Annexes to COM(2023)738 - 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) (codification) - Main contents
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| dossier | COM(2023)738 - Protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work (Sixth ... |
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| document | COM(2023)738  |
| date | November 27, 2023 |
(3) Entered in the legislative programme for 2023.
(4) See Part A of Annex V to this proposal.
(5) OJ C […], […], p. […].
(6) OJ C […], […], p. […].
(7) 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) (OJ L 158, 30.4.2004, p. 50).
(8) See Part A of Annex V.
(9) 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).
(10) OJ C 428, 13.12.2017, p. 10.
(11) 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).
(12) 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).
(13) 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).
(14) Directive 2009/148/EC of the European Parliament and of the Council of 30 November 2009 on the protection of workers from the risks related to exposure to asbestos at work (OJ L 330, 16.12.2009, p. 28).
(15) OJ L 123, 12.5.2016, p. 1.
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EUROPEAN COMMISSION
Brussels, 27.11.2023
COM(2023) 738 final
ANNEXES
to the
Proposal for a
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
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) (codification)
🡻 Corrigendum, OJ L 229, 29.6.2004, p. 23
🡺1 2014/27/EU Art. 5.6
ANNEX I
List of substances, 🡺1 mixtures 🡸 and processes
(Article 2, point (a)(ii))
1.Manufacture of auramine.
2.Work involving exposure to polycyclic aromatic hydrocarbons present in coal soot, coal tar or coal pitch.
3.Work involving exposure to dusts, fumes and sprays produced during the roasting and electro-refining of cupro-nickel mattes.
4.Strong acid process in the manufacture of isopropyl alcohol.
5.Work involving exposure to hardwood dusts 1 .
🡻 2017/2398 Art. 1.4
6.Work involving exposure to respirable crystalline silica dust generated by a work process.
🡻 2019/130 Art. 1.2
7.Work involving dermal exposure to mineral oils that have been used before in internal combustion engines to lubricate and cool the moving parts within the engine.
8.Work involving exposure to diesel engine exhaust emissions.
_____________
🡻 Corrigendum, OJ L 229, 29.6.2004, p. 23
ANNEX II
Practical recommendations for the health surveillance of workers
(Article 15(7))
🡻 2022/431 Art. 1.16 (adapted)
1.The doctor and/or authority responsible for the health surveillance of workers exposed to carcinogens, mutagens or reprotoxic substances ⌦ shall ⌫ be familiar with the exposure conditions or circumstances of each worker.
🡻 Corrigendum, OJ L 229, 29.6.2004, p. 23 (adapted)
2.Health surveillance of workers ⌦ shall ⌫ be carried out in accordance with the principles and practices of occupational medicine; it ⌦ shall ⌫ include at least the following measures:
–keeping records of a worker's medical and occupational history,
–a personal interview,
–where appropriate, biological surveillance, as well as detection of early and reversible effects.
Further tests may be decided upon for each worker when ⌦ the worker ⌫ is the subject of health surveillance, in the light of the most recent knowledge available to occupational medicine.
_____________
🡻 2019/130 Art. 1.3 and Annex (adapted)
🡺1 2019/983 Art. 1.2 and Annex
🡺2 2022/431 Art. 1.17 and Annex .1(a)
🡺3 2022/431 Art. 1.17 and Annex .1(b)
(adapted)
ANNEX III
LIMIT VALUES AND OTHER DIRECTLY RELATED PROVISIONS (ARTICLE 17)
A.LIMIT VALUES FOR OCCUPATIONAL EXPOSURE
| 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 (5) | ppm (6) | f/ml (7) | |||||
| Hardwood dusts | — | — | 2 (8) | — | — | — | — | — | — | |
| Chromium (VI) compounds which are carcinogens within the meaning of Article 2, point (a)(i) (as chromium) | — | — | 0,005 | — | — | — | — | — | — | Limit value 0,010 mg/m3 until 17 January 2025 Limit value: 0,025 mg/m3 for welding or plasma cutting processes or similar work processes that generate fume until 17 January 2025 |
| Refractory ceramic fibres which are carcinogens within the meaning of Article 2, point (a)(i) | — | — | — | — | 0,3 | — | — | — | — | |
| Respirable crystalline silica dust | — | — | 0,1 (9) | — | — | — | — | — | — | |
| 🡺2 Benzene 🡸 | 🡺2 200-753-7 🡸 | 🡺2 71-43-2 🡸 | 🡺2 0,66 🡸 | 🡺2 0,2 🡸 | 🡺2 – 🡸 | 🡺2 – 🡸 | 🡺2 – 🡸 | 🡺2 – 🡸 | 🡺2 Skin (15) 🡸 | 🡺2 Limit value 1 ppm (3,25 mg/m3) until 5 April 2024. Limit value 0,5 ppm (1,65 mg/m3) from 5 April 2024 until 5 April 2026. 🡸 |
| Vinyl chloride monomer | 200-831-0 | 75-01-4 | 2,6 | 1 | — | — | — | — | — | |
| Ethylene oxide | 200-849-9 | 75-21-8 | 1,8 | 1 | — | — | — | — | skin (10) | |
| 1,2-Epoxypropane | 200-879-2 | 75-56-9 | 2,4 | 1 | — | — | — | — | — | |
| Trichloroethylene | 201-167-4 | 79-01-6 | 54,7 | 10 | — | 164,1 | 30 | — | skin (10) | |
| Acrylamide | 201-173-7 | 79-06-1 | 0,1 | — | — | — | — | — | skin (10) | |
| 2-Nitropropane | 201-209-1 | 79-46-9 | 18 | 5 | — | — | — | — | — | |
| o-Toluidine | 202-429-0 | 95-53-4 | 0,5 | 0,1 | — | — | — | — | skin (10) | |
| 4,4′-Methylenedianiline | 202-974-4 | 101-77-9 | 0,08 | — | — | — | — | — | skin (10) | |
| Epichlorohydrine | 203-439-8 | 106-89-8 | 1,9 | — | — | — | — | — | skin (10) | |
| Ethylene dibromide | 203-444-5 | 106-93-4 | 0,8 | 0,1 | — | — | — | — | skin (10) | |
| 1,3-Butadiene | 203-450-8 | 106-99-0 | 2,2 | 1 | — | — | — | — | — | |
| Ethylene dichloride | 203-458-1 | 107-06-2 | 8,2 | 2 | — | — | — | — | skin (10) | |
| Hydrazine | 206-114-9 | 302-01-2 | 0,013 | 0,01 | — | — | — | — | skin (10) | |
| Bromoethylene | 209-800-6 | 593-60-2 | 4,4 | 1 | — | — | — | — | — | |
| Diesel engine exhaust emissions | 0,05 (*) | For underground mining and tunnel construction the limit value shall apply from 21 February 2026. | ||||||||
| Polycyclic aromatic hydrocarbons mixtures, particularly those containing benzo[a]pyrene, which are carcinogens within the meaning of this Directive | skin (10) | |||||||||
| Mineral oils that have been used before in internal combustion engines to lubricate and cool the moving parts within the engine | skin (10) | |||||||||
| 🡺1 Cadmium and its inorganic compounds 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 0,001 (11) 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 Limit value 0,004 mg/m (12) until 11 July 2027 🡸 | |
| 🡺1 Beryllium and inorganic beryllium compounds 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 0,0002 (11) 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 dermal and respiratory sensitisation (13) 🡸 | 🡺1 Limit value 0,0006 mg/m3 until 11 July 2026 🡸 |
| 🡺1 Arsenic acid and its salts, as well as inorganic arsenic compounds 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 0,01 (11) 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | |
| 🡺1 Formaldehyde 🡸 | 🡺1 200-001-8 🡸 | 🡺1 50-00-0 🡸 | 🡺1 0,37 🡸 | 🡺1 0,3 🡸 | 🡺1 — 🡸 | 🡺1 0,74 🡸 | 🡺1 0,6 🡸 | 🡺1 — 🡸 | 🡺1 dermal sensitisation (14) 🡸 | 🡺1 Limit value of 0,62 mg/m3 or 0,5 ppm (3) for the health care, funeral and embalming sectors until 11 July 2024 🡸 |
| 🡺1 4,4′-Methylene-bis (2-chloroaniline) 🡸 | 🡺1 202-918-9 🡸 | 🡺1 101-14-4 🡸 | 🡺1 0,01 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 — 🡸 | 🡺1 skin (10) 🡸 | |
| 🡺3 Acrylonitrile 🡸 | 🡺3 203-466-5 🡸 | 🡺3 107-13-1 🡸 | 🡺3 1 🡸 | 🡺3 0,45 🡸 | 🡺3 – 🡸 | 🡺3 4 🡸 | 🡺3 1,8 🡸 | 🡺3 – 🡸 | 🡺3 Skin (10) Dermal sensitisation (14) 🡸 | 🡺3 The limit values shall apply from 5 April 2026. 🡸 |
| 🡺3 Nickel compounds 🡸 | 🡺3 – 🡸 | 🡺3 – 🡸 | 🡺3 0,01 (15) 0,05 (16) 🡸 | 🡺3 – 🡸 | 🡺3 – 🡸 | 🡺3 – 🡸 | 🡺3 – 🡸 | 🡺3 – 🡸 | 🡺3 Dermal and respiratory sensitisation (13) 🡸 | 🡺3 The limit value (15) shall apply from 18 January 2025 The limit value (16) shall apply from 18 January 2025. Until then a limit value of 0,1 mg/m (16) shall apply. 🡸 |
| 🡺3 Inorganic lead and its compounds 🡸 | 🡺3 0,15 🡸 | |||||||||
| 🡺3 N,N-Dimethylacetamide 🡸 | 🡺3 204-826-4 🡸 | 🡺3 127-19-5 🡸 | 🡺3 36 🡸 | 🡺3 10 🡸 | 🡺3 72 🡸 | 🡺3 20 🡸 | 🡺3 Skin (10) 🡸 | |||
| 🡺3 Nitrobenzene 🡸 | 🡺3 202-716-0 🡸 | 🡺3 98-95-3 🡸 | 🡺3 1 🡸 | 🡺3 0,2 🡸 | 🡺3 Skin (10) 🡸 | |||||
| 🡺3 N,N Dimethylformamide 🡸 | 🡺3 200-679-5 🡸 | 🡺3 68-12-2 🡸 | 🡺3 15 🡸 | 🡺3 5 🡸 | 🡺3 30 🡸 | 🡺3 10 🡸 | 🡺3 Skin (10) 🡸 | |||
| 🡺3 2-Methoxyethanol 🡸 | 🡺3 203-713-7 🡸 | 🡺3 109-86-4 🡸 | 🡺3 1 🡸 | 🡺3 Skin (10) 🡸 | ||||||
| 🡺3 2-Methyoxyethyl acetate 🡸 | 🡺3 203-772-9 🡸 | 🡺3 110-49-6 🡸 | 🡺3 1 🡸 | 🡺3 Skin (10) 🡸 | ||||||
| 🡺3 2-Ethoxy ethanol 🡸 | 🡺3 203-804-1 🡸 | 🡺3 110-80-5 🡸 | 🡺3 8 🡸 | 🡺3 2 🡸 | 🡺3 Skin (10) 🡸 | |||||
| 🡺3 2-Ethoxyethyl acetate 🡸 | 🡺3 203-839-2 🡸 | 🡺3 111-15-9 🡸 | 🡺3 11 🡸 | 🡺3 2 🡸 | 🡺3 Skin (10) 🡸 | |||||
| 🡺3 1-Methyl-2-pyrrolidone 🡸 | 🡺3 212-828-1 🡸 | 🡺3 872-50-4 🡸 | 🡺3 40 🡸 | 🡺3 10 🡸 | 🡺3 80 🡸 | 🡺3 20 🡸 | 🡺3 Skin (10) 🡸 | |||
| 🡺3 Mercury and divalent inorganic mercury compounds including mercuric oxide and mercuric chloride (measured as mercury) 🡸 | 🡺3 0,02 🡸 | |||||||||
| 🡺3 Bisphenol A; 4,4′-Isopropylidenediphenol 🡸 | 🡺3 201-245-8 🡸 | 🡺3 80-05-7 🡸 | 🡺3 2 (11) 🡸 | |||||||
| 🡺3 Carbon monoxide 🡸 | 🡺3 211-128-3 🡸 | 🡺3 630-08-0 🡸 | 🡺3 23 🡸 | 🡺3 20 🡸 | 🡺3 117 🡸 | 🡺3 100 🡸 | ||||
| (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, of Regulation (EC) No 1272/2008. (2)CAS No: Chemical Abstract Service Registry Number. (3)Measured or calculated in relation to 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 related to 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. (8)Inhalable fraction: if hardwood dusts are mixed with other wood dusts, the limit value shall apply to all wood dusts present in that mixture. (9)Respirable fraction. (10)Substantial contribution to the total body burden via dermal exposure possible. 🡺1 (11)Inhalable fraction. 🡸 🡺1 (12)Inhalable fraction. Respirable fraction in those Member States that implement, on the date of the entry into force of this Directive, a biomonitoring system with a biological limit value not exceeding 0,002 mg Cd/g creatinine in urine. 🡸 🡺1 (13)The substance can cause sensitisation of the skin and of the respiratory tract. 🡸 🡺1 (14)The substance can cause sensitisation of the skin. 🡸 (15)Respirable fraction, measured as nickel. (16)Inhalable fraction, measured as nickel. (*)Measured as elemental carbon. |
B.OTHER DIRECTLY RELATED PROVISIONS
p.m.
_____________
ê 2022/431 Art. 1.17 and Annex point 2 (adapted)
ANNEX IV
BIOLOGICAL LIMIT VALUES AND HEALTH SURVEILLANCE MEASURES
(Article 17(4))
1.Lead and its ionic compounds
1.1.Biological monitoring ⌦ shall ⌫ include measuring the blood-lead level (PbB) using absorption spectrometry or a method giving equivalent results. The binding biological limit value is:
70 μg Pb/100 ml blood
1.2.Medical surveillance ⌦ shall be ⌫ carried out if exposure to a concentration of lead in air is greater than 0,075 mg/m3, calculated as a time-weighted average over 40 hours per week, or a blood-lead level greater than 40 μg Pb/100 ml blood is measured in individual workers.
_____________
é
ANNEX V
Part A
Repealed Directive
with [list of the successive amendments thereto/the amendment thereto]
(referred to in Article 25)
| Directive 2004/37/EC of the European Parliament and of the Council (OJ L 158, 30.4.2004, p. 50) | |
| Directive 2014/27/EU of the European Parliament and of the Council (OJ L 65, 5.3.2014, p. 1) | Only Article 5 |
| Directive (EU) 2017/2398 of the European Parliament and of the Council (OJ L 345, 27.12.2017, p. 87) | |
| Directive (EU) 2019/130 of the European Parliament and of the Council (OJ L 30, 31.1.2019, p. 112) | |
| Directive (EU) 2019/983 of the European Parliament and of the Council (OJ L 164, 20.6.2019, p. 23) | |
| Regulation (EU) 2019/1243 of the European Parliament and of the Council (OJ L 198, 25.7.2019, p. 241) | Only point III(12) of the Annex |
| Directive (EU) 2022/431 of the European Parliament and of the Council (OJ L 88, 16.3.2022, p. 1) |
Part B
Time-limits for transposition into national law and date of application
(referred to in Article 25)
| Directive | Time-limit for transposition | [Date of application] |
| Directive 2004/37/EC | 31/12/1992; 27/06/2000; 29/04/2003; | 20/05/2004 |
| Directive 2014/27/EU | 01/06/2015 | 25/03/2014 |
| Directive (EU) 2017/2398 | 17/01/2020 | 16/01/2018 |
| Directive (EU) 2019/130 | 20/02/2021 | 20/02/2019 |
| Directive (EU) 2019/983 | 11/07/2021 | 10/07/2019 |
| Directive (EU) 2022/431 | 05/04/2024 | 05/04/2022 |
_____________
ANNEX VI
Correlation Table
| Directive 2004/37/EC | This Directive |
| Article 1 | Article 1 |
| Article 2, points (a) and (b) | Article 2, points (a) and (b) |
| Article 2, point (ba) | Article 2, point (c) |
| Article 2, point (bb) | Article 2, point (d) |
| Article 2, point (bc) | Article 2, point (e) |
| Article 2, point (c) | Article 2, point (f) |
| Article 2, point (d) | Article 2, point (g) |
| Article 2, point (e) | Article 2, point (h) |
| Article 3 | Article 3 |
| Article 4 | Article 4 |
| Article 5(1), (2) and (3) | Article 5(1), (2) and (3) |
| Article 5(3a) | Article 5(4) |
| Article 5(3b) | Article 5(5) |
| Article 5(4) | Article 5(6) |
| Article 5(5) | Article 5(7) |
| Article 6 | Article 6 |
| Article 7 | Article 7 |
| Article 8 | Article 8 |
| Article 9 | Article 9 |
| Article 10 | Article 10 |
| Article 11 | Article 11 |
| Article 12 | Article 12 |
| Article 13 | Article 13 |
| Article 13a | Article 14 |
| Article 14 | Article 15 |
| Article 15(1) | Article 16(1) |
| Article 15(1a) | Article 16(2) |
| Article 15(2) | Article 16(3) |
| Article 16 | Article 17 |
| Article 16a | Article 18 |
| Article 17 | Article 19 |
| Article 17a | Article 20 |
| Article 17b | Article 21 |
| Article 18 | Article 22 |
| Article 18a | Article 23 |
| Article 19 | Article 24 |
| Article 20 | Article 25 |
| Article 21 | Article 26 |
| Article 22 | Article 27 |
| Annex I | Annex I |
| Annex II | Annex II |
| Annex III | Annex III |
| Annex IIIa | Annex IV |
| Annex IV | – |
| Annex V | – |
| – | Annex V |
| – | Annex VI |
_____________
(1) A list of some hardwoods is to be found in Volume 62 of the Monographs on the Evaluation of Carcinogenic Risks to Humans ‘Wood Dust and Formaldehyde’, published by the International Agency for Research on Cancer, Lyon, 1995.
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