Overwegingen bij 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 IIIa - Hoofdinhoud
Dit is een beperkte versie
U kijkt naar een beperkte versie van dit dossier in de EU Monitor.
| 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  |
| datum | 18 juli 2025 |
(2) Directive 2004/37/EC covers substances or mixtures which meet 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 of the European Parliament and of the Council 48 as well as substances, mixtures or processes referred to in Annex I to that Directive. Robust scientific evidence is to be provided for any new addition to the list of substances, mixtures and processes referred to in that Annex I to demonstrate that these substances, mixtures and processes fall under the scope of Directive 2004/37/EC, based on available valid scientific sources such as the ECHA, the International Agency for Research on Cancer (IARC) and national bodies, paying particular attention to peer-reviewed published literature on that substance.
(3) The IARC classified welding fumes as ‘carcinogenic to humans’ (Group 1 of the IARC classification). According to the ECHA scoping study 49 , welding fumes are complex and may include carcinogens, mutagens or reprotoxic substances, such as chromium(VI) compounds, nickel compounds, cadmium and its inorganic compounds. The complexity and heterogeneity of welding fumes, together with the absence of harmonised classification in the Regulation (EC) 1272/2008, contribute to a lack of clarity on their possible dangerousness for workers, and therefore a lack of appropriate risk management measures at the workplace. Addressing that absence of classification for welding fumes at Union level would ensure more legal clarity in terms of the application of Directive 2004/37EC. It is therefore appropriate, in line with the opinion of the ACSH 50 , to include in Annex I to Directive 2004/37/EC 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.
(4) Cobalt metal and several cobalt compounds meet the criteria for classification as carcinogenic and reprotoxicant (category 1B) in accordance with Regulation (EC) No 1272/2008 and are therefore carcinogens or reprotoxics within the meaning of Directive 2004/37/EC. Workers are often exposed to a mixture of cobalt compounds and occupational exposure limit values should be applied to all cobalt inorganic compounds. It is therefore appropriate, based on available information, including scientific and technical data, to establish a limit value for cobalt and its inorganic compounds in Directive 2004/37/EC.
(5) The Advisory Committee on Safety and Health at Work (ACSH) set up by Council Decision of 22 July 2003 51 , based on the RAC opinion 52 , agreed that exposure to cobalt and its inorganic compounds in the workplace may also result in dermal sensitisation and sensitisation of the respiratory tract. It is therefore appropriate to establish limit values for both the inhalable and respirable fractions of cobalt and its inorganic compounds within the scope of Directive 2004/37/EC and to assign to it a notation for dermal and respiratory sensitisation.
(6) For cobalt and its inorganic compounds, it is foreseeable that it will be difficult to comply with a limit value of 0,01 mg/m³ for the inhalable fraction and 0,0025 mg/m³ for the respirable fraction in the short term. It is therefore appropriate to introduce a transitional period of six years after entry into force of this Directive, during which the limit values of 0,02 mg/m³ (inhalable fraction) and 0,0042 mg/m³ (respirable fraction) should apply.
(7) Certain polycyclic aromatic hydrocarbons (PAHs) mixtures, particularly those containing benzo[a]pyrene, meet the criteria for classification as carcinogenic, mutagenic or reprotoxicant (category 1A or 1B) in accordance with Regulation (EC) No 1272/2008 and therefore fall under the scope of Directive 2004/37/EC. The RAC 53 has identified the possibility of significant uptake through the skin for those mixtures and the ACSH has agreed on the importance of introducing an occupational exposure limit value for all PAH mixtures falling under the scope of Directive 2004/37/EC, measured as benzo(a)pyrene, and to maintain a skin notation already contained in Annex III.
(8) For PAHs mixtures, it is foreseeable that it will be difficult for some sectors to comply with a limit value of 0,00007 mg/m³ (measured as benzo(a)pyrene) in the short term. It is therefore appropriate to introduce a transitional period of six years after entry into force of this Directive, during which the limit value of 0,00014 mg/m³ (measured as benzo(a)pyrene) should apply. That transitional period should be limited to the following sectors: (a) steel and iron foundries, which includes ferroalloy manufacturers; (b) aluminium manufacturers; (c) carbon and graphite electrode manufacturers; (d) coking plants; (e) coal tar distillation; (f) refractory products manufacturers; (g) welding of train tracks; (h) other non-ferrous metallurgical processes; and (i) casting of metals.
(9) 1,4-dioxane meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and is therefore a carcinogen within the meaning of Directive 2004/37/EC. It is therefore appropriate, based on the available information, including scientific and technical data, including the RAC 54 and ACSH opinions, to establish a long- and short-term occupational exposure limit value of 7,3 mg/m³ (2 ppm) and 73 mg/m³ (20 ppm), respectively, supplemented by a skin notation and a biological limit value of 45 mg HEAA in urine/g creatinine, at the end of exposure or shift.
(10) The Commission has carried out a two-stage consultation of social partners in accordance with Article 154 of the Treaty on the Functioning of the European Union. It has also consulted the ACSH, which has adopted opinions for all substances subject to this Directive and recommended one or several binding limit values for each of them, and notations and transitional values for some of them, where appropriate. Transitional values should allow employers make the necessary investments in additional risk management measures and develop technical means of ensuring compliance. In this regard, existing Union programmes, such as Horizon Europe, could help to develop innovative solutions to protect workers’ health.
(11) It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making 55 . When establishing or revising limit values, the Commission should consult the RAC and the ACSH to ensure that they are evidence-based, proportionate and measurable.
(12) Since the objective of this Directive, namely to protect workers from exposure to carcinogens, mutagens and reprotoxic substances at work, cannot be sufficiently achieved by the Member States acting alone but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary to achieve that objective. Directive 2004/37/EC should therefore be amended accordingly.