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We investigated the level of protection of reproductive and developmental toxicity offered through occupational exposure limits (OELs) and Derived No-Effect Levels for workers' inhalation exposure (wDNELs). We compared coverage of substances that have a harmonised classification as reproductive toxicant 1 A or 1B (Repr.1 A/B), numerical values and scientific basis of 12 lists of OELs and wDNELs from REACH Registrants' and the Committee for Risk Assessment. Across the 14 sources of OELs and wDNELs, 53 % of the Repr1A/B-substances had at least one exposure limit (counting groups of metals as one entry). Registrants' wDNELs covered the largest share, 40 %. The numerical values could be highly variable for the same substance across the lists. How often reproductive toxicity is identified as the critical effect varies between the examined lists, both due to different assessments of the same substance and different substance coverage. Reviewing the margin of safety to reproductive toxicity cited in the documents, we found that 15 % of safety margins were lower to reproductive toxicity than the critical effect. To conclude, neither the REACH nor work environment legislation supply wDNELs or OELs for a substantial share of known reproductive toxicants. EU OELs cover among the fewest substances in the range, and in many cases national OELs or wDNELs are set at more conservative levels., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Linda Schenk, Piia Taxell Pasi Huuskonen, Mimmi Leite, Inese Martinsone, Karl-Christian Nordby, Linda Paegle, and Loreta Strumylaite report financial support was provided by European Commission. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: Hexavalent chromium (Cr(VI)) is classified as a human carcinogen. Occupational Cr(VI) exposure can occur during different work processes, but the current exposure to Cr(VI) at Swedish workplaces is unknown., Methods: This cross-sectional study (SafeChrom) recruited non-smoking men and women from 14 companies with potential Cr(VI) exposure (n = 113) and controls from 6 companies without Cr(VI) exposure (n = 72). Inhalable Cr(VI) was measured by personal air sampling (outside of respiratory protection) in exposed workers. Total Cr was measured in urine (pre- and post-shift, density-adjusted) and red blood cells (RBC) (reflecting Cr(VI)) in exposed workers and controls. The Bayesian tool Expostats was used to assess risk and evaluate occupational exposure limit (OEL) compliance., Results: The exposed workers performed processing of metal products, steel production, welding, plating, and various chemical processes. The geometric mean concentration of inhalable Cr(VI) in exposed workers was 0.15 μg/m 3 (95% confidence interval: 0.11-0.21). Eight of the 113 exposed workers (7%) exceeded the Swedish OEL of 5 μg/m 3 , and the Bayesian analysis estimated the share of OEL exceedances up to 19.6% for stainless steel welders. Median post-shift urinary (0.60 μg/L, 5th-95th percentile 0.10-3.20) and RBC concentrations (0.73 μg/L, 0.51-2.33) of Cr were significantly higher in the exposed group compared with the controls (urinary 0.10 μg/L, 0.06-0.56 and RBC 0.53 μg/L, 0.42-0.72). Inhalable Cr(VI) correlated with urinary Cr (r S  = 0.64) and RBC-Cr (r S  = 0.53). Workers within steel production showed the highest concentrations of inhalable, urinary and RBC Cr. Workers with inferred non-acceptable local exhaustion ventilation showed significantly higher inhalable Cr(VI), urinary and RBC Cr concentrations compared with those with inferred acceptable ventilation. Furthermore, workers with inferred correct use of respiratory protection were exposed to significantly higher concentrations of Cr(VI) in air and had higher levels of Cr in urine and RBC than those assessed with incorrect or no use. Based on the Swedish job-exposure-matrix, approximately 17 900 workers were estimated to be occupationally exposed to Cr(VI) today., Conclusions: Our study demonstrates that some workers in Sweden are exposed to high levels of the non-threshold carcinogen Cr(VI). Employers and workers seem aware of Cr(VI) exposure, but more efficient exposure control strategies are required. National strategies aligned with the European strategies are needed in order to eliminate this cause of occupational cancer., Competing Interests: Declaration of Competing interest The authors declare no conflicts of interest., (Copyright © 2023 The Authors. Published by Elsevier GmbH.. All rights reserved.)

Using data from the Swedish Products Register, hosted by the Swedish Chemicals Agency (KemI), national occupational injury and disease statistics, and call records from the Swedish Poisons Information Centre (PIC) we characterize health hazards of marketed cleaning products and recorded injuries, disease, and incidents linked to cleaning or disinfection agents. The results show that cleaning agents pose many kinds of health hazards, although corrosion and irritation hazards dominate, in particular for the eyes (54% of all included products). Few products were recognized as inhalation hazards. The nature of the health hazards is reflected in the occupational disease and injury statistics and PIC records for eyes and skin but not for the respiratory tract. Among occupational disease cases attributed to cleaning or disinfection agents, 61% concern skin and 26% the respiratory tract. Among occupational injury cases 64% concern chemical burns. However, only a small part (<0.5%) of all reported diseases and injuries were explicitly attributed to cleaning or disinfection agents. On average, there were 11 cases of disease attributed to cleaning or disinfection agents per million workers and year. For occupational injuries the corresponding number was 8. The data concern a broad range of sectors and occupations, but notable sectors were healthcare, accommodation and food service, and manufacturing. Women were more likely to suffer from disease, men and women equally likely to suffer from injury. PIC cases were evenly distributed between men and women, but the clear risk cases more frequently involved men. Occupational diseases increased many-fold in 2020 while injuries decreased, which could be due to COVID-19 changing use patterns of cleaning and disinfection agents at work. We conclude that cleaning agents pose a variety of risks to a large part of the workforce, although particular attention for preventive efforts may need to be directed to the healthcare, accommodation and food service, and manufacturing sectors., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.)

Our aim was to evaluate policies and procedures for management of conflict of interest (CoI) and other sources of bias, implemented in Occupational Exposure Limit (OEL) expert groups. First, we compiled procedural criteria applicable to OEL-setting, based on literature on CoI and systematic reviews. Second, we identified 58 global OEL-sources and sought the underlying expert groups and operating procedures. We identified eleven active groups, of which five have documented CoI policies. In all five, CoI management is based on declarations of interests (DoIs) and removal of experts from decisions in which they have an interest. Notable differences include publication of DoIs (three of five groups), limitation of DoI to current interests (two groups), quantitative limits for financial interests (none specified to ≥€10,000 per interest), control procedures for undisclosed CoI (one group), and procedures in case of discovery of undisclosed CoI (three groups). Methods to evaluate study quality are described by three groups, while reproducible and comprehensive strategies to identify and select data receive less attention. We conclude that procedures to manage CoI and bias are not broadly implemented, or at least not openly and transparently communicated. This lack of visible procedures is remarkable, considering OEL's impact on health and economy., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Lead exposure is still a major concern for occupations that regularly train or work with firearms, such as law enforcement and military personnel. Due to the increasing number of women of fertile age in such professions, there is a strong incentive to monitor lead exposures during firearms training. Personal air sampling was performed during two sessions of a nine-day urban combat training (UCT) course for cadets in the Swedish Armed Forces, one session employing leaded ammunition (leaded scenario) and one session employing unleaded ammunition (unleaded scenario). Blood lead levels (BLLs) were measured before and after the course for 42 cadets and five instructors. During the leaded scenario, the instructors' airborne exposure (geometric mean, GM, 72.0 μg/m 3 ) was higher than that of cadets (GM 42.9 μg/m 3 ). During the unleaded scenario, airborne concentrations were similar for instructors and cadets and considerably lower than during the leaded scenario (GM 2.9 μg/m 3 ). Despite comparably low external lead exposures during the course, we saw a statistically significant increase in systemic exposure for cadets (BLL GM increased from 1.09 to 1.71 μg/dL, p < 0.001). For the five instructors, notable differences were seen depending on task. The largest increase was seen for the two instructors performing close supervision during the leaded scenario (BLL GM increased from 2.41 μg/dL to 4.83 μg/dL). For the remaining three instructors the BLLs were unchanged (BLL GMs were 1.25 μg/dL before the course and 1.26 μg/dL after). None of the participants exceeded the applicable biological exposure limits, but extrapolating our findings shows that instructors in the leaded scenario may reach levels around 10 μg/dL after a year of repeated exposures. We conclude that comparably low airborne concentrations can contribute to the body burden of lead and that additional measures to reduce exposure are warranted, particularly for instructors., (Copyright © 2021 The Authors. Published by Elsevier GmbH.. All rights reserved.)

At the 8th conference of Occupational and Environmental Exposure of the Skin to Chemicals (OEESC) (16-18 September 2019) in Dublin, Ireland, several researchers performing skin permeation assays convened to discuss in vitro skin permeability experiments. We, along with other colleagues, all of us hands-on skin permeation researchers, present here the results from our discussions on the available OECD guidelines. The discussions were especially focused on three OECD skin absorption documents, including a recent revision of one: i) OECD Guidance Document 28 (GD28) for the conduct of skin absorption studies (OECD, 2004), ii) Test Guideline 428 (TGD428) for measuring skin absorption of chemical in vitro (OECD, 2004), and iii) OECD Guidance Notes 156 (GN156) on dermal absorption issued in 2011 (OECD, 2011). GN156 (OECD, 2019) is currently under review but not finalized. A mutual concern was that these guidance documents do not comprehensively address methodological issues or the performance of the test, which might be partially due to the years needed to finalize and update OECD documents with new skin research evidence. Here, we summarize the numerous factors that can influence skin permeation and its measurement, and where guidance on several of these are omitted and often not discussed in published articles. We propose several improvements of these guidelines, which would contribute in harmonizing future in vitro skin permeation experiments., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: Setting and implementing occupational exposure limits (OELs) is one of the measures taken to protect workers from adverse effects of hazardous chemicals. The EU Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) introduced an additional kind of exposure guidance values for workers; namely, the derived no effect level (DNEL) for workers' inhalation exposure (worker DNEL). About 500 substances have a Swedish OEL, while roughly 5000 substances have a worker DNEL derived by REACH registrants. This work aims to investigate how the Swedish OELs and worker DNELs are perceived at Swedish workplaces, and whether worker DNELs are considered a possible alternative to OELs when the latter are lacking., Material and Methods: An online questionnaire was designed and sent to Swedish companies identified through the European Chemicals Agency's database of registered substances (N = 126) and the Swedish Chemicals Agency's registry of companies that import or manufacture notifiable chemical products (N = 227). The response rates were 52% and 38%, respectively., Results: The respondents stated that they were using the Swedish OELs and most of them considered these to be a suitable risk management tool. As about one-third of the respondents expressed that they had some experience in using substances without the Swedish OELs, there are certain data gaps that worker DNELs may fill. One-third of the respondents familiar with worker DNELs stated that they would consider using worker DNELs for substances without the Swedish OELs. However, nearly half of the respondents reported to be unfamiliar with worker DNELs., Conclusions: Poor familiarity with DNELs may pose an obstacle to properly recognizing DNELs' potential as well as the possible limitations of individual DNELs. There is a need for education about DNELs, as well as for tools facilitating the evaluation of DNELs and OELs from other sources in cases where the applicable Swedish OEL is lacking. Int J Occup Med Environ Health. 2020;33(5):611-20., (This work is available in Open Access model and licensed under a CC BY-NC 3.0 PL license.)

The Netherlands' system for occupational exposure limits (OELs) encompasses two kinds of OELs: public and private. Public OELs are set by the government. Private OELs are derived by industry and cover all substances without a public OEL. In parallel, the regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) has introduced an exposure guidance value similar to the OEL, namely the Derived No-Effect Level (DNEL) for workers' inhalation exposure. This study aimed to investigate issues encountered by occupational health professionals regarding private OELs, and how they perceive the DNELs for workers in relation to private OELs. Towards this aim, we sent out a web-based questionnaire to the members of the Dutch professional organization for occupational hygienists (Nederlandse Vereniging voor Arbeidshygiëne [NVVA], n = 513) and to members of the Dutch professional organization for safety engineers (NVVK, n = 2916). Response rates were 27% (n = 139) and 7% (n = 198), respectively. More occupational hygienists (59%) than safety engineers (17%) reported to derive private OELs themselves. Our respondents reported several challenges with the derivation of private OELs. Fifty-one percent of the occupational hygienists and 20% of the safety engineers stated to see a role of REACH Registrants' worker DNELs as private OELs. However, more than half of our respondents were undecided or unfamiliar with worker DNELs. In addition, stated opinions on where worker DNELs fit in the hierarchy of private OELs varied considerably. To conclude, both these professional groups derive private OELs and stated that they need more guidance for this. Furthermore, there is a lack of clarity whether worker DNELs may qualify as private OELs, and where they would fit in the hierarchy of private OELs., (© The Author(s) 2019. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.)

Derived no-effect levels for workers (wDNELs) under the European REACH legislation have many aspects in common with occupational exposure limits (OELs). In an attempt to examine under which circumstances wDNELs might be used as exposure guidance outside their intended application, we compared derivation methods, coverage of substances and numerical values of wDNELs against two regulatory OEL lists (European Commission and Sweden) and three sets of recommendations (European SCOEL, German MAK and US ACGIH). Finally, we looked closer at wDNELs where SCOEL concluded that data were insufficient to derive an OEL. Major differences between wDNELs and OELs include regulatory background, intended use, actors involved, substance selection criteria, transparency and procedure of derivation, and operationalisation in terms of risk management measures. As of summer 2018, approximately five times more substances were covered by wDNELs than by the five sets of OELs examined herein. Meanwhile, many occupationally relevant pollutants were not covered by wDNELs, e.g. one-third of Swedish OELs lack corresponding wDNELs. We also note that wDNELs and OELs for the same substance may vary considerably, up to several orders of magnitude. In conclusion, with extensive substance coverage, wDNELs extend the landscape beyond the OELs. That said, important limitations are (1) that many air pollutants relevant for workers' health are not covered by REACH, and (2) concerns for inconsistencies in the derivation of wDNELs and in their level of protection. In particular, that route-to-route extrapolation is a common practice that may be grossly misleading when the effect of concern is local, e.g. sensitisation.

Decision on the safety margin, for instance by using uncertainty factors (UFs), is a key aspect in setting Occupational Exposure Limits (OELs). We analyzed the UFs in 128 OEL recommendations from the European Commission's Scientific Committee on Occupational Exposure Limits (SCOEL). We investigated factors expected to potentially influence the UFs, as well as a selection of factors that might influence how expert groups perceive quality or reliability of key studies. We extracted UFs explicitly stated in the recommendations (EUFs) and, when EUFs were missing, calculated an implicit safety margin (ISM) by dividing the point of departure (PoD) by the OEL. EUFs and ISMs were lower for recommendations based on human data than those based on animal data. EUFs and ISMs were also lower for No-Observed Adverse Effect Concentrations (NOAECs) than Lowest Observed Adverse Effect Concentrations (LOAECs). We saw no differences based on local vs systemic critical effects. Acute data resulted in lower EUFs and ISMs than subchronic. We saw no influence from status of key study (publication status, performer or funder), but high tonnage substances (1,000,000+ tonnes) have lower EUFs and ISMs than substances currently not registered under REACH. Although SCOEL methodology stated that UF should be documented, only 65 out of 128 OEL recommendations included an EUF. Indeed, the ratio of EUFs to ISMs even decreased from 1991-2003 to 2004-2017. Additionally, EUFs were, on average, 1.8 times higher than ISMs. We conclude that a more articulate framework for using UFs could enhance consistency and transparency of the SCOEL recommendations.

Records of injuries and incidents provide an important basis for injury prevention related to hazardous substances at the workplace. The present study aimed to review available data on injuries and incidents involving hazardous substances and investigate how data from the Poisons Information Centre could complement the records of the Swedish Work Environment Authority. We found two major obstacles for using injury/incident data based on employers' mandatory reporting. First, it was not possible to quickly and reliably identify injuries caused by hazardous substances, and second, data identifying substances or products are not systematically included. For two out of five investigated injuries with lost working days likely due to chemical injuries, we could not identify substances and/or products involved. The records based on calls to the Poisons Information Centre allow better understanding of chemical hazards and products. Besides the large share of unidentified chemical hazards in the injury statistics, the most striking difference was found for cleaning agents. Cleaning agents were implicated in one-third of the occupational cases that the consulting Poisons Information Centre expert judged to pose a major risk and in need of immediate healthcare. Only one in 10 injuries with lost days reported by employers was related to this type of product. The identification of exposures and symptoms by the Poisons Information Centre allow recognition of chemicals with problematic occupational uses. Hence, these records may serve as an important complement to official injury statistics related to incidents with hazardous substances at work.

Asthma, a chronic respiratory disease, can be aggravated by exposure to certain chemical irritants. The objectives were first to investigate the extent to which experimental observations on asthmatic subjects are taken into consideration in connection with the registration process under the EU REACH regulation, and second, to determine whether asthmatics are provided adequate protection by the derived no-effect levels (DNELs) for acute inhalation exposure. We identified substances for which experimental data on the pulmonary functions of asthmatics exposed to chemicals under controlled conditions are available. The effect concentrations were then compared with DNELs and other guideline and limit values. As of April 2015, only 2.6% of 269 classified irritants had available experimental data on asthmatics. Fourteen of the 22 identified substances with available data were fully registered under REACH and we retrieved 114 reliable studies related to these. Sixty-three of these studies, involving nine of the 14 substances, were cited by the REACH registrants. However, only 17 of the 114 studies, involving four substances, were regarded as key studies. Furthermore, many of the DNELs for acute inhalation were higher than estimated effect levels for asthmatics, i.e., lowest observed adverse effect concentrations or no-observed adverse effect concentrations, indicating low or no safety margin. We conclude that REACH registrants tend to disregard findings on asthmatics when deriving these DNELs. In addition, we found examples of DNELs, particularly among those derived for workers, which likely do not provide adequate protection for asthmatics. Copyright © 2016 The Authors Journal of Applied Toxicology Published by John Wiley & Sons Ltd., (Copyright © 2016 The Authors Journal of Applied Toxicology Published by John Wiley & Sons Ltd.)

In 2007, the Dutch Working Conditions Act was revised with the goal to decrease the regulatory burden, and to open up for company-specific solutions of establishing a safe and healthy work environment. One tool geared towards company-specific solutions is the compilation of the Arbocatalogs, which are company or sector-level collections of safe working methods and guidelines developed both by employers and employees. The revision also introduced a new occupational exposure limit (OEL) system in the Netherlands. This system encompasses two kinds of OELs: private and public. Private OELs are to be derived by the industry, while public OELs are issued by the Ministry of Social Affairs and Employment. With this change, the majority of the previously set Dutch OELs were removed, as the substances in question now are falling under the private realm. The motivations, expectations, and practical impacts of these revisions have been investigated through interviews with stakeholder organizations and a questionnaire study targeted at occupational hygienists. The questionnaire results show that although the Arbocatalogs seem to be relatively well received, a majority of the Dutch occupational hygienists are still relatively negative to the changes. There is a fear that private OELs will be less scientifically robust than public OELs and that the lack of robustness will have a negative impact on the field of occupational hygiene as a whole.

The efficiency of a risk management tool, such as occupational exposure limits (OELs), partly depends on the responsible parties' awareness and understanding of it. The aim of this study was to measure the awareness and understanding of OELs at Swedish workplaces and to collect opinions on their use and function. Through a web-based questionnaire targeting workers that are exposed to air pollutants or chemicals, and persons working with occupational health and safety or in management at workplaces where workers are exposed to air pollutants or chemicals 1017 responses were collected. The results show that awareness and understanding of Swedish OELs is low among workers, as well as managers and occupational health and safety employees. Statistically significant, but small, differences were found depending on the size of the company and the position in the company. Based on the results, it is recommended that authorities and the social partners target this lack of awareness and understanding regarding OELs. Also, other tools to ascertain a safe working environment with regards to chemicals exposure might be useful for Swedish workplaces., (Copyright © 2013 Elsevier Inc. All rights reserved.)

The new European Union (EU) REACH legislation requires derived no-effect levels (DNELs) to be calculated for substances produced in quantities above 10 tonnes/year. Meanwhile, the setting of occupational exposure limits (OELs) continues both at the member state and the EU levels. According to REACH, indicative OEL values (IOELVs) from the Commission may under some circumstances be used as worker-DNELs. On the other hand, worker-DNELs will be derived for several thousand substances, far more than the approximately 100 substances for which IOELVs have been established. Thus, the procedure to set health-based OELs may become influential on that of DNELs and vice versa. In this study, we compare the safety margins of 88 Scientific Committee on OELs (SCOEL) recommendations with those of the corresponding worker-DNELs, derived according to the default approach as described in the REACH guidance document. Overall, the REACH safety margins were approximately six times higher than those derived from the SCOEL documentation but varied widely with REACH/SCOEL safety margin ratios ranging by two orders of magnitude, from 0.3 to 58 (n = 88). The discrepancies may create confusion in terms of legal compliance, risk management, and risk communication. We also found that the REACH guidance document, although encompassing detailed advice on many issues, including default assessment factors for species and route extrapolation, gives little quantitative guidance on when and how to depart from defaults.

The aim of this study was to investigate how the Scientific Committee on Occupational Exposure Limits (SCOEL) of the European Commission uses uncertainty factors when proposing health-based indicative occupational exposure limit values (IOELVs). In total, 75 IOELVs in 62 summary documents published from 1991 to 2003 were analyzed. For 31 of the IOELVs, no explicit uncertainty factor (EUF) was stated. For these, we calculated an implicit safety margin (ISM) as the ratio between the point of departure (POD, derived from the NOAEL or LOAEL of the critical effect) and the proposed IOELV. We further analysed whether date of recommendation, type of critical effect, nature of POD or amount of available data influenced the magnitude of the EUFs and ISMs. The ISMs varied little (range 1-5), while the EUFs showed more variability (range 1-50). The EUFs remained unaffected over time and the ISMs decreased slightly. Significant differences in the magnitude of the EUFs, but not ISMs, were found between critical effects, however, contrary to expected the average EUFs and ISMs for irritation were similar to those for more severe systemic effects. The nature of the POD affected the ISMs and EUFs only slightly and less than expected. Both EUFs and ISMs showed a weak but significant negative correlation with the amount of available toxicological data, measured as the number of relevant publications in PubMed, whereas SCOEL statements on data sufficiency had no influence. Overall, the most striking difference was that between EUFs and ISMs, the former being on average 2.1 times higher.

The occupational exposure limits (OELs) established by seven different national regulatory agencies of EU member states are compared with those of the European Commission (EC). The comparison concerned: (1) what chemicals have been selected, (2) the average level of exposure limits for all chemicals, and (3) the similarity between the OELs of different EU member states and the OELs recommended by the European Commission. The average level of the exposure limits has declined during the past 10 years in four of the five countries in our study for which historical data were available to us. Poland has not changed its level noticeably and Germany has increased it. Since the first list of indicative OELs was established by the EC, a few of the EU exposure limits have been lowered. The similarity index indicates that the exposure limits of EU member states are converging towards the European Commission's recommended OELs. Still, the average level of OELs differs between organizations--the Estonian OELs are on average 35% higher than the Polish OELs.

Occupational exposure limits (OELs) are used as an important regulatory instrument to protect workers' health from adverse effects of chemical exposures. The OELs mirror the outcome of the risk assessment and risk management performed by the standard setting actor. In this study we compared the OELs established by 18 different organisations or national regulatory agencies. The OELs were compared with respect to: (1) what chemicals have been selected and (2) the average level of exposure limits for all chemicals. Our database contains OELs for a total of 1341 substances; of these 25 substances have OELs from all 18 organisations while more than one-third of the substances are only regulated by one organisation. The average level of the exposure limits has declined during the past 10 years for 6 of the 8 organisations in our study for which historical data were available; it has increased for Poland and remained nearly unchanged for Sweden. The average level of OELs differs substantially between organisations; the US OSHA exposure limits are (on average) nearly 40 % higher than those of Poland. The scientific or policy-related motivations for these differences remain to be analysed.