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

• CELEX: Directive (EU) 2024/869
• Articles: 7

Article 1

Directive 98/24/EC is amended as follows:

(1)

Annex I is amended in accordance with Annex I to this Directive;

(2)

in Annex II, points 1, 1.1, 1.2 and 1.3 are deleted.

Article 2

Directive 2004/37/EC is amended as follows:

(1)

in Article 2(1), point (b) is replaced by the following:

‘(b)

“mutagen” means:

(i)

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;

(ii)

a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex;’;

(2)

Article 18a is amended as follows:

(a)

the first to seventh paragraphs are numbered 1 to 7;

(b)

the following paragraphs are added:

‘8.   No later than 30 June 2024, the Commission shall initiate an assessment of the effects of exposure to a combination of substances with a view to preparing Union guidelines thereon where appropriate. The Commission shall take into account the latest developments in scientific knowledge, the opinion of the Committee for Risk Assessment of the European Chemicals Agency established by Regulation (EC) No 1907/2006 of the European Parliament and of the Council  ( *1 ) , the opinion of the ACSH and the best practices in the Member States, and shall conduct appropriate consultations of relevant stakeholders. Those guidelines shall be published on the EU-OSHA website and disseminated in all Member States by the relevant competent authorities.

9.   No later than 9 April 2026, the Commission shall initiate the procedure to obtain a scientific assessment of endocrine disruptors that can affect the health and safety of workers, with a view to evaluating the appropriateness of including them within the scope of this Directive in order to better protect the health and safety of workers. Where appropriate the Commission shall, after consulting the ACSH, submit a legislative proposal.

10.   In the context of its evaluation pursuant to Article 17a(4) of Directive 89/391/EEC, the Commission shall, no later than 9 April 2029, assess the occupational limit values for lead and its inorganic compounds. Where appropriate, the Commission shall, taking into account the latest developments in scientific knowledge and after consulting the ACSH, submit a legislative proposal to amend those limit values.

11.   No later than 9 April 2026, the Commission shall, after appropriate consultation of relevant stakeholders, draw up Union guidelines for health surveillance, including biological monitoring. Those guidelines shall include advice on the implementation of provisions regarding blood lead level, taking into account the slow removal of lead from the body and the special protection of female workers of childbearing age.

( *1 )   Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC ( OJ L 396, 30.12.2006, p. 1 ).’;"

(3)

Annexes I, III and IIIa to Directive 2004/37/EC are amended in accordance with Annex II to this Directive.

Article 3

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 9 April 2026. They shall immediately inform the Commission thereof.

When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive.

Article 4

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Article 5

This Directive is addressed to the Member States.

Schedules & Appendices

ANNEX I

ANNEX I

Annex I to Directive 98/24/EC is replaced by the following:

‘ANNEX I

LIST OF BINDING OCCUPATIONAL EXPOSURE LIMIT VALUES

Name of agent

EC No  ( 1 )

CAS No  ( 2 )

Limit values

Notation

Transitional measures

8 hours  ( 3 )

Short-term  ( 4 )

μg/m 3

( 5 )

ppm  ( 6 )

f/ml  ( 7 )

μg/m 3

( 5 )

ppm  ( 6 )

f/ml  ( 7 )

Diisocyanates

(measured as NCO  ( 10 ) )

6

12

Skin  ( 8 )

Dermal and respiratory sensitisation  ( 9 )

A limit value of 10 μg NCO/m 3 in relation to a reference period of 8 hours and a short-term exposure limit value of 20 μg NCO/m 3 shall apply until 31 December 2028.

’.

( 1 )   EC No, i.e., Einecs, ELINCS or NLP, is the official number of the substance within the European Union, as defined in Annex VI, Part 1, Section 1.1.1.2, to Regulation (EC) No 1272/2008.

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

( 3 )   Measured or calculated in relation to a reference period of 8-hour 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 )   μg/m 3 = micrograms 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/m 3 ).

( 7 )   f/ml = fibres per millilitre.

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

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

( 10 )   NCO refers to isocyanate functional groups of the diisocyanate compounds.

ANNEX II

ANNEX II

Annexes I, III and IIIa to Directive 2004/37/EC are amended as follows:

(1)

in Annex I, the title is replaced by the following:

‘

List of substances, mixtures and processes (Article 2, points (a)(ii) and (b)(ii))

’;

(2)

in Annex III, point A, the row related to inorganic lead and its compounds is replaced by the following:

‘Name of agent

EC No  ( 1 )

CAS No  ( 2 )

Limit values

Notation

Transitional measures

8 hours  ( 3 )

Short-term  ( 4 )

mg/m 3

( 5 )

ppm  ( 6 )

f/ml  ( 7 )

mg/m 3

( 5 )

ppm  ( 6 )

f/ml  ( 7 )

Lead and its inorganic compounds

0,03  ( 8 )

Non-threshold reprotoxic substance

(3)

Annex IIIa is replaced by the following:

‘ANNEX’ IIIa

BIOLOGICAL LIMIT VALUES AND HEALTH SURVEILLANCE MEASURES (Article 16(4))

Lead and its inorganic compounds

1.1.

Biological monitoring must 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 is 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  ( 9 )

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 is 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 is also 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.

.

( 9 )   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."

( 9 )   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.’

( 1 )   EC No, i.e. Einecs, ELINCS or NLP, is the official number of the substance within the European Union, as defined in Annex VI, Part 1, Section 1.1.1.2, to Regulation (EC) No 1272/2008.

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

( 3 )   Measured or calculated in relation to a reference period of 8-hour 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/m 3 = 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/m 3 ).

( 7 )   f/ml = fibres per millilitre.

( 8 )   Inhalable fraction.’;