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 International Scientific Advisory Board and Research platform
- 6 Development Strategy
- 7 Implementation at a company and supply chain level
- 8 References
Stoffenmanager® is a validated, web-based instrument intended to support both small and medium-sized enterprises (SMEs) and large organisations to identify the chemical hazards, control the exposure at workplaces and communicate in an understandable, transparent manner to managers, employees and external stakeholders. The online system 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, export and distribute workplace instruction cards (safety cards). It is a multilingual system, currently available in English, Dutch, German, Finnish, Swedish, Polish, Spanish, French, Italian and Danish. More languages will follow soon according to the developers.
The Stoffenmanager® Basic licence 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® licence, fee-based licences of Stoffenmanager® are available, namely Product +, Risk+ and Premium. These licences are intended for companies dealing with larger volumes of hazardous substances. Besides the functions for risk assessment and non-measuring estimation of exposure, these licences also offer extended functionalities 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 platform Stoffenmanager®. The company was founded in 2014 as a spin-off of the initial developers of the instrument TNO and Arbo Unie. With the establishment of Cosanta B.V., the developers have taken Stoffenmanager® to a next level – a continuous development platform with a new release twice a year. The developers encourage partners and users to jointly innovate. Cosanta B.V. established the independent Stoffenmanager® International Scientific Advisory Board (ISAB) and launched a ‘research platform’ called Stoffenmanager® Research. 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.
The development of Stoffenmanager® is driven by the 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 Austrian General Accident Insurance Board (AUVA), Austria, the National Research Centre for the Working Environment (NRCWE), Denmark, the Finnish Institute of Occupational Health (FIOH), Finland, the Institute of Occupational Safety and Health of the German Social Accident Insurance (IFA), Germany, the University of Insubria, Risk Assessment for Human Health (RAHH), Italy, the Netherlands Organisation for Applied Scientific Research (TNO), the Netherlands, the Central Institute for Labour Protection – National Research Institute (CIOP-PIB), Poland, the Spanish Association of Industrial Hygiene (AEHI), Spain, the Dalarna University, Sweden, the Institute of Occupational Medicine and Industrial Hygiene of the National Taiwan University, Taiwan. Stoffenmanager®, with its latest, ISAB approved algorithms and functionalities, can be found only at the official website www.stoffenmanager.com.
This article provides a detailed description of the Stoffenmanager® functionalities, historical background, relevant legislation, business model, development strategy, validation and science behind the modelling, 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 the EU legislation is taken into account in the continuous development of the instrument. Outside of the European Union, one must 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) and its later amendments
- 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) and its later amendments
- 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 and its later amendments.
- 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). Including its later amendments.
- 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.
- Directive 2017/164/EU - indicative occupational exposure limit values of 31 January 2017 establishing a fourth list of indicative occupational exposure limit values pursuant to Council Directive 98/24/EC, and amending Commission Directives 91/322/EEC, 2000/39/EC and 2009/161/EU (Text with EEA relevance)
- Further lists on indicative occupational exposure limit values.
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 licence and support there are payable services such as the fee-based licences and modules of Stoffenmanager®, consultancy and training on implementation at both company and supply chain level (see 4.2.2 Stoffenmanager® Licences).
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® licences are developed according to user requirements and wishes, and therefore encourages joint innovation with the Stoffenmanager® users. Each year Cosanta B.V. organises a users’ day for the customers (all fee-based licences). During this event, the company collects feedback, creates an opportunity for knowledge and experience exchange and fosters 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.
A summary of the Stoffenmanager® main functionalities and modules is presented in the table below:
The Stoffenmanager® modules are explained in more detail below:
- Control Banding. Stoffenmanager® was initially developed as a tool for SMEs to prioritise their health risks of working with hazardous products in the workplace 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 Dangerous Substances Report 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. An applicability domain for this route is provided for the users at the official Stoffenmanager® website.
- 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. An applicability domain for this route is provided for the users at the official Stoffenmanager® website.
- 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. An applicability domain for this route is provided for the users at the official Stoffenmanager® website.
- 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.
- SHARE. This is a module for an easy update and distribution of workplace instruction cards (WICs) and safety data sheets (SDSs) within the organisation or outside, e.g. supply chain or authorities. WICs and SDSs are disseminated via protected link - URL of 64 characters, with a (optional) password. Stoffenmanager® SHARE is synchronized with Stoffenmanager® and in case of change in the risk assessment the WICs disseminated via SHARE will be automatically updated too. The information from SHARE can be downloaded in PDF or printed in XML format and imported directly into the Stoffenmanager® account of a customer, for example. Anyone provided with the URL and the password can view the WICs and SDSs. It is compatible with PC, tablet and smartphone. It is available in all Stoffenmanager® languages.
Stoffenmanager® is available in four different licences, Basic (free), Product+, Risk+ and Premium. All the licences enable users to:
- Manage your hazardous substances register
- Manage your CMR substances register
- Prioritise risks of inhalation and skin exposure
- Assess risks of inhalation (qualitative and quantitative) and compare them with limit values
- Calculate the effects of control measures and include them in an action plan
- Automatically generate workplace instruction cards (WICs)
- Work in multiple languages
To start using the platform, one can create a free Stoffenmanager® Basic account at www.stoffenmanager.com.
Stoffenmanager® Basic is free of charge and is suitable for new users and small and medium-sized companies with a limited number of products. Users are limited to entering 35 products and performing 35 risk assessments. For these users, Cosanta B.V. provides basic support (helpdesk) and complimentary webinars free of charge.
Stoffenmanager® Product+ lends itself to the needs of users with over 35 products. It allows users to enter up to 100 products and perform 35 risk assessments.
Stoffenmanager® Risk+, lets users enter up to 100 products and perform 100 risk assessments.
Stoffenmanager® Premium is the optimal choice for users with more extensive requirements. Besides unlimited entry of products and unlimited risk assessments this licence boasts enhanced functionality for hazardous substances management. For these users, Cosanta B.V. provides an additional quality assurance, priority helpdesk and a guarantee for future business continuity.
Both free and fee-based licences use the same algorithms for the risk assessment, the main difference being that the fee-based licences have more functionalities for a company and hazardous substance management. A manual in English, Dutch and Swedish can be downloaded from the Stoffenmanager® main page. The manual is updated when new functionalities are added.
The fee-based licences (Product+, Risk+ and Premium) come with a Management Dashboard that displays key figures and risks as graphics. Those 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 language into business language that makes a huge impact.
More information regarding the functionalities offered by the fee-based licences can be found [here]. Figure 3 presents the main differences between the licences.
International Scientific Advisory Board and Research platform
The developers of Stoffenmanager® encourage cooperation with universities and scientific institutes. Therefore, Cosanta B.V. established the Stoffenmanager® International Scientific Advisory Board (ISAB) and launched a ‘research platform’ called Stoffenmanager® Research.
The independent international Scientific Advisory Board (ISAB)
An independent International Scientific Advisory Board (ISAB) is affiliated to Stoffenmanager®. The members of ISAB are prominent research institutes and universities from Europe and beyond. Its focus is to advise on the ongoing development of Stoffenmanager® and undertake or commission Stoffenmanager®-related research. The International Scientific Advisory Board is a guarantee that Stoffenmanager® complies with the EU regulations and is in line with the latest scientific developments. The statutes of the ISAB can be found here. The current ISAB members are:
- Austrian General Accident Insurance Board (AUVA), Austria
- National Research Centre for the Working Environment (NRCWE), Denmark
- Finnish Institute of Occupational Health (FIOH), Finland
- Institute of Occupational Safety and Health of the German Social Accident Insurance (IFA), Germany
- University of Insubria, Risk Assessment for Human Health (RAHH), Italy
- Netherlands Organisation for Applied Scientific Research (TNO), the Netherlands
- Central Institute for Labour Protection – National Research Institute (CIOP-PIB), Poland
- Spanish Association of Industrial Hygiene (AEHI), Spain
- Dalarna University, Sweden
- Institute of Occupational Medicine and Industrial Hygiene of the National Taiwan University, Taiwan
Stoffenmanager® is a continuous development platform. The underlying algorithms in the models are being evaluated and improved based on the state-of-the-art scientific evidence and changes in regulations. Any change in the algorithms is approved by ISAB. The list of scientific publications of the studies based on which changes are implemented is available at the official website of Stoffenmanager® (www.stoffenmanager.com). However, in the cases of private funding of research, not all details of the algorithms are fully described. Therefore, only at the official Stoffenmanager® website, can users find the latest ISAB approved algorithms. Researchers and authorities can have insight into the underlying specifications and algorithms under a Non-Disclosure Agreement with the developers.
In order to stimulate the great deal of ongoing research on existing chemical exposure models and to boost scientific development, the developers from Cosanta have established an open Stoffenmanager® Research platform. Stoffenmanager® Research is an open development website. Researchers all over the world, can have access to this website and, in cooperation with the ISAB and Cosanta, can develop and test new models or adapt / extend and test the current algorithms. Cosanta gives researchers access to Stoffenmanager® research under a Non-Disclosure Agreement.
Validation and comparison with other tools
A great deal of research and the respective 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. Thereafter, a wealth of validation studies underpinned by more than 6,000 measurements on Stoffenmanager® and other tools have been published         . A comprehensive overview of the scientific publications can be found at the official Stoffenmanager® website. Overall, the conclusion, on the basis of all available scientific literature, is that, in general, Stoffenmanager® as a tier 1.5 tool is the most balanced, robust and sufficiently conservative tool. For specific details we refer to the applicability domain provided for the users at the official Stoffenmanager® website
Stoffenmanager® is a continuous development platform. Not only functionalities are being continuously improved and extended, but also the underlying algorithms for the risk assessment. And new languages are being added.
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
The new functionalities of Stoffenmanager® are developed in consultation with customers. The developers encourage strategic partners and users to jointly innovate.
- Scientific development and regulatory compliance
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. A history of the main changes per version including change of or addition to the algorithms e.g. based on, starting from the presentation of the demo version on 27 October 2003, can be found on Stoffenmanager website under [https://stoffenmanager.com/what-is-stoffenmanager/ “What is Stoffenmanager®]”.
- International growth
Stoffenmanager® currently has more than 35 000 registered users and this number is growing at an average of 200 users each month. Although, Stoffenmanager® was initially developed in the Netherlands it is currently an internationally accepted and well-known platform. Currently, approximately 53% of the users originate from outside the Netherlands, including all European countries and countries from Asia, North and South America, Africa and Australia. Also, validation studies have been performed in EU MS, USA, Taiwan, Korea and South Africa. Stoffenmanager® is available in 10 languages, namely English, Dutch, German, French, Finnish, Swedish, Spanish, Polish, Italian and Danish. More languages will be available in the 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 . However, more than 15 years' 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 Stoffenmanager®. This approach consists of providing a free flow of 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 approach is based on a 2.5-year intervention project undertaken by the developers TNO and ArboUnie in 2012-2014 and the experience of the Cosanta experts rolling out Stoffenmanager® within multinationals and SMEs.
The experts from Cosanta B.V. are recommending an implementation ladder to assess the companies’ progress in using Stoffenmanager® as a tool in improving chemicals management in the workplace. The implementation ladder provides a means to assess progress in a well-structured manner and as objectively as possible (figure 4)
The conclusion made as a result of applying the above approach and by the developers is:
- 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® 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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