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Data gap analysis, read-across and waiving strategies

Once the information requirements as laid out in Annexes V to VIII have been established and the already existing data have been compiled and evaluated ARCHE experts can help you in making a list of clear data gaps and proposals to close these, considering both waiving and read-across arguments. In the framework of REACH several possibilities are anticipated to exempt (waiving) from conducting individual tests, when this step is adequately documented and justified.

 

MIND THE GAP

Of importance here are: 

  • the theoretically generally anticipatable possibility, not to conduct tests when this is scientifically not necessary or technically not feasible, corresponding to Annex IX; 
  •  consideration in Annex IX of the REACH-Regulation of general provisions for deviations from the standard testing programmes according to Annexes V to VIII, in particular the customized testing according to Chapter 3. According to Annex IX the tests according to Annexes VII and VIII can be waived, if in the chemical safety report corresponding exposure scenarios were developed; 
  • special waiving-conditions for individual tests (example: according to Annex VI.6.6.1: Exemption from the 28-day-test for non-relevant exposure of humans), as specified in Annexes VI to VIII (Column 2).
  • Or exposure-based waiving could be considered. Which means here the exemption from the conducting of studies according to Annex VI, when the justification for the waiving is based on the fact that there is no relevant exposure of humans and environment to the substance to be registered.

Keep track of our latest news

  • New Soil PNEC calculator is available!

    A new updated version of the soil PNEC calculator is available for download on our website. Apart from a new layout, this new version now also includes data for Co and Mo. All calculations are now based on the data and methods selected for the EU REACH dossiers (Registration, Evaluation, Authorisation and Restriction of Chemicals; Regulation EC No 1907/2006) for Cu, Ni, Zn, Pb, Cd, Mo and Co, as available in August 2012."

     

    UPDATED SOIL PNEC CALCULATOR

  • From Soil screening values to Metal Clean-up values

    Dr. Koen Oorts (ARCHE) is invited by the North American Metals Council (NAMC) to actively participate in a workshop on "Ecological Soil Levels-Next Steps in the Development of Metal Clean-up Values"  scheduled for September 17-20, 2012 in Utah. The workshop's main goal is to provide regulators with the methods and processes developed over the last ten years to move from soil screening values to clean-up values.

  • SPERC tool for metals is updated!

    The first version of the metal SPERCs was published in 2010 for the purpose of the 2010 REACH registration deadline and underwent a review process conducted by Lüskow et al. (2011) on behalf of the Federal Environment Agency of Germany (UBA). The second version of the metal SPERCs were improved based on the recommendations by Lüskow et al. (2011) and Tolls et al. (in press) and were further updated with new data for the purpose of the 2013 REACH registration deadline.  This second version is currently undergoing a scientific review process but can already been find on this website.

     

    UPDATED SPERC TOOL

  • Our QSARCHE model is released

    Vertebrate testing under REACH is discouraged by promoting use of alternative non-testing approaches such as QSARs (Quantitative Structure Activity Relationships). Many QSARs are available, however, robust REACH compliant QSARs predicting chronic ecotoxicity to fish are largely lacking. ARCHE filled this data gap by the release of its QSARCHE fish toxicity model. Click to the right to read on.

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