A quantitative comparison of the safety margins in the European indicative occupational exposure limits and the derived no-effect levels for workers under REACH
2011 (English)In: Toxicological Sciences, ISSN 1096-6080, E-ISSN 1096-0929, Vol. 121, no 2, 408-416 p.Article in journal (Refereed) PublishedText
The new European Union (EU) REACH legislation requires Derived No-Effect Levels (DNEL) to be calculated for substances produced in quantities above 10 tonnes/year. Meanwhile, the setting of occupational exposure limits (OEL) continues both at the member state and the EU level. According to REACH, Indicative OEL Values (IOELVs) from the Commission may under some circumstances be used as worker-DNELs. On the other hand, worker-DNELs will be derived for several thousand substances, far more than the roughly 100 substances for which IOELVs have been established. Thus, the procedure to set health-based OELs may become influential on that of DNELs and vice versa. In this study, we compare the safety margins of 88 SCOEL recommendations with those of the corresponding worker-DNELs, derived according to the default approach as described in the REACH guidance document. Overall, the REACH safety margins were approximately six times higher than those derived from the SCOEL documentation but varied widely with REACH/SCOEL safety margin ratios ranging by two orders of magnitude, from 0.3 to 58 (n=88). The discrepancies may create confusion in terms of legal compliance, risk management and risk communication. We also found that the REACH guidance document, although encompassing detailed advice on many issues, including default assessment factors for species and route extrapolation, gives no quantitative guidance on when and how to depart from defaults.
Place, publisher, year, edition, pages
2011. Vol. 121, no 2, 408-416 p.
Chemicals regulation, DNEL, IOELV, Occupational Exposure Limit, REACH, SCOEL.
Environmental Health and Occupational Health
IdentifiersURN: urn:nbn:se:sh:diva-29725DOI: 10.1093/toxsci/kfr056ISI: 000290931000018PubMedID: 21389111ScopusID: 2-s2.0-79957844799OAI: oai:DiVA.org:sh-29725DiVA: diva2:911673
Som manuskript i avhandling. As manuscript in dissertation.2011-02-152016-03-142016-03-14Bibliographically approved