Carcinogens, Mutagens or Reprotoxic Substances at Work

L.N. 165 of 2026

HEALTH AND SAFETY AT WORK ACT

(CAP. 646)

Protection of Workers from the Risks related to Exposure to

Carcinogens, Mutagens or Reprotoxic Substances at Work

(Amendment) Regulations, 2026

IN EXERCISE of the powers conferred by article 45 of the

Health and Safety at Work Act, the Minister responsible for health and

safety at work has made the following regulations:-

The title of these regulations is the Protection of Workers

from the Risks related to Exposure to Carcinogens, Mutagens or

Reprotoxic Substances at Work (Amendment) Regulations, 2026 and

these regulations shall be read and constructed as one with the

Protection of Workers from the Risks related to Exposure to

Carcinogens, Mutagens or Reprotoxic Substances at Work, hereinafter

referred to as the "principal regulations".

In paragraph (f) of sub-regulation (6) of regulation 1 of the

principal regulations the words "at work." shall be substituted by the

words "at work; and" and immediately thereafter there shall be added

the following new paragraph

"(g) Directive (EU) 2024/869 of the European Parliament

and of the Council of 13 March 2024 amending Directive 2004/

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

Council Directive 98/24/EC as regards the limit values for lead

and its inorganic compounds and for diisocyanates.".

In regulation 2 of the principal regulations the definition

"mutagen" shall be substituted by the following new definition

" "mutagen" means

(a) a substance or mixture which meets the criteria

for classification as a category 1A or 1B germ cell mutagen

stipulated 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;

(b) a substance, mixture or process referred to in

Schedule I as well as a substance or mixture released by a

process referred to in Schedule I;".

In Schedule III to the principal regulations the item Amends

"Inorganic lead and its compounds" shall be substituted by the Schedule

the principal

following new item

regulations.

Non threshold

"Lead and

0.03

its inorganic

-

-

-

-

-

-

-

-

reprotoxic

( 11 )

compounds

substance".

Schedule IV to the principal regulations shall be substituted Substitutes

Schedule IV to

by the following new Schedule

the principal

regulations.

"SCHEDULE IV

BIOLOGICAL LIMIT VALUES AND HEALTH SURVEILLANCE

MEASURES

(regulation 16(3))

Lead and its inorganic compounds

1.1. Biological monitoring shall include measuring the blood

lead level (PbB) using absorption spectrometry or a method giving

equivalent results.

1.1.1. Until 31 December 2028, the binding biological limit

value is: 30 μg Pb/100 ml blood for workers whose blood lead

level exceeds the biological limit value of 30 μg Pb/100 ml blood

due to exposure which has occurred before 9 April 2026, but is

below 70 μg Pb/100 ml blood, medical surveillance shall be

carried out on a regular basis. If a declining trend towards the

limit value of 30 μg Pb/100 ml blood is established in those

workers, they may be allowed to continue with work involving

exposure to lead.

1.1.2. From 1 January 2029, the binding biological limit

value is: 15 μg Pb/100 ml blood ( 1 ) for workers whose blood

lead level exceeds the biological limit value of 15 μg Pb/100 ml

blood due to exposure which has occurred before 9 April 2026,

but is below 30 μg Pb/100 ml blood, medical surveillance shall

be carried out on a regular basis. If a declining trend towards the

limit value of 15 μg Pb/100 ml blood is established in those

workers, they may be allowed to continue with work involving

exposure to lead.

1.2. Medical surveillance is carried out if exposure to a

concentration of lead in air is greater than 0.015 mg/m 3 , calculated as a

time-weighted average over 40 hours per week, or a blood lead level

greater than 9 μg Pb/100 ml blood is measured in individual workers.

Medical surveillance shall also be carried out with regard to female

workers of childbearing age whose blood lead level exceeds 4.5 μg Pb/

100 ml blood or the national reference value of the general population

not occupationally exposed to lead, if such a value exists.

(1) It is recommended that the blood lead level in women of childbearing age does not

exceed the reference values of the general population not occupationally exposed to lead in the

respective EU Member State. When national reference levels are not available, it is recommended

that blood lead levels in women of childbearing age do not exceed the Biological Guidance Value of

4,5 μg/100 ml.".

€0.27