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In 2006, the revised chemicals management legislation mandated that manufacturers of hazardous chemical substances conduct risk assessments for the entire substance life cycle. Additionally, they must communicate use-specific safe handling advice (exposure scenarios) to their customer, as annex to the Safety Data Sheet (SDS). Despite significant efforts to develop workable solutions for chemical mixtures, this goal has not yet been fully achieved. Therefore, a Cefic research project (LRI B23) was commissioned on how to ensure meaningful health risk communication for workers across supply chains. The research project determined that risk-based safe use advice generated by manufacturers, often does not reach the intended end-user and was seen as not tailored to specific user needs. Recipients of the advice are also not prepared to act based on information developed by suppliers. From an industry perspective, the complexity of supply chains and substance life cycles are considered major barriers for effective safe use communication. Exposure scenarios for substance use in industrial work environments are often perceived as adding little value compared to existing safe use arrangements required by other health, safety, and environmental legislation applicable to employers and duty-holders. To attain meaningful use-specific safe handling advice for workers, including those at non-industrial premises who may benefit most from such advice, knowledge transfer and close collaboration between manufacturers and formulators remain key elements, supported by enhanced regulatory appreciation. [ABSTRACT FROM AUTHOR]

We describe a procedure to quantify emissions of chemicals for environmental protection, assessment, and management purposes. The procedure uses production and use volumes from registration dossiers and combines these with Specific Environmental Release Category data. The procedure was applied in a case study. Emission estimations were made for chemicals registered under the European Union chemicals regulations for industrial chemicals (Registration, Evaluation, Authorisation and Restriction of Chemicals [REACH]) and for the active ingredients of medicines and crop protection products. Emissions themselves cannot be validated. Instead, emission estimates were followed by multimedia fate modeling and mixture toxic pressure modeling to arrive at predicted environmental concentrations (PECs) and toxic pressures for a typical European water body at steady state, which were compared with other such data. The results show that screening‐level assessments could be performed, and yielded estimates of emissions, PECs, and mixture toxic pressures of chemicals used in Europe. Steady‐state PECs agreed fairly well with measured concentrations. The mixture toxic pressure at steady state suggests the presence of effects in aquatic species assemblages, whereby few compounds dominate the predicted impact. The study shows that our screening‐level emission estimation procedure is sufficiently accurate and precise to serve as a basis for assessment of chemical pollution in aquatic ecosystems at the scale of river catchments. Given a recognized societal need to develop methods for realistic, cumulative exposures, the emission assessment procedure can assist in the prioritization of chemicals in safety policies (such as the European Union REACH regulation), where "possibility to be used safely" needs to be demonstrated, and environmental quality policies (such as the European Union Water Framework Directive), where "good environmental quality" needs to be reached. Environ Toxicol Chem 2020;39:1839–1851. © 2020 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC. [ABSTRACT FROM AUTHOR]

Background Prevention of the impact of chemicals on human health and the environment is an increasing focus of public health polices and policy makers. The World Health Organization European Centre for Environment and Health wanted to know what were stakeholders' priorities for improving chemicals management and prevention. Methods Semi-structured interviews were undertaken with 18 diverse stakeholders to answer this question. The interview questionnaire was developed using current WHO chemical meeting reports, the Evidence Implementation Model for Public Health Systems and categories of the theory of diffusion. Stakeholder views were attained on three main questions within the questionnaire. (i) What priority actions should be undertaken to minimize the negative impact of chemicals? (ii) Who needs to be more involved and what roles should they have? (iii) How can science and knowledge on chemicals and health be translated into policies more effectively and what are the greatest barriers to overcome? Results Cross cutting issues, such as legislation strengthening and enforcement, further collection of information, capacity building, education and awareness raising were considered priorities. The responders had the same vision on roles and responsibilities of different stakeholders. The greatest barrier to adoption, implementation and enforcement of evidence-based policies reported was leadership and political commitment to chemical safety. Conclusions Priorities raised differed depending on knowledge, professional background and type of stakeholder. Factors influencing priority identification at the national level include international and global context, availability of information, knowledge of the current situation and evidence-based good practice, and risks and priorities identified through national assessments. [ABSTRACT FROM AUTHOR]

Objectives: The work is aimed to present and promote the Chemical Safety Management Training Hub for Chemicals Users (ChemSM-Hub) project implemented by the Nofer Institute of Occupational Medicine in cooperation with the Lodz University of Technology, Poland, and other partners from Germany (Oekopol GmbH), Greece (Prolipsis) and Romania (Romtens). The project is co-funded by the European Commission under the Erasmus+ program, whose aim is to support downstream users (DUs) and distributors (Ds) of chemicals in complying with the REACH and CLP Regulations by developing an innovative training program in chemical safety management (CSM), available via the online project platform, adapted to the real needs of the target groups.Material and Methods: The methodology for implementing the ChemSM-Hub project includes: 1) conducting survey research among the target groups, 2) conducting a state-of-the-art review of literature and websites, 3) developing the Dissemination and Promotion Plan, 4) developing the Monitoring and Evaluation Procedure, 5) developing the CSM training curriculum, 6) designing the project e-learning platform and mobile app, 7) developing the "Training pattern for trainers" guidance, and 8) organizing training events.Results: The project is being implemented in response to the changing EU legislation on chemicals. As a result of the project, a CSM training program has been established consisting of 3 modules (introductory, basic and advanced) with varying degrees of complexity. In addition, a pocket guide has been developed that contains basic information for DUs and Ds regarding the REACH and CLP Regulations, as well as the "Training pattern for trainers" guidance containing a CSM training session plan for trainers. All these materials will be available via the project platform, and their selected elements also via a mobile app.Conclusions: The publication is aimed to familiarize the potential users of the ChemSM-Hub training program with its thematic scope, the structure of the training and the expected results. It is also a way to promote online training adapted to the needs of its target groups. Int J Occup Med Environ Health. 2020;33(3):247-61. [ABSTRACT FROM AUTHOR]

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) earlier this year recommended to suspend some marketing authorisations for Gadolinium Containing Contrast Agents (GCCAs) based on linear chelators due to the potential risk of gadolinium retention in the human body. These recommendations have recently been re-evaluated by EMA's Committee for Medicinal Products for Human Use (CHMP), and confirmed the final opinion of the European Medicines Agency. This editorial provides an overview of the available GCCAs and summarises the recent evidence of gadolinium retention. Moreover, a critical appraisal of the strengths and limitations of the scientific evidence currently available on gadolinium retention is given.Key Points: • EMA recommended suspension of some EU marketing authorisations of four linear GCCAs. • Brain MRI findings indicating gadolinium retention have been confirmed by mass spectrometry. • Current scientific evidence for gadolinium retention has several methodological limitations. • No clear clinical evidence exists indicating that gadolinium retention causes neurotoxicity. • Long-term safety of GCCAs, however, remains unclear. [ABSTRACT FROM AUTHOR]

The Extended One-Generation Reproductive Toxicity Study (EOGRTS) is a standard information requirement under Registration, Evaluation, Authorization and restriction of Chemicals (REACH) in Europe. Inclusion of an F2 generation is considered useful if this impacts hazard identification or when it provides additional information altering the reproductive or developmental No Observed Adverse Effect Level (NOAEL) and subsequent risk assessment. In this retrospective analysis the added value of the F2 generation in 24 EOGRTS was evaluated. Our retrospective analysis showed an added value of the second generation in 1/24 EOGRTS only, where extending with the F2 generation lowered both the reproductive and developmental NOAEL. For this substance, extension with the F2 generation led to classification for effects on fertility. Hazard identification for developmental effects was not impacted based on clear developmental toxic effects already observed in the F1 generation and in previous studies with this substance. Risk assessment may be impacted if the developmental toxic effects are the most critical effects observed for this substance. For 23/24 studies included in this retrospective analysis, hazard and risk assessment were unaffected by inclusion of the F2 generation. Moreover, for 13/13 studies with external triggers for inclusion of the F2 generation hazard and risk assessment were unaffected. By decreasing the number of EOGRTS that are extended with an F2 generation, the number of animals used in regulatory developmental and reproductive toxicity studies may be significantly reduced in the future without negatively affecting the ability to identify potentially harmful chemicals. • The F2 generation in an EOGRTS did not affect hazard and risk assessment in 23/24 studies. • External triggers for inclusion of the F2 generation do not alter hazard/risk assessment. • Exclusion of the F2 generation significantly reduces animal numbers in regulatory DART studies. [ABSTRACT FROM AUTHOR]

Abstract: Chemical substances policies in Europe are aiming towards chemical safety and at the same time a reduction in animal testing. These goals are alleged to be reachable by mining as many relevant data as possible, evaluate these data with regard to validity, reliability and relevance, and use of these data in so-called Integrated Testing Strategies (ITS). This paper offers an overview of four human health endpoints that were part of the EU-funded OSIRIS project, aiming to develop ITS fit for the EU chemicals legislation REACH. The endpoints considered cover their categorical as well as continuous characteristics: skin sensitisation, repeated dose toxicity, mutagenicity and carcinogenicity. Detailed papers are published elsewhere in this volume. The stepwise ITS approach developed takes advantage of existing information, groups information about similar substances and integrates exposure considerations. The different and possibly contradictory information is weighted and the respective uncertainties taken into account in a weight of evidence (WoE) approach. In case of data gaps, the ITS proposes the most appropriate method to acquire the missing information. Each building block for the ITS, i.e. each in vivo test, in vitro test, (Q)SAR model or human evidence, is evaluated with regard to quality. [Copyright &y& Elsevier]

Abstract: Manufactured chemicals are used extensively to produce a wide variety of consumer goods and are required by important industrial sectors. Presently, information is insufficient to estimate risks posed to human health and the environment from the over ten thousand chemical substances currently in use and the hundreds more that are introduced each year. The vast majority of chemicals in products with wide commercial use are not measured in the environment, and potential for human exposure is not quantified. Regulatory agencies in North America and Europe have increased calls to address exposure to these chemicals. New, more reliable approaches are needed to characterize thousands of environmental chemicals on the basis of both hazard and exposure in a rapid and efficient manner, and to prioritize chemicals based on potential risk. Various approaches for prioritization based on exposure potential are summarized and compared. Knowledge gaps and research needed to facilitate rapid exposure-based prioritization for chemical evaluation are highlighted. [Copyright &y& Elsevier]

The Operational Priority Substances (OPS) model is part of the European Union System for the Evaluation of Substances (EUSES) and is used to estimate air concentrations and atmospheric depositions for risk assessment of chemicals. Traditionally, EUSES assesses environmental exposure using a standardized scenario based on explicit assumptions and default parameter settings. Under the new European Union REACH legislation-which stands for Registration, Evaluation, Authorisation, and restriction of Chemicals-industry is responsible for the risk assessment of chemicals. The current work investigates the potential impact and importance of source parameter refinement on the emission distribution and environmental fate of chemicals as modelled by OPS. In total, 60 scenarios with different combinations of (non) default values for emission heat content, emission source height, and emission source radius, were run for a typical particle-bound substance. Increasing heat content and emission source height reduced the modelled air concentrations and depositions and caused maximum air concentrations to occur further away from the emission source. Results show that estimated air concentrations and total depositions used for risk assessment can become more realistic by using more site-specific emission source parameters. This article proposes risk assessment refinement options and provides recommendations on future updates of EUSES. [ABSTRACT FROM AUTHOR]

In recent years, several approaches have been proposed for the application of control banding concepts to the assessment and management of various workplace health and safety risks. Whilst many of the earlier approaches have originated in the UK, several of the most recent examples have been developed in Europe. The European schemes have attempted to build upon the lessons learned from the earlier control banding schemes and to apply them to new areas of health and safety. This paper analyses the evolution of the earlier approaches and reviews the more recent European developments in the context of continuing regulatory and societal demands for the improved assessment and regulation of workplace chemical risks. [ABSTRACT FROM AUTHOR]

The legal systems for the classification and labelling of chemical substances have an incentives structure that discourages rather than encourages companies to test their products. This is shown in a logical analysis of the European classification system and also in an analysis of recent changes in the classification of individual substances. Finally two methods to improve the incentives structure are proposed and discussed: the introduction of negative clauses that allow new information to lead to less strict classifications, and a new danger-class and a symbol (a question mark) that indicates serious lack of data. [ABSTRACT FROM AUTHOR]

We aimed to identify high-priority organophosphorus flame retardants for action and research. We thus critically reviewed literature between 2000 and 2019 investigating organophosphorus flame retardants' presence indoors and human exposure in Europe, as well as epidemiological evidence of human effects. The most concentrated compounds indoors were tris(2-butoxyethyl)phosphate (TBOEP), tris(1-chloro-2-propyl)phosphate (TCIPP), tris(2,3-dichloropropyl)phosphate (TDCIPP). TBOEP and TCIPP were the most consistently detected compounds in humans' urine, hair or breast milk as well as tris (butyl) phosphate (TNBP) and tris (phenyl) phosphate (TPHP). Notably, epidemiological evidence concerned reprotoxicity, neurotoxicity, respiratory effects and eczema risk for TDCIPP, eczema increase for TBOEP, and neurodevelopmental outcomes for Isopropylated triarylphosphate isomers (ITPs). Given the ubiquitous presence indoors and the prevalence of exposure, the growing health concern seems justified. TDCIPP and TPHP seem to be of particular concern due to a high prevalence of exposure and epidemiological evidence. TBOEP and TNBP require epidemiological studies regarding outcomes other than respiratory or dermal ones.

The author reflects on the approval of the registration, evaluation, authorization and restriction of chemicals (REACH) legislation in Europe in 2006. The author stresses that European companies are required to file comprehensive safety data on more than 3,000 substances by December 2010. It emphasizes that the legislation has got companies to work together and share data and has motivated them to dig around their archives and make public old safety data.

The article reports that toxicologist Thomas Hartung has accused European Commission's Joint Research Center (JRC) of not disclosing his study that could have altered the course of Europe's Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH). His 2006 study suggests that at least eight to nine million animals would be needed for REACH chemical-safety testing by 2018. It says that JRC had issued estimates in 2003 and 2004, which were 2.1-3.9 million animals. In his Opinion piece published in the journal "Nature" in 2009, Hartung claimed that producing REACH data could compel up to 54 million animals and cost around 10 billion Euros over 2018. Toxicologist Manfred Liebsch agreed on the credibility of Hartung's estimate and considered JRC's estimates unrealistic.

In this article, the authors reflect on the aims of the European Union's (EU) 2006 Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to assess the toxicity of all chemicals sold in Europe. They describe REACH as the biggest investment into consumer safety. Also mentioned are factors that could reduce the costs of REACH including the progress in the availability of alternative methods to animal testing and availability of safety data from other sources.

REACH provides the opportunity to advance public health and environmental protection and to boost public confidence in the use of chemicals.Not surprisingly at this stage there are many uncertainties on the details of its implementation. From a risk assessor's viewpoint relevant issues are: The criteria to be used to identify priority substancesThe suitability of the available methodology for hazard and exposure characterisationThe independence, transparency and of expertise specifiedThe compatibility of the procedures with those used for other substances and productsThe nature of the database; its accessibility and utilityAvailability of experts in risk and benefit assessment These issues are discussed and key concerns are highlighted.Journal of Exposure Science and Environmental Epidemiology (2007) 17, S101–S104; doi:10.1038/sj.jes.7500596; published online 14 November 2007 [ABSTRACT FROM AUTHOR]

The article reports that the European Union is imposing tough new laws on testing of chemicals used in manufacture of pharmaceutical products. The regulations will go into effect in April 2007. The new rules called REACH (Registration, Evaluation and Authorization of Chemicals) require companies to provide safety and handling information of most chemicals. The article mentions that many products may be withdrawn from the market and US companies importing chemicals from Europe will be affected.

The author investigates the impact of Europe's latest directive on equipment suppliers. [ABSTRACT FROM AUTHOR]

Reports on the unrecognized hazards associated with dihydroxy-acetone (DHA), a chemical used in spray tans, in Europe. Action taken by the U.S. Food and Drug Administration regarding the use of spray tanning; Information on the DHA chemical; Recommendations on the use of products containing DHA according to the British Health & Safety Executive.

The European Regulation 1907/2006 (REACH--Registration, Evaluation, Authorization and Restriction of Chemicals) obliges manufacture companies and import chemicals to assess the risks arising from their use and to take the necessary measures to manage the risks identified. The Chemical Safety Report provides an accurate assessment of hazards to human health and the environment necessary to prepare an exposure scenario for the "identified uses" of the substance. An exposure scenario is the set of conditions that describe how the substance is manufactured or used during its life cycle and how the manufacturer or importer controls, or recommends downstream users to control the 'exposure to humans and the environment. Firms therefore need specific skills. The spectrum of toxicological risk is extremely large, the information required in some cases are very complex and undoubtedly require a thorough knowledge in toxicology and environmental industry. The expertise and experience in toxicology of the occupational physician in this case may become useful in the environmental field as well as another familiar figure of relevant importance is the occupational hygienist who develop exposure scenarios for workers and their uses experience for the exposure scenarios for the consumer. It provides an obvious involvement of medical toxicologists and occupational hygienists for public tasks of control and inspection of chemical safety reports and, locally, even the accuracy of risk that arise from this.