OEL Process

OEL Process

There are a series of steps involved in setting OELs, as laid down in the process chart.

Firstly, the European Commission (DG EMPL) decides which substances need new or updated OELs. The priority substances are discussed in the tripartite Working Party on Chemicals with Commission representatives, experts from Member States and representatives of employer and worker organisations.

Secondly, DG EMPL requests ECHA to provide a scientific recommendation on the specific substances.

ECHA sends the RAC opinion to DG EMPL which serves as a basis for the subsequent steps in the legislative process.

Asset 1 1 Selection of chemicals for Scientific Evaluation DG EMPL establishes lists of priorities for scientific e v aluation based on inputs from v arious sources and application of priori t y criteria. 3 * WPC-ACSH The working P ar t y on Chemicals (WPC) discusses the scientific R ecommendation and v arious feasibili t y issues and comes up with a consensus based suggestion for the OEL v alue. This is integ r ated in a d r aft opinion for adoption b y the Plenary of ACSH. 4 Impact Assessment (IA) DG EMPL d r afts IA containing policy options and associated impacts. IA is discussed within an Interservice Steering Group and submitted to the R egulatory Scruti n y Board (RSB). A positi v e reply is required. 5 Draft legislative proposal DG EMPL prepares the d r aft legislati v e proposal and submits it to the inter/service consultation. Thereafte r , a final d r aft legislati v e proposal is prepared. 6 College of Commissioners The college of Commissioners adopts the proposal and sends it to Council and P arliament for negotiation and subsequent adoption. As a Directi v e. 7 Adopted Directive published in EU Official Journal MSs will t r anspose the legal text into national legislation b y the date set in the Directi v e. 2 Scientific Recommendation DG EMPL issues mandates to scientific committee, who will deli v er as a rule the exposure- ris k -relationships (ERR) for non-threshold carcinogens, or a p r actical threshold when possible. Scientific R ecs are subject to external consultation before adoption.

ECHA tasks

Following the request from DG EMPL, ECHA prepares a scientific report for its Committee for Risk Assessment (RAC) based on the available scientific data and any relevant information collected through a 90-day call for evidence.

The scientific report is subject to a 60-day open consultation. RAC then develops its opinion based on a review of ECHA’s scientific report and the information provided during the consultation. ECHA’s scientific report becomes an integral part of RAC’s opinion and forms an annex to the opinion.  ECHA sends the adopted final RAC opinion DG EMPL and publishes it on its website.

European Commission’s role

DG EMPL discusses RAC’s opinion (with the annex) in the tripartite Working Party on Chemicals. This working party prepares a draft opinion on the proposed occupational exposure limit, and presents it to the tripartite Advisory Committee on Safety and Health for adoption.

In the end, the Commission adopts a legislative proposal. 

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

Binding OELs

The legislative proposal goes through the ordinary legislative procedure for adoption by the Council and the European Parliament.

Under the Carcinogens, Mutagens or Reprotoxic substances Directive or the Chemical Agents Directive, such binding OELs provide a minimum level of protection for all workers in the EU. Member States must set a corresponding binding limit that does not exceed the EU value.

Indicative OELs

The legislative proposal becomes a Commission directive.

Under the Chemical Agents Directive, OELs are health-based limits. They are established for substances for which it is possible to set a level where there is no risk to workers’ health. Member States must establish a corresponding national OEL value in accordance with their national legislation and practice, taking the EU value into account.