Carcinogens or Mutagens at Work (Amendment) Regulations, 2024

L.N. 102 of 2024

OCCUPATIONAL HEALTH AND SAFETY AUTHORITY ACT

(CAP. 424)

Protection of Workers from the Risks related to Exposure to

Carcinogens or Mutagens at Work (Amendment) Regulations, 2024

IN EXERCISE of the powers conferred by article 12 of the

Occupational Health and Safety Authority Act, the Minister

responsible for occupational health and safety, after seeking the advice

of the Occupational Health and Safety Authority, has made the

following regulations:-

The title of these regulations is the Protection of Workers Citation.

from the Risks related to Exposure to Carcinogens or Mutagens at

Work (Amendment) Regulations, 2024, and these regulations shall be

read and construed as one with the Protection of Workers from the

Risks related to Exposure to Carcinogens or Mutagens at Work S.L. 424.22.

Regulations, hereinafter referred to as the "principal regulations".

Regulation 1 of the principal regulations shall be amended Amends

by the following

regulation 1 of

the principal

regulations.

(a) in the title thereof the words "the Risks related to

Exposure to Carcinogens or Mutagens" shall be substituted by

the words "the Risks related to Exposure to Carcinogens,

Mutagens or Reprotoxic Substances";

(b) sub-regulation (2) thereof shall be substituted by the

following new sub-regulation

"(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.";

(c) sub-regulation (3) thereof shall be substituted by the

following new sub-regulation

"(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."; and

(d) sub-regulation (6) thereof shall be substituted by the

following new sub-regulation

"(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 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.".

Regulation 2 of the principal regulations shall be amended Amends

regulation 2 of

by the following

the principal

regulations.

(a)

immediately after the definition "Authority" thereof

there shall be added the following new definition

" "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";

(b)

immediately after paragraph (a) of the definition

"carcinogen" thereof there shall be added the following new

paragraphs

"(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)

immediately after the definition "doctor" thereof

there shall be added the following new definition

" "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."; and

(d) the definition "limit value" thereof

shall

be

substituted by the following new definition

" "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;".

Regulation 3 of the principal regulations shall be amended

by the following

(a) sub-regulation (1) thereof shall be substituted by the

following new sub-regulation

"(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."; and

(b) sub-regulation (3) thereof shall be substituted by the

following new sub-regulation

"(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.".

Sub-regulation (1) of regulation 4 of the principal

regulations shall be substituted by the following new sub-regulation

"(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.".

Sub-regulations (2), (3), (4) and (5) of regulation 5 of the

principal regulations shall be substituted by the following new sub-

regulations

"(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

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.".

Paragraphs (a) and (b) of regulation 6 of the principal

regulations, shall be substituted by the following

"(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;".

Sub-regulation (1) of regulation 10 of the principal Amends

regulations shall be amended by the following

regulation 10 of

the principal

regulations.

(a) the words "Employers shall be obliged, in the case of

all activities for which there is a risk of contamination by

carcinogens or mutagens, to take appropriate measures to ensure

that" thereof shall be substituted by the words "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:"; and

(b) paragraph (a) thereof shall be substituted by the

following new paragraph

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

areas where there is a risk of contamination by carcinogens,

mutagens or reprotoxic substances;".

Regulation 11 of the principal regulations shall be amended Amends

by the following

regulation 11 of

the principal

regulations.

(a)

in sub-regulation (1) thereof the words "The training

shall be

- adapted to take account of new or changed risk, and

- repeated periodically if necessary." shall be substituted by

the words

"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."; and

(b) sub-regulation (2) thereof shall be substituted by the

following new sub-regulation

"(2) Employers shall inform workers of installations

and related containers containing carcinogens, mutagens or

reprotoxic 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.".

Regulation 14 of the principal regulations shall be amended

by the following

(a) sub-regulation (3) and (4) thereof shall be substituted

by the following new sub-regulations

"(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 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."; and

(b) sub-regulation (8) thereof shall be substituted by the

following new regulation

"(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.".

Sub-regulation (1) of regulation 15 of the principal Amends

regulations, shall be substituted by the following new sub-regulations: regulation 15 of

the principal

regulations.

"(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.".

Item 1 of Schedule II to the principal regulations shall be Amends

substituted by the following new item

Schedule II to the

principal

regulations.

"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.".

Schedule III to principal regulations shall be substituted by Substitutes

the following new Schedule

Schedule III to

the principal

regulations.

"

Name of

EC No CAS No Limit values

Notation Transi-

Short-term

8 hours ( 3 )

agent

tional

( 1 )

( 2 )

measures

( )

ppm f/ml mg/ pp f/ml

mg/m 3

( 6 ) ( 7 ) m3 m ( 7 )

( 5 )

( 5 ) ( 6)

Hardwood

-

-

-

Limit

2 ( 8 )

dusts

value

3 mg/m3

until 17

January

Chromium -

-

0.005

-

-

-

-

-

-

Limit

(VI) com-

value

pounds which

0.010 mg/

are carcino-

m3 until 17

gens within

January

the meaning

of paragraph

(a) of the

Limit

defenition

value

"carcinogen"

0.025 mg/

in regulation

m3 for

welding or

(as chro-

plasma cut-

mium)

ting pro-

cesses or

similar

work pro-

cesses that

generate

fume until

17 January

Refractory -

-

-

-

0.3 -

-

-

-

-

ceramic fibres

which are car-

cinogens

within the

meaning of

paragraph (a)

of definition

"carcinogen"

in regulation

Respirable

-

-

-

-

-

-

-

-

-

0.1 ( 9 )

crystalline sil-

ica dust

Benzene

200- 71-43-2 0.66

0.2 -

-

-

-

skin (10) Limit value

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

200- 75-21-8 1.8

-

-

-

-

skin (10) -

oxide

849-9

1,2- Epoxy- 200- 75-56-9 2.4

-

-

-

-

-

-

propane

879-2

Trichloroeth- 201- 79-01-6 54.7

-

164 30 -

skin (10) -

ylene

167-4

.1

Acrylamide 201- 79-06-1 0.1

-

-

- - -

skin (10) -

173-7

2-Nitropro- 201- 79-46-9 18

-

-

-

-

-

-

pane

209-1

o-Toluidine 202- 95-53-4 0.5

0.1 -

-

-

-

skin (10) -

429-0

4,4’-Methyl- 202- 101-77-9 0.08

-

-

-

-

-

skin (10) -

enedianiline 974-4

Epichlorohy- 203- 106-89-8 1.9

-

-

-

-

-

skin (10) -

drine

439-8

Ethylene

203- 106-93-4 0.8

0.1 -

-

-

-

skin (10) -

dibromide

444-5

1,3-Butadiene 203- 106-99-0 2.2

-

-

-

-

-

-

450-8

Ethylene

203- 107-06-2 8.2

-

-

-

-

skin (10) -

dichloride

458-1

Hydrazine

206- 302-01-2 0.013

0.01 -

-

-

-

skin (10) -

114-9

Bromoethyl- 209- 593-60-2 4.4

-

-

-

-

-

-

ene

800-6

Diesel engine -

-

0.05( * ) -

-

-

-

-

-

The limit

exhaust emis-

value shall

sions

apply from

21 Febru-

ary 2023.

For under-

ground

mining and

tunnel con-

struction

the limit

value shall

apply from

21 Febru-

ary 2026.

Polycyclic

-

-

-

-

-

-

-

-

skin (10) -

aromatic

hydrocarbons

mixtures, par-

ticularly those

containing

benzo[a]pyr-

ene, which

are carcino-

gens within

the meaning

of these regu-

lations

Mineral oils -

-

-

-

-

-

-

-

skin (10) -

that have been

used before in

internal com-

bustion

engines to

lubricate and

cool the mov-

ing parts

within the

engine

Cadmium and -

-

0.001( 11 ) -

-

-

-

-

-

Limit

its inorganic

value

compounds

0.004 mg/

m 3 ( 12 )

until 11

July 2027

Beryllium and -

-

0.0002

-

-

-

-

-

dermal Limit

inorganic

and res- value

( 11 )

beryllium

piratory 0.0006 mg/

compounds

sensitisa- m 3 until 11

tion ( 13 ) July 2026

Arsenic acid -

-

0.01 ( 11 ) -

-

-

-

-

-

For the

and its salts,

copper

as well as

smelting

inorganic

sector, the

arsenic com-

limit value

pounds

shall apply

from 11

July 2023

Formalde-

200- 50-00-0 0.37

0.3 -

0.7 0.6 -

dermal Limit

hyde

001-8

sensitisa- value

tion ( 14 ) 0.62 mg/

m 3 or 0.5

ppm ( 3 ) for

the health

care,

funeral and

embalm-

ing sectors

until 11

July 2024

4,4’-Methyl- 202- 101-14-4 0.01

-

-

-

-

-

skin ( )

ene-bis(2-

918-9

chloroaniline)

Acrylonitrile 203- 107-13-1 1

0.45 -

1.8 -

Skin ( 10 ) The limit

466-5

Dermal values shall

sensitisa- apply from

5 April

tion ( 14 )

2026. Nickel com- -

-

0.01 ( 15 ) -

-

-

-

-

Dermal The limit

pounds

and res- value ( 15 )

0.05 ( 16 )

piratory shall apply

sensitisa- from 18

tion ( 13 ) January

2025. The limit

value ( 16 )

shall apply

from 18

January

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 36

-

72 20 -

Skin ( 10 ) -

lacetamide 826-4

Nitrobenzene 202- 98-95-3 1

0.2 -

-

-

-

Skin ( 10 ) -

716-0

N,N-

200- 68-12-2 15

-

30 10 -

Skin ( 10 ) -

Dimethylfor- 679-5

mamide

2-Methox-

203- 109-86-4 -

-

-

-

-

Skin ( 10 ) -

yethanol

713-7

2-Methox- 203- 110-49-6 -

-

-

-

-

Skin ( 10 ) -

yethyl acetate 772-9

2-Ethoxyetha- 203- 110-80-5 8

-

-

-

-

Skin ( 10 ) -

nol

804-1

2-Ethox-

203- 111-15-9 11

-

-

-

-

Skin ( 10 ) -

yethyl acetate 839-2

1-Methyl-2- 212- 872-50-4 40

-

80 20 -

Skin ( 10 ) -

pyrrolidone 828-1

Mercury and -

-

0.02

-

-

-

-

-

-

-

divalent inor-

ganic mercury

compounds

including

mercury

oxide and

mercury chlo-

ride (meas-

ured as

mercury)

Bisphenol A; 201- 80-05-7 2 ( 11 )

-

-

-

-

-

-

-

4,4'-Isopro- 245-8

pylidenedi-

phenol

Carbon mon- 211- 630-08-0 23

-

117 100 -

-

-

oxide

128-3

(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 Reg-

ulation (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 mer-

cury 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 bio-

logical 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.

".

Immediately after Schedule III to the principal regulations

Adds new

there shall be added the following new Schedule IV

Schedule IV to

the principal

regulations.

"SCHEDULE IV

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.".

€1.62