 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 minimise the release of

carcinogens, mutagens or reprotoxic substances into

the place of work;

(d) evacuation of carcinogens, mutagens or reprotoxic

substances at source, local extraction system or

general ventilation, all such methods 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, mutagens or reprotoxic

substances, in particular for the early detection of

abnormal exposures resulting from an unforeseeable

event or an accident;

(f)

application of suitable working procedures and

P R O T E C T I O N O F W O R K E R S THE RISKS RELATED

TO EXPOSURE TO CARCINOGENS, MUTAGENS OR

REPROTOXIC SUBSTANCES AT W O RK

methods;

(g) collective protection measures and, or, where exposure

may not be avoided by other means, individual

protection measures;

(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, mutagens or reprotoxic substances;

(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 visibly

labelled containers;

(m) means for safe collection, storage and disposal of waste

by workers, including the use of sealed and clearly and

visibly labelled containers.

Where the results of the assessment referred to in

regulation 3 reveal a risk to workers’ health or safety, an employer

shall, when requested, make available to the Authority appropriate

information on

(a) the activities and, or industrial processes carried out,

including the reasons for which carcinogens, mutagens or

reprotoxic substances are used;

(b) the quantities of substances or mixtures manufactured or

used which contain carcinogens, mutagens or reprotoxic

substances;

(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.

(1) In the event of an unforeseeable event or an accident

which is likely to result in an abnormal exposure of workers, the

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 respiratory

protection equipment which they must wear; the

REPROTOXIC SUBSTANCES AT W O R K

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.

(1) For certain activities such as maintenance, in respect of

which it is foreseeable that there is the potential for a significant

increase in exposure of workers, and in respect of which all scope

for further technical preventive measures for limiting workers’

exposure has already been exhausted, the employer shall determine,

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 of

w o r k e r s ’ e x p o s u r e t o t h e m i n i m u m p o s s i b l e a n d t o e n su r e

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

p r ot e c t i on e q ui p m e n t w hi c h t h e y m u s t w e a r a s l o ng as th e

abnormal exposure persists; that exposure may not be permanent

and shall be kept to the strict minimum of time necessary for each

worker.

(3) Appropriate measures shall be taken to ensure that the areas

in which the activities referred to in subregulation (1) take place

are clearly demarcated and indicated or that unauthorized persons

are prevented by other means from having access to such areas.

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 accessible

solely to workers who, by reason of their work or duties, are

required to enter them.

(1) Employers shall be obliged, in the case of all activities

for which there is a risk of contamination by carcinogens, mutagens or

reprotoxic substances, to take appropriate measures to ensure that

(a) workers do not eat, drink or smoke in working areas

where there is a risk of contamination by carcinogens,

mutagens or reprotoxic substances;

(b) workers are provided with appropriate protective

clothing or other appropriate special clothing;

(c) separate storage places are provided for working or

protective clothing and for street clothes;

(d) workers are provided with 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 replaced before further use.

(2)

Workers may not be charged for the cost of these measures.

P R O T E C T I O N O F W O R K E R S THE RISKS RELATED

TO EXPOSURE TO CARCINOGENS, MUTAGENS OR

REPROTOXIC SUBSTANCES AT W O RK

(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 appropriate

training, on the basis of all available information, in particular in

the form of information and instructions, concerning

(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 protective equipment and clothing;

(e) steps to be taken by workers, including rescue

workers, in the case of incidents and to prevent

incidents.

The training shall be

(i)

adapted to take account of new or changed risk, in

particular when workers are or likely to be exposed to

new carcinogens, mutagens or reprotoxic substances or

to a number of different carcinogens, mutagens or

reprotoxic substances, including those contained in

hazardous medicinal products, or in case of changing

circumstances related to work,

(ii) provided periodically in healthcare settings to all

workers who are exposed to carcinogens, mutagens or

reprotoxic substances, in particular where new

hazardous medicinal products containing those

substances are used, and

(iii) repeated periodically in other settings if necessary.

(2) Employers shall inform workers of installations and related

contai ners co ntai ning carci nogen s, m ut ag ens or repro toxi c

substances, ensure that all containers, packages and installations

containing carcinogens, mutagens or reprotoxic substances are

labelled clearly and legibly, and display clearly visible warning and

hazard signs.

Where a biological limit value has been set out in Schedule IV,

health surveillance shall be mandatory for working with the

carcinogen, mutagen or reprotoxic substance in question, in

accordance with the procedures laid down in that Schedule. Workers

shall be informed of that requirement before being assigned to the task

involving the risk of exposure to the carcinogen, mutagen or

reprotoxic substance indicated.

Appropriate measures shall be taken to ensure that

(a) workers and, or any workers’ representatives in the

undertaking or establishment 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

REPROTOXIC SUBSTANCES AT W O R K

of the selection, wearing and use of protective

clothing and equipment, without prejudice to the

employer’s responsibility for determining the

effectiveness of protective 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 for

determining such measures;

(b) workers and, or any workers’ representatives in the

undertaking or establishment are informed as quickly

as possible of abnormal exposures, including those

referred 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 a

risk 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 Authority as well as all other

persons who have responsibility for health and safety

at work at the employer’s workplace have access to the

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.

(1) Employers shall consult workers and, or their

representatives and allow them to take part in discussions on all

questions relating to safety and health at work. This presupposes

-

the consultation of workers,

-

the right of workers and, or their representatives to

make proposals,

-

balanced participation in accordance with the General

Provisions for Health and Safety at Work Places

Regulations.

(2) Workers or workers’ representatives with specific

responsibility for the safety and health of workers shall take part in

a balanced way, in accordance with applicable laws and, or

practices, and shall be consulted in advance and in good time by the

employer with regard to

(a) any measure which may substantially affect safety and

health;

(b) the designation of worker or workers which the

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employer is obliged to designate to carry out activities

related to the protection and prevention of

occupational risks for the undertaking and, or

establishment and the workers which the employer is

obliged to designate to implement measures inter alia,

for first aid, fire-fighting 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 workers

exposed to particular risks;

(ii) the protective measures 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 three

working days;

(iv) reports on occupational accidents suffered by his

workers;

(v) the safety and health risks and protective and

preventive measures and activities in respect of

both the undertaking and, or establishment in

general and each type of workstation and, or job;

(vi) the measures taken in relation to first aid, fire-

fighting and the evacuation of workers;

(vii)

the appropriate measures taken so that

employers of workers from any outside

undertakings and, or establishments engaged in

work in his undertaking and, or establishment

receive adequate information concerning the

points referred to in subparagraphs (v) and (vi);

(viii) the appropriate measures 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 to

have access, to carry 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 competent

personnel in the undertaking and, or establishment;

REPROTOXIC SUBSTANCES AT W O R K

(e) the planning and organization of the training to each

worker regarding adequate safety and health training,

in particular in the form of information and

instructions 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 the

safety and health of workers shall have the right to ask the

employer to take appropriate measures and to submit proposals to

him to that end to mitigate hazards for workers and, or to remove

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 subregulations (2) and (3).

(5) Employers must allow workers’ representatives with

specific responsibility for the safety and health of workers adequate

time off work, without loss of pay, and provide them with the

necessary means to enable such representatives to exercise their

rights and functions.

(6) Workers and, or their representatives are entitled to appeal

to the Authority if they consider that the measures taken and the

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 during

inspection visits by the Authority.

(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 indicate that health surveillance must

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 occupational

hygiene measures.

(3) If a worker is found to be suffering from an abnormality which

is suspected to be the result of exposure to carcinogens, mutagens or

reprotoxic substances, or if a biological limit value is found to have

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been exceeded, the doctor or authority responsible for the health

surveillance of workers may require other workers who have been

similarly exposed to undergo health surveillance.

(4) In cases where health surveillance is carried out, an individual

medical record shall be kept and the doctor or authority responsible for

health surveillance shall propose any protective or preventive

measures to be taken in respect of any individual workers. Biological

monitoring and related requirements may form part of health

surveillance.

(5) Information and advice must be given to workers regarding

any health surveillance which they may undergo following the end

of exposure.

(6) Workers shall have access to the results of the health

surveillance which concern them, and the workers concerned or the

em ployer m ay request a review of the results of the health

surveillance.

(7) Practical recommendations for the health surveillance of

workers are given in Schedule II.

(8) All cases of cancer, adverse effects on sexual function and

fertility in adult male and female workers or developmental toxicity in

their offspring identified in accordance with national law or practice as

resulting from occupational exposure to a carcinogen, mutagen or

reprotoxic substance shall be notified to the competent authority.

(1) With regard to carcinogens and mutagens, the list

referred to in paragraph (c) of regulation 12, and the medical record

referred to in regulation 14(4) shall be kept for at least forty (40)

years following the end of exposure, in accordance with national

law or practice.

(1A) With regard to reprotoxic substances, the list referred to in

paragraph (c) of regulation 12, and the medical record referred to in

regulation 14(4) shall be kept for at least five (5) years following the

end of exposure, in accordance with national law or practice.

(2) Those documents shall be made available to the Authority

in cases where the undertaking ceases activity.

Limit values and other directly related provisions are set

out in Schedule III.

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.

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.

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TO EXPOSURE TO CARCINOGENS, MUTAGENS OR

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