Safe Use Of Chemicals Research Articles

Agricultural chemical use and the rural-urban divide in Canada

ABSTRACT Innovation is of fundamental importance for improving food production, as well as sustainability food production. Since 1960, food production has benefited from innovations in plant breeding technologies, fertilizer, chemicals and equipment. These innovations have dramatically increased food production, while the amount of land used has minimally increased. However, future food production increases are jeopardized from widening knowledge gaps between rural food producers and large urban food consuming populations. Over time, that gap has fueled disinformation. The development of disinformation business models contributes to urban consumers receiving inaccurate information about the importance of inputs essential to food production, resulting in political pressures being applied that are targeted at reductions in the use of many food production inputs. The use of chemicals are a frequent target of disinformation campaigns. This article examines how the lack of government clarity about the safe use of chemicals contributes to a lack of public information.

Expected Risk as basis for assessment of safe use of chemicals

This paper describes a straightforward modeling procedure to derive ‘expected risk’ (ER) of chemical substances. Starting from proposed use volumes, intended uses, physical and chemical substance properties and toxicity information, the procedure combines multimedia environmental fate modeling with species sensitivity modeling to derive the probability that exposure concentrations exceed critical effect concentrations. The procedure was tested on 1977 so-called mono-constituent organic chemicals that had been registered to be marketed in the EU, after ‘possibility to be used safely’ had been demonstrated by showing that the possible Risk Quotients (RQ) defined as PEC/PNEC ratios (Predicted Exposure Concentration & Predicted No Effect Concentration) were expected to remain below the value of 1, as required by REACH. It appears from this study that (i) RQ and ER of chemicals can be calculated readily, reliably, transparently and reproducibly, that (ii) both RQ and ER can be used to assess whether a new chemical may exceed a chosen acceptability level, but that (iii) in addition ER can be straightforwardly used to rank chemicals according to expected environmental safety. In conclusion, the paper states that modeling ER of chemicals (instead of estimating RQ values), could strengthen the scientific basis of environmental risk assessment for use in REACH. The paper further recommends that more robust environmental risk calculation can be done by using acute EC50, instead of chronic NOEC as critical effect concentration.

PACEMweb: a tool for aggregate consumer exposure assessment

BackgroundTo ascertain the safe use of chemicals that are used in multiple consumer products, the aggregate human exposure, arising from combined use of multiple consumer products needs to be assessed.ObjectiveIn this work the Probabilistic Aggregate Consumer Exposure Model (PACEM) is presented and discussed. PACEM is implemented in the publicly available web tool, PACEMweb, for aggregate consumer exposure assessment.MethodsPACEM uses a person-oriented simulation method that is based on realistic product usage information obtained in surveys from several European countries. PACEM evaluates aggregate exposure in a population considering individual use and co-use patterns as well as variation in product composition. Product usage data is included on personal care products (PCPs) and household cleaning products (HCPs).ResultsPACEM has been implemented in a web tool that supports broad use in research as well as regulatory risk assessment. PACEM has been evaluated in a number of applications, testing and illustrating the advantage of the person-oriented modeling method. Also, PACEM assessments have been evaluated by comparing its results with biomonitoring information.SignificancePACEM enables the assessment of realistic aggregate exposure to chemicals in consumer products. It provides detailed insight into the distribution of exposure in a population as well as products that contribute the most to exposure. This allows for better informed decision making in the risk management of chemicals.ImpactRealistic assessment of the total, aggregate exposure of consumers to chemicals in consumer products is necessary to guarantee the safe use of chemicals in these products. PACEMweb provides, for the first time, a publicly available tool to assist in realistic aggregate exposure assessment of consumers to chemicals in consumer products.

REACH Worker Exposure Assessments: Ensuring Meaningful Health Risk Communication.

Within the chemical legislation, REACH was implemented in order to improve safe working conditions with hazardous substances. Literature and real-life experiences by those concerned have shown that there are still gaps with a need for improved risk communication. This study elaborated on how information provided by REACH is understood and acted on by down- and upstream users, and how it can be further improved. An extensive literature study including 21 studies and 13 tools was carried out. The outcomes were discussed and further supplemented by means of 18 interviews concerning 37 internal safety and REACH documents to build six different use cases representing different Dutch downstream companies. For the upstream perspective also 2 sector organizations and 2 registrants were interviewed. Three online workshops were organized in order to share insights and gather input on international recognition, potential suggestions and further recommendations with 30 participants from nine different EU countries. Although the methods to collect the data differed between the different stages of the study, the general results from all three stages elucidated similar themes in the data and each of the stages used the results from the previous stage as a starting point. Recurring themes concerned the (i) complexity of documents, (ii) deficiencies as experienced by SMEs in REACH, (iii) feedback and responsibilities in the supply chain, and (iv) the cooperation between REACH and OSH. The study at hand revealed that even though there are currently several activities to improve communication on safe-use of chemicals, communication on safe-use in the scope of REACH should be improved. This includes e.g. the future involvement of actual end-users in activities and development related to communication of safe-use information in the scope of REACH including feedback, less complicated and complex documents and clear communication concerning legislations and updates of documents. Furthermore, the issues recognized in the Netherlands are mostly also recognized by international workshop participants, thereby indicating international benefits in various areas by means of improved communication. The study confirmed that many of our generic conclusions were already part of the shared knowledge in the REACH community, but that it is very valuable that this knowledge has been explicated, validated and reported in a structured way in the present project. Besides uncovering some crucial aspects that offer potential improvements regarding risk communication, this study offers possible solutions and next steps to be taken.

Penyuluhan Meminimalkan Residu Pestisida pada Bahan Pangan di MTs Lempur Kecamatan Gunung Raya Kabupaten Kerinci

Farmers in their daily farming activities cannot be separated from the use of chemicals, especially fertilizers and pesticides. From an early age, it is necessary to seek an understanding of farmer children about the safe use of chemicals in their use and the impact of these chemicals on the safety of the agricultural products (vegetables and fruit). The purpose of this activity is to provide knowledge and awareness about how to minimize pesticide residues on vegetables and fruit so that these agricultural products are safe for family consumption for students at MTs Lempur, Gunung Raya District, Kerinci Regency, Jambi. The method used is face-to-face counseling by providing literature of material and conducting questions and answers deepening the material as well as quizzes with prizes at the end of the session. Community service activities regarding counseling on how to minimize pesticide residues in food, vegetables and fruit have been carried out well, and have received enthusiastic responses from students at MTs Lempur, Gunung Raya District, Kerinci Regency.

Assessing Detergent Residuals for Reusable Device Cleaning Validations.

Cleaning chemistries are detergent-based formulations that are used during the processing of reusable medical devices. Manufacturers are responsible for demonstrating the safety of cleaning formulations when they are used during a device processing cycle, including the risk of device-associated cytotoxicity over the concentration ranges for recommended use and rinsing during cleaning. However, no regulation currently exists requiring manufacturers to demonstrate such safety. Although manufacturers' safety data sheets (SDSs) provide information on the safe use of chemicals for users, this information may not provide sufficient detail to determine the risks of residual chemicals on device surfaces. SDSs are not required to contain a comprehensive list of chemicals used, only those of risk to the user. They should be supplemented with information on the correct concentrations that should be used for cleaning, as well as instructions on the rinsing required to reduce the levels of chemicals to safe (nontoxic) levels prior to further processing. Supporting data, such as toxicity profiles or cytotoxicity data that support the instructions for use, would provide medical device manufacturers and healthcare personnel with the necessary information to make informed decisions about selection and correct use of detergents. In the current work, cytotoxicity profiles for eight commonly used cleaning formulations available internationally were studied. Although all of these products are indicated for use in the cleaning of reusable medical devices, results vary across the serial dilution curves and are not consistent among detergent types. The information presented here can be leveraged by both medical device manufacturers and processing department personnel to properly assess residual detergent risks during processing. This work also serves as a call to cleaning formulation manufacturers to provide this information for all chemistries.

Assessing Detergent Residuals for Reusable Device Cleaning Validations

Cleaning chemistries are detergent-based formulations that are used during the processing of reusable medical devices. Manufacturers are responsible for demonstrating the safety of cleaning formulations when they are used during a device processing cycle, including the risk of device-associated cytotoxicity over the concentration ranges for recommended use and rinsing during cleaning. However, no regulation currently exists requiring manufacturers to demonstrate such safety. Although manufacturers' safety data sheets (SDSs) provide information on the safe use of chemicals for users, this information may not provide sufficient detail to determine the risks of residual chemicals on device surfaces. SDSs are not required to contain a comprehensive list of chemicals used, only those of risk to the user. They should be supplemented with information on the correct concentrations that should be used for cleaning, as well as instructions on the rinsing required to reduce the levels of chemicals to safe (nontoxic) levels prior to further processing. Supporting data, such as toxicity profiles or cytotoxicity data that support the instructions for use, would provide medical device manufacturers and healthcare personnel with the necessary information to make informed decisions about selection and correct use of detergents. In the current work, cytotoxicity profiles for eight commonly used cleaning formulations available internationally were studied. Although all of these products are indicated for use in the cleaning of reusable medical devices, results vary across the serial dilution curves and are not consistent among detergent types. The information presented here can be leveraged by both medical device manufacturers and processing department personnel to properly assess residual detergent risks during processing. This work also serves as a call to cleaning formulation manufacturers to provide this information for all chemistries.

GHS Implementation to Strengthen Global Chemical Hazard Communication: Will We Ever Get There?

The establishment of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) is one of the global initiatives to promote effective chemical hazard communication worldwide. Ultimately, the GHS aims to enhance safe use of chemicals, as well as to facilitate chemical trading across national borders. Countries that are now adopting GHS into their respective national legislations include the EU, US, Japan, Korea, Taiwan, and Malaysia. Nonetheless, challenges exist that might impede GHS implementation worldwide. These challenges have been identified and are discussed in this paper, namely, (i) adoption of different versions of the GHS document, (ii) adoption of building blocks, (iii) list of classified chemicals, (iv) different chemical mixture classification throughout the supply chain, and (v) the definition of GHS implementation. The challenges discussed in this paper are not to discourage countries from implementing GHS but, rather, to serve as input for the relevant entities to further strengthen GHS implementation worldwide.

Roundup causes embryonic development failure and alters metabolic pathways and gut microbiota functionality in non-target species

BackgroundResearch around the weedkiller Roundup is among the most contentious of the twenty-first century. Scientists have provided inconclusive evidence that the weedkiller causes cancer and other life-threatening diseases, while industry-paid research reports that the weedkiller has no adverse effect on humans or animals. Much of the controversial evidence on Roundup is rooted in the approach used to determine safe use of chemicals, defined by outdated toxicity tests. We apply a system biology approach to the biomedical and ecological model species Daphnia to quantify the impact of glyphosate and of its commercial formula, Roundup, on fitness, genome-wide transcription and gut microbiota, taking full advantage of clonal reproduction in Daphnia. We then apply machine learning-based statistical analysis to identify and prioritize correlations between genome-wide transcriptional and microbiota changes.ResultsWe demonstrate that chronic exposure to ecologically relevant concentrations of glyphosate and Roundup at the approved regulatory threshold for drinking water in the US induce embryonic developmental failure, induce significant DNA damage (genotoxicity), and interfere with signaling. Furthermore, chronic exposure to the weedkiller alters the gut microbiota functionality and composition interfering with carbon and fat metabolism, as well as homeostasis. Using the “Reactome,” we identify conserved pathways across the Tree of Life, which are potential targets for Roundup in other species, including liver metabolism, inflammation pathways, and collagen degradation, responsible for the repair of wounds and tissue remodeling.ConclusionsOur results show that chronic exposure to concentrations of Roundup and glyphosate at the approved regulatory threshold for drinking water causes embryonic development failure and alteration of key metabolic functions via direct effect on the host molecular processes and indirect effect on the gut microbiota. The ecological model species Daphnia occupies a central position in the food web of aquatic ecosystems, being the preferred food of small vertebrates and invertebrates as well as a grazer of algae and bacteria. The impact of the weedkiller on this keystone species has cascading effects on aquatic food webs, affecting their ability to deliver critical ecosystem services.DJLGvZ7sRDZZrJVKuLAEkAVideo

Optimising testing strategies for classification of human health and environmental hazards – A proof-of-concept study

This paper outlines a new concept to optimise testing strategies for improving the efficiency of chemical testing for hazard-based risk management. While chemical classification based on standard checklists of information triggers risk management measures, the link is not one-to-one. Toxicity testing may be performed with no impact on the safe use of chemicals . Each hazard class and category is not assigned a unique pictogram and for the purpose of this proof-of-concept study, the level of concern for a chemical for the population and the environment is simplistically considered to be reflected by the hazard pictograms. Using active substances in biocides and plant protection products as a dataset, three testing strategies were built with the boundary condition that an optimal approach must indicate a given level of concern while requiring less testing (strategy B), prioritising new approach methodologies (strategy C) or combining the two considerations (strategy D). The implementation of the strategies B and D reduced the number of tests performed by 6.0% and 8.8%, respectively, while strategy C relied the least on in vivo methods. The intentionally simplistic approach to optimised testing strategies presented here could be used beyond the assessment of biocides and plant protection products to gain efficiencies in the safety assessment of other chemical groups, saving animals and making regulatory testing more time- and cost-efficient.

Safe use of chemicals and risk communication among dentists and dental students in Greece.

Use of chemicals, most often classified for intrinsic hazards, is rather common among dentists. To date, no data have been recorded in the European Union (EU) on dentists' awareness regarding the safe use of chemicals. In the EU regulatory framework, two Regulations with wide applications, namely Regulations (EC) 1907/2006 (REACH) and 1272/2008 (CLP), have been introduced to protect human health and the environment and clearly communicate hazards posed by chemicals to workers and consumers. The aim of this study was to assess the extent of comprehension of hazard communication of chemicals among Greek dentists. For this, a closed-ended, anonymous and validated questionnaire was initially distributed to a total of 300 Greek dentists, both professionals and university students, over a period of 4 months. The collected data from 240 final responders were subjected to statistical analysis (frequencies, percentages, chi-square (χ2) and significance (p < 0.05)). The vast majority (90%) of the interviewed dentists are not aware of the CLP. Main sources of information regarding chemical hazard and safe use was the supplier through direct communication (90%), while some dentists also consulted the product labels (39%) and the material safety data sheets (54%). Regarding hazard communication, the perceived information from the pictograms is confusing to the vast majority of the dentists (86%), especially for systemic hazards (carcinogenicity and/or reproductive toxicity). In addition, 88% of the professional dentists have not noticed any changes in the labelling of chemical products, which also shows the low input of labels to hazard communication. On the other hand, 90% of the responders always utilize personal protective equipment (PPE), although it is not clear whether this PPE is adequate. In conclusion, rising awareness campaigns are needed, in collaboration with universities and dental care professional associations, to inform dentists about the safe use of chemicals not only to ensure protection of their own health but also to contribute to environmental sustainability.

Vitamin K antagonist rodenticides display different teratogenic activity

Vitamin K antagonists (VKA) are not recommended during pregnancy because warfarin (a first-generation VKA) is associated with a malformation syndrome “the fetal warfarin syndrome” (FWS). VKA are also used for rodent management worldwide. Recently, the Committee for Risk Assessment responsible for the European chemical legislation for advances on the safe use of chemicals had classed 8 anticoagulant used as rodenticides in the reprotoxic category 1A or 1B. This classification emerges from a read-across prediction of toxicity considering the warfarin malformation syndrome. Herein, our study explores the teratogenicity of warfarin at the human therapeutic dose and that of bromadiolone, a second-generation anticoagulant rodenticide. Using a rat model, our study demonstrates that warfarin used at the therapeutic dose is able to induce teratogenicity, while in the same conditions bromadiolone does not induce any teratogenic effect, challenging the classification of all VKA as reprotoxic molecules.

Impact of European chemicals regulation on the industrial use of plasticizers and patterns of substitution in Scandinavia

REACH aims at promoting the safe use of chemicals in Europe, inter alia by identification and regulation of substances of very high concern (SVHCs). Once identified, SVHCs need to be substituted by safer alternatives. However, substitutes are frequently not safer than the substances that they replace but rather show similar hazard profiles, resulting in regrettable substitution. This paper investigates the impact of chemicals regulation on substitution of chemicals by analyzing time trends in the industrial use of chemicals from 2000 to 2014 in Scandinavia. It is shown that the use of ten water-relevant SVHCs decreased by about 90% in the considered period in Sweden as compared to a control group of unregulated substances which decreased by only 20%. A closer inspection of the use of 23 highly used plasticizers revealed that the use of regulated phthalate plasticizers decreased while the use of non-phthalate plasticizers increased. A first comparison of hazardous properties showed that during the 15-years period chemical substitution drastically reduced the chemical hazard burden of plasticizers in Scandinavia for both, the environment and human health. This study shows that regulation and the related discussion on chemicals safety have significantly reduced the chemical hazard burden from plasticizers in Scandinavia since the year 2000. It is assumed that similar trends can be found for the whole European Union. To combat regrettable substitution, mitigation options are suggested, including information-based tools for the identification of safer alternatives and an improved accessibility of information on production volumes and uses of chemicals to allow for an improved assessment of chemical's risk.

Prevalidation of an Acute Inhalation Toxicity Test Using the EpiAirwayIn VitroHuman Airway Model

Introduction: Knowledge of acute inhalation toxicity potential is important for establishing safe use of chemicals and consumer products. Inhalation toxicity testing and classification procedures currently accepted within worldwide government regulatory systems rely primarily on tests conducted in animals. The goal of the current work was to develop and prevalidate a nonanimal (in vitro) test for determining acute inhalation toxicity using the EpiAirway™ in vitro human airway model as a potential alternative for currently accepted animal tests.Materials and Methods: The in vitro test method exposes EpiAirway tissues to test chemicals for 3 hours, followed by measurement of tissue viability as the test endpoint. Fifty-nine chemicals covering a broad range of toxicity classes, chemical structures, and physical properties were evaluated. The in vitro toxicity data were utilized to establish a prediction model to classify the chemicals into categories corresponding to the currently accepted Globally Harmonized System (GHS) and the Environmental Protection Agency (EPA) system.Results: The EpiAirway prediction model identified in vivo rat-based GHS Acute Inhalation Toxicity Category 1–2 and EPA Acute Inhalation Toxicity Category I–II chemicals with 100% sensitivity and specificity of 43.1% and 50.0%, for GHS and EPA acute inhalation toxicity systems, respectively. The sensitivity and specificity of the EpiAirway prediction model for identifying GHS specific target organ toxicity-single exposure (STOT-SE) Category 1 human toxicants were 75.0% and 56.5%, respectively. Corrosivity and electrophilic and oxidative reactivity appear to be the predominant mechanisms of toxicity for the most highly toxic chemicals.Conclusions: These results indicate that the EpiAirway test is a promising alternative to the currently accepted animal tests for acute inhalation toxicity.

Safe use of chemicals by professional users and health care specialists.

The awareness of Greek professional users and health care specialists regarding the safe use of chemicals was investigated, to be the best of our knowledge, for the first time after the introduction of Regulations (EC) 1907/2006 (REACH) and 1272/2008 (CLP) on chemicals. A total of 200 professional users and 150 health care specialists from various regions of Greece contributed to the use of a closed-ended, anonymous and validated questionnaire. The findings showed that over 85% of the responders were not aware of classification, labelling and packaging (CLP) and 67.8% of the responders were unaware of any changes made in the labeling of the products they were using. The majority (>75%) of individuals were cognizant that they were using hazardous products; however, the perception of hazard varied significantly between the two groups (P=0.012) and statistically were dependent on the educational (P=0.022) and the profession (P=0.014) level. One third of the professional users read the label as the main source of information for the product, while for health care specialists the number increased to 65% and a strong correlation was detected with the educational level (P=0.017). In both groups, 7% of professional users and health care specialists declared that hazard communication through product labeling is not well understood. The use of personal protective equipment (PPE) is almost universal for health care specialists with women being more sensitive (P=0.041), while 25% of the professional users do not use any PPE. Almost 60% of the health care specialists are required to provide instructions regarding the safe use of chemicals or the action to be undertaken in case of accident. In the latter situation, the National Poisoning Centre is the reference point for information. Limited use of the safety data sheets has been observed both for professional users (18%) and health care specialists (23%). In conclusion, rising awareness campaigns are needed, in collaboration with trade unions and health care professional associations, in order to alert professionals regarding the safe use of chemicals and protect human health and the environment.

(Q)SARs as Adaptations to REACH Information Requirements.

REACH is a regulation of the European Union adopted to improve the safe use of chemicals with regard to human health and the environment. The safe use of chemicals can be achieved only if the hazard and the exposure of the substances are well characterized. Testing on animals has been traditionally the main tool for hazard assessment. For ethical and economic reasons, alternative ways of testing that do not use laboratory animals have been developed by different parties (regulatory agencies, researchers, industry) over the recent decades, and their proper use in hazard assessment is encouraged under REACH. In this chapter, we describe how (Q)SAR models and predictions are included into REACH and their adequate use promoted by the European Chemicals Agency (ECHA).

Implementation of a novel taxonomy based on cognitive work analysis in the assessment of safety performance

Purpose. The aim of this study was to examine how the developed taxonomy of cognitive work analysis (CWA) can be applied in combination with statistical analysis regarding different sociotechnical categories. Materials and methods. This study applied a combination of quantitative and qualitative methodologies. Workers (n = 120) and managers (n = 85) in the chemical industry were asked in a questionnaire how different occupational safety and health (OSH) measures were being implemented. The exploration of the qualitative CWA taxonomy consisted of an analysis of the following topics: (a) work domain; (b) control task; (c) strategies; (d) social organization and cooperation; (e) worker competencies. Results and conclusions. The following hypotheses were supported – activities of the management had positive impacts on the aggregated variables: near-accident investigation and instructions (H1); OSH training (H2); operations, technical processes and safe use of chemicals (H3); use of personal protective equipment (H4); measuring, follow-up and prevention of major accidents (H5). The CWA taxonomy was applied in mixed methods when testing H1–H5. A special approach is to analyze the work demands of complex sociotechnical systems with the taxonomy of CWA. In problem-solving, the CWA taxonomy should seek to capitalize on the strengths and minimize the limitations of safety performance.

Green Chemistry at the present in Korea.

ObjectivesDespite the great contribution made by chemical substances to the development of modern civilization, their indiscriminate use has caused various kinds of damage to the global environment and human beings. Accordingly, the major developed countries and international society have tried to ensure the safe use of chemicals and a reduction in the use of hazardous chemicals through the establishment of the United Nations Environment Programme and various international agreements. In this reason, we tried to introduce about Green Chemistry progress at the present in worldwide and Korea.MethodsWe checked and analyzed relative journals, reports using keyword as like Green Chemistry, alternative chemicals, eco-friendly etc. and major country’s government homepage search.ResultsGreen Chemistry theory, which argues for the reduction or removal of harmfulness in chemicals throughout their entire life-cycle, has been spreading, and major developed countries, such as the US and Denmark, have developed and operate programs to provide reliable chemical information to help replace hazardous chemicals. Korea has also been conducting studies as like eco-innovation project. Through this project the “Alternative Chemical Search program,” has been developed, distributed, and operated since 2011 to provide reliable information to small and medium-sized businesses that have difficulties collecting information to ensure conformity to international regulations. The program provides information that includes the regulations of major countries and Korea, information on 340 alternative chemicals, 70 application cases, and 1:1 consulting.ConclusionsThe Alternative Chemical Search program is expected to contribute to the establishment of response systems for regulation of Korean small and medium-sized businesses, and it also will be used to provide basic data for Korean hazardous chemical regulation, together with the Act on the Registration and Evaluation, etc. of Chemical Substances and the Chemical Control act, making it possible to establish an infrastructure for Green Chemistry in Korea and to increase national competitiveness.

A Review of Aquaculture Practices and Their Impacts on Chemical Food Safety from a Regulatory Perspective.

Aquaculture is currently one of the most rapidly growing food production industries in the world. The increasing global importance for this industry stems primarily from the fact that it is reducing the gap between the supply and demand for fish products. Commercial aquaculture contributes significantly to the economies of many countries since high-value fish species are a major source of foreign exchange. This review looks at the aquaculture industry, the issues raised by the production of fish through aquaculture for food security, the sustainability of the practice to agriculture, what the future holds for the industry in the next 10-20 years, and why there is a need to have available analytical procedures to regulate the safe use of chemicals and veterinary drugs in aquaculture.

White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals

The vision of a sustainable and safe use of chemicals to protect human health, preserve the environment and maintain the ecosystem requires innovative and more holistic approaches to risk assessment (RA) in order to better inform decision making. Integrated risk assessment (IRA) has been proposed as a solution to current scientific, societal and policy needs. It is defined as the mutual exploitation of environmental risk assessment (ERA) for human health risk assessment (HHRA) and vice versa in order to coherently and more efficiently characterize an overall risk to humans and the environment for better informing the risk analysis process. Extrapolating between species which are relevant for HHRA and ERA requires a detailed understanding of pathways of toxicity/modes of action (MoA) for the various toxicological endpoints. Significant scientific advances, changes in chemical legislation, and increasing environmental consciousness have created a favourable scientific and regulatory environment to develop and promote the concept and vision of IRA. An initial proof of concept is needed to foster the incorporation of IRA approaches into different chemical sectorial regulations and demonstrate their reliability for regulatory purposes. More familiarity and confidence with IRA will ultimately contribute to an overall reduction in in vivo toxicity testing requirements. However, significant progress will only be made if long-term support for MoA-related research is secured. In the short term, further exchange and harmonization of RA terminology, models and methodologies across chemical categories and regulatory agencies will support these efforts. Since societal values, public perceptions and cultural factors are of increasing importance for the acceptance of risk analysis and successful implementation of risk mitigation measures, the integration of socio-economic analysis and socio-behavioural considerations into the risk analysis process may help to produce a more effective risk evaluation and consideration of the risks and benefits associated with the use of chemicals.