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Background

Stoffenmanager® is available since October 2003 as a free web application. A user needs only an email address to apply for an account. The instrument is developed by TNO, Arbo Unie and BECO(EY) commissioned by the Dutch Ministry of Social Affairs and Employment (SAE). Next to the free version also a Premium Package is available. From May 2014 onward all activities related to further development, training, helpdesk, communication, promotion are carried out by Cosanta BV.

Stoffenmanager is a spearhead in the Dutch Ministry of SAE pursuit of a simple, accessible and practicable substances policy for application in companies. In this capacity, Stoffenmanager is recognised by the Dutch Labour Inspectorate and by ECHA (REACH) as a reliable tool for use in the assessment of exposure situations via inhalation as part of the Risk Inventory and Evaluation (RI&E). In addition, Stoffenmanager is also capable of assessing the risks of exposure via the skin. The name Stoffenmanager has been registered within the EU.

Stoffenmanager® is a continuous development platform. The independent International Scientific Advisory Board is a guarantee that the tool complies with regulations and is in line with latest scientific developments. Cosanta encourages the cooperation with universities and scientific institutes. Under a cooperation agreement Cosanta can give such organisations access to the www.stoffenmanager.nl Premium package and also give insight in the underlying specifications and algorithms as written down in the functional design. 

Below you will find relevant public information on the different modules, the scientific basis, including references and the validity domain of Stoffenmanager®.

Stoffenmanager® has the following modules:

  1. Control Banding. Stoffenmanager® was initially developed as a tool for SME’s to prioritize their health risks of working with hazardous products in the working place and to determine effective control measures. To arrive at a risk priority Stoffenmanager® combines hazard information of a product with an estimate of exposure by inhalation or skin contact. If risks are identified control measures can be selected. The risk assessments can be opened as report and saved to the computer. An Action Plan shows the selected control measures. Pimex movies and workplace instruction cards can be used for information exchange and risk communication. The Report Dangerous Substances generates an overview of all dangerous products that are being used within the company. Next to this a special CMR-registration is available (carcinogenic, mutagenic and reprotoxic substances). Here mandatory information can be registered on the use of these substances.

  2. 2. Quantitative Exposure Assessment*. Stoffenmanager® contains a quantified and validated exposure module to estimate exposure to powders and vapours in mg/m3. Stoffenmanager® estimates the worst-case task concentration, the so called 90-percentile. Next to this other percentiles of the exposure distribution are available (e.g. 50, 75 or 95-percentile). The exposure during the task can be compared with an occupational exposure limit (OEL). Subsequently the daily average concentration can be calculated for one or more tasks. This outcome can also be compared with an OEL. If risks are identified control measures can be selected. The risk assessments can be opened as report and saved to the computer. An Action Plan shows the selected control measures.

  3. 3. REACH Worker exposure. Stoffenmanager® contains a REACH exposure module to quantitatively estimate exposure by inhalation**. This is the same model as the quantitative exposure assessment module but specified for REACH. Stoffenmanager® presents the complete exposure distribution and the corresponding percentiles. The exposure estimate can be compared with the DNEL of the substance. This module is only available in the Premium Package.

    4. Nano module. This is a separate module to qualitatively assess the risks of working with manufactured nano objects. Just like the control banding module hazard properties and information on exposure are combined to derive a risk score. Risk management measures can be selected to control exposure.

    5. PGS-15. This is a special module for the chemical storage management in accordance with the Dutch PGS-15 guideline. This module is online available in Dutch and in the Premium Package.

    6. ATEX. This is a module for the assessment of workplace explosion safety in accordance with the European ATEX guidelines. This module is online available in Dutch and in the Premium Package.

* The quantitative exposure assessment via inhalation is accepted by the Dutch Labour Inspectorate as a validated method to evaluate exposure to hazardous substances in the workplace.
** Stoffenmanager is included in the official REACH Guidance (R.14) document as a recommended tool. Meaning the European Commission officially recognizes Stoffenmanager® as instrument to comply with the REACH regulation.

Scientific basis

Control Banding. Stoffenmanager® classifies hazards of a product based on the R/H phrases as described in COSHH Essentials scheme (Technical documentation at COSHH Website). The Stoffenmanager inhalation exposure model is based on the source-receptor approach by Cherrie (Cherrie et al, 1999). The most important determinants of exposure are task, local control measures, general ventilation and product characteristics. These are scored on a logarithmic scale (Marquart et al, 2008). The model for the assessment of dermal exposure is based on the RISKOFDERM Toolkit (Goede et al, 2003). The toolkit is based on a large number of measurements of dermal exposure in real work situations and is considered to be a valid tool for assessing dermal exposure.

Quantitative Exposure assessment
. The exposure model for inhalation is quantified with the use of about 700 exposure measurements. The (Spearman) correlation between the qualitative Stoffenmanager® scores and the measured exposure is rs ~0.8 (Tielemans et al, 2008). The Stoffenmanager inhalation exposure model was subsequently validated with approximately 250 exposure measurements. From the results of this validation study it was concluded that Stoffenmanager generally estimates exposure well and is sufficiently conservative, but in some specific cases adaptation of the model was necessary. The model has been adapted accordingly for the specific scenarios (Schinkel et al, 2009). Click here for additional information about the model adaptations. In addition a validation study for powders and abrasive activities with wood and stone was performed by Koppisch et al, (2012).
 

The results of the "Evaluation of Tier 1 Exposure Assessment Models under REACH" (ETEAM) Study are published on the homepage of the BAuA<http://www.baua.de/en/Publications/Expert-Papers/F2303-D26-D28.html>. The Final Overall Project Summary Report says that "Stoffenmanager® appeared to provide the most balanced performance with regard to the level of conservatism and predictive power for volatile liquids and powders" (Lamb et al, 2015).

 

Applicability

Control Banding. For the control banding module the information of the material safety data sheet (MSDS) of the product is leading. This part of Stoffenmanager® is not useful for substances or products without MSDS or for which R/H-phrases are not known or not available (e.g. certain pesticides or pharmaceutical substances). If you would use Stoffenmanager for such substances, we advise you to determine the R/H-phrases with the help of an expert. The inhalation part of the prioritization part has no restrictions.  
 
Quantitative Exposure assessment and REACH worker exposure. These modules can be used to estimate exposure to powders, low-volatile and volatile substances to a wide range of activities (figure 1). The model can also be used to estimate exposure to abrasive activities using wood (inhalable dust) and stone (inhalable and respirable dust). For other abrasive activities like using plastic, glass or metal the model has not been validated. Stoffenmanager® cannot be used to estimate inhalation exposure to fibres, gases and hot work techniques like welding, soldering and diesel exhaust. 

Figure 1. Applicability domain for the quantitative inhalation exposure model

Product

 

Activity

Gas Volatile liquids Non-volatile liquids Powders Fibers Objects
Moving and agitating           n.a.
Gravitational transfer           n.a.
Spreading and immersion           n.a.
Air dispersive techniques           n.a.
Hot work techniques           n.a.
Abrasion and impact: Wood and stone n.a. n.a. n.a. n.a. n.a.  
Abrasion and impact: other activities like plastic, glass or metal n.a. n.a. n.a. n.a. n.a.  

Green = Falls within the applicability domain of Stoffenmanager®
Red = Not within the applicability domain of Stoffenmanager®
n.a. = Not applicable; this situation cannot occur.

References:

Cherrie J, Schneider T. (1999) Validation of a new method for structured subjective assessment of past concentrations. Ann Occup Hyg; 43(4) 235. 

COSHH website

Duuren-Stuurman B, Vink SR, Verbist KJM, Heussen HG, Brouwer DH, Kroese DE, Van Niftrik MF, Tielemans E, Fransman W. (2012): Stoffenmanager Nano version 1.0: a web-based tool for risk prioritization of airborne manufactured nano objects. Ann Occup Hyg: 56(5): 525-41.

Goede H, Tijssen S, Schipper H, Warren N, Oppl R, Kalberlah F, van Hemmen J. (2003) Classification of dermal exposure modifiers and assignment of values for a risk assessment toolkit. Ann Occup Hyg; 47(8):609-18, DOI: 10.1093/annhyg/meg070 

Koppisch D, Schinkel J, Gabriel S, Fransman W, Tielemans E. (2012). Use of the MEGA exposure database for the validation of the Stoffenmanager model. Ann Occup Hyg: 56(4): 426-39.

Lamb J, S. Hesse, B. G. Miller, L. MacCalman, K. Schroeder, J. Cherrie, M. van Tongeren (2015) Evaluation of Tier 1 Exposure Assessment Models under REACH (eteam) Project - Final Overall Project Summary Report. 1. edition. Dortmund: Bundesanstalt für Arbeitsschutz und Arbeitsmedizin. ISBN: 978-3-88261-160-1, 169 pages, Project number: F 2303, PDF-Datei link to document (PDF file, 3 MB)<http://www.baua.de/en/Publications/Expert-Papers/F2303-D26-D28.pdf?__blob=publicationFile&v=4>

Landberg HE et al (2015): Comparison and Evaluation of Multiple Users’ Usage of the Exposure and Risk Tool: Stoffenmanager 5.1. Ann Occ Hyg: doi: 10.1093/annhyg/mev027

Marquart H, Heussen H, Le Feber M, Noy D, Tielemans E, Schinkel J, West J, Van der Schaar, D (2008) ‘Stoffenmanager’, a web-based control banding tool using an exposure process model. Ann. Occup. Hyg.; 52 (6), 429, doi:10.1093/annhyg/men032 


REACH Guidance on Information Requirements and CSA, Chapter R.14 Occupational Exposure Estimation, November 2012;

Riedmann RA et al (2015): Sensitivity Analysis, Dominant Factors, and Robustness of the ECETOC TRA v3, Stoffenmanager 4.5, and ART 1.5 Occupational Exposure Models. Risk Anal. 2015 Feb;35(2):211-25.

Schinkel J, Fransman W, Heussen H, Kromhout H, Marquart H, and Tielemans E. (2010) Cross-validation and refinement of the Stoffenmanager as a first tier exposure assessment tool for REACH. Occup. Environ. Med. 2010 (67), 125

Terwoert J, Verbist K, Heussen H (2015) An intervention study on the implementation of control banding in controlling exposure to hazardous chemicals in SMEs. Safety and Health at Work. http://dx.doi.org/10.1016/j.shaw.2015.12.002

Tielemans E, Noy D, Schinkel J, Heussen H, van der Schaaf D, West J, Fransman W (2008) Stoffenmanager exposure model: development of a quantitative algorithm. Ann. Occup. Hyg., 52(6) 443, doi:10.1093/annhyg/men033 

Tielemans E, Schneider T, Goede H, Tischer M, Warren N, Kromhout H, van Tongeren M, van Hemmen J and Cherrie JW (2008) Conceptual Model for Assessment of Inhalation, Exposure: Defining Modifying Factors. Ann. Occup. Hyg., 52(7), 577, doi:10.1093/annhyg/men059 

Verbist KJM, Marquart H, Heussen HG, Schinkel J, West J, Fransman W, Van Niftrik MF, Tielemans E. (2011): Stoffenmanager: een web-based control banding tool.
Dutch only.

Zalk DM, Nelson DI (2008) 
History and Evolution of Control Banding: A Review. J. Occup. Environm. Hyg. 5(5): 330-346