Annexes to 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

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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 EN
date March 13, 2024
Annex 8). However, workers may be exposed to lead when working on buildings and structures that were painted prior to the entry into force of the restriction.
(20) RPA (2021), Study on collecting information on substances with the view to analyse health, socio-economic and environmental impacts in connection with possible amendments of Directive 98/24/EC (Chemical Agents) and Directive 2009/148/EC (Asbestos). Final report for lead and its compounds and final report for diisocyanates (external study supporting the impact assessment report).
(21) Council Directive 82/605/EEC of 28 July 1982 on the protection of workers from the risks related to exposure to metallic lead and its ionic compounds at work )first individual Directive within the meaning of Article 8 of Directive 80/1107/EEC) (OJ L 247, 23.8.1982, p. 12)
(22) https://op.europa.eu/en/publication-detail/-/publication/b8827eb0-bb69-4193-9d54-8536c02080c1/language-en  
(23) RAC opinion on lead (2020) https://echa.europa.eu/documents/10162/ed7a37e4-1641-b147-aaac-fce4c3014037 RAC opinion on diisocyanates (2020) https://echa.europa.eu/documents/10162/4ea3b5ee-141b-63c9-8ffd-1c268dda95e9  
(24) 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.)
(25) ACSH opinion on lead (2021) https://circabc.europa.eu/ui/group/cb9293be-4563-4f19-89cf-4c4588bd6541/library/60b206e1-ee10-40c2-9540-fb6510c11a0c/details      ACSH opinion on diisocyanates (2021) https://circabc.europa.eu/ui/group/cb9293be-4563-4f19-89cf-4c4588bd6541/library/0d11d394-b1e8-4e1a-a962-5ad60f4ab2ae/details  
(26) Estimates show that the majority of the workforce in sectors involving lead is male (around 97%).
(27) Data on identifiable health effects are nevertheless insufficient to be properly assessed. (see section below on impact assessment).
(28) Biological guidance values (BGVs) are exposure-related values, representing the upper concentration of the chemical agent or one of its metabolites in any appropriate biological medium corresponding to a certain percentile (generally the 90th or 95th percentile) in a defined reference population. Where the available data do not support deriving a BLV, a biological guidance value (BGV) may be established. BGVs are often also called reference values. They may be useful for workers, employers and occupational physicians when dealing with worker protection issues. For instance, they can be an indicator of occupational exposure that may require attention to consider the need for additional risk management measures. BGVs are not a limit for health effects. Source: https://echa.europa.eu/documents/10162/23036412/ircsa_r8_appendix_oels_en.pdf/f1d45aca-193b-a7f5-55ce-032b3a13f9d8
(29) See footnote 23.
(30) Commission Regulation (EU) 2020/1149 of 3 August 2020 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards diisocyanates (OJ L 252, 4.8.2020, p. 24).
(31) Diisocyanate substances have a common mechanism of inducing hypersensitivity. Therefore, a group approach is supported by the RAC to cover a broad range of individual diisocyanate substances.
(32) Balmes J, Becklake M, Blanc P et al. (2003) American Thoracic Society Statement: occupational contribution to the burden of airway disease. Am J Crit Care Med. 167:787- 797.
(33) https://www.hse.gov.uk/statistics/causdis/asthma.pdf  
(34) https://academic.oup.com/annweh/article/65/8/893/6247067  
(35) RPA (2021), See footnote 20.
(36) See footnote 20.
(37) The NCO group refers to the nitrogen, carbon, and oxygen atom of the isocyanate group.
(38) Several expert committees concluded that a joint assessment for all diisocyanates based on NCO concentration is adequate. The RAC proposes this approach as well, but also states that there is not enough data to assess potency differences for individual diisocyanates.
(39) The RAC opinion states that there are indicators that peak exposures are important for the risk of asthma development. However, measuring peaks in human epidemiological studies is not practically possible because of measurement difficulties.
(40) RPA (2021), See footnote 20.
(41) See footnote 3.
(42) Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work. OJ L 183, 29.6.1989, p. 1.
(43) OJ C 326, 26.10.2012, p. 391–407.
(44) Lead can pass the placenta resulting in blood lead concentration in the umbilical cord at birth being close to the blood lead level of the mother (source: RPA, 2021 external study section 2.2.4.7, see footnote 19).
(45) Council Directive 92/85/EEC of 19 October 1992 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding. OJ L 348, 28.11.1992, p. 1–7.
(46) See footnote 25.
(47) See footnote 23.
(48) See RAC opinion, footnote 23.
(49) A first joint meeting of the competent authorities for REACH and the interest groups of ACSH/WPC took place on 5 April 2022 to discuss OSH aspects of the current revision of REACH.
(50) https://echa.europa.eu/documents/10162/22dd9386-7fac-4e8d-953a-ef3c71025ad4  
(51) https://echa.europa.eu/documents/10162/ffd7653b-98cc-4bcc-9085-616559280314  
(52) https://echa.europa.eu/documents/10162/61845f2b-f319-ab2e-24aa-6fc4f8fc150f  
(53) https://echa.europa.eu/documents/10162/503ac424-3bcb-137b-9247-09e41eb6dd5a  
(54) See footnote 25.
(55) https://ec.europa.eu/environment/pdf/waste/batteries/Proposal_for_a_Regulation_on_batteries_and_waste_batteries.pdf    
(56) https://www.hbm4eu.eu/about-us/ 
(57) For more information see Scholten, B; Kenny, L; Duca, R; Pronk, A; Santonen, T; Galea, K.S; Loh, M; Huumonen, K; Sleeuwenhoek, A; Creta, M; Godderis, L; and Jones, K. 2020. ‘Biomonitoring for occupational exposure to diisocyanates: A systematic review. Annals of Work Exposures and Health 64(6): 569-585. https://academic.oup.com/annweh/article/64/6/569/5822987?login=true  
(58) Communication from the Commission to the European Parliament and Council - Europe’s Beating Cancer Plan. COM (2021) 44 final.
(59) Communication from the Commission to the European Parliament and Council, The European Economic and Social Committee and the Committee of the Regions - A Renovation Wave for Europe - greening our buildings, creating jobs, improving lives. COM (2020) 662 final
(60) BG, HR, CZ, DK, FI, FR, DE, HU, IT, LV, NL, PL, SK, SI, SE.
(61) HR, IE, LT.
(62) RPA (2021) See footnote 21.
(63) See footnote 23.
(64) The process for setting and/or revising limit values involves the identification by the Commission of priority substances for scientific evaluation including stakeholder engagement at Member States and Social Partner levels, a scientific evaluation of the Committee for Risk Assessment of the European Chemicals Agency, a public consultation, the tripartite consultation of employers’, workers’ and governments’ representatives via the Advisory Committee on Safety and Health at Work, and an impact assessment based on an external study.
(65) https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52017SC0010&from=en  
(66) See footnote 3.
(67) The RAC recommends stating in the CAD that the exposure of fertile women to lead should be avoided or minimised in the workplace because the BLV for lead is not protective of the offspring of women of childbearing age. In ETUC’s view, this is discriminatory as it could create a situation where women might not be hired in workplaces where they can be exposed to lead and its compounds.
(68) See footnote 45.  
(69) See footnote 24.  
(70) See footnote 25.
(71) See footnote 25.
(72) For a detailed overview of the differing views, see the ACSH opinion (see footnote 25) and the impact assessment report accompanying this proposal.
(73) The time required for its concentration to decrease by half.
(74) See footnote 23.
(75) See footnotes 31 and 37.
(76) RPA (2021) See footnote 20. When the study was launched, both the introduction of limit values for diisocyanates and the update of limit values for lead were to be carried out under the CAD. However, the impact assessment report was drafted after the agreement between the European Parliament and Council in January 2022 to expand the scope of the CMD and therefore took account of the inclusion of reprotoxic substances under the CMRD and its implications.
(77) RAC opinion. See footnote 23.
(78) See footnote 25 .
(79) Available at: https://ec.europa.eu/info/better-regulation-guidelines-and-toolbox_en .
(80) Companies operating with lead will only face costs of RMMs.
(81) Tool # 22 of the Better Regulation toolbox on SMEs.
(82) https://ec.europa.eu/eurostat/web/experimental-statistics/european-occupational-diseases-statistics  
(83) The campaign pursued several objectives, including raising awareness on the importance of preventing risks from dangerous substances, promoting risk assessment, heightening awareness of risks of exposure to carcinogens at work, and increasing knowledge of the legislative framework. The campaign ran in 2018-2019. One of its features is a database of guidance and good practices available at https://osha.europa.eu/en/themes/dangerous-substances/practical-tools-dangerous-substances .
(84) 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 or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50).
(85) Directive (EU) 2022/431 of the European Parliament and of the Council of 9 March 2022 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (OJ L 88, 16.3.2022, p. 1).
(86) Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p 11).
(87) Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.06.1989, p.1).
(88) 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.)
(89) 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).
(90) ACSH opinion on lead (2021). https://circabc.europa.eu/ui/group/cb9293be-4563-4f19-89cf-4c4588bd6541/library/60b206e1-ee10-40c2-9540-fb6510c11a0c/details  
(91) 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.)
(92) On the evaluation of the occupational exposure limits for lead and its compounds, delivered on 11 June 2020. (See section 8.2.4. of the annex to the opinion). https://echa.europa.eu/documents/10162/ed7a37e4-1641-b147-aaac-fce4c3014037
(93) See footnote 8.
(94) ACSH opinion on diisocyanates (2021) https://circabc.europa.eu/ui/group/cb9293be-4563-4f19-89cf-4c4588bd6541/library/0d11d394-b1e8-4e1a-a962-5ad60f4ab2ae/details