Martie van Tongeren, Institute of Occupational Medicine, Edinburgh
There is not currently a formal and universally recognised definition of a process-generated substance. Process-generated contaminants can be generated as emissions from combustion processes, abrasion and/or other processes that physically or chemically degrade or otherwise modify the starting material(s), e.g. degradation/composting of organic materials. Such emissions are generally complex and variable mixtures of substances that are generated by processes or activities and are incidentally released (i.e. the substances are not supplied or intentionally produced). They can consist of gases, vapours, mists, fumes and/or particles (fibres and non-fibrous) with their physical and chemical composition determined by the starting material, the process conditions and the level and type of energy applied or generated, and any control measures applied to reduce emissions. Well-known process-generated contaminants include welding fumes, diesel engine exhaust, crystalline silica dust and organic dusts such as wood dust and materials associated with microorganisms such as endotoxins.
The following examples are not considered to be process-generated contaminants:
- Evaporation of volatile agents from a mixture, as this represents a change of state of a substance that is present in the mixture.
- Particles released from handling, scooping, mixing, etc. of powders.
In neither of these examples is the activity or process causing a chemical or major physical transformation in agents present in the mixture prior or during the emission, although due to differences in vapour pressure and dustiness, the relative composition of the released materials may be different from that in the original liquid mixture or powdered materials.
Examples of process-generated substances
All combustion processes will result in the production of a complex mixture of gases, vapours and solids depending on the fuel, the combustion conditions (e.g. temperature, level of oxygen) and any control measures adopted to reduce emission of hazardous materials.
One commonly encountered example is diesel exhaust fumes, arising from the combustion of diesel fuel in compression ignition engines. Emissions from diesel engines are complex mixtures of gases, liquids and solids. Many of the individual components have their own specific toxicity, and some have exposure limits assigned to them. The gas phase comprises of carbon monoxide, nitrogen oxides and volatile organic compounds such as benzene and formaldehyde. The particle fraction consists of elemental and organic carbon, ash, sulphates and metals. Polycyclic aromatic hydrocarbons and nitroarenes are distributed within both the gas and the particle phases. Diesel engine exhaust is classified as a human carcinogen by the International Agency for Research on Cancer (IARC).
The exact composition of diesel engine exhaust depends on the type and age of the engine, the fuel composition, the performance of the engine, and the duty cycle. Diesel engine emissions have changed (both qualitatively and quantitatively) substantially over time due to changes in engine technology (to improve efficiency and reduce emissions) and due to changes in composition. The sources of occupational exposures to diesel engine exhaust include motor vehicles, locomotives, and diesel-powered equipment such as tractors, portable generators and forklift trucks.
Any process or activities that involve heating, cutting or soldering or welding metal will produce a fume that again will contain a mixture of gases and particulate materials.
The composition of welding fume depends on the type of welding process, the composition of the welding rod and the material being welded. The majority of the fume from metal welding is generated by the consumable (welding rod) rather than the substrate being welded. Information on the composition of the fume should be given on the safety data sheet provided with the consumable. Stainless steel, and other specialist alloys containing high levels of chromium, nickel and manganese carry a particularly high risk. Manual metal arc (stick) welding generates more fume than other techniques, such as MIG and TIG welding (metal inert gas, and tungsten inert gas). Although welding is most commonly used to join metals, other materials, such as plastics, are also welded and these processes can also generate toxic fumes which must be controlled.
The physical and chemical composition of aerosols generated from metal cutting depends on the composition of the metal and any products applied to the surface of the metal. High exposures to welding and other metal fumes can cause metal fume fever, which can present itself as non-specific flu-like symptoms such as fever, chills etc.
Other processes involving heating materials can lead to generation of process-generated contaminants. One example is Rubber fumes. There is a wide range of different base rubbers, both natural and synthetic, each with a unique chemical structure. In addition, during the production of rubber products, a wide range of varying chemical agents are used as fillers, vulcanising agents, accelerators and inhibitors, antidegradants and antioxidants, plasticisers, etc. Rubber fumes have been defined by the Health and Safety Executive (UK) as fumes evolved in the mixing, milling and blending of rubber and in the processes which convert the blended rubber into the finished products. The composition of rubber fumes varies depending on the production process and temperatures, as well as on the raw materials used in the production of the rubber product. Chemical agents present in rubber fumes may include various volatile agents (e.g. benzene, toluene, xylenes, ethylbenzene, dimethylbenzenes, diisopropylbenzenes), polyaromatic hydrocarbons, and other agents. As is generally the case for process-generated fumes, many of the individual components have their own specific toxicity, and some have exposure limits assigned to them. The composition of rubber fumes has also changed over the years. For example, concerns related to PAH- and N-nitrosoamine levels in rubber fumes have resulted in changes in the raw materials used, decreasing the levels of these compounds in rubber fumes.
Many activities within the construction sector, as well as in the mining and quarrying sector, produce dusts which are released into the air. The exact composition of the dust will depend on factors such as: the types of activities; the materials/products that are being used; the materials used in the buildings that are being built, repaired or demolished; or the composition of the ore that is being mined or quarried. Dust generated in these activities often includes some amount of respirable crystalline silica (RCS). Similarly, asbestos exposure in Europe now mainly occurs during the repair, maintenance or demolition of buildings and hence could be considered a process-generated contaminant.
Organic dusts may also be considered to be process-generated contaminants as they are emitted from organic materials that have undergone some degradation, resulting in a release of a complex mixture that can include a range of viable micro-organisms (e.g. fungal spores, bacteria, viruses) and their by-products including toxins, constituents of their cell-walls (e.g. endotoxins and glucans) and parts of living organisms. Exposure to organic dusts can occur in occupations and industry sectors that involve working with animals, plants and organic materials, including farming and collection and processing (e.g. composting) of household and other waste. Workers in wastewater treatment plants may come into contact with sewage and unstable sludge containing various pathogens such as viruses, bacteria, and human and animal parasites. These microorganisms can be transmitted to the ambient air in wastewater droplets, which are generated during aeration or mechanical moving of the sewage. Other organic contaminants may be released as aerosols, for example during the slaughtering and butchering of animals.
An example of an organic dust is Wood dust, which is generated from sawing, sanding and other woodworking processes, and carries a variety of health risks. This includes the dust from hard and soft woods, and also composite materials such as medium density fibreboard (MDF) and chipboard, wood chippings used for animal litter or in the paper and pulp industry, or mulch made of wood chippings. Wood dust can cause asthma and is also classified by IARC as a carcinogen.
Health risk from exposure to Process-Generated Substances
As is clear from the above there are a wide variety of process-generated contaminants, with widely varying physical, chemical and biological composition, to which workers might be exposed. Consequently, any health risks will also vary. However, many commonly encountered process-generated substances have been linked to malignant (lung cancer) and non-malignant respiratory disease (e.g. Chronic obstructive pulmonary disease - COPD). Exposure to organic dusts, consisting of viable micro-organisms and agents such as endotoxin and glucans have been associated with infectious diseases as well as syndromes such as Organic Dust Toxic Syndrome, which is a potentially severe flu-like syndrome which has been observed amongst others in farmers and mushroom workers.
IARC has classified several process-generated substances as Group 1 – Carcinogenic to humans (e.g. diesel engine exhaust, coal combustion, soot, welding fumes, and wood dust) and Group 2a – probably carcinogenic to humans (e.g. bitumen, biomass fuel emissions, gasoline engine exhaust). In addition, several occupations and industries are classified as Group 1 (e.g. rubber industry, painter) or Group 2b (e.g. firefighter, petroleum industry) where the causal agent has not been established, but where the process-generated emissions are likely to play an important role.
Impact on Occupational Health
A large proportion of workers in the EU are potentially exposed to process-generated contaminants, in particular to RCS and diesel exhaust fumes. Research carried out by the IOM in Edinburgh investigated the health impact of proposed changes in the occupational exposure limits for these and other agents (the SHEcan project), and estimated for example that over 5 million workers in the EU are potentially exposed to RCS, the majority of whom work in the construction industry. It was estimated that in 2010 there were approximately 7,000 deaths from lung cancer in the EU that were attributable to past exposure to RCS . About 4 million workers were potentially exposed to diesel exhaust fumes above background levels, with an estimated 4000 deaths in 2010 from lung cancer that could be attributable to past exposure to diesel engine exhaust particulates. In addition, the research estimated that approximately 170,000 workers were exposed to rubber fumes, approximately 1 million workers were exposed to used engine oils and 3 million workers were exposed to hardwood dust.
From these figures it is clear that a large number of workers in the EU are exposed to process-generated contaminants, often at fairly high levels, and consequently these substances contribute substantially to the total burden of chronic disease (malignant as well as non-malignant) that is thought to be caused by people’s work.
Risk management and control of exposure to process-generated substance relies predominantly on EU and national Health and Safety legislation, rather than REACH. Process-generated substances are generally exempt from registration under REACH and are not subject to classification under the Classification, Labelling and Packaging (CLP) Regulations. However, REACH Annex I Section 5.2.4 states that an estimation of exposure “shall take account of transformation and/or degradation products”. A substance emitted from/with a metalworking fluid would need to be addressed by the registrant of the specified registered substance, whether it is a main component or an additive, or a transformation product of the registered substance. However, it is not clear to what extent such issues are being addressed within the REACH registration and authorisation dossiers. As materials such as wood, stone, sand etc. are not covered in REACH, emission such as RCS arising from working on stone, and dust arising from woodworking are not covered. However, if a coating has been applied to the wood, that material may be covered under REACH and potential exposure to it will require some consideration during registration under the life-cycle requirement.
In contrast to the REACH and CLP Regulations, the Chemical Agents Directive and the Carcinogen and Mutagen Directive do consider process-generated substances although these are generally considered on a case-by-case basis and so not all such substances are covered. Thus, under the Chemical Agents Directive a chemical agent is defined as ‘any chemical or compound, on its own or admixed, as it occurs in the natural state or as produced, used or released, including as waste, by any work activity, whether or not produced intentionally and whether or not placed on the market’. Employers therefore have a duty to consider materials produced or emitted as process-generated substances in any assessment.
The Carcinogen and Mutagen Directive (CMD) requires employers to eliminate or otherwise minimise exposure of workers to cancer-causing ('carcinogenic') chemicals and elaborates the general requirement in the Framework Directive to eliminate all risks to workers. The CMD establishes certain measures specific to given chemical carcinogens, including identification of 'process-generated' carcinogens (Annex I to the CMD), and limit values over which exposure of workers is not allowed (Annex III). In the period 2017-2019 three directives have been published making amendments to the CMD directive. These amendments have added substances to Annex III of the directive and imposed more stringent limit values. Also annex I has undergone changes and several process-generated carcinogens were added e.g. respirable silica dust. Annex 1 of the directive now (2020) lists 8 process-generated carcinogens:
- Manufacture of auramine.
- Work involving exposure to polycyclic aromatic hydrocarbons present in coal soot, coal tar or coal pitch.
- Work involving exposure to dusts, fumes and sprays produced during the roasting and electro-refining of cupro-nickel mattes.
- Strong acid process in the manufacture of isopropyl alcohol.
- Work involving exposure to hardwood dusts.
- Work involving exposure to respirable silica dust generated by a work process
- Work involving dermal exposure to mineral oils that have been used before in internal combustion engines to lubricate and cool the moving parts within the engine.
- Work involving exposure to diesel engine exhaust emissions.
Prevention and control
As noted above, many industrial processes generate contaminants which can be hazardous to health. These can be generated through combustion, mechanical abrasion (sanding, grinding, sawing) or other processes which physically or chemically degrade the starting material. Process-generated contaminants can sometimes be difficult to identify, and safety data sheets are seldom available to help with the risk assessment process. In addition, the uncertain and variable composition of the emissions makes the risk assessment more complicated.
The general hierarchy of control also applies to process-generated substances. However, substitution may not an option, unless the whole process can be substituted with another process that does not produce any process-generated emissions. The composition of the process-generated substances can however, be modified through changes in the materials used and the process itself. One important example is the change in diesel engine exhaust emissions, where due to the combination of changes in the fuel as well as engine design, the composition of the exhaust fumes has significantly changed over the recent the last decades . Consequently, the hazardous nature of the fume has been reduced, although it is not entirely clear whether this has eliminated any risk from exposure.
- IARC - International Agency for Research of Cancer, Diesel engine exhaust carcinogenic, Press release N° 213, 12 June 2012. Available at: 
- IARC (2012) Monograph: Occupational exposures in the rubber-manufacturing industry. Available at: 
- EU-OSHA - European Agency for Safety and Health at Work, Exposure to biological agents and related health effects in the waste management and wastewater treatment sectors, Available at: 
- IARC - International Agency for Research of Cancer, Monographs on the Evaluation of Carcinogenic Risks to Humans, Volume 62, Wood dust and formaldehyde, 1995. Available at: 
- Health, socio-economic and environmental aspects of possible amendments to the EU Directive on the protection of workers from the risks related to exposure to carcinogens and mutagens at work: Respirable crystalline silica. Available at: 
- Cherrie JW, et al. (2017) Prioritising action on occupational carcinogens in Europe: a socioeconomic and health impact assessment. British Journal of Cancer 1-8 doi: 10.1038/bjc2017.161
- Health, socio-economic and environmental aspects of possible amendments to the EU Directive on the protection of workers from the risks related to exposure to carcinogens and mutagens at work: Diesel engine exhaust emissions. Available at: 
- Health, socio-economic and environmental aspects of possible amendments to the EU Directive on the protection of workers from the risks related to exposure to carcinogens and mutagens at work: Rubber process fumes and dust. Available at: 
- Health, socio-economic and environmental aspects of possible amendments to the EU Directive on the protection of workers from the risks related to exposure to carcinogens and mutagens at work: Mineral oils as used engine oils. Available at: 
- Health, socio-economic and environmental aspects of possible amendments to the EU Directive on the protection of workers from the risks related to exposure to carcinogens and mutagens at work: Hardwood dust. Available at: 
- 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). Available at: 
- Directive 2004/37/EC 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). Available at: 
- IARC (2013) Monograph 105: Diesel and Gasoline Engine Exhausts and Some Nitroarenes. Available at: 
- HEI (2015) Special Report 19: Diesel Emissions and Lung Cancer: An Evaluation of Recent Epidemiological Evidence for Quantitative Risk Assessment. Available at: 
Links for further reading
EU-OSHA - European Agency for Safety and Health at Work, Practical tools and guidance on dangerous substances. Available at: 
EU-OSHA - European Agency for Safety and Health at Work, Dangerous Substances e-tool. Available at: 
EU-OSHA - European Agency for Safety and Health at Work (2010) E-fact 53: Risk assessment for biological agents. Available at 
EU-OSHA - European Agency for Safety and Health at Work, E-fact 53: Risk assessment for biological agents, Available at: 
EU-OSHA - European Agency for Safety and Health at Work, Biological agents and work-related diseases: results of a literature review, expert survey and analysis of monitoring systems, Available at: 
EU-OSHA - European Agency for Safety and Health at Work, Exposure to biological agents and related health problems in animal-related occupations, Available at: 
EU-OSHA - European Agency for Safety and Health at Work, Exposure to biological agents and related health problems in arable farming, Available at: 
EU-OSHA - European Agency for Safety and Health at Work, Exposure to biological agents and related health problems for healthcare workers, Available at: 
EU-OSHA - European Agency for Safety and Health at Work, Exposure to biological agents and related health effects in the waste management and wastewater treatment sectors, Available at: 
EU-OSHA - European Agency for Safety and Health at Work, Biological agents and associated work-related diseases in occupations that involve travelling and contact with travellers, Available at: