Abstract
The first deadline for REACH registration has passed and registration data for the first set of substances are now public. According to ECHA, 4,599 substances have been registered so far, and the corresponding dossiers of many of them are now partially available in a public database. A sample of 400 records was randomly selected and analyzed with regard to reproductive and developmental toxicity. Most dossiers do not follow the strict requirements in the official guidelines, and some dossiers lack some very basic information. A broad variety of existing data is used, and the read-across opportunity is very much exploited. Surprisingly, a number of in vivo tests have been performed already, apparently for REACH purposes, in spite of the legal requirement to make a public proposal and wait for authorization by ECHA. The number of animals used so far, plus the number of animals that will derive from testing proposals of the first REACH deadline, is very high; it may add up to 1.6 million animals just to accomplish reproductive and developmental toxicity endpoints if the data collected from 400 dossiers are extrapolated to the total number of registered substances. In vitro tests are completely absent, even though there are many tests that may be used to complement either read-across strategies or partially reliable existing data. It is recommended, in the spirit of REACH, to protect human health through an in-depth assessment of the chemicals and simultaneously, to promote the use of in vitro alternatives.
Highlights
On December 30, 2006, the Regulation on Registration, Evaluation, Authorization and restriction of Chemicals (REACH, 2006) was published in the Official Journal of the European Union
This Regulation requires that all chemicals that are marketed and/or manufactured in the European Union in quantities above one ton per year must be fully characterized as to the impact they may have on both human health and the environment
10 t/a the registration dossier must contain a Chemical Safety Report (CSR) that is the result of an extensive Chemical Safety Assessment (CSA)
Summary
On December 30, 2006, the Regulation on Registration, Evaluation, Authorization and restriction of Chemicals (REACH, 2006) was published in the Official Journal of the European Union. The possible risk of chemicals is a major concern for European citizens: when asked how likely they feel, personally, that environmental chemicals damage their health, Eurobarometers from 2005 and 2010 stably indicated that 18% considered this “very likely” and 43% “fairly likely” (Eurobarometer 73.5 from 06/2010 and 64.1 from 09-10/2005). This Regulation requires that all chemicals that are marketed and/or manufactured in the European Union in quantities above one ton per year must be fully characterized as to the impact they may have on both human health and the environment. 10 t/a the registration dossier must contain a Chemical Safety Report (CSR) that is the result of an extensive Chemical Safety Assessment (CSA)
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