EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work - Main contents

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dossier	COM(2020)571 - Amendment of Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens ...
document	COM(2020)571
date	March 9, 2022

ANNEX

The Annexes to Directive 2004/37/EC are amended as follows:

(1)

in Annex III, point A is amended as follows:

(a)

the row related to benzene is replaced by the following:

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	ppm	f/ml
‘Benzene	200-753-7	71-43-2	0,66	0,2	–	–	–	–	Skin (8)	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.’

(b)

the following rows are added:

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	ppm	f/ml
‘Acrylonitrile	203-466-5	107-13-1	1	0,45	–	4	1,8	–	Skin (8) Dermal sensitisation (9)	The limit values shall apply from 5 April 2026.
Nickel compounds	–	–	0,01 (10) 0,05 (11)	–	–	–	–	–	Dermal and respiratory sensitisation (12)	The limit value (10) shall apply from 18 January 2025 The limit value (11) shall apply from 18 January 2025. Until then a limit value of 0,1 mg/m3 (11) shall apply.
Inorganic lead and its compounds			0,15
N,N-Dimethylacetamide	204-826-4	127-19-5	36	10		72	20		Skin (8)
Nitrobenzene	202-716-0	98-95-3	1	0,2					Skin (8)
N,N Dimethylformamide	200-679-5	68-12-2	15	5		30	10		Skin (8)
2-Methoxyethanol	203-713-7	109-86-4		1					Skin (8)
2-Methyoxyethyl acetate	203-772-9	110-49-6		1					Skin (8)
2-Ethoxy ethanol	203-804-1	110-80-5	8	2					Skin (8)
2-Ethoxyethyl acetate	203-839-2	111-15-9	11	2					Skin (8)
1-Methyl-2-pyrrolidone	212-828-1	872-50-4	40	10		80	20		Skin (8)
Mercury and divalent inorganic mercury compounds including mercuric oxide and mercuric chloride (measured as mercury)			0,02
Bisphenol A; 4,4′-Isopropylidenediphenol	201-245-8	80-05-7	2 (13)
Carbon monoxide	211-128-3	630-08-0	23	20		117	100

(2)

the following annex is inserted:

‘ANNEX IIIa

BIOLOGICAL LIMIT VALUES AND HEALTH SURVEILLANCE MEASURES

(Article 16(4))

Lead and its ionic compounds

1.1.	Biological monitoring must 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 is 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.

’.

(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, to 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) Substantial contribution to the total body burden via dermal exposure possible.

(9) The substance can cause sensitisation of the skin.

(10) Respirable fraction, measured as nickel.

(11) Inhalable fraction, measured as nickel.

(12) The substance can cause sensitisation of the skin and of the respiratory tract.

(13) Inhalable fraction.’;

Joint statement of the European Parliament and the Council on the scope of Directive 2004/37/EC

The European Parliament and the Council share the common understanding that hazardous medicinal products which contain substances which meet the criteria for classification as carcinogenic (categories 1A or 1B), mutagenic (categories 1A or 1B) or reprotoxin (categories 1A or 1B) in accordance with Regulation (EC) No 1272/2008 fall under the scope of Directive 2004/37/EC. All requirements of Directive 2004/37/EC apply to hazardous medicinal products accordingly.