CELEX 02004L0037 · v20240408

Article 2 / Definitions

For the purposes of this Directive,

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(a) 

‘carcinogen’ means:

(i) 

a substance or mixture which meets the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council ( 2 );

(ii) 

a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex;

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(b) 

‘mutagen’ means:

(i) 

a substance or mixture which meets the criteria for classification as a category 1A or 1B germ cell mutagen set out in Annex I to Regulation (EC) No 1272/2008;

(ii) 

a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex;

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(ba) 

‘reprotoxic substance’ means a substance or mixture, which meets the criteria for classification as a category 1A or 1B reproductive toxicant set out in Annex I to Regulation (EC) No 1272/2008;

(bb) 

‘non-threshold reprotoxic substance’ means a reprotoxic substance to which there is no safe level of exposure for workers’ health and which is identified as such in the notation column of Annex III;

(bc) 

‘threshold reprotoxic substance’ means a reprotoxic substance for which a safe level of exposure exists below which there is no risk to workers’ health and which is identified as such in the notation column of Annex III;

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(c) 

‘limit value’ means, unless otherwise specified, the limit of the time-weighted average of the concentration for a carcinogen, mutagen or reprotoxic substance in the air within the breathing zone of a worker in relation to a specified reference period as set out in Annex III;

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(d) 

‘biological limit value’ means the limit of the concentration in the appropriate biological medium of the relevant agent, its metabolite, or an indicator of effect;

(e) 

‘health surveillance’ means the assessment of an individual worker to determine the state of health of that individual, as related to exposure to specific carcinogens, mutagens or reprotoxic substances at work.

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