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dossier COM(2025)418 - Amendment of Directive 2004/37/EC as regards the addition of substances and setting limit values in its Annexes I, III and ...
document COM(2025)418 EN
datum 18 juli 2025
Annex XVII to REACH: Benzo[a]pyrene, Benzo[e]pyrene, Benzo[j]fluoranthene, Benzo[a]anthracene, Chrysene, Dibenzo[a,h]anthracene, Benzo[k]fluoranthene and Benzo[b]fluoranthene; Entry 50a of Annex XVII to REACH: Acenaphthene, Acenaphthylene, Anthracene, Benzo[a]anthracene, Benzo[a]pyrene, Benzo[def]chrysene, Benzo[b]fluoranthene, Benzo[e]acephenanthrylene, Benzo[e]pyrene, Benzo[ghi]perylene, Benzo[j]fluoranthene, Benzo[k]fluoranthene, Chrysene, Dibenzo[a,h]anthracene, Fluoranthene, Fluorene, Indeno[1,2,3cd]pyrene, Naphthalene, Phenanthrene, Pyrene.
(16) Entry 31 of Annex XVII to the REACH Regulation, available at: https://echa.europa.eu/documents/10162/a27e80a3-3798-3c76-01a0-32357cc09f6f .
(17) Decision of ECHA dated 23 June 2021 on the inclusion of substances of very high concern in the candidate list for eventual inclusion in Annex XIV, available at: ECHA decision on inclusion in Candidate List (europa.eu) .
(18) Communication from the Commission to the European Parliament and the Council Europe’s Beating Cancer Plan, COM/2021/44 final.
(19) Italy, Luxembourg, Malta, Portugal and Slovenia.
(20) 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, OJ L 353, 31.12.2008, p. 1-1355.
(21) The SLIC has the mandate to give its opinion on all matters relating to the enforcement by the Member States of EU legislation on health and safety at work. It consists of representatives of the labour inspection services of the Member States, as mentioned in the Commission Decision of July 1995 setting up a Committee of Senior Labour Inspectors (95/319/EC). The Committee shall comprise on full member per Member State and one alternate member may be appointed for each full member.
(22) SLIC (2018), Guidance for National Labour Inspectors on addressing health risks from Welding Fume. Available at: https://circabc.europa.eu/ui/group/fea534f4-2590-4490-bca6-504782b47c79/library/2997b89a-1fbd-4f35-9874-9a9b5ea1a403?p=1&n=-1&sort=name_ASC  
(23) ACSH (2023), Opinion on an EU binding Occupational Exposure Limit Value (BOEL) and notations for cobalt and its inorganic compounds, Doc. 005/23, available at: ACSH Adopted opinion Cobalt and inorganic compounds 22.09.23-EN.pdf (europa.eu) .
(24) ACSH (2023), Opinion on an EU binding Occupational Exposure Limit Value (BOEL) for Polycyclic Aromatic Hydrocarbons (PAHs), Doc. 003/23, available at: ACSH Adopted opinion PAHs 22.09.23-EN.pdf (europa.eu) .
(25) ACSH (2023), Opinion on an EU binding Occupational Exposure Limit Value (BOEL), Short-Term Exposure Limit (STEL), Biological Limit Value (BLV) and skin notation for 1.4-dioxane, Doc. 007/23, available at: ACSH Adopted opinion 1_4-dioxane 22.09.23-EN.pdf (europa.eu) .
(26) ACSH (2023), Opinion on an EU binding Occupational Exposure Limit Value (BOEL), for isoprene, Doc. 004/23, available at: ACSH Adopted opinion Isoprene 22.09.23-EN.pdf (europa.eu) .
(27) ACSH (2023), Opinion on introducing work involving exposure to fumes from welding processes containing substances that meet the criteria for CMR category 1A/1B set out in Annex I to the CLP Regulation, Doc. 006/23, available at: ACSH Adopted opinion Welding fumes 22.09.23-EN.pdf (europa.eu) .
(28) ACSH (2023), Addendum to the ACSH opinion 003/23 on an EU binding Occupational Exposure Limit Value (BOEL) for Polycyclic Aromatic Hydrocarbons (PAHs), Doc. 003/23/2, available at: Addendum to ACSH opinion PAHs-EN.pdf (europa.eu) .
(29) ECHA (2022), Scoping Study report for evaluation of limit values for welding fumes and fumes from other processes that generate fume in a similar way at the workplace, available at: report_welding_fumes_en.pdf (europa.eu) .
(30) Available at: RAC opinions on scientific evaluations of OELs - ECHA (europa.eu) .
(31) Inhalable fraction.
(32) Respirable fraction.
(33) 2 842 restrictive lung disease, 7 363 upper airway irritation, 38 developmental toxicity, 3 157 male infertility, 497 kidney effects, 633 liver effects and 4 382 local irritation in the nasal cavity.
(34) Application of willingness-to-pay values to each case (= method 1). Willingness-to-pay values measure an individual’s willingness to pay to avoid a case of a disease.
(35) In the absence of data for welding fumes, the impact on employment could not be quantified.
(36) The EU-OSHA created this set of tools, available at  Online interactive Risk Assessment , in 2009 to provide easy-to-use tools to guide micro and small organisations through the risk assessment process.
(37) In this case, public authority means firefighting organisations. According to the evidence gathered for the impact assessment, it is assumed that 758 firefighting organisations are active across in the EU (mostly at province level).
(38) As mentioned in the impact assessment, public authorities will need to transpose in their national legislations the package of preferred options as soon as the latter is stricter than existing national rules. Since Member States are expected to carry out the transposition in one go, the transposition costs for each substance will not be cumulative. Since no Member State currently has a national legislation which is in full compliance with the package of preferred options, it is reasonable to assume that Member State will need to dedicate up to €100,000 (corresponding to the highest transposition costs for welding fumes) for the transposition of the new rules.
(39) This would include for example risk management measures such as installations of closed systems to comply with the new limit value.
(40) United Nations resolution entitled ‘Transforming our World: the 2030 Agenda for Sustainable Development, adopted at the UN Sustainable Development Summit on 25 September 2015 in New York.
(41) In particular, target 3.4 (‘by 2030, reducing by one third premature mortality from non-communicable diseases through prevention’) and target 3.9 (‘by 2030, substantially reducing the number of deaths and illnesses from hazardous chemicals’).
(42) In particular, target 8.8 (‘promoting safe and securing working environments for all workers’).
(43) OJ C […], […], p. […].
(44) OJ C […], […], p. […].
(45) 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) (codified version), (OJ L 158, 30.4.2004, p. 50).
(46) 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, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).
(47) Council Decision of 22 July 2003 setting up an Advisory Committee on Safety and Health at Work (OJ C 218, 13.9.2003, p. 1).
(48) 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 (OJ L 353, 31.12.2008, p. 1).
(49) ECHA (2022), Scoping Study report for evaluation of limit values for welding fumes and fumes from other processes that generate fume in a similar way at the workplace, available at: report_welding_fumes_en.pdf (europa.eu)
(50) ACSH (2023), Opinion on introducing work involving exposure to fumes from welding processes containing substances that meet the criteria for CMR category 1A/1B set out in Annex I to the CLP Regulation, Doc. 006/23, available at: ACSH Adopted opinion Welding fumes 22.09.23-EN.pdf (europa.eu)
(51) OJ C 218, 13.9.2003, p. 1.
(52) https://echa.europa.eu/oels-activity-list/-/substance-rev/69405
(53) https://echa.europa.eu/oels-activity-list/-/substance-rev/63901
(54) https://echa.europa.eu/oels-activity-list/-/substance-rev/61801
(55) OJ L 123, 12.5.2016, p. 1.