EUROPEAN COMMISSION
Brussels, 18.7.2025
COM(2025) 418 final
ANNEX
to the
Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
amending Directive 2004/37/EC as regards the addition of substances and setting limit values in its Annexes I, III and IIIa
{SEC(2025) 217 final} - {SWD(2025) 191 final} - {SWD(2025) 192 final} - {SWD(2025) 193 final}
ANNEX
ANNEX
Annexes I, III and IIIa to Directive 2004/37/EC are amended as follows:
(1) in Annex I, the following point 9 is added:
‘9. Work involving exposure to fumes from welding processes containing substances that meet the criteria for a substance or mixture which meets the criteria for classification as a category 1A or 1B carcinogen, mutagen or reprotoxic set out in Annex I to Regulation (EC) No 1272/2008 1 ;
(2) in Annex III, point A is amended as follows:
(a) in the Table the row related to polycyclic aromatic hydrocarbons mixtures, particularly those containing benzo[a]pyrene, which are carcinogens within the meaning of this Directive, 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/m3 (5) |
ppm (6) |
f/ml (7) |
mg/m3 |
ppm |
f/ml |
|||||
|
Polycyclic aromatic hydrocarbons mixtures, particularly those containing benzo[a]pyrene, which are carcinogens, mutagens or reprotoxicants within the meaning of this Directive |
0,00007(*2) |
Skin (10) |
Limit value 0,00014(*2) until …[OJ: six years after the date of entry into force of the amending Directive] limited to the following sectors: (1) steel and iron foundries, which includes ferroalloy manufacturers, (2) aluminium manufacturers, (3) carbon and graphite electrode manufacturers, (4) coking plants, (5) coal tar distillation, (6) refractory products manufacturers, (7) welding of train tracks, (8) other non-ferrous metallurgical processes, and (9) casting of metals. |
|||||||
’
(b) in the Table, the row related to mercury and divalent inorganic mercury compounds including mercuric oxide and mercuric chloride (measured as mercury) 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/m3 (5) |
ppm (6) |
f/ml (7) |
mg/m3 |
ppm |
f/ml |
|||||
|
Mercury and divalent inorganic mercury compounds that fall under the scope of this Directive (measured as mercury) |
0,02 |
|
|
|
|
|||||
’;
(c) in the table the following rows are added
‘
|
Name of agent |
EC No (1) |
CAS No (2) |
Limit values |
Notation |
Transitional measures |
|||||
|
8 hours (3) |
Short-term (4) |
|||||||||
|
mg/m3 (5) |
ppm (6) |
f/ml (7) |
mg/m3 |
ppm |
f/ml |
|||||
|
Cobalt and inorganic cobalt compounds |
0,01(11) 0,0025(9) |
|
|
|
|
dermal and respiratory sensitisation(13) |
Limit value of 0,02(11) and 0,0042(9) until …[OJ: six years after the date of entry into force of the amending Directive] |
|||
|
1,4-dioxane |
7,3 |
2 |
73 |
20 |
Skin (10)
|
|||||
’;
(d) in the footnotes after the Table, the following footnote (*2) is added:
‘(*2) Measured as benzo[a]pyrene.’;
(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, to Regulation (EC) No 1272/2008.
(2) CAS No: Chemical Abstract Service Registry Number.
(3) Measured or calculated for a reference period of eight hours time-weighted average (TWA).
(4) Short-term exposure limit (STEL). A limit value above which exposure should not occur and which is for 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.
(9) Respirable fraction.
(10) Substantial contribution to the total body burden via dermal exposure possible.
(11) Inhalable fraction.
(13) The substance can cause sensitisation of the skin and of the respiratory tract.
(3) in Annex IIIa, the following point is added:
‘1,4-dioxane
2. The binding biological limit value is 45 mg HEAA*in urine/g creatinine.’
________________
*(2-Hydroxyethoxy)acetic acid’.