Stoffenmanager_Watermark

What is Stoffenmanager®?

Background

Stoffenmanager® is validated based on more than 7000 measurements and is (inter)nationally recognised by local governments and the EU. With Stoffenmanager® you run through the four steps of the Self-inspection Tool on Hazardous Substances of the Dutch Ministry SZW. Stoffenmanager® is mentioned in the REACH R.14 Guidance of the European Chemicals Agency (ECHA, August 2016): "Table R14-13: Domain of reliable application of Stoffenmanager® (the algorithms can only be found at www.stoffenmanager.com in its most recent version)". Although Stoffenmanager® can be applied worldwide, the developers can only guarantee that changes in EU and/or Dutch legislation will be taken into account in the development of the tool. Outside the EU it is the user's responsibility to check if local legislation accepts the use of Stoffenmanager®.

Validation

Stoffenmanager® develops continuously. Not only functionalities are improved or extended but also the underlying algorithms.

Prioritisation

Stoffenmanager® version 7.0 and later classifies the hazards of a product based on the H-phrases as described in Arnone et al (2015). The classification in earlier versions was based on COSHH Essentials.

The inhalation exposure model of Stoffenmanager® is based on the source-receptor approach of Cherrie and Schneider (1999) and Marquart et al (2008) (version 3.5)). Subsequent modifications to the model are available to authorities and scientific partners under a non-disclosure  agreement. The model for estimating skin exposure is based on the RISKOFDERM Toolkit (Goede et al (2003).

Assessment

The quantification of the inhalation exposure model of Stoffenmanager® version 3.0 and 3.5 is described in Tielemans et al (2008). A further refinement of the model (Stoffenmanager® version 4.0) based on about 1000 measurements is published in Schinkel et al (2010).  The authors conclude that the 90-percentile estimate is sufficiently conservative.

Subsequent versions of Stoffenmanager® were further validated and/or compared with other tools in various studies. Meanwhile the validation of the tool is based on more than 7000 measurements. From these studies it can be concluded that Stoffenmanager® is the most balanced, robust and sufficiently conservative tool. With the exception that the exposure to low volatile compounds, released as a result of spraying activities taking place outside without local exhaust ventilation (aerosol formation - PROC11), might be underestimated Tongeren van et al (2017).


Scope

Figure 1. Applicability domain for the quantitative inhalation exposure model

  • Falls within the applicability domain of Stoffenmanager®
  • Not within the applicability domain of Stoffenmanager®
  • n.a. Not applicable, this situation cannot occur
  • !: Exposure to low volatile substances, released from spraying activities outdoors without local exhaust ventilation (aerosol formation - PROC7 and PROC11; ‘Handling of liquids at high pressure resulting in substantial generation of mist or spray/haze’), is possibly underestimated (based on Tongeren van et al (2017). For such activities it is recommended to use the 95-percentile estimation or to comply with an RCR = 0.5 (instead of RCR= 1).

Additional guidance is given in REACH R.14 Guidance (A.14-1.4.1.1. Applicability domain). Here PROCs are listed which can NOT be used in Stoffenmanager®. Modifications in the models are available to authorities and scientific partners under a non-disclosure agreement.

References

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