Occupational Exposure Limit (OEL) REPORTS


Several hundred APIs substances OEL-OEB reports have already been developed.


New reports are regularly developed.


Any OEL-OEB report can be developed upon request.


Our rates of OEL-OEB reports are based on the status of development for such active substance, and discounts can be granted upon scale up quantities.

List of OELs




Protection of workers from the risk of chemical agents  and fixation of an upper exposure limit: OEL


Occupational Exposure Limits (OEL) are regulatory values which indicate levels of exposure to be safe (health based) for a chemical substance in a work place.

OELs are adopted under 2 EU legal frameworks: Chemical Agents Directive (Directive 98/24/EC) and Carcinogens and Mutagens Directive (Directive 2004/37/EC).

As stated in the Questions and answers EMA/CHMP/CVMP/SWP/246844/2018Health Based Exposure Limits, i.e. PDEs but as well OELs, are required for all medicinal products and have to be established by experts.

OEL value is used as data, to assign the chemical in a category or band, to which correspond containment measures and personal protective equipment.


The determination of an OEL involves :


  • The derivation of occupational exposure limit is based on the equation published by Galer et al. (1992), Naumann and Weideman (1995), Sargent and Kirk (1988), and Schwartz (1995): from a NOAEL/LOAEL, human body weight, safety factors and human breathing rate.

    For one API, OELs are calculated considering all sensitive species.

    NOEL in healthy volunteers as the highest exposure level at which there are no effects (adverse or non adverse) has preference to calculate an OEL more than NOAEL in animals.

    Safety concerns detailed in the Risk Management Plan of the medicine are reviewed in order to detect other critical effects in humans.

  • Hazard statements and precautionary statements prevention and response  according to CLP, are given.
  • From those toxicological criteria and for the specific work conditions, is determined  a category according the NTP 1104, INSHT or Safebridge banding scheme.

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