Directive 2004/37/CE (CMD): Isoprene in evidence OEL

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OEL Isoprene

Directive 2004/37/CE (CMD): Isoprene in evidence OEL

ID 15014 | 25.11.2021 / Report in attachment

The Commission, in view of the preparation of the proposals for amendment of Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (CMD), and in line with the 2017 Commission Communication ‘Safer and Healthier Work for All’ - Modernisation of the EU Occupational Safety and Health Legislation and Policy1 , asked the advice of RAC to assess the scientific relevance of occupational exposure limits for some carcinogenic chemical substances . Therefore, the Commission made a request on 11 Dec 2020 to ECHA in accordance with the Service Level Agreement (SLA) (Ares(2019)18725), to evaluate, in accordance with the Directive 2004/37/EC, isoprene which is classified as a carcinogen Category 1B in CLP legislation.

In support of the Commission’s request, ECHA has prepared a scientific report concerning occupational limit values for isoprene at the workplace. In the preparatory phase of making this report, a call for evidence was started on 14 April 2021 to invite interested parties to submit comments and evidence on the subject by 13 July 2021.

The scientific report was made publicly available at: Occupational exposure limits – Consultations on OEL recommendation - ECHA ( on 11 October 2021 and interested parties were invited to submit comments by 10 December 2021.

The Committee for Risk Assessment (RAC) will develop its opinion on the basis of the scientific report submitted by ECHA. During the preparation of the opinion on occupational limit values for isoprene, the scientific report will be further developed as the Annex to the RAC opinion.

Occupational Exposure Limits (OELs) - 8h TWA proposed isoprene

Thus, it can be anticipated that the additional cancer risk would be minimal if the work-life long isoprene exposure level was 3 ppm. Based on this an 8 h TWA of 3 ppm (8.5 mg/m3) isoprene is proposed.

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