Stoffenmanager® for smart chemicals management and business continuity
Erika Ustailieva, Albert Hollander, Henri Heussen, Cosanta B.V.
- 1 Introduction
- 2 Relevant legislation
- 3 Stoffenmanager® Mission
- 4 Product/Service Description
- 5 Development Strategy
- 6 Implementation at a company and supply chain level
- 7 References
Stoffenmanager® is a validated web-based instrument intended to support both small and medium-sized enterprises (SMEs) and large organisations in prioritising and controlling the risks of handling hazardous substances in the workplace. The tool consists of modules for conducting a risk assessment such as control banding, quantitative exposure assessment and REACH worker exposure assessment. In addition to these modules, Stoffenmanager® offers the facility to register hazardous substances as well as create and export workplace instruction cards. It is available in Dutch, English, German, Finnish, Swedish and Polish. Spanish and French will be included by the end of 2016 and more languages will follow in the near future.
Stoffenmanager® Basic can be used on the internet free of charge and is intended in particular to support SMEs in performing risk assessments. Up to 35 products and risk assessments can be saved online. Besides the free Stoffenmanager® version, a fee-based Premium version of Stoffenmanager® is available. This version is intended for companies dealing with larger numbers of hazardous substances. In the Premium version, the number of products and risk assessments is not limited. Besides the functions for risk assessment and non-measuring estimation of exposure, this version also offers extended functionality for a company and hazardous substance management in order to make the chemical management faster, smarter and more efficient, with a focus on implementation. Cosanta B.V. provides the users with quality assurance and a guarantee for the future business continuity. This is achieved by (1) applying a “freemium business model”, which guarantees the long-term sustainability of the instrument, (2) providing support, coaching and training, which are necessary to avoid making errors when applying Stoffenmanager® and (3) using a validated tool embedded in a community platform, which supports companies in organising and structuring their chemical risk management in a business-like manner.
Cosanta B.V. is the legal owner of the online tool Stoffenmanager®. The company is a joint venture of the initial developers of the instrument TNO and Arbo Unie. The IT part is carried out by EY. With the establishment of Cosanta B.V., the developers have taken Stoffenmanager® to a next level – a continuous development platform with a new release a few times a year. Stoffenmanager® can be found only here.
The development of Stoffenmanager® is driven by the Premium users for the tool’s functionalities and by the International Scientific Advisory Board (ISAB) for the scientific developments and regulatory compliance. The ISAB members are the Netherlands Organisation for Applied Scientific Research (TNO), the Finnish Institute of Occupational Health (FIOH), the Swedish Lund and Dalarna Universities, the German Social Accident Insurance (IFA), the Polish Institute for Occupational Medicine (Nofer) and the Austrian Social Accident Insurance (AUVA). The developers encourage partners and Premium users to jointly innovate. Therefore, Stoffenmanager® has moved away from “just” a risk assessment instrument such as ART, ECETOC TRA, MEASE, EMKG-EXPO-TOOL, Riskofderm or COSHH Essentials, towards a smart chemicals management platform.
This article provides a detailed description of the Stoffenmanager® functionalities and background, relevant legislation, business model, development strategy and implementation at company and supply chain level.
Stoffenmanager® is in line with the current EU legislation on exposure to chemical agents and chemical safety. Although the Stoffenmanager® algorithms can be applied globally, the developers only guarantee that any change in EU legislation is taken into account in the continuous development of the instrument. Outside of the European Union, one has to check whether local legislation accepts the use of models to estimate exposure.
The legislation directly applicable to Stoffenmanager® is:
- Directive 98/24/EC - risks related to chemical agents at work of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
- Directive 2004/37/EC - carcinogens or mutagens at work of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) Directive 89/391/EEC)
- Regulation (EC) No 1907/2006 - REACH of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency. Occupational exposure assessment (Chapter R.14) (23/08/2016) of the REACH technical Guidance on Information Requirements and Chemical Safety Assessment
- Regulation (EC) No 1272/2008 - classification, labelling and packaging of substances and mixtures of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance)
- Directive 2009/161/EU - indicative occupational exposure limit values of 17 December 2009 establishing a third list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC and amending Commission Directive 2000/39/EC (Text with EEA relevance)
- Directive 2006/15/EC - indicative occupational exposure limit values of 7 February 2006 establishing a second list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC and amending Directives 91/322/EEC and 2000/39/EC
- Directive 91/322/EEC - indicative limit values of 29 May 1991 on establishing indicative limit values by implementing Council Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work.
- Directive 2000/39/EC - indicative occupational exposure limit values of 8 June 2000 establishing a first list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work.
The traditional management of chemical exposure in the workplace relies on technical experts to evaluate workplace hazards and risks, conduct exposure monitoring, compare with the existing occupational exposure limits (OELs) and recommend control measures. The continuous changes in regulations, working conditions and product composition create difficulties for companies to keep chemical management at a workplace up to date. Consulting external advisors is often expensive and does not provide a sustainable solution.
The mission of Stoffenmanager® is to empower owners/operators to evaluate their own workplaces for hazards and risks and to focus resources on practical control solutions rather than expensive exposure measurements. This is an innovative approach to chemicals risk management that allows the users of Stoffenmanager® to easily comply with their legal and moral obligations for a safe workplace. The Stoffenmanager® platform provides SMEs as well as large companies with the necessary knowledge, a validated and up-to-date tool and expert/technical support to implement this smart chemicals management at their organisations.
Stoffenmanager® has been available since October 2003 as a free web application. The instrument was developed by TNO, Arbo Unie and Beco (currently EY Nederland LLP) commissioned by the Dutch Ministry of Social Affairs and Employment (SAE). Between 2003-2007, the Dutch Ministry of Social Affairs and Employment carried out the 'VASt programme’ (in Dutch: Versterking Arbeidsomstandighedenbeleid Stoffen or 'Reinforcing the Working Conditions Policy on Hazardous Substances').
The aim of the programme was to work together with the industry to strengthen the health policy on hazardous substances in order to embed responsibility in the chain and build a stronger knowledge infrastructure regarding the handling of chemicals. The programme's budget was EUR 12 million. The programme was aimed mainly at 25 high-risk sectors and product chains. Industry sectors and product chains were able to obtain financial support for action plans that were linked to the VASt programme and aimed at improvements. In addition, projects were carried out to provide the industry with effective instruments like the Stoffenmanager®, to assess and control exposure to hazardous substances.
The VASt programme contributed mostly to opening up the available information and knowledge on working safely with hazardous substances, aiming especially at SMEs. Stoffenmanager® was the most successful instrument developed as part of the VASt programme. Over a period of 11 years, Stoffenmanager has become a mature and validated tool for the management of risks in the field of hazardous substances and is recognised as such by the Dutch Labour Inspectorate and ECHA (REACH). Apart from SME users with relatively few substances, Stoffenmanager® has also attracted larger organisations with a multiplicity of substances. In 2012 the Dutch Ministry of Social Affairs and Employment decided to stop funding the instrument. The government transferred the ownership of Stoffenmanager® to its developers, and has given them a transition period of two years to develop a sustainable business model for the instrument (see Stoffenmanager® Business Model). During this period the Premium version was developed for more intensive users, offering a range of extra functionalities that enable working with Stoffenmanager® to be faster, easier and more efficient for a larger number of substances and risk assessments.
In May 2014 the developers established the private limited company Cosanta B.V., which is currently the legal owner of Stoffenmanager® and carries out all activities related to further development, training, helpdesk, communication and promotion of the tool. The IT part is carried out by EY. With the establishment of Cosanta B.V., the developers have taken Stoffenmanager® to a next level – a continuous development platform with a new release a few times a year. The figure below presents the historical development of the Stoffenmanager® from 2003 up to now.
Stoffenmanager® Business Model
Stoffenmanager® applies a “freemium business model”. Freemium means that in addition to the free–of-charge Basic version and support there are payable services such as the fee-based Premium version of Stoffenmanager®, consultancy and training on implementation at both company and supply chain level (see Stoffenmanager® Basic versus Premium).
Cosanta B.V. provides Stoffenmanager® users with quality assurance and a guarantee for future business continuity by (1) applying the “freemium business model”, which guarantees the long-term sustainability of the instrument, (2) providing support, coaching and training, which are necessary to avoid making errors when applying Stoffenmanager® and (3) using a validated tool embedded in a community platform, which supports companies in organising and structuring their chemical risk management in a business-like manner. Cosanta B.V. is committed to assuring that the functionalities in the Stoffenmanager® Premium are developed according to user requirements and wishes, and therefore encourages, joint innovation with the Stoffenmanager® Premium users. Each year Cosanta B.V. organises a users’ day for the Premium customers. During this event, the company collects feedback, creates an opportunity for knowledge and experience exchange and stimulates cooperation.
The Stoffenmanager® business model is a good example of how governmental investment can be multiplied and sustained in the long term. There are numerous examples of instruments developed as part of governmental programmes whose development and use have declined after the funding has stopped. Stoffenmanager® is not one of them. It still provides support free of charge for small and medium-sized companies in performing risk assessments and in increasing their knowledge regarding the handling of chemicals. At the same time, using resources from the payable services assures ongoing functional and scientific development, regulatory compliance and, therefore, the long-term sustainability of the instrument.
Key functionalities and modules
The key functionalities of Stoffenmanager® are:
- Dashboard presenting key figures and risks in graphical form
- Management of the hazardous substances register including import and export possibilities
- Management of CMR substances including the CMR exposure register
- Risk prioritisation for inhalation and skin exposure
- Quantitative exposure assessment and comparison with limit values
- Quantitative calculation of the effect of control measures
- Generation of Action Plans
- Generation of Workplace Instruction Cards
- Generation of reports and overviews in Word and Excel
- Multiple users with different rights and role
- Multi-language - Dutch, English, German, Finnish, Swedish and Polish, Spanish and French.
Stoffenmanager® has the following modules:
- Control Banding. Stoffenmanager® was initially developed as a tool for SMEs to prioritise 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 the 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 a 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. In addition to this, a special CMR (carcinogenic, mutagenic and reprotoxic substances) registration is available. Here mandatory information can be registered on the use of these substances.
- Quantitative Exposure Assessment. Stoffenmanager® contains a quantified and validated exposure module to estimate exposure to (mixtures of) powders and vapours in mg/m3. Stoffenmanager® estimates the worst-case task concentration, the so called 90-percentile. Furthermore, 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 a report and saved to the computer. An Action Plan shows the selected control measures.
- 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 whereby calculations are done for substances instead of mixtures. 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 version. Stoffenmanager ® is included in the official REACH Guidance (R.14) document as a recommended tool, meaning the European Commission officially recognises Stoffenmanager® as an instrument to comply with the REACH regulation.
- Nano module. This is a separate module to qualitatively assess the risks of working with manufactured nano-objects. Just as in 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.
- PGS-15. This is a special module for the chemical storage management in accordance with the Dutch PGS-15 guideline. This module is only available in Dutch and in the Premium version.
- ATEX. This is a module for the assessment of workplace explosion safety in accordance with the European ATEX guidelines. This module is only available in Dutch and in the Premium version.
Stoffenmanager® Basic versus Premium
Stoffenmanager® is available as a free Basic and fee-based Premium version. The Basic version is suitable for small and medium-sized companies with limited data. They can enter a limited number of products and risk assessments. For these users, Cosanta B.V. provides basic support (helpdesk) and complimentary webinars free of charge. The Premium version is intended for companies dealing with a larger number of hazardous substances and there is no limit on the number of products and risk assessments. For these users, Cosanta B.V. provides an additional quality assurance, priority help desk and a guarantee for future business continuity. Both Basic and Premium versions use the same algorithms, the main difference being that the Premium has more functionalities for a company and hazardous substance management. A manual in Dutch and English can be downloaded from the Stoffenmanager® main page in both versions. The manual is updated when new functionalities are added.
Stoffenmanager® Basic consists of the basic functionalities like control banding, exposure and risk assessment, control measures and production of Work Instruction Cards (WIC). Users are limited to entering 35 products and performing 35 risk assessments.
Stoffenmanager® Premium offers a number of attractive functionalities, like working with multiple users, version management and archive, import and export of data, location management and dashboard. Users have no limitations concerning the number of products and risk assessments. Besides the functions for risk assessment and non-measuring estimation of exposure (also in Stoffenmanager® Basic), this version also offers extended functionality for a company and hazardous substance management in order to make the chemical management faster, smarter and more efficient with a focus on implementation. For example, the management dashboard with key figures and risks graphically explained. These key figures prove to be powerful drivers in companies’ management reviews making the management board of a company more aware of occupational health risks by turning technical occupational expert language into a business language that really matters (see Figure 2).
More information regarding the Premium functionalities can be found [here]. Figure 3 presents the main differences between the two versions.
Validation and comparison with other tools
Stoffenmanager® is a continuous development platform and the algorithms in its most recent version can only be found at www.stoffenmanager.nl. The International Scientific Advisory Board (ISAB) is a guarantee that the tool complies with the EU regulations and is in line with the latest scientific developments. The ISAB members are the Netherlands Organisation for Applied Scientific Research (TNO), the Finnish Institute of Occupational Health (FIOH), the Swedish Lund and Dalarna Universities, the German Social Accident Insurance (IFA), Polish Institute for Occupational Medicine (Nofer) and the Austrian Social Accident Insurance (AUVA). Several publications concerning the development and the further refinement of the model are available. Originally the tool is based on a published scientific conceptual model of exposure  followed by a quantification of the model algorithms (i.e. the calibration with measured data) by. Schinkel et al. published a cross-validation and further refinement of the model and based on a database containing around 1000 measurements concluded that the 90th percentile estimates of the model are verified to be sufficiently conservative and therefore can be used as a tier 1 exposure assessment tool for REACH. This was again demonstrated by Koppisch et al. who focused on estimating workers’ exposure to inhalable dust. In the recent ETEAM study, a dataset of almost 2100 measurements was constructed to evaluate all five REACH tier 1 tools (ECETOC TRA, Stoffenmanager®, RISKOFDERM, MEASE, EMKG-Expo-Tool). The authors concluded that Stoffenmanager® 4.5 appeared to provide the most balanced performance with regard to the level of conservatism and predictive power for volatile liquids and powders. In another study, Landberg et al. evaluated the conservatism of Stoffenmanager® 5.1 by testing whether the 90th percentiles are above the measured exposure values. They showed that only two of the eleven scenarios tested had slightly higher measured median exposure values than modelled concentrations and concluded that the model performed well. Finally, a sensitivity analysis on ECETOC TRA v3, Stoffenmanager® 4.5 and ART 1.5 was performed by Riedmann et al. to determine dominant factors for the three models and to assess the robustness of each model. The authors stated that, “when the entry data are uncertain or difficult to use, practitioners should consider using Stoffenmanager as their default occupational exposure model since: (1) it provides mean exposure estimates and various confidence intervals (CIs) in a reasonable range, and (2) it is the most robust model. Besides, Stoffenmanager appears also to be the most balanced model with regard to physical phenomena such as source emission and dilution.” Overall, the conclusion, on the basis of all available scientific literature, is that the Stoffenmanager® model is robust, has sufficiently predictive power and is conservative enough (for a REACH tier 1 tool).
The development of the Stoffenmanager® platform is an ongoing business. The strategy of Cosanta B.V. for the future development has three main elements that the developers believe will assure the long-term sustainability of the instrument:
- Functional development
- Scientific development and regulatory compliance
- International growth
The new functionalities of Stoffenmanager® are developed in consultation with Premium customers. The developers encourage strategic partners and Premium users to jointly innovate. Changes in the EU legislation are closely monitored and new scientific insights are used to refine the model. The Stoffenmanager® International Scientific Advisory Board (ISAB) plays the main role in this element of the development strategy. Stoffenmanager® currently has more than 30,000 registered users and this number is growing at an average of 200 users each month. Currently, approximately 35% of the users originate from outside the Netherlands, including all European countries and some countries outside Europe like Australia, the USA, Brazil, China, Korea and South Africa. Stoffenmanager® is available in Dutch, English, German, Finnish, Swedish and Polish. Spanish and French languages will be launched by the end of 2016. More languages will be available in the near future and the developers are open to strategic partnerships in the respective countries.
Implementation at a company and supply chain level
In order to facilitate the implementation in companies, the Stoffenmanager® platform provides information, technical support and access to experts. Significant efforts have been put into Stoffenmanager® to design a user-friendly interface, especially in its Premium version. However, more than 13 years of experience with Stoffenmanager® has shown that just ‘offering’ a risk assessment and chemicals management instrument, without providing active support, does not automatically result in its active and proper use by companies and experts. This is proven by numerous research studies on the evaluation of the implementation of Stoffenmanager® and similar instruments in companies. Results from research and the developers’ experience suggests that providing guidance, explanation and training prior to using exposure assessment tools is crucial for their successful implementation at company level and in the supply chain. Moreover, users must understand the limitations of the tools in terms of applicability and output, which is why reading the guidance and support material is regarded essential. Therefore, the experts from Cosanta B.V. have developed a structured approach to supporting the users of both Basic and Premium Stoffenmanager®. This approach consists of providing a free information and complimentary webinars and fee-based tailor-made consultancy and training to assist companies to improve their chemical risk management, and to avoid making mistakes when using and applying Stoffenmanager®.
The above-mentioned approach is based on a 2.5-year intervention project undertaken by the developers TNO and ArboUnie in 2012-2014. Within the project, active support was provided to a group of 45 participating companies. The project aimed at improving the implementation of Stoffenmanager® as well as chemical risk management in a wider sense. In order to get clues to enable the development of a tailored support to companies willing to optimise chemicals’ management, the central research question addressed within the framework of this project was: “Which characteristics of the tool Stoffenmanager® itself, of the intended user and of the intended user’s organisation determine the success or failure of its active and successful implementation and proper use?”.
The experts from Cosanta B.V. are using a 7-phase implementation evolutionary ladder to assess the companies’ progress in using Stoffenmanager® as a tool in improving substance management. The implementation ladder is based on the above-mentioned project and provides a means to assess progress in a well-structured manner and as objectively as possible (see Figure 4).
The conclusion made as a result of applying the above approach are [11, experience Stoffenmanager® developers]:
- Training and coaching help companies to establish smart chemical management
- Active training and coaching help to avoid making mistakes when using and applying Stoffenmanager®
- Use of validated tools embedded in an online platform supports companies to organise and structure their chemical risk management in a business-like manner
- Much depends on motivated occupational health and safety professionals, management support and willingness to invest time and resources.
In addition, Stoffenmanager® Premium is continuously developing to be applied at a supply chain level and to be used for corporate social responsibility (CSR) reporting. Training and coaching help companies apply the instrument at this level too.
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