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Occupational exposure limits

Occupational exposure limits

The European Commission seeks advice from independent scientific committees on the assessment of priority chemicals, in order to support proposed actions to adopt new or revised Occupational Exposure Limits (OELs) under Directive 2004/37/EC and Directive 98/24/EC.  European Chemicals Agency, through its Committee for Risk Assessment (RAC), supports the European Commission’s Directorate-General for Employment, Social Affairs and Inclusion (DG EMPL) by providing scientific opinions on OELs. RAC has recently taken over responsibility for work previously carried out by DG Employment’s Scientific Committee on Occupational Exposure Limits (SCOEL).

OELs are a measure for minimising worker exposure to hazardous substances in the workplace. Such limits are set taking into account the available information (including the most recent data) on the hazards of a substance, particularly with respect to carcinogenicity, mutagenicity and toxicity to reproduction, and on the acute effects of exposure.

OELs are mainly intended to prevent workers from inhaling chemicals as vapours, mists or dusts. However, RAC may also provide recommendations for a skin notation indicating that dermal protection is needed. Other notations are also possible, for example: sensitisation or noise. Additionally, RAC may recommend Biological Limit Values (BLV, biomonitoring exposure levels) or Biological Guidance Values (BGV, biomonitoring background levels).

OEL process

OELs are established following a process involving a series of steps. The process for the substances being considered for binding OELs under the Carcinogens and Mutagens Directive (2004/37/EC) or the Chemical Agents Directive (98/24/EC), is the ordinary legislative procedure which is shown in the diagram below. Once agreed, these are binding OELs. Substances being considered under the Chemical Agents Directive (98/24/EC) for indicative OELs go through a lighter legislative procedure and a decision is taken by the European Commission. Once agreed, these are indicative OELs.  

In addition, for certain policy initiatives the Commission will consult the social partners at EU level in accordance with the social policy provisions of the Treaty on the Functioning of the EU.

ECHA/RAC tasks in the OEL process 

ECHA starts its work when it receives a request from the Commission to prepare a scientific report for consideration by RAC for substances selected from the DG EMPL lists of priority substances (Steps 1 and 2). 

Request from EC ECHA RAC EC services Interested parties Call for evidence Optional call for evidence to collect additional literature and evidence for the preparation of the scientific report * When a substance is evaluated under the Chemical Agents Directive (CAD) and the occupational exposure limit is indicative, the decision is made by the European Commission** When a substance is evaluated under the Carcinogens and Mutagens Directive (CMD), the decision is made in agreement between the Council and the European Parliament based on a proposal put forward by the European Commission The scientific report becomes background document for RAC RAC finalises opinion Mandatory 60-day public consultation on the scientific report Public consultation Preparation of the scientific report RAC develops opinion Decision process *) **) Submission of the scientific report Final opinion published Publication in the Official Journal Draft RAC opinion 12-24 months

*When a substance is evaluated under the Chemical Agents Directive (CAD) and the occupational exposure limit is indicative, the decision is made by the European Commission.

**When a substance is evaluated under the Carcinogens and Mutagens Directive (CMD), the decision is made in agreement between the Council and the European Parliament based on a proposal put forward by the European Commission.

ECHA prepares the scientific report for evaluation of the OELs. The preparation of the scientific report may also rely on relevant information collected through a call for evidence. The completed scientific report is subject to a two-month public consultation. RAC then develops its opinion based on a review of ECHA’s scientific report and the information provided during the public consultation. During the opinion development process the scientific report becomes the background document supporting the RAC opinion.

After RAC has adopted its final opinion on the scientific report, the opinion and supporting documents are sent to the Commission.

Commission tasks in the OEL process 

The Commission (DG EMPL) discusses the outcome of the RAC scientific evaluation with Member States’ experts and the social partners (employers’ and workers’ representatives) in the tri-partite Working Party on Chemicals (WPC).

The WPC prepares a draft Opinion on the proposed OEL, which is presented to the tri-partite Advisory Committee on Safety and Health for adoption.

Thereafter, there are a number of other steps to be followed before the Commission can adopt a legislative proposal which then follows the ordinary legislative procedure for adoption by Council and the European Parliament (for binding OELs), or a Commission Directive (for indicative OELs).

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