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Introduction

Occupational exposure limit values (OELs) are set to prevent occupational diseases or other adverse effects in workers exposed to hazardous chemicals in the workplace. OELs assume that exposed persons are healthy adult workers, although in some cases the OELs should also protect vulnerable groups – e.g. pregnant women or other more susceptible people. They are tools to help employers protect the health of workers who may be exposed to chemicals in the working environment. OELs are usually set for single substances, but sometimes they are also produced for common mixtures in the workplace, for example solvent mixes, oil mists, fumes from welding or diesel exhaust fume.

Basic definitions

Council Directive 80/1107/EEC, as amended by Council Directive 88/642/EEC, on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work, introduced into EU legislation of the objective of establishing occupational exposure limits (OELs)[1]. Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work replaced 80/1107/EEC and defined OEL as the limit of the time-weighted average of the concentration of a chemical agent in the air within the breathing zone of a worker in relation to a specified reference period[2].

This Directive sets out general principles for assessing and preventing risks at work from the use of chemical agents, and includes the legal framework for indicative occupational exposure limit values (IOELVs), binding occupational exposure limit values (BOELVs) and binding biological limit values:

Table 1: Acronyms
Table 1: Acronyms
  • Indicative OELs are health-based limits conventionally established only for substances for which it is possible to establish a threshold or a no effect level considered to be protective of health. To establish OEL, a thorough assessment of the available scientific information is essential as a first step. This was undertaken by the European Commission’s Scientific Committee for Occupational Exposure Limits (SCOEL). These limit values should be established or revised taking into account the availability of measurement techniques. Member States should keep workers' and employers' organisations informed of IOELVs set at a Community level. For any chemical for which an IOELV is established at a Community level, Member States should establish a national occupational exposure limit value, taking into account the Community limit value, determining its nature in accordance with national legislation and practice[2].
  • Binding OELs (BOELVs) may be drawn up at a Community level and, in addition to the factors considered when establishing IOELVs, socio-economic and technical feasibility factors should be taken into account and intend to provide a level of minimum protection for all workers in the Community. For any chemical agent for which a BOELV is established, Member States should establish a corresponding national binding occupational exposure limit value based on, but not exceeding the Community limit value.
  • Biological Limit Values (BLVs) are reference values for the evaluation of potential health risks in the practice of occupational health. They were established by SCOEL on the basis of available scientific data. The BLVs define maximum levels of substances in humans, their metabolite, or indicator of effect e.g. in blood, urine or breath. For many substances, the data are too limited to support a biological monitoring method, or a metabolite or indicator cannot be defined. In general, SCOEL set BLVs for compounds with skin notation as a priority[3][4].
  • Binding biological limit values (BBLVs) may be drawn up at a Community level on the basis of evaluation as described for IOELVs and on the availability of measurement techniques, and should reflect feasibility factors while maintaining the aim of ensuring the health of workers at work. For any chemical agent for which a binding biological limit value is established, Member States should establish a corresponding national binding biological limit value based on, but not exceeding, the Community limit value. The BBLV is established for lead and its ionic compounds[2].
  • Skin notation is used to warn about skin contact where it can add significantly to the body burden, in addition to that caused by inhalation. Skin notation setting is not standardised across countries and agencies. A skin notation assigned to an OEL identifies the possibility of significant uptake through the skin. The SCOEL used all available information as a basis for making an assessment of whether or not the criteria for application of a skin notation were met (direct measurement of percutaneous absorption in humans or animals, comparison of dermal and intravenous or intraperitoneal toxicity, physicochemical data, including volatility, or structure/activity relationships)[3][4].

When selecting candidate priority substances for setting OELs in the EU, the following criteria are taken into account:

  • Epidemiological evidence including reported cases of ill-health in the workplace
  • Availability of toxicological data
  • Severity of effects
  • Number of persons exposed
  • Availability of data on exposure
  • Availability of measurement methods

Before 2019 the process of harmonising exposure limits in EU countries began with the establishment of IOELVs by the Scientific Committee on Occupational Exposure Limits to Chemical Agents (SCOEL), an advisory body of the European Commission. The first stage in the OEL setting process was to assemble all the information available on the hazards of the substance and decide whether this provides an adequate database on which to proceed. The SCOEL prepared a short summary document (SCOEL/SUM) on each compound, and, if the SUM document was agreed upon by the SCOEL members, it was circulated to interested parties for comments. After a comment period of about 6 months, the SCOEL re-discussed the document in light of the received comments. After clarification of the raised questions, the final version was adopted and submitted to the Commission for publication. When the European Commission disposed of a sufficient number of approved SCOEL recommendations, it prepared a draft Commission Directive setting out proposed new IOELVs.

From 2019, the scientific evaluation of the relationship between the health effects of hazardous chemical agents and the level of occupational exposure is conducted by the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA).[5] RAC has taken over the role of SCOEL in giving scientific opinions on OELs for the European Commission. Members of RAC are appointed by ECHA's Management Board based on candidates nominated by the Members States.[6] The initial report of RAC is subject to open consultation and is complemented by ECHA’s scientific report on the subject. This is transmitted to the tripartite Advisory Committee on Safety and Health at Work with an opinion from the Working Party on Chemicals in the Workplace (a subgroup of the Advisory Committee for Safety and Health at Work). The Advisory Committee gives its opinion on the proposal, if necessary establishing its view by means of a vote. If the Advisory Committee has an agreed position in favour of the proposal, binding OELs are processed via the ordinary legislative procedure for adoption by the Council and the European Parliament whereas indicative OELs are published in Commission directives. The Directives are published in the Official Journal of the European Union. Member States then have a fixed timescale (typically 18 months) to implement the Directive in their national legislation[7][3].

OELs are usually expressed as milligram per cubic meter (mg/m3) of air, which can be converted to parts per million (ppm) for gases and vapours, corresponding to cm3 of gases or vapours per m3 of air. At 1 atm and 25 °C, the conversion is 1 ppm = (the molecular weight of the compound) /24.45 mg/m3. OELs for non-volatile airborne particulates (dust, smoke and vapours) are given in mg/m3, except for fibres, where the OELs are often set as a number of fibres per cm3.[7][8] On the national level, the Ministry of Labour is responsible for establishing these values in most EU countries[9].

OELs are usually established for single substances. When two or more harmful substances, which act upon the same target organ, are present, their combined effect, rather than that of either individually, should be taken into account. In the absence of information to the contrary, the effects of the different hazards should be considered as additive.

When there is a good reason to believe that the principal effects of the different harmful substances are, in fact, not additive but independent, as when purely local effects on different organs of the body are produced by the various components of the mixture, then the above rule cannot be applied. In such cases, the occupational exposure limit value for the mixture is exceeded only when at least one member of the series (C1/OELV1 or C2/OELV2 etc.), itself, has a value exceeding unity. The same situation applies for carcinogens and mutagens. Synergistic effects, when substances combine to give a greater effect than expected from simple linear addition, may occur with some combinations of atmospheric contaminants; such cases at present must be determined individually[7].

The European Union to date has only set a limited number of OELs. Many countries have set more limit values, making use of similar criteria and after assessment in national scientific committees and consultation with interested parties.

Health effects of chemicals and OELs

Chemical substances occur in the form of gases, vapours, liquids, dusts or fumes in the working environment. They are absorbed into the body mostly through the respiratory tract and skin or from the gastrointestinal tract. Gases and vapours are absorbed directly by the respiratory tract, depending on the physical activity. Fumes in the liquid phase can be absorbed directly by the lung alveoli (terminal dilations of the air passageways). Biopersistent aerosols (dusts and fumes) are not totally absorbed – some dusts can be eliminated with mucus, coughed up with sputum or swallowed.

The body’s response to chemicals depends on the dose/concentration, the chemicals’ physicochemical properties and absorption route, the health, sex and age of the exposed person and the condition of both the endocrine (hormonal) and immune systems, in addition to external factors such as temperature, exposure period and humidity.

If harmful effects of a substance occur in a relatively short period of time (within 24 hours), it indicates an acute type of exposure. This most often happens with a sudden event, referred to as an ‘accident’ at work. When harmful effects occur after prolonged exposure to low doses or concentrations of substances present in the workplace, it is a chronic type of exposure. Occupational exposure is usually chronic.

Harmful (hazardous, dangerous) substances are the substances that can cause adverse effects, including (sensory) irritation from the airways and the eyes, headache, as well as sedation and narcotic effect depending on the dose (the amount of substance that is ingested, inhaled, or absorbed through the skin). Research methods on the toxicity of chemicals and principles of classification are globally harmonised. The ever growing European list of dangerous substances can be found in the CLP regulation. They fall into at least one of the following categories, according to health effect: highly toxic, toxic, harmful, corrosive irritant, sensitising, carcinogenic, mutagenic, toxic for reproduction[10].

The first stage in the OEL setting process is to assemble all the information available on the hazards of the substance, as well as physicochemical properties. High quality human data (individual case reports, studies in human volunteers, or cohort and case-control studies) are preferred to animal data, but frequently may not be available, and clear dose-response relationships (the change in effect on an organism caused by different doses or concentrations after exposure time) are rarely demonstrated. The second stage is to identify the adverse effects that may arise from exposure to the substance, and then establish which adverse effect is crucial in deriving the level of OEL. From the key study (or studies) describing the critical effect(s) of chemical, the No Observed (Adverse) Effect Level (NO(A)EL) is established. In those cases where it is not possible to establish a NO(A)EL, a Lowest Observed (Adverse) Effect Level (LO(A)EL) may be determined:[4]

The NOAEL (No Observed Adverse Effect Level) is the highest level of a test substance to which organisms can be exposed without causing any observed and statistically significant adverse effects on the organism compared with the controls.

The LOAEL (Lowest Observed Adverse Effect Level) is the lowest level of a test substance, to which organisms can be exposed causing an adverse alteration of morphology, functional capacity, growth, development, or life span of a target organism compared with the control organisms of the same species and strain under defined conditions of exposure.

The NOAEL is the common point of departure in establishing OELs. The OELs are set lower than the experimentally determined NOAEL due to the imprecision of the data and differences in sensitivity between and within species. Additionally, the length of the study, extrapolation from the LOAEL to the NOAE, as well as an incomplete database is taken into account[4].

For the majority of substances, only data from animals are available, and the OEL may be set by dividing the NOAEL by uncertainty factors (UFs, also termed safety factors and assessment factors, AFs). UFs are used in the process of extrapolating animal data to humans, route-to-route extrapolation, differences between species, intraspecies, exposure duration, dose-response and the quality of the whole database[11]. There are large differences between UFs listed in the European Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) to establish DNELs (Derived No-Effect Levels)[12], and others used by the SCOEL to establish OELs[4] or proposed by the European Centre for Ecotoxicology and Toxicology of Chemicals[13] to derive DNELs.

There are two main groups of substances for which NOAEL cannot be identified: respiratory sensitisers acting via immunological mechanisms and genotoxic carcinogens.

The SCOEL took into account available information on groups of people at special risk. However, the variability of response between individuals at the same level of exposure, and the existence of special risk groups, may mean that the recommended OEL may not provide adequate protection for every individual. Depending on the specific chemical database, SCOEL might have not recommended a health-based OEL for certain chemicals. In the workplace, sensitisers may affect the respiratory system (and the conjunctiva) and also the skin. For some substances (for example those causing respiratory sensitisation via non-immunological mechanism) it might be possible to identify a threshold of exposure below which a state of sensitisation is unlikely to be induced. It is considered unlikely that such a threshold could be identified for substances acting via immunological mechanisms. Where sufficient data were not available, the SCOEL could not set a health-based OEL and it recommended only a ‘sensitisation notation’ in the front of documentation. The SCOEL also took the view that it was not possible to set health based OELs which would provide protection against the elicitation of responses among persons who had already become sensitised to particular substances[4].

Some substances show adverse effects on reproduction at exposure levels considerably lower than those causing other forms of toxicity. Because of the relative sensitivity of the rapidly developing individual to specific toxic effects, OELs established to protect adults cannot a priori guarantee the absence of pre- or post-natal adverse effects. Young people, pregnant or lactating women may represent a special risk group in the workplace[14]. According to Council Directive 89/391/EEC[15], Council Directive 92/85/EC[16] on pregnant workers and Council Directive 94/33/EC[17] on young people at work, the SCOEL, when recommending OELs, consider reproductive effects along with all other aspects of toxicity and recommending OEL is sufficiently low to protect workers against such adverse effects[4].

Occupational exposure limits for carcinogenic compounds

Exposure to some chemicals can cause uncontrolled growth of cells leading to cancer. For most carcinogenic substances, an effect threshold cannot be determined. For a long time, occupational exposure limits for non-genotoxic carcinogens have been established, but it is extremely difficult to derive a safe level of exposure to a genotoxic carcinogen (genotoxic substances – substances that damage genetic material).

For carcinogenic substances in many countries, exposure limits are not established because it is not possible to determine safe exposure levels. Instead of proposing an exposure limit, a quantitative risk assessment may be carried out. Different government agencies and national or international organisations active in establishing or proposing admissible exposure levels for carcinogenic substances use the concept of so-called acceptable risk. The level of acceptable risk depends on commonly accepted social and economic criteria. In this respect, the decision is usually taken by three interest groups comprised of employee representatives, employers and state administrators, whose task is to perform law enforcement surveillance. A few Member States (e.g. Germany, the Netherlands, Poland) are reported to apply criteria on acceptability of risk[18][1].

Determination of IOELVs (indicative occupational exposure limit values) for carcinogenic substances by the European Scientific Committee on Occupational Exposure Limits (SCOEL) depends on the type and mechanism of their carcinogenic effect, that is, on whether or not the substance produces genotoxic effects. Thus, SCOEL has divided carcinogenic substances into the following groups:

  • Group A – non-threshold genotoxic carcinogens: Risk assessment involves a linear non-threshold (LNT) model of extrapolation of test results from animals (high doses) to humans (low doses); e.g. 1,3-butadiene, vinyl chloride and dimethyl sulfate.
  • Group B – genotoxic carcinogens: The existing data are not sufficient to apply the LNT model; e.g. acrylonitrile, benzene, naphthalene and wood dusts.
  • Group C – genotoxic carcinogens: A practical threshold can be set based on existing data; e.g. formaldehyde, vinyl acetate, nitrobenzene, pyridine, crystalline silica and lead.
  • Group D – non-genotoxic and non DNA-reactive carcinogens: A threshold can be set based on NOAEL; e.g. example, carbon tetrachloride and chloroform.

Health-based OELs were derived by the Scientific Committee on Occupational Exposure Limits only for carcinogens of groups C and D[2][4].

From 2017 a series of binding limit values were drawn for many carcinogen substances based on the relevant scientific expertise from SCOEL and the RAC, and the opinions of the Advisory Committee on Safety and Health at Work (ACSH) and the monographs of the IARC.

Where possible, a health risk assessment for regulating carcinogens should be based on epidemiological studies. However, this approach is only possible for a limited number of compounds, and risk assessment has to be based on animal studies in most instances. In this case, several points of departure are used in risk assessments in combination with various extrapolation models[7].

Short term exposure limits (STEL) and ceiling (STEL-C)

Some substances have set short term exposure limits (STELs). STEL is the concentration that workers can be exposed to continuously for a short period of time without risking acute effects, such as throat irritation, that will not be controlled by the application of an 8-hour OEL. In these cases, one substance has two limit values. In addition to the ‘normal’ 8-hour OEL, there is a STEL. These exposure limits are often set for 15 minutes and referred to as Short-Term Exposure Limits – 15 minutes. Some countries have also limited the frequency of peaks to a maximum of 4 peaks/day with a minimal interval of 1 hour. Short term exposure limits are intended for use in normal work situations. They must not be used to protect against emergency situations. The European Scientific Committee on Occupational Exposure Limits has established STELs for substances, usually related to 15 minutes, based on a case-by-case review of available data[4].

For other substances, peak concentrations are determined, where this level should not be exceeded during any time of the workday. A ceiling limit may be set without setting an OEL. Ceiling exposure limits are used for substances, for which short-term peaks of exposure could result in serious health effects – for example, respiratory irritants such as chlorine. For those substances, continuous, direct-reading or short-term instantaneous measurements should be available. If such monitoring is not feasible, sampling should be conducted for the minimum period of time sufficient to detect exposure at or above ceiling value[1].

Legislative aspects

The European Union has established a legal basis for setting OELs and Biological Limit Values for chemicals with a threshold effect. The OELs are termed Indicative Occupational Exposure Limit Values (IOELV), and they were established by the SCOEL (Scientific Committee on Occupational Exposure Limits), and later also by the RAC. IOELVs are health-based, non-binding values established on the basis of the latest data and with the use of available measuring techniques. They determine threshold exposure levels below which exposure is not expected to lead to adverse effects. IOELVs are necessary for determination and assessment of risk incurred by the employer in accordance with Art. 4 of 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)[2]. They have to be considered by the Member States when establishing their own national OELs.

The indicative occupational exposure limit values are published in five directives:

  • Commission Directive 91/322/EEC 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[20]
  • Commission Directive 2000/39/EC 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[21]
  • Commission Directive 2006/15/EC 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[22]
  • Commission Directive 2009/161/EU 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[23]
  • Commission Directive (EU) 2019/1831 of 24 October 2019 establishing a fifth list of indicative occupational exposure limit values pursuant to Council Directive 98/24/EC and amending Commission Directive 2000/39/EC[24]

For some non-threshold carcinogenic substances for which indicative occupational exposure limit values (IOELVs) cannot be set, Binding Occupational Exposure Limit Values – BOELVs have been adopted. They are established on the basis of currently available scientific data, socio-economic criteria and technical possibilities to achieve these values in the industry. The first binding values have been set for the following substances: asbestos (actinolite, anthophyllite, chrysotile, grunerite, crocidolite, tremolite), benzene, hardwood dusts, lead and its inorganic compounds, vinyl chloride monomer[2][25][26]. Later directives set stricter limit values, added skin notations and set limit values for Chromium (VI) compounds, Refractory ceramic fibres, Respirable crystalline silica dust, Ethylene oxide, 1,2-Epoxypropane, Acrylamide, 2-Nitropropane, o-Toluidine, 1,3-Butadiene, Hydrazine, Bromoethylene, Trichloroethylene, 4,4′-Methylenedianiline, Epichlorohydrine, Ethylene dibromide, Ethylene dichloride, Diesel engine exhaust emissions, Polycyclic aromatic hydrocarbons mixtures (particularly those containing benzo[a]pyrene, which are carcinogens within the meaning of the Directive), Mineral oils that have been used before in internal combustion engines to lubricate and cool the moving parts within the engine, Cadmium and its inorganic compounds, Beryllium and inorganic beryllium compounds, Arsenic acid and its salts, as well as inorganic arsenic compounds, Formaldehyde, and 4,4′-Methylene-bis (2-chloroaniline) – MOCA.

A report on the role of OELs in the health and safety systems of 14 EU Member States found broadly comparable structures and systems for setting OELs in all member states and identified a variety of strategies undertaken in different countries to improve managing risks of working with hazardous chemicals. It was invariably made clear that OELs were not regarded as safe limits and they were frequently accompanied by recommendations to reduce exposures to as low as is possible below the limit. It was also noted that "Generally regulatory inspectorates rarely engage in proactive acts of monitoring compliance with specific OELs themselves. However, where there is concern over workplace airborne pollution that may be approaching or exceeding limits, there are requirements in some countries to inform and involve the regulatory agencies in monitoring. It is not clear how much this happens in practice"[27].

Relations between occupational exposure limits and derived no effect levels

Within the frame of the Community regulation on chemicals and their safe use (REACH), DNELs (Derived No Effect Levels) have been introduced in Europe. These represent levels of exposure above which humans (inclusive of consumers, workers, etc.) should not be exposed. Manufacturers and importers are required to calculate DNELs as part of their chemical safety assessment (CSA) for any chemicals used in quantities of 10 tonnes or more per year[28][1].

The DNEL is used in the risk characterisation part of the chemical safety assessment as a benchmark to determine adequate control for specified exposure scenarios. DNELs reflect the likely routes and duration and frequency of exposure. If more than one route of exposure is likely to occur (oral, dermal or inhalation), then a DNEL must be established for acute and repeated exposure, for each route of exposure and for the exposure from all routes combined. It may also be necessary to identify different DNELs for each relevant human population (e.g. workers, consumers or humans subject to exposure indirectly via the ambient environment), and possibly for certain vulnerable sub-populations (e.g. children, pregnant women)[2].

The starting point in establishing DNELs is a ‘No Observed Adverse Effect Level’ (NOAEL) or a ‘Lowest Observed Adverse Effect Level’ (LOAEL) from human data or animal studies[30]. The next step in the calculation of a DNEL is to address assessment factors extrapolating from experimental data to a real human exposure situation. This may result in a very conservative figure, perhaps two or three orders of magnitude lower than that from the traditional OEL setting process[13]. When an EU IOELV has been set, this may be applied as a DNEL for workers. Where an EU Binding Exposure Limit Value (BOELV) has been set taking into account socio-economic factors and technical feasibility, this cannot be used as a DNEL. Where a health-based national OEL has been set, the toxicological information used must be evaluated, and any differences to the REACH calculation must be taken into account[13].

The REACH regulation lays down general provisions for assessing substances and preparing chemical safety reports. For substances for which is not possible to determine a DNEL, a qualitative assessment should be carried out. In order to make this concept more precise, ECHA has developed the concept of Derived Minimal Effect Levels (DMEL) within the guidance document “Characterisation of dose [concentration]-response for human health". A DMEL is a reference risk level considered to be of very low concern for a certain exposure scenario. It is not a level where no potential effects can be foreseen, it rather expresses an exposure level corresponding to a low, possibly theoretical risk. The starting point for DMEL derivation is the dose descriptor for the most critical effect. For non-threshold effects, the dose descriptor is usually derived from cohort or case-control studies reporting Relative Risks (RR) or comparable measures to describe a dose-response association. The RR is the ratio between the risk of the health effect in the exposed divided by the risk in the unexposed population. The next step in the derivation of a DMEL is to address variability and uncertainty in the differences between the population in the source data and the target population (i.e. the actual whole human population or those potentially exposed to the substance). The DMEL concept is still under debate[31].

In the beginning, safety margins in REACH were found to be many time higher than the ones derived from SCOEL documentation, which discrepancy caused substantial confusion among employers and workers[32]. The topic was discussed at a meeting organised by the European Commission in 2014[33]. The ECHA/RAC – SCOEL joint task force targeted the issue and from 2019 RAC started providing recommendations for occupational exposure limits[34].

Conclusions

Recent developments in European limit values can help preventing many deaths and ill-health among workers. However, values should be considered as starting points (and not final goal): everyone should constantly strive for minimising workplace exposure[35].

 

References

[1] Council Directive of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (80/1107/EEC). Consolidated text. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A01980L1107-19950101

[2] 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, Official Journal of the European Communities L 131 of 5 May1998. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:131:0011:0023:EN:PDF

[3] SCOEL – Scientific Committee on Occupational Exposure Limits, Further information about SCOEL's involvement in setting Occupational Exposure Limits, 2009. Available at: http://ec.europa.eu/social/main.jsp?catId=153&langId=en&internal_pagesId=684&moreDocuments=yes&tableName=INTERNAL_PAGES

[4] SCOEL – Scientific Committee on Occupational Exposure Limits, Methodology for the Derivation of Occupational Exposure Limits: Key Documentation (version 6), European Commission Directorate-General for Employment, Industrial Relations and Social Affairs, 2010. Available at: http://ec.europa.eu/social/main.jsp?catId=153&langId=en&internal_pagesId=684&moreDocuments=yes&tableName=INTERNAL_PAGES

[5] Health and safety at work - Scientific Committee on Occupational Exposure Limits. Directorate-General for Employment, social affairs and inclusion. Retrived 13/01/2021 from: https://ec.europa.eu/social/main.jsp?catId=148&langId=en&intPageId=684

[6] ECHA. Committee for Risk Assessment. Available at: https://echa.europa.eu/about-us/who-we-are/committee-for-risk-assessment

[7] Nielsen, G. D., Øvrebø, S., ‘Background, approaches and recent trends for setting health-based occupational exposure limits: A mini review’, Regulatory Toxicology and Pharmacology, 51, 2008, pp. 253–269.

[8] ECHA. OEL Process. Available at: https://echa.europa.eu/oel-process

[9] Pośniak, M., Skowroń, J., ‘Harmful chemical agents in the working environment’, Edited by Danuta Koradecka, Handbook of Occupational Safety and Health, Series Editor Gavriel Salvendy, CRC Press Taylor & Francis Group, Boca Raton, 2010, pp. 103-137.

[10] Regulation (EC) No 1272/2008 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, Official Journal of the European Union L 353/1 of 31 December 2008. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:EN:PDF

[11] ECHA – European Chemicals Agency, Guidance on information requirements and chemical safety assessment Part B: Hazard Assessment, 2008, pp. 33-40. Available at: https://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment

[12] ECHA – European Chemicals Agency, Guidance on information requirements and chemical safety assessment Part B: Hazard Assessment, 2008, pp. 33-40. Available at: https://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment 

[13] ECETOC – European Centre for Ecotoxicology and Toxicology of Chemicals, Guidance on Assessment Factors to Derive a DNEL, Technical Report No 100, 2010. Available at: http://www.ecetoc.org/publications

[14] EU-OSHA – European Agency for Safety and Health at Work, OSH in figures: Young workers - Facts and figures. 2007. Available at: http://osha.europa.eu/en/publications/reports/7606507 

[15] Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work. Available at: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&numdoc=31989L0391&model=guichett&lg=en

[16] Council Directive 92/85/EEC of 19 October 1992 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding (tenth individual Directive within the meaning of Article 16 (10 of Directive 89/39/EEC)).Available at: https://osha.europa.eu/en/legislation/directives/sector-specific-and-worker-related-provisions/osh-directives/10

[17] Council Directive 94/33/EC of 22 June 1994 on the protection of young people at work. OJ L 48, 19.2.1997, p. 3. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31994L0033:en:HTML

[18] EU-OSHA – European Agency for Safety and Health at Work, Exploratory survey of occupational exposure limits for carcinogens, mutagens and reprotoxic substances at EU Member States level, 2009. Available at: http://osha.europa.eu/en/publications/reports/548OELs/view

[19] Bolt, H. M., Huici-Montagud, A., ‘Strategy of the Scientific Committee on Occupational Exposure Limits (SCOEL) in the derivation of occupational exposure limits for carcinogens and mutagens’, Arch Toxicol., 82, 2008, pp. 61-64.

[20] Commission Directive 91/322/EEC 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. OJ L 177, 5.7.1991, p. 22. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31991L0322:EN:HTML

[21] Commission Directive 2000/39/EC 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. OJ L 142, 16.6.2000, p. 432. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:142:0047:0050:EN:PDF

[22] Commission Directive 2006/15/EC 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, OJ L 38, 9.2.2006, pp. 36-39. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:038:0036:0039:EN:PDF

[23] Commission Directive 2009/161/EU 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. OJ L 338, 19.12.2009, pp. 87-89. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:338:0087:0089:EN:PDF

[24] Commission Directive (EU) 2019/1831 of 24 October 2019 establishing a fifth list of indicative occupational exposure limit values pursuant to Council Directive 98/24/EC and amending Commission Directive 2000/39/EC. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019L1831

[25] Directive 2003/18/EC of the European Parliament and of the Council of 27 March 2003 amending Council Directive 83/477/EEC on the protection of workers from the risks related to exposure to asbestos at work, OJ L 97, 15.4.2003, p. 48. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:097:0048:0052:EN:PDF

[26] Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (codified version), Official Journal of the European Union L 158 of 30 April 2004. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:229:0023:0034:EN:PDF

[27] HSE (2003) The role of occupational exposure limits in the health and safety systems of EU Member States. RR172. Available at: http://www.hse.gov.uk/research/rrpdf/rr172.pdf

[28] 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, OJ L 396, 30 December 2006. Available at:http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907:en:NOT

[29] Workshop of the Federal Ministry of Labour and Social Affairs on 6 December 2010 in Berlin on the issue “How to use REACH information for Health and safety at work". Available at: http://www.bmas.de/portal/49768/2010__12__08__reach.html 

[30] ECHA – European Chemicals Agency, DNEL/DMEL Derivation from Human Data, draft, rev. 2.1., 2010. Available at http://guidance.echa.europa.eu/docs/draft_documents/R8_DNEL_HD_Draft_Rev2.1_final_clean.pdf

[31] Workshop “DMEL and risks in occupational exposure to carcinogenic compounds", 17.05.2011, Dortmund. Available at: http://www.baua.de/en/Topics-from-A-to-Z/Hazardous-Substances/Workshops/DMEL-2011/DMEL-2011.html

[32] Schenk L, Johanson G. A quantitative comparison of the safety margins in the European indicative occupational exposure limits and the derived no-effect levels for workers under REACH. Toxicol Sci. 2011 Jun;121(2):408-16. doi: [[10.1093/toxsci/kfr056]]. Epub 2011 Mar 9.

[33] EC Internal Market, Industry, Entrepreneurship and SMEs. Commission Workshop on "Managing risks related to chemicals: REACH and Occupational Safety and Health (OSH) Legislation." Available at: https://ec.europa.eu/growth/content/commission-workshop-managing-risks-related-chemicals-reach-and-occupational-safety-and-0

[34] ECHA. New guidance on occupational exposure limits. Available at: https://echa.europa.eu/-/new-guidance-on-occupational-exposure-limi-1

[35] Cherrie JW. Binding occupational exposure limits for carcinogens in the EU - necessary but not sufficient to reduce risk. Scand J Work Environ Health. 2019;45(4):423‐424. Available at: https://www.sjweh.fi/show_abstract.php?abstract_id=3836

Further reading

Bolt, H. M., Foth, H., Hengstler, J. G. & Degen, G.H., ‘Carcinogenicity categorization of chemicals – new aspects to be considered in a European perspective’, Toxicol. Lett., 151, 2004, pp. 29–41.

European Scientific Committee on Occupational Exposure Limits: http://en.wikipedia.org/wiki/Scientific_Committee_on_Occupational_Exposure_Limit_Values

GESTIS International Limit Values for Chemical Agents: http://www.dguv.de/ifa/en/gestis/limit_values/index.jsp

Special Issue of the Journal of Occupational and Environmental Hygiene: State of the Science of Occupational Exposure Limit Methods and Guidance (open access): http://www.tandfonline.com/toc/uoeh20/12/sup1

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