Limit Values European Union - IOELV and BOELV

From 1995 to 2018 the European Commission received scientific advice on OELs from the Scientific Committee for Occupational Exposure Limits to Chemical Agents (SCOEL). The SCOEL was part of the DG EMPL, the European Commission's Directorate-General for Employment, Social Affairs and Inclusion. Since 2019, ECHA/RAC have supported the Commission's DG EMPL by providing scientific opinions on occupational exposure limits, assuming this responsibility from SCOEL. The Committee for Risk Assessment (RAC) is part of the European Chemicals Agency (ECHA) and consists of 56 members, 5 co-opted members and 2 EEA members from Norway¹.

The members nominated by EU/EEA Member States are appointed by the ECHA Management Board for a renewable term of three years. The members act in a personal capacity as independent experts. Several steps are involved in setting European occupational exposure limits (https://echa.europa.eu/oel-process). The European Commission decides which substances require OELs. The decision is based on inputs from various sources and the application of priority criteria. The Commission then requests that the ECHA/RAC prepare a scientific opinion on the specific substances. The ECHA develops a scientific report with a summary of all available scientific data and any relevant information, including that received from parties responding to a call for evidence. The report includes the recommendation for OELs and the supporting information on relevant exposures at the workplace, the critical effects and assessment of health risks, the extrapolation techniques used, and any data on possible risks to human health and the technical feasibility of monitoring exposure.

The RAC forms its opinion based on a review of the ECHA's scientific report, taking the information received during a 60-day public consultation phase into consideration, and recommends OELs when possible. The ECHA's scientific report becomes an integral part of the RAC's opinion, is developed further and forms an annex to the report. The final RAC opinion is forwarded to the DG EMPL. Following discussion by the DG EMPL and the tripartite Working Party on Chemicals (WPC), a consensus-based proposal for the OEL value is stated in a draft opinion for adoption by the Plenary of ACSH (the tripartite Advisory Committee on Safety and Health).

Binding OELs are adopted by the Council and the European Parliament by way of the ordinary legislative procedure. Indicative OELs are subject to a simplified legislative procedure. Finally, the adopted directive is published in the Official Journal of the European Union.

The proposed values for a particular substance may include an OEL defined as an eight-hour time-weighted average (TWA), short-term limits/excursion limits (STEL) and biological limit values. The OELs may be supplemented, as appropriate, by further notations, such as a skin notation indicating that dermal protection is needed. Other notations for sensitisation or noise are also possible. The RAC may in addition recommend biological limit values (BLVs, biomonitoring exposure levels) or biological guidance values (BGVs, biomonitoring background levels).

July 2020

¹ European Economic Area countries: the EU Member States and Iceland, Liechtenstein and Norway