Risk management tools for dangerous substances

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Urs Schlüter and Gudrun Walendzik, The German Federal Institute for Occupational Safety and Health, Germany


Introduction

The European Agency for Safety and Health at Work (EU-OSHA) defines dangerous substances as ‘any liquid, gas or solid that poses a risk to workers’ health or safety’.[1] Risk assessment for these can be a complicated issue for employers. Many, especially small and medium sized enterprises (SME), do not have the resources (knowledge, time, personnel) for sound risk assessments. On the one hand European Directives set minimum standards:

  • Directive 98/24/EC[2] describes a minimum level of worker protection in Europe
  • Directive 2004/37/EC establishes stricter provision for carcinogens and mutagens in particular on substitution and preventive measures.
  • Other Directives apply to cover for example fire and explosion and risks linked to explosion.

On the other hand different systems of worker protection and differing systems of enforcement are in place in individual Member States of the European Union.

In all cases the assessor needs information about the substance and the exposure that occurs. The employer is obliged to take measures to minimise exposure to hazardous substances. By this, risk shall be eliminated or reduced and controlled. Prevention measures have to be considered, in order of priority:

Substitution (substance or process);

Technical controls;

Organisational measures;

Personal protective equipment (PPE).


This ‘STOP’ principle is the foundation of occupational safety and health for handling hazardous substances.

Tools for risk assessment described below are designed and helpful for supporting substitution and/or carrying out a sound risk assessment and setting prevention measures.

Substitution–focused models and tools

Rules for substitution

If the risks to the health and safety of workers at work involving hazardous substances cannot be eliminated, employers are obliged to reduce them to a minimum according to Directive 98/24/EC[2]. The next measure to take according to the hierarchy of control measures is substitution, meaning that the employer has to replace the hazardous substance with a chemical agent or process which, under its condition of use, is not hazardous or less hazardous to workers' safety and health. Substitution is the risk mitigation measure that has to be chosen with priority over technical, organisational or personal measures (‘STOP’ principle). Carcinogenic and mutagenic substances have to be replaced as far as technically possible according to Directive 2004/37/EC[3]. Some Member States have extended this provision to substances or products that are toxic to reproduction in their national legislation.

The following processes usually should receive special attention because they may lead to high exposure:

  • open processes, e.g. painting or spraying of big surfaces
  • mixing/compounding in open containers
  • processes generating dusts, vapours or fumes or dispersing liquids

In case the process cannot be modified to eliminate risks at the source, it is recommended to substitute substances with the following properties:

  • substances increasing fire and explosion risks
  • volatile substances
  • aerosols, dusts
  • substances causing acute health risks
  • substances causing chronic health risks
  • substances regulated by specific national rules for the workplace
  • substances that already caused problems at the workplace
  • substances that cause occupational diseases
  • substances requiring regular health monitoring
  • substances absorbable through the skin
  • substances requiring personal protective equipment

Technical rule 600 and the column model

As a support for employers who have to make an assessment of possible substitute substances/mixtures, the German Technical Rule for Hazardous Substances No. 600 ’Substitution’ [4] was established in form of a detailed guideline. The rule is available in English and offers an extensive description on how to perform and document a substitution check.

Additionally the Institute for Occupational Safety and Health of the German Social Accident Insurance has developed the Column model (Spaltenmodell)[5].Based on a few data from the safety data sheet (SDS) of the potential substitute, two or more alternative substances can be assessed with the help of a rather simple table that is available for free download . The model is based on six columns in which the following hazard categories are described: •Acute health hazards •Chronic health hazards •Fire and explosion hazards •Environmental hazards •Exposure Potential •Process hazards

The method relies on the supply of sound data sheets and correct transfer of the data by the user. Preparations/mixtures are assessed only on the basis of their labelling.

The substitution check can be done in three easy steps. In the first step information about each of the alternatives is transferred from the SDS to the corresponding column of the table. The model comprises the following columns: acute health hazards, chronic health hazards, environmental hazards, physico-chemical hazards, hazards from release behaviour and process-related hazards. In the second step the columns are compared independently for each product. In the third step the result has to be interpreted. If a product rates better in all five columns than all the other products this product should be used as a substitute. In most cases, however, one product will rate better in some columns, but worse others. In this case, the the employer needs to assess which of the potential hazards is most important to be eliminated in the particular working situation (i.e. which column(s) is/are the most important to be considered). A decision about a substitution or non-substitution has to be explained and documented.

Additional support for the interpretation of data in the column model is provided in the above mentioned TRGS 600.


SUBSPORT – Substitution Support Portal

SUBSPORT[6] is a European project with four partners (Kooperationsstelle Hamburg IFE GmbH (KOOP), Instituto Sindical de Trabajo Ambiente y Salud (ISTAS), Madrid; International Chemical Secretariat (ChemSec), Gothenburg; Grontmij A/S, Copenhagen) that developed an internet portal. It does not only provide information on alternative substances and equipment, but also tools and guidance for substance evaluation and substitution management.

In addition, the project has created a network of experts and stakeholders who are active in substitution. This network assists in development and promotion of the portal as well as ensuring updates and maintenance.

On a dedicated Website, the project partners offer the following information in four languages (English, German, French and Spanish):

  • a structured presentation of legal information on substitution
  • a database of hazardous substances that are legally or voluntarily restricted or subjects of public debates
  • a compilation of common criteria for the identification of hazardous substances
  • a report of existing substitution tools
  • a database with general information on alternatives
  • a database containing practical experiences in the substitution of 10 substances of very high concern
  • concepts and materials for substitution training programmes
  • interactive elements for discussion, networking, exchange



Types of risk management tools

Control banding models

Control banding (CB) is a qualitative approach for assessing and managing hazards associated with chemical exposures in the workplace. The conceptual basis for CB is the grouping of chemical exposures according to similar physical and chemical characteristics, intended processes/handling, and an anticipated exposure situation (use pattern, amount of substance etc.). Based on these factors, a dangerous substance is assigned to a control strategy or ‘control band’, which is based on the level of risk, where the risk according to the use of a substance is a function of its health hazard and exposure potential. The control bands represent appropriate risk management options for each of the combinations of hazard and exposure considered by the model.

CB uses standard preventive measures (typically presented as so-called control guidance sheets) that experts have developed previously for the control of chemical exposures in a selection of tasks . These model solutions can also be used to address similar exposure situations in other tasks . CB is being applied in conjunction with occupational health and safety principles such as the ‘STOP’ principle.

Control guidance sheets (CGS) are a suitable instrument to provide small firms with advice on how to apply control approaches in practice as they can serve as a standard for a 'good working practice'. They cover unit operations or working procedures rather than specific processes. This has the advantage of providing a broad base of advice for different working processes. The CGS format allows a quick view on essential information for chemical risk management.

Examples for this type of tools (e.g. Stoffenmanager) are presented and discussed below.

Notable limitations to CB tools are the need for the users to transfer the data themselves from the SDS. Some SDSs may be incorrect[7][8] and may not mention nanomaterials, biological agents or Endocrine Disrupting Compounds (EDCs ). Furthermore, it is difficult to establish what hazardous materials are generated during processes, such as fumes, dusts, and mould. This situation should improve as some CB tools store substance/mixture/process information (and gradually increase the knowledge base), and some producers voluntarily include not yet required information in their SDS. However, the prevention measures may need critical reflection and additional expert judgment or exposure measurements may be warranted.

Control guidance sheets can also be used to fulfil the requirements of the REACH regulation and set up exposure scenarios or risk management measures defined under REACH in a way that effectively supports safety and health at workplaces.


Hazard information systems

The advantage of hazard information systems is that they do not require the user to transfer SDS data (as it is needed in CB tools, see above). Information on products and substances is collected with the help of the industry and analysed by experts and summarised in information sheets. The experts group similar mixtures and substances with similar hazards. These groups are further differentiated by work processes and tasks and then assigned related control and prevention measures. Because these are developed by experts, users can be sure to be on the safe side as long as they have similar conditions and apply the measures strictly. The hierarchy of prevention measures is shown by the codes that are assigned to the groups; i.e. the lower the code number the safer the products.

One example is GISBAU (see below), which was elaborated by the German Accident Insurance Association for the Construction Sector (Berufsgenossenschaft der Bauwirtschaft).

The disadvantage of this type of tool is that the maintenance of these systems is laborious compared to control banding systems. This is why, although they are much more user friendly, there are so far only few tools of this type available, normally for specific industrial sectors.


Mathematical models

Exposure models applying mathematical approaches, statistical methods or probabilistic processes to describe occupational exposure are an essential part of exposure assessment, which is itself a part of the workplace risk assessment. Mathematical models can contribute valuable input for workplace risk assessments as it would be a huge task to conduct measurements for every exposure scenario at every workplace.[9]

However, the evelopment of quantitative connections between exposure of workers and their determinants remains demanding. One approach has been a source-receptor model[10] to describe exposure schematically by deterministic exposure modifiers[11][12][13].

Usually these kinds of models describe the transport of a substance from the source and its pattern of transport to the receptor. Especially for the emission and the transport several influencing factors can be identified. The most frequently used are:

  • emission potential of the task (for example working activity or process);
  • emission potential of substance;
  • controls (e.g. local exhaust ventilation (LEV), separation, segregation);
  • dilution;
  • worker behaviour (e.g. compliance in using safety measures, personal hygiene, experience);
  • surface contamination of the working place;
  • respiratory protective equipment (RPE);
  • personal protective equipment (PPE).

The proportional influence of these factors on the exposure has to be quantified.

A mechanistic model based on this approach has been developed by Cherrie and colleagues[14][15]. This principle has been used for example to develop the ‘Stoffenmanager’[16].

A similar approach was used for dermal exposure[15] and resulted in an algorithm for dermal exposure assessment[17][18][19]. Additionally this methodology was used to describe inhalation exposure schematically[20] and develop the advanced REACH tool (ART).

Additionally to the above described theoretical basis modern tools often integrate databases with worked examples of exposure scenarios or the possibility to compare modelled scenarios with measured exposure data. Some tools offer search algorithms that compare the measurement database using data provided on a scenario and return the most appropriate generic data sets. Automated statistical analysis gives summary statistics and recommends indicative exposure values. A pooled analysis of all adequate generic exposure data sets weighs each data set by its strength of analogy to the assessment scenario using a hierarchical Bayesian model.

These models are usually very complicated and only experts with a strong background and good knowledge of exposure assessment, occupational safety and health and sometimes even mathematics are able to produce meaningful assessments.

Job-exposure matrices

Job-exposure matrices (JEMs) are tools for converting job title information into occupational risk factor data. A job exposure matrix consists of jobs on one axis and substances on the other, with matrix elements describing the likelihood of an individual's exposure to a substance in a given job. Where quantitative data are available, all workers with the same job title and duration are usually assigned similar cumulative exposures, expressed in mg/m3 × years.

In order to set priorities for policy and prevention, several countries have used job-exposure matrices to estimate cumulative exposures of workers, in epidemiological studies and to estimate the number of workers exposed to a certain substance or mixture in order to set priorities for policy and prevention (see below). Moreover, using JEMs is often the only reasonable choice in large retrospective studies where exposure assessment at the individual level is not feasible. Studies using JEMs have also estimated the link between exposures and specific forms of cancer and their proportion attributable to occupational exposures.

Researchers feel that studies to evaluate the validity of such matrices are greatly needed.[21] A proposed development of job-exposure matrices that allows for a more differentiated appreciation of exposure are task exposure matrices. By summing the cumulative exposures of a worker over all the tasks worked within a job title, it is possible to address the variability of exposure within the job title, and reduce possible exposure misclassification. JEMs do not normally allow the deduction of workplace preventive measures. They rather give recommendations at policy level, i.e. in which sectors specific work processes would need further attention.


Established risk management tools

COSHH Essentials – Control of substances hazardous to health essentials

In the early 1990s occupational health experts in the United Kingdom (UK) examined the correlation between hazard classification, occupational exposure limits (OELs) and data on exposure and control systems. This led to one of the first control banding toolkits: the Control Of Substances Hazardous to Health (COSHH) essentials[22]. The toolkit was developed to help small-and-medium sized enterprises (SMEs) comply with the UK regulations. COSHH Essentials is seen as a qualitative approach to guide the assessment and management of workplace risks to support employers to carry out a suitable and sufficient risk assessment, and take steps to ensure that exposure is prevented or adequately controlled[23]. The toolkit was developed to help small-and-medium sized enterprises (SMEs) comply with the UK regulations. The COSHH Regulations 2002 provided the main legislation in Great Britain to protect against health risks arising from hazardous substances, with a detailed ‘Approved Code of Practice’ included[24].

This generic risk assessment scheme groups hazard information and the exposure potential into bands and predicts the control strategy necessary to ensure that the hazardous substance is used safely. In the scheme two model approaches are combined: a hazard model (using R-phrases of the Dangerous Substances Directive or H-statements of the CLP-Regulation as a surrogate for lacking exposure limits and an exposure model (using bands for used quantities and exposure potential of a chemical). The model approaches were mainly based on exposure data and expert judgment from the UK.

The following factors are used in risk assessment to identify appropriate control measures:

HEALTH HAZARD To describe the health hazard the substance is allocated to a Hazard Group using R-phrases or H-statements (hazard and precautionary statements according to CLP) assigned to substances or products/mixtures.

EXPOSURE POTENTIAL To describe the exposure potential a substance is allocated to a dustiness or volatility band and a band for the amount used in an operation or batch process.

GENERIC RISK ASSESSMENT Combination of health hazard with exposure potential factors determine the necessary degree of control.

CONTROL APPROACH The tool provides a practical route for selecting an appropriate control approach: general ventilation; engineering control – local exhaust ventilation, e.g. dust or vapour extraction or containment.

For some common operations (e.g. mixing, filling, weighing), the scheme indicates appropriate 'Direct advise sheets' that contain basic descriptions of control equipment and good practice. Furthermore a series of CGS for special tasks and working processes with specific advice for the risk management at workplaces are provided for the user of the scheme.[25].

EMKG – Einfaches Maßnahmenkonzept Gefahrstoffe (easy-to-use workplace control scheme for hazardous substances)

In 2005, the German Federal Institute for Occupational Safety and Health (BAuA) published the “Einfaches Maßnahmenkonzept Gefahrstoffe” (EMKG) (easy-to-use workplace control scheme for hazardous substances)[26]. EMKG is a non-binding guidance for workplace risk assessment in SMEs. Using easy available information from SDS and workplace inspections the user of EMKG can derive control strategies to minimise chemicals exposure via inhalation or skin contact. EMKG is quite similar to COSHH Essentials and the International Chemical Control Toolkit (ICCT) described below.

The EMKG does not provide regulatory guidance, but, like COSHH Essentials, is well supported by legal obligations and Codes of Practice from the tripartite Hazardous Substances Committee in Germany. The main differences to COSSH essentials are some divergent allocations of hazard statements to hazard bands[27] and a more detailed tool to assess dermal exposure[28]. The EMKG uses three input parameters: volatility or dustiness, amount of substance used, and control strategy. The control strategy is defined with factors that aim at exposure reduction (general ventilation, local exhaust ventilation, containment). Like COSHH Essentials the EMKG makes use of control guidance sheets (CGS). In 2007 the generic control guidance sheets were supplemented with specific sheets for activities with chemicals in the rubber industry. In 2009 an updated module for the use of EMKG under the new classification and labelling of chemicals (CLP) regulation has been published.

ICCT – International chemical control toolkit

The International Chemical Control Toolkit was designed for SMEs in developing countries. It outlines a scheme for protection against dangerous chemicals and provides relevant instructions (guidance sheets) for the safe handling of a substance under given conditions[29].

The first step is to identify the hazard group of the substance on the scale from A (safest) to E (most dangerous). The user is supported to match the inhalation risks and safety data available for the substance with the EU Risk Phrases or GHS Hazard Classes to choose the appropriate hazard group. Furthermore the user gets detailed instructions to identify the ability of the substance to become airborne and the scale of use.

In addition to the inhalation-related risks, the tool provides a procedure to identify possible skin and eye risks of the substance and assign it to a hazard group for skin/eye risks by considering the EU R-phrases or GHS hazard classes.

The whole procedure leads to a final selection of the control approach from a list of task-specific guidance sheets. If any of the guidance sheets associated with the substance indicates the need for respiratory protection equipment or other safety measures, the user can draw on task specific control sheets for respirators and other safety issues.

Because of the widespread use of pesticides in developing countries, the toolkit includes a shortcut for pesticides. In the case of pesticide use the workplace risk assessment can rely on standard assessments that lead to a series of pesticide specific guidance sheets which can be used directly. For some frequently used solvents there is a similar offer.

GTZ-Tool – Chemical Management Guide for Small and Medium Sized Enterprises

In 1998, the German Association for Technical Cooperation (Gesellschaft für Technische Zusammenarbeit, GTZ merged with the German Development Service in 2011 to Gesellschaft für Internationale Zusammenarbeit) launched the Convention Project on Chemical Safety in developing countries. The project aimed to support developing countries in implementing concepts for chemical risk management measures in SMEs on the basis of the Rotterdam [30] and Stockholm Conventions[31].

A main aim was to demonstrate via pilot measures how chemical safety in the developing countries could be improved and sustainably implemented in line with international standards.

A Chemical Management Guide (CM Guide) for SMEs was developed and tested in practice. The CM Guide should convince companies that sound management of chemicals can reduce costs related to production, increase product quality and reduce risk to workers’ health and the environment[32].

When designing the GTZ-Tool, the ILO Safework Chemical Control Toolkit was already available[29]. Since the ILO Toolkit was regarded as an ideal building block for chemical management, it was introduced into the CM Guide. To widen the application scope of the CM Guide additionally to larger enterprises, a step-by-step approach was chosen. This should enable the companies to implement improvement in a continuous way, without making too many changes at one time.

The first step is based on identifying ‘hot spots’, defined as places where inefficient storage, handling and use can be observed, and where improved practices could give cost savings, or where, due to the handling of chemicals, particularly hazardous situations may occur. The second step implies the configuration of a chemical inventory. These steps provide the information for the third step that aims to calculate losses, consider substitutes, and determine and evaluate adequate controls on the basis of the ILO Toolkit.

In total, there are six sub-modules to support the chemical management process: basic concepts for risk assessment; description of control approaches; using the SDS, risk phrases for hazardous substances, safety phrases for hazardous substances and symbols used for labelling hazardous substances. Alternatively the tool explains the GHS system.

In order to establish the GTZ tool, training sessions on the correct use of the tool were organised by GTZ in Latin America and Africa, in cooperation with regional partners. It was important to understand that the way to engage company owners and managers is with economic arguments, for example referring to the loss, waste and expiry of materials, and the need to comply with quality standards expected from importing countries.


Stoffenmanager

The Stoffenmanager was originally developed by Dutch institutes but is already widely used in Europe and translated into several languages including English. For example, the German Social Accident Insurance (DGUV - Deutsche gesetzliche Unfallversicherung) has established a tool called GESTIS-Stoffenmanager, which is also accessible via the general Stoffenmanager website.[33]

Stoffenmanager can be used by different types of users because of different functionalities and differentiated routes a user can take. It has been officially recognised as a useful method to evaluate the risks from dangerous substances at the workplace by the Dutch Labour Inspectorate.

The Stoffenmanager was initially a tool using a control banding approach allowing SME to evaluate the risks to the health of their workers caused by dangerous substances and to determine effective control measures. The tool combines hazard information of a substance or preparation/mixture with an inhalation and/or dermal exposure assessment to calculate a risk score. When risks cannot be avoided, effects of different control measures can be examined. An action plan gives an overview of the risk assessment results and proposed control measures.

The hazards of a product are classified on basis of the R-phrases. The inhalation exposure algorithm is based on the source-receptor approach by Cherrie[15]. The dermal exposure model is based on the RISKOFDERM Toolkit[34].

Stoffenmanager can also be used to estimate inhalation exposure concentrations in mg/m³. The developers of Stoffenmanager consider the tool on their website to contain a ‘quantified and validated exposure model for estimating inhalation exposure to both inhalable dust and vapour’. The quantification was done by using about 700 exposure measurements and correlating these to qualitative Stoffenmanager scores. The model was then validated with about 250 of these exposure measurements. It was concluded that Stoffenmanager’s exposure estimations are generally sufficiently conservative, but for several particular situations adaptation of the model was necessary[35].

GISBAU

GISBAU was established by the German accident insurance association as a hazard information system for the construction sector. The tool is available on the internet, and there is a version for smartphones. [52] Since many products present comparable risks to health, and therefore call for the same protective measures to be taken, GISBAU assembles the information on individual products into product group information. The result is that for a few groups information can be given regarding a large number of products of the same type. The users can select the type of chemical or mixture they are working with, and receive information about the necessary protective measures. This system has the advantage that experts scan the available SDS (usually provided by manufacturers) and include results of exposure measurements at workplaces. Therefore errors, such as incorrect SDS and user oversights, are ruled out. In addition, scientific developments and possible precautionary measures can be quickly weighed up.

Besides GISBAU there are two more systems available in Germany: GISChem for the German chemical sector and GISMET for the German metal sector.

Selected job-exposure matrices

Known examples of job-exposure matrices are the FINJEM and the French SUMEX database. FINJEM was constructed in the 1990s for epidemiological research, hazard surveillance and risk assessment purposes (Kauppinen, Toikkanen & Pukkala, 1998; Gueguen et al., 2004). The SUMEX job-exposure matrix was constructed from data collected via a cross-sectional survey of a sample of French workers representative of the main economic sectors through the SUMER-94 survey: 1,205 occupational physicians questioned 48,156 workers, and inventoried exposure to 102 chemicals. The companies' economic activities and the workers' occupations were coded according to the official French nomenclatures. A segmentation method was used to construct job groups that were homogeneous for exposure prevalence to chemical agents. The matrix was constructed in two stages: consolidation of occupations according to exposure prevalence; and establishment of exposure indices based on individual data from all the subjects in the sample.

Job-exposure matrices are developed and used in conjunction with measurement database results (for example the MEGA database of the German DGUV, or the French COLCHIC database).

The COLCHIC database consolidates all occupational exposure data collected in French companies by the Caisses Régionales d'Assurance Maladie (regional health insurance funds, CRAM) and the Institut National de Recherche et de Sécurité (national institute for research and safety, INRS). Presentation of base data by activity branch, activity sector or workplace permits identification of situations, for which prevention efforts are most essential.

The data may be helpful to occupational physicians performing occupational screening of exposed workers and to epidemiologists seeking information for building job-exposures matrices. For example, occupational exposure to mineral fibres, asbestos fibres, ceramic fibres and man-made mineral fibres other than ceramic fibres was estimated using data from COLCHIC. A database (FIBREX) of the results was made available on the web site of the French Institut National de Recherche et de Sécurité (National institute for research and safety, INRS).

BEAT – Bayesian Exposure Assessment Toolkit

An example for the exposure models that use mathematical approaches and statistical methods is the Bayesian Exposure Assessment Toolkit (BEAT) that was developed by the British Health & Safety Laboratory for exposure assessment of biocides but can be used for other dangerous substances as well[36]. BEAT consists of a number of integrated databases, search algorithms and statistical routines developed to assist exposure evaluation for professional use scenarios. The system includes the following elements:

  • database of worked examples of exposure assessments for use scenarios for all 23 product types in the biocidal product directive[37] including a description of the scenario, details of tasks, pattern of use, PPE, and all other quantitative data required;
  • export facility to an Excel exposure calculator that presents a calculation of internal dose, the amount of a substance which is systemically available in the body;
  • database of measured exposure data (inhalation and dermal) for a broad variety of occupational exposure scenarios relevant to biocides;
  • task-based search algorithms that search the measurement database using information provided on an exposure scenario and return the most appropriate generic data sets (only analogy between dermal exposure scenarios is assessed, not for inhalation exposure);
  • visualisation of the distribution of dermal exposure to the body using a 3-dimensional mapping.

Users can create new worked examples for their own exposure scenarios, add measurements to the data base, search for appropriate generic data and suitable indicative exposure values and calculate internal doses. It is inherent to BEAT that it can be developed further via the incorporation of additional measured exposure data and expansion of the catalogue of worked examples of exposure assessments. However, BEAT is a tool that should be applied by skilled users with advanced knowledge on risk assessment.

Tools addressing fire and explosion hazards

One of the modules of the Stoffenmanager tool deals with explosion risks. By answering rather simple (non-expert) questions about the working situation the module presents an assumption whether a situation is in compliance with the legislation, or not. If the situation is not in compliance, the tool directs the user to possible control measures.

In order to integrate fire and explosion hazards into control banding BAuA has developed a module “Fire and Explosion Risks” for the EMKG described above[38]. The module assists SMEs in risk assessment for physico-chemical risks at workplaces. In a transdisciplinary field study a test version of the module was evaluated for practicability. New control guidance sheets for fire and explosion protection are being generated to facilitate communication of risk reduction measures. The module will be integrated into the EMKG version 3.0.


Tools addressing skin exposure

RISKOFDERM was a shared-cost project funded under the Fifth Framework Programme of the European Community developed by partners from 11 different EU Member States with expertise in exposure assessment. The project aimed to reduce acute and chronic ill-health through dermal contact with chemicals, developing two essential tools for management of dermal exposure and prevention of ill-health:

  • a validated predictive model for estimating dermal exposure of single chemicals and
  • a practical dermal exposure risk management tool for workplaces.

The following remarks focus on the RISKOFDERM risk management tool which helps SMEs estimate whether there might be any health risk to their workers from skin exposure. The tool offers suggestions for risk control and management by providing employers with means of ranking dermal exposure risks and with guidance on control measures. It is based on a considerable number of measurements of dermal exposure in real work situations and is considered to be a valid tool for assessing dermal exposure.

However, the quality and reliability of the toolkit’s results depend strongly on the quality of the detailed information from the exposure scenarios that are considered. Additionally the toolkit cannot be used safely without fundamental understanding on how exposure of the skin occurs and how health risks can arise from this. Furthermore, several limitations have to be taken into account when assessing dermal exposure and risk:

  • The exposure assessment could be only carried out for one chemical product and only one exposure scenario at a time. This means that cumulative effects are not considered by the model.
  • The tool is designed to give a very rough estimate of hazard, exposure and risk, therefore over- or underestimation cannot be excluded completely.

Several publications explaining scientific background and model approach were pooled in the November 2003 issue of the Annals of Occupational Hygiene[39].

Besides RISKOFDERM Stoffenmanager, GISBAU and most of the above mentioned tools address skin exposure.


OiRA – Online interactive Risk Assessment

The European Agency for Safety and Health at Work (EU-OSHA) has developed OiRA to give access to sectoral risk assessment tools created and maintained with expert assistance by social partners at the national level.[40] The basic tool was developed as an open source software and tailored to micro and small enterprises/organisations.

The developed online tools give assistance to micro and small enterprises to perform a practical occupational risk assessment following a step by step process – starting with the identification and evaluation of workplace risks, through decision making on preventive actions – whereby users may select from comprehensive solution suggestions - and the taking of action, to monitoring and reporting. The online document can be printed and serve as evidence that the company has done the risk assessment. It can serve as basis for continuous risk assessment updates.

Often these tools have been developed on European level by European social partners (assisted by experts) and can be translated and adapted to the national requirements by national social partners. The tools cover all workplace risks including those from chemicals.

At the beginning of 2015, nearly 100 tools had been established or were under development, covering many sectors where dangerous substances are widely used, such as cleaning, hairdressing, leather and tanning, and woodworking.[41] Because of its comprehensiveness, the exchange at European level, the expert assistance and the support by social partners, this tool can be seen as one of the most important developments in European risk assessment for SMEs.

REACH-compatible tools

REACH is expected to increase the information available for workplace risk assessments. One important aspect of REACH risk assessments is the exposure assessment. The information generated during exposure assessments is valuable for workplace risk assessments.

On the other hand workplace risk assessments produced in the past provide valuable information which should be used for REACH registrations. It therefore makes a lot of sense to use the same approaches and information for both risk assessments whenever that is possible.

Substance risk assessment and exposure assessment tools under REACH

In the last years several tools for substance risk assessment under REACH were developed to facilitate REACH obligations for registrants. These tools are focused on the needs of these registrants (producers and importers of chemicals) when performing risk assessments for chemicals and developing exposure scenarios at workplaces. However, REACH-information produced by REACH registrants is available in Chemical Safety Reports and extended safety data sheets (SDS) and can also be used by actors at the enterprise level for workplace risk assessment. Consequently a general understanding of these REACH tools would be useful at every workplace with hazardous substances in order to make the best use of all available information.

The following important REACH-compatible tools are available:

  • CHESAR – CHEmical Safety Assessment and Reporting tool[42]
  • ECETOC TRA – Targeted Risk Assessment[43]
  • ES modifier – Exposure Scenario modifier[44]
  • ART – Advanced REACH Tool[45]

Control Banding and REACH

Until now control banding was used for workplace risk assessments world wide, but it (CB) is also established in several contextual parts of REACH. For example REACH explicitly allows using control banding information in safety data sheets[46]. Additionally, control guidance sheets (CGS) are repeatedly pointed out in the REACH Guidance Document R.14[45]. In Appendix R.14-3 of that document the CGS numbering system of COSHH essential is published. Currently several projects are carried out in Europe to enhance the integration of CB principles under REACH.

Chemical safety reports (CSR) include risk characterisations for work safety which are deducted from an assessment of effects (toxicology) and the exposure assessment of workers to a specific chemical. Exposure assessments are conducted in a tiered approach. Exposure assessments under REACH can be carried out at different levels (‘tiers’). The first tier exposure estimations (Tier 1) are meant to be conservative and may be well above actual exposure levels. The higher tier exposure estimations (e.g. Tier 2) are much more specific and require more details about the estimation parameters and exposure determinants.

REACH guidance includes a selection of recommended models for Tier 1. In order to achieve more confidence about the accuracy, precision, and reliability of model predictions a research project is currently being carried out by the German Federal Institute for Occupational Safety and Health (BAuA). The title of this project is ‘Evaluation of Tier 1 Exposure Assessment Models under REACH’, in short: “E-TEAM”. In this context a comprehensive model validation which focuses on the comparison of model outcome with independent measurement data is being performed.[47]

Another project of BAuA aims at establishing a standardised set of EU Control Guidance Sheets (CGS) for REACH. The phrases of the CGS shall as much as possible overlap with the phrases used in the EuPhraC (European standard phrases catalogue for EU safety data sheets) Catalogue for SDS. The EuPhraC Catalogue contains a selection of generally accepted standard phrases in accordance with current law. This selection can be supplemented by sectoral catalogues harmonised throughout the sectors, containing sector-specific standard phrases. The EuPhraC can be downloaded free of charge in English from the homepage www.euphrac.eu. The current version is already available in 31 languages. The set of EU CGS shall be realised via harmonising the linguistic formulations contained in existing CGS and the EuPhraC Catalogue[48]. Standardised CGS will facilitate the communication of occupational safety measures under REACH and will sustainably alleviate the communication of REACH exposure scenarios as risk assessments.

The following tools originally developed for workplace risk assessment have been recommended by ECHA to fulfil requirements under REACH:

  • EMKG ExpoTool – “Easy-to-use workplace control scheme for hazardous substances”[49]
  • Stoffenmanager (see above)


References

  1. EU-OSHA - European Agency for Safety and Health at Work (no date). Dangerous Substances. Retrieved 28 January 2015, from: [1]
  2. 2.0 2.1 EC – European Commission, ‘Council Directive 98/24/EC 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), Official Journal of the European Union, L131, 1998 a, pp. 11-23. Available at: [2]
  3. EC – European Commission, ‘Directive 2004/37/EC of the European Parliament and the Council 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) of Council Directive 89/391/EEC’, Official Journal of the European Union, L229, 2004 a, pp. 23-34. Available at: [3]
  4. TRGS 600 – Technical Rule for Hazardous Substances 600 “Substitution” (August 2008), Bundesministerium für Arbeit und Soziales GMBl Nr. 46/47 S. 970-989 (22.9.2008), an unofficial English version is available at: [4], mandatory is the current German version
  5. IFA – Institute for Occupational Safety and Health of the German Social Accident Insurance, ‘Column model for chemical substitutes’, 2014. Available at: [5]
  6. Subsport project consortium (no date). Substitution Support Portal. Retrieved 13 July 2015, from: [6]
  7. Lawson, C.C., Grajewski, B., Daston, G.P., Frazier, L.M., Lynch, D., McDiarmid, M., Murono, E., Perreault, S.D., Robbins, W.A., Ryan, M.A., Shelby, M. & Whelan, E.A., 'Workgroup Report: Implementing a National Occupational Reproductive Research Agenda—Decade One and Beyond', Environmental Health Perspectives, volume 114, number 3, March 2006. Available at: [7]
  8. Geyer, A., Kittel, G. & Wriedt, H., Assessment of the usefulness of material data sheets (MSDS) for SMEs, SAFE project, final report, Linz, 1999. Available at: [8]
  9. Jayjock, M. A., Chaisson, C. F., Arnold, S., Dederick, E. J., ‘Modeling framework for human exposure assessment’, J. Expo. Sci. Environ. Epidemiol., 17 Suppl. 1, 2007, pp. S81–589.
  10. Smith, T. J., Hammond, S. K., Hallock, M., Woskie, S. R., ‘Exposure assessment for epidemiology, characteristics of exposure’, Appl. Occup. Environ. Hyg., 6, 1991, pp. 441–447.
  11. Schneider, T., Olsen, J. O., Lauersen, B., ‘Evaluation of exposure information’, Appl. Occup. Environ. Hyg., 6, 1991, pp. 475–481.
  12. Woskie, S. R., Hammond, S. K., Hines, C. J., Hallock, M. F., Schenker, M. B., ‘Algorithms for estimating personal exposures to chemical agents in the Semiconductor Health Study’, Am. J. Ind. Med., 28, 1995, pp. 699–711.
  13. Creely, K. S., Tickner, J., Soutar, A. J., Hughson, G. W., Pryde, D. E., Warren, N. D., Rae, R., Money, C., Phillips, A., Cherrie, J. W., ‘Evaluation and further development of EASE model 2.0’, Ann. Occup. Hyg., 49, 2005, pp.135–46.
  14. Cherrie, J. W., Schneider, T., Spankie, S., Quinn, M. M., ‘A new method for structured subjective assessments of past concentrations’, Occupational Hygiene, 3, 1996, pp. 75–83.
  15. 15.0 15.1 15.2 Cherrie, J. W., Schneider, T., ‘Validation of a new method for structured subjective assessment of past concentrations’, Ann. Occup. Hyg., 43, 1999, pp. 235–245.
  16. Marquart, H., Heussen, H., le Feber, M., Noy, D., Tielemans, E., Schinkel, J., West, J., van der Schaaf, D., ‘Stoffenmanager, a web-based control banding tool using an exposure process model’, Ann. Occup. Hyg., 52, 2008, 429–441.
  17. Van Wendel de Joode, B., Brouwer, D. H., Vermeulen, R., van Hemmen, J. J., Heederik, D., Kromhout, H, ‘DREAM, a method for semiquantitative dermal exposure assessment’, Ann. Occup. Hyg., 47, 2003, pp.71–87.
  18. Van Wendel de Joode, B., van Hemmen, J. J., Meijster, T., Major, V., London, L., Kromhout, H. ‘Reliability of a semiquantitative method for dermal exposure assessment DREAM’, J. Expo. Anal. Environ. Epidemiol., 15, 2005 a, pp.111–20.
  19. Van Wendel de Joode, B., Vermeulen, R., van Hemmen, J. J., Fransman, W., Kromhout, H., ‘Accuracy of a semiquantitative method for dermal exposure assessment DREAM’, Occup. Environ. Med., 62, 2005 b, pp.623–632.
  20. Tielemans, E., Schneider, T., Goede, H., Tischer, M., Warren, N., Kromhout, H., van Tongeren, M., van Hemmen, J., Cherrie, J. W., ‘Conceptual Model for Assessment of Inhalation Exposure – Defining Modifying Factors’, Ann. Occup. Hyg., Vol. 52, No. 7, 2008, pp. 577–586.
  21. Brouwers, M.M., van Tongeren, M., Hirst, A., Bretveld, R.W. & Roeleveld, N., ‘Occupational exposure to potential endocrine disruptors: further development of a job exposure matrix’, Occupational Environmental Medicine, 66, 2009, pp. 607–614. Available at: [9]
  22. HSE – British Health and Safety Executive, ‘COSHH Essentials, easy steps to control chemicals’ Accessed December 29, 2008. Available at: [10]
  23. HSE – British Health and Safety Executive, ‘The technical basis for COSHH essentials, Easy steps to control chemicals’, 2009. Available at: www.coshh-essentials.org.uk/assets/live/CETB.pdf
  24. HSE – British Health and Safety Executive, Control of substances hazardous to health Fifth edition. The Control of Substances Hazardous to Health Regulations 2002 as amended, Approved Code of Practice and guidance L5, Fifth edition HSE Books 2005, 2005.
  25. HSE – health and Safety Executive (no date). Direct advise sheest. Retrieved 13 July 2015, from: [11]
  26. Packroff, R., Görner, B., Guhe, C., Lechtenberg-Aufferth, E., Lotz, G., Tischer, M., ‘Easy-to-use workplace control scheme for hazardous substances’, Federal Institute for Occupational Safety and Health, BAuA, Dortmund, Germany, 2006. Available at: [12]
  27. TRGS 400 – Technical Rule for Hazardous Substances “Risk assessment for activities involving hazardous substances” (December 2010), Bundesministerium für Arbeit und Soziales, GMBl 2011 Nr. 2S. 19-32 (31.1.2011) an unofficial English version is available at: [13], mandatory is the current German version
  28. TRGS 401 – Technical Rule for Hazardous Substances “Risks resulting from skin contact - determination, evaluation, measures” (June 2008), Bundesministerium für Arbeit und Soziales GMBl Nr. 40/41 S. 818-845 (19.8.2008), corrected: GMBl 2010 Nr. 5-6 S. 111 (v.4.2.2010), an unofficial English version is available at: [14], mandatory is the current German version
  29. 29.0 29.1 ILO – International Labour Organization, ‘Draft ILO chemical control toolkit’, 2009. Available at: [15]
  30. UN – United Nations, ‘The Rotterdam Convention on the prior informed consent procedure for certain hazardous chemical and pesticides in international trade’, United Nations Environment Programme, 2002. Available at: [16]
  31. UN – United Nations, ‘Stockholm Convention on persistent organic pollutants’, United Nations Environment Programme, 2001. Available at: [17]
  32. Tischer, M., Schoelen, S., ‘Chemical Management and Control Strategies, Experiences from the GTZ Pilot Project on Chemical Safety in Indonesian Small and Medium-sized Enterprises’, Ann. Occup. Hyg., 47, 7, 2003, pp. 571-575.
  33. Stoffenmanager 4.0 ‘Work safe with hazardous substances‘. Available at: [18]
  34. Goede, H., Tijssen, S., Schipper, H., Warren, N., Oppl, R., Kalberlah, F., van Hemmen, J., ‘Classification of dermal exposure modifiers and assignment of values for a risk assessment toolkit’, Ann. Occup. Hyg., 478, 2003, pp. 609-618.
  35. Schinkel, J., Fransman, W., Heussen, H., Kromhout, H., Marquart, H., Tielemans, E., ‘Cross-validation and refinement of the Stoffenmanager as a first tier exposure assessment tool for REACH’, Occup. Environ. Med., 67, 2010, pp.125.
  36. TNsG on Human Exposure to Biocidal Products, June 2007, Ex-ECB at IHCP (Ex European Chemicals Bureau at the Institute for Health and Consumer Protection of the Joint Research Centre in Ispra, Italy) Available at: [19]
  37. EC – European Commission, ‘Directive 98/8/EC of the European Parliament and the Council of 16 February 1998 concerning the placing of biocidal products on the market’, Official Journal of the European Communities, L123, 1998b, pp. 1-63. Available at: [20]
  38. BAuA 2010 “Field Study on a Future Module “Fire and Explosion Risks” for an Easy-to-use Control Scheme for Hazardous Substances at the Workplace (EMKG)”. Available at: [21]
  39. RISKOFDERM, Annals of Occupational Hygiene, Vol. 47, Issue 8, 2003. Available at: [22]
  40. EU-OSHA - European Agency for Safety and Health at Work (no date). Online Interactive Risk Assessment - OiRA. Retrieved 28 January 2015, from: [23]
  41. EU-OSHA - European Agency for Safety and Health at Work (no date). OiRA Tools. Retrieved 28 January 2015, from: [24]
  42. EC – European Commission, Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, Official Journal of the European Union, L136, 2006, pp. 3-280. Available at: [25]
  43. ECETOC – European Centre for Ecotoxicology and Toxicology of Chemicals, ‘Technical Report 93’, Brussels, 2004. Available at: [26]
  44. ES-modifier, The Exposure Scenario modifier, 2010. Available at: [27]
  45. 45.0 45.1 ECHA – European Chemical Agency, ‘REACH Guidance Document, Guidance on information requirements and chemical safety assessment Chapter R.14: Occupational exposure estimation’, 2010. Available at: [28]
  46. EC – European Commission, ‘COMMISSION REGULATION EU No 453/2010 amending Regulation EC No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals REACH’, Official Journal of the European Union, L133, 2010, pp. 1-43. Available at: [29]
  47. BAuA – Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (2012) Welcome to the eteam project. Retrieved 28 January 2015, from: [30]
  48. WG EuPhraC – Working Group EuPhraC (2010). Available at: [31]
  49. ExpoTool – EMKG-EXPO-TOOL, “Easy-to-use workplace control scheme for hazardous substances”, 2008. Available at: [32]


Links for further reading

NIOSH – National Institute for Occupational Safety and Health USA, ‘Risk Characterization and Management of Occupational Hazards Control Banding (CB)’, NIOSH Publication, No. 2009-152, 2009. Available at: [33]

Packroff, R., Schlüter, U., Wilmes, A., Karababa, I., Tischer, M., Federal Institute for Occupational Safety and Health BAuA, Germany Kahl, A. University of Wuppertal, Germany ‘Prevention Today’, Special Issue IOHA 2010.

HSE - Health and Safety Executive UK (no date). Substance substitution. Retrieved 12 July 2015, from: [34]

EU-OSHA - European Agency for Safety and Health at Work (no date). Advice for employers: elimination and substitution. Retrieved 14 July 2015, from: [35]

Workplace Safety & Health Topics: Control Banding – National Institute for Occupational Safety and Health USA. Available at: [36]

Control of Substances Hazardous to Health (COSHH) Essentials guidance publications – Health and Safety Executive UK. Available at: [37]

Benke, G., Sim, M., Fritschi, L., Aldred, G. & L. Beyond the Job Exposure Matrix (JEM): the Task Exposure Matrix (TEM), Am. J. Epidemiol., 137 (4),1993, pp. 472-481. Available at: [38]

INRS - French Institut National de Recherche et de Sécurité (National institute for research and safety) (no date). FIBREX. Retrieved 14 July 2015, from: [39]

CHEmical Safety Assessment and Reporting tool – European Chemicals Agency. Available at: [40]

Exposure Scenario Modifier – ES-modifier project group. Available at: [41]

Exposure estimate at the workplace – German REACH-CLP Helpdesk of the Federal Authorities. Available at: [42]


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OSH: Dangerous substances managementExposure assessmentREACHRisk analysis and managementRisk assessment
NACE: Growing of non-perennial cropsGrowing of perennial cropsAnimal productionMixed farmingSupport activities to agriculture and post-harvest crop activitiesLoggingSupport services to forestryFishingAquacultureMining of hard coalMining of ligniteExtraction of crude petroleum and natural gasMining of metal oresQuarrying of stoneMining support service activitiesProcessing and preserving of meat and production of meat productsTanning and dressing of leather; dressing and dyeing of furSawmilling and planing of woodManufacture of products of woodManufacture of paper and paper productsPrinting of newspapersOther printingBinding and related servicesManufacture of coke oven productsManufacture of basic chemicalsManufacture of pesticides and other agrochemical productsManufacture of paintsManufacture of soap and detergentsManufacture of perfumes and toilet preparationsManufacture of explosivesManufacture of gluesManufacture of man-made fibresManufacture of basic pharmaceutical productsManufacture of pharmaceutical preparationsManufacture of rubber and plastic productsManufacture of articles of concreteManufacture of concrete products for construction purposesCuttingManufacture of basic metalsManufacture of structural metal productsManufacture of tanksForgingTreatment and coating of metals; machiningMachiningManufacture of cutleryManufacture of other fabricated metal productsManufacture of electric motorsManufacture of domestic appliancesManufacture of general-purpose machineryManufacture of other general-purpose machineryManufacture of agricultural and forestry machineryManufacture of metal forming machineryManufacture of other special-purpose machineryManufacture of motor vehiclesManufacture of other transport equipmentManufacture of furnitureRepair and installation of machinery and equipmentManufacture of gas; distribution of gaseous fuels through mainsSteam and air conditioning supplySewerageWaste collectionDismantling of wrecksOFFICE CLERKSCivil engineeringDemolition and site preparationElectricalBuilding completion and finishingRoofing activitiesSale of cars and light motor vehiclesMaintenance and repair of motor vehiclesRetail trade of motor vehicle parts and accessoriesWholesale trade of motor vehicle parts and accessoriesSaleWholesale of solidWholesale of woodWholesale of hardwareWholesale of chemical productsRetail sale of automotive fuel in specialised storesRetail sale of hardwareDispensing chemist in specialised storesRetail sale of cosmetic and toilet articles in specialised storesRetail sale of flowersOther passenger land transportFreight transport by roadTransport via pipelineSea and coastal passenger water transportSea and coastal freight water transportInland passenger water transportInland freight water transportAir transportCleaning activitiesHospital activitiesMedical and dental practice activitiesResidential care activitiesRepair of computers and personal and household goodsWashing and (dry-Hairdressing and other beauty treatment