How consistent are the Derived No-Effect Levels (DNELs) in the European REACH legislation?

• The new European REACH regulation places more responsibility than hitherto on manufacturers and importers of chemicals (“industry”) to provide safety information. An important part of the development of a REACH Chemical Safety Report is derivation of Derived No-Effect Levels (DNELs) which represent “the level of exposure above which humans should not be exposed”. In order to study the consistency, we compared DNELs presented by industry at the website of the European Chemicals Agency (ECHA) with those derived by us in our interpretation of the REACH guidance (Chapter R.8: Characterisation of dose [concentration]-response for human health, http://echa.europa.eu/documents/10162/13632/information_requirements_r8_en.pdf). There are various DNELs, e.g. representing short-term, long-term, inhalation and dermal exposure, as well as workers and the whole population. We limited our study to “worker-DNELs long-term” for inhalation route as they resemble occupational exposure limits (OELs). We found 24 substances for which (1) such DNELs were given in the ECHA chemical database (http://echa.europa.eu/web/guest/information-on-chemicals/registered-substances) and (2) a scientific basis for OEL had been published by the Swedish Criteria Group within the last 15 years in the serial Arbete och Hälsa (https://gupea.ub.gu.se/handle/2077/3194?locale=en). The results were startling, as the DNELs given by industry were 2.4 to 1,100 times higher than ours for 23 substances and 260,000 times higher for trimellitic anhydride. Some of the discrepancy is explained by different choice of key studies/points of departure (PODs). However, the choice of assessment factors (AFs) also differed markedly, as industry’s total AFs (calculated implicitly from the POD and the DNEL) were 1-230 times lower than ours. We conclude that although the REACH guidance is relatively detailed, many arbitrary choices remain that will influence the DNEL. A major problem is that little advice is given on when and how to depart from default AFs.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Hälsovetenskap -- Arbetsmedicin och miljömedicin (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Health Sciences -- Occupational Health and Environmental Health (hsv//eng)

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