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A quantitative comparison of the safety margins in the European indicative occupational exposure limits and the derived no-effect levels for workers under REACH
KTH, Filosofi.ORCID iD: 0000-0003-3799-4814
Institute of environmental Medicine, Karolinska Institutet.
2011 (English)In: Toxicological Sciences, ISSN 1096-6080, E-ISSN 1096-0929, Vol. 121, no 2, 408-416 p.Article in journal (Refereed) PublishedText
Abstract [en]

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.
Keyword [en]
Chemicals regulation, DNEL, IOELV, Occupational Exposure Limit, REACH, SCOEL.
National Category
Environmental Health and Occupational Health
Identifiers
URN: urn:nbn:se:sh:diva-29725DOI: 10.1093/toxsci/kfr056ISI: 000290931000018PubMedID: 21389111ScopusID: 2-s2.0-79957844799OAI: oai:DiVA.org:sh-29725DiVA: diva2:911673
Note

Som manuskript i avhandling. As manuscript in dissertation.

Available from: 2011-02-15 Created: 2016-03-14 Last updated: 2016-03-14Bibliographically approved
In thesis
1. Setting occupational exposure limits: Practices and outcomes of toxicological risk assessment
Open this publication in new window or tab >>Setting occupational exposure limits: Practices and outcomes of toxicological risk assessment
2011 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Occupational Exposure Limits (OELs) are used as an important regulatory instrument to protect workers’ health from adverse effects of chemical exposures. The main objective of this thesis is to study risk assessment practices in the setting of OEL in order to produce knowledge that will help improve the consistency and transparency of OELs.

For the purpose of paper I a database of OELs for a total of 1341 substances was compiled. Of these, only 25 substances have OELs from all 18 included organisations while more than one third of the substances are only regulated by one organisation alone. The average level of OELs differs substantially between organisations; the US OSHA exposure limits are (on average) nearly 40 % higher than those of Poland.

In paper II six EU member states’ OELs are compared to the European Commission’s OELs. Also within Europe there is a large difference concerning the average level of OELs (35%). The average level of lists tends to decrease over time, although there are exceptions to this. There are also indications that the exposure limits of EU member states are converging towards the European Commission’s OELs.

The work presented in paper III identifies steps in the risk assessment that could account for the large differences in OELs for 14 different substances. Differences in the identification of the critical effect could explain the different level of the OELs for half of the substances. But the age of the data review could not account for all the differences in data selection, only one fifth of the documents referred to all available key studies. Also the evaluation of the key studies varied significantly.

The aim of paper IV was to investigate how the Scientific Committee on Occupational Exposure Limits (SCOEL) of the European Commission uses assessment factors when proposing health-based indicative OELs. For only one third of the investigated OELs were explicit assessment factors given. On average the safety margin of the recommendations was 2.1 higher when an explicit assessment factor had been used. It is recommended that the SCOEL develop and adhere to a more articulate framework on the use of assessment factors.

Paper V focuses on the Derived No-Effect Levels (DNELs) which are to be calculated under the new European Union REACH legislation. It is a comparison of 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 documentations but varied widely with REACH/SCOEL safety margin ratios ranging by two orders of magnitude, from 0.3 to 58.

Place, publisher, year, edition, pages
Stockholm: KTH Royal Institute of Technology, 2011. viii, 40 p.
Series
Theses in Risk and Safety from the Division of Philosophy at the Royal Institute of Technology, ISSN 1654-627X ; 6
Keyword
Assessment Factor, DNEL, Euroepan Union, Occupational Exposure Limit, REACH, Risk Assessment, Regulatory Toxicology, SCOEL, Uncertainty Factor
National Category
Pharmacology and Toxicology
Identifiers
urn:nbn:se:sh:diva-29722 (URN)978-91-7415-853-3 (ISBN)
Public defence
2011-02-28, F3, Lindstedtsvägen 26, Stockholm, 09:30 (English)
Opponent
Supervisors
Available from: 2016-03-14 Created: 2016-03-14 Last updated: 2016-03-14Bibliographically approved

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