Considerations on COM(2023)71 - Amendment of Council Directive 98/24/EC and Directive 2004/37/EC as regards the limit values for lead and its inorganic compounds and diisocyanates - Main contents
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| dossier | COM(2023)71 - Amendment of Council Directive 98/24/EC and Directive 2004/37/EC as regards the limit values for lead and its inorganic ... |
|---|---|
| document | COM(2023)71  |
| date | March 13, 2024 |
(2) Pursuant to its Article 1(3), Directive 98/24/EC is to apply to carcinogens, mutagens and reprotoxic substances at work without prejudice to more stringent or specific provisions set out in Directive 2004/37/EC. To ensure legal certainty and avoid ambiguities and possible confusion over the applicable limit values for lead and its inorganic compounds, those Directives should be amended. This will provide for a revised binding occupational exposure limit value and biological limit value in Directive 2004/37/EC only, more specifically its Annexes III and IIIa containing more specific provisions on reprotoxic substances such as lead and its inorganic compounds. Therefore, the specific provisions setting the occupational exposure limit value for lead and its inorganic compounds in Annex I to Directive 98/24/EC and a biological limit value for lead and its ionic compounds in Annex II to Directive 98/24/EC should be deleted.
(3) New and revised limit values should be set out in light of available information, including up-to-date scientific evidence and technical data, based on a thorough assessment of the socioeconomic impact and availability of exposure measurement protocols and techniques at the place of work.
(4) In accordance with the recommendations 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 88 , and the Advisory Committee on Safety and Health at Work, limit values for the inhalation route of exposure are usually established in relation to a reference period of an 8-hour time-weighted average (long-term exposure limit values). For certain chemicals, limit values are also set with reference to a shorter reference period, in general a 15-minute time-weighted average (short-term exposure limit values) in order to limit, to the extent possible, the effects arising from short-term exposure.
(5) To ensure a more comprehensive level of protection, it is also necessary to consider absorption pathways other than inhalation for diisocyanates, including the possibility of uptake through the skin. Further notations for hazardous substances and mixtures are laid down in Regulation (EC) No 1272/2008 of the European Parliament and of the Council 89 .
(6) Lead and its inorganic compounds are key occupational reprotoxicants that can affect both fertility and the development of the foetus and meet the criteria for classification as toxic for reproduction (category 1A) in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council and are therefore a reprotoxic substances within the meaning of Article 2, point (ba), of Directive 2004/37/EC.
(7) Oral and inhalation exposure are both relevant routes for the uptake of lead and its inorganic compounds into the human body. Taking into account the most recent scientific data and new findings with regard to lead and its inorganic compounds, it is necessary to improve the protection of workers exposed to a potential health risk, by reducing both the occupational exposure and biological limit values for lead. Therefore, a revised biological limit value equal to 15 µg/100ml blood, accompanied by a revised occupational exposure limit value equal to 0.03 mg/m3 as an 8-hour time-weighted average (TWA) should be established.
(8) Moreover, to strengthen the health surveillance of workers exposed to lead and its inorganic compounds and thus contribute to the prevention and protection measures to be undertaken by the employer, it is necessary to amend the existing requirements that apply when workers are exposed to certain levels of lead and its inorganic compounds. To that end, detailed medical surveillance should be required when exposure to lead and its inorganic compounds exceeds 0.015 mg/m3 in air (50% of current OEL) or 9 µg/100ml blood (approx. 60% of the current BLV).
(9) Specific measures should be put in place with regard to risk management, including specific health surveillance that should take into consideration the circumstances of individual workers. Under the general requirements of Directive 2004/37/EC, employers are obliged to ensure the substitution of the substance when technically possible, the use of closed systems, or the reduction of exposure to as low as technically possible. In addition, as suggested in the opinion of the Advisory Committee on Safety and Health at Work 90 , the blood level of lead and its inorganic compounds in women of childbearing age should not exceed the reference values of the general population not occupationally exposed to lead and its inorganic compounds in the respective Member State. The Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA), established by Regulation (EC) No 1907/2006 of the European Parliament and of the Council 91 , advised the use of a biological guidance value (BGV) as there was insufficient scientific evidence to set a BLV for women of childbearing age. When national reference levels are not available, blood levels of lead and its inorganic compounds in women of childbearing age should not exceed the BGV of 4.5 µg/100ml, as recommended by the opinion of the RAC 92 . The BGV is an indicator of exposure but not of identifiable adverse health effects. Therefore, it acts as a sentinel marker to alert employers on the need to pay specific attention to this specific potential risk and to introduce measures to ensure that any exposure to lead and its inorganic compounds does not result in adverse developmental health effects in the foetus or offspring of female workers.
(10) Diisocyanates are skin and respiratory sensitisers (asthmagens) that can have harmful respiratory health effects such as occupational asthma, isocyanate sensitisation and bronchial hyper-responsiveness, as well as dermal occupational disease. They are considered as hazardous chemical agents within the meaning of Article 2, point (b), of Directive 98/24/EC and thus fall within its scope. Currently there is no binding occupational exposure limit value or short-term exposure limit value for diisocyanates at Union level.
(11) It is not scientifically possible to identify levels below which exposure to diisocyanates would not lead to adverse health effects. Instead, an exposure-risk relationship can be established, facilitating the setting of an occupational exposure limit by taking into account an acceptable level of excess risk. As a consequence, limit values for diisocyanates should be established in order to reduce the risk by lowering exposure levels. It is therefore possible, based on the available information, including scientific and technical data, to set a long-term and short-term limit value for that group of chemical agents.
(12) Diisocyanates can be absorbed through the skin and exposure to diisocyanates at the place of work may also result in dermal sensitisation and sensitisation of the respiratory tract. It is therefore appropriate to establish an occupational exposure limit of 6 µg/m³ and a short-term exposure limit of 12 µg/m³ for this group of chemical agents and to assign a skin, dermal and respiratory sensitisation notation to it.
(13) It may be difficult to comply with an occupational exposure limit equal to 6 µg/m³ for diisocyanates, accompanied by an associated short-term exposure limit equal to 12 µg/m³. This difficulty is due to technical measurement feasibility issues and the time needed to implement risk management measures in particular in downstream sectors involving activities such as applications of paints, work with lead metal, demolition, repair and scrap management, other waste management and soil remediation. Therefore, a transitional value of 10 µg/m³ with an associated short-term exposure limit equal to 20 µg/m³ should apply until 31 December 2028.
(14) The Commission has consulted the Committee for Risk Assessment) which provided opinions on both substances. The Commission has carried out a two-stage consultation of management and labour at Union level in accordance with Article 154 of the Treaty. It has also consulted the Advisory Committee on Safety and Health, which adopted opinions regarding the revision of the limit values for lead and its inorganic compounds 93 and establishment of an occupational limit value for diisocyanates 94 , with recommendations for appropriate notations.
(15) The limit values established in this Directive should be kept under regular scrutiny and review to ensure consistency with Regulation (EC) No 1907/2006.
(16) The objective of this Directive, namely to protect workers against risks to their health and safety arising from or likely to arise from exposure to chemical agents and reprotoxic substances at work, including the prevention of such risks, cannot be sufficiently achieved by the Member States acting alone. Rather, by reason of its scale and effects, it can be better achieved at Union level. Therefore, 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.
(17) Since this Directive concerns the protection of the health and safety of workers at the place of work, it should be transposed within two years of the date of its entry into force.
(18) Directives 98/24/EC and 2004/37/EC should therefore be amended accordingly.