Registration, Evaluation, Authorisation And Restriction Of Chemicals Research Articles

Is read-across for chemicals comparable to medical device equivalence and where to use it for conformity assessment?

Novel medical devices must conform to medical device regulation (MDR) for European market entry. Likewise, chemicals must comply with the Registration, Evaluation, Authorization and Restriction of Chemicals (REACh) regulation. Both pose regulatory challenges for manufacturers, but concordantly provide an approach for transferring data from an already registered device or compound to the one undergoing accreditation. This is called equivalence for medical devices and read-across for chemicals.Although read-across is not explicitly prohibited in the process of medical device accreditation, it is usually not performed due to a lack of guidance and acceptance criteria from the authorities. Nonetheless, a scientifically justified read-across of material-based endpoints, as well as toxicological assessment of chemical aspects, such as extractables and leachables, can prevent failure of MDR device equivalence if data is lacking. Further, read-across, if applied correctly can facilitate the standard MDR conformity assessment.The need for read-across within medical device registration should let authorities to reconsider device accreditation and the formulation of respective guidance documents. Acceptance criteria like in the European Chemicals Agency (ECHA) read-across assessment framework (RAAF) are needed. This can reduce the impact of the MDR and help with keeping high European innovation device rate, beneficial for medical device patients.

Chemical management in electronics manufacturing: Protecting worker health and the environment

In the realm of electronics manufacturing, the management of chemicals is paramount to safeguarding both worker health and environmental sustainability. This review delves into the strategies and challenges associated with chemical management within this industry. The utilization of various chemicals in electronics manufacturing processes presents potential hazards to both workers and the environment. From cleaning agents to solvents and fluxes, these substances pose risks ranging from acute toxicity to long-term health effects and environmental contamination. Effective chemical management strategies are therefore indispensable. This review discusses the proactive measures implemented by electronics manufacturers to mitigate these risks. It explores the adoption of alternative, less hazardous chemicals and the implementation of engineering controls to minimize exposure. Additionally, stringent protocols for handling, storage, and disposal are essential components of comprehensive chemical management programs. Furthermore, regulatory frameworks play a pivotal role in shaping chemical management practices within the electronics manufacturing sector. Compliance with local and international regulations such as REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) and RoHS (Restriction of Hazardous Substances) is imperative to ensure the safety of workers and the environment. However, despite these efforts, challenges persist. Balancing the need for innovation and productivity with chemical safety requirements remains a significant challenge for manufacturers. Additionally, global supply chain complexities add another layer of complexity to chemical management efforts. Effective chemical management in electronics manufacturing demands a multi-faceted approach encompassing technological innovation, regulatory compliance, and a commitment to worker health and environmental stewardship. By addressing these challenges collaboratively, the industry can strive towards safer and more sustainable practices.

Electrochemical Deposition in Vertical Tubes : An Hydrodynamic and Mass Transfer Study

The present work is part of the research project NXCHROME led by IRT M2P. It concerns the chemical engineering of metallic hard chromium coatings on internal surface of large tubular parts. These parts are intended to be used in several sectors of activity (aeronautics, armament, energy...). Thus, taking into account severe specifications related to these applications, the parts will be very strongly solicited thermomechanically during their use, which requested high performances to increase substrate's life. In the current process, tubes are treated vertically, by electrodeposition from a hexavalent chromium salt based (chromic acid) electrolyte. These electrolytes have the advantage of being efficient, easy to use, with well known functions. However, they have a low faradic yield (<20%), leading to an important production of bubbles (cathodic and anodic).These bubbles create the fluid motion, and eventually govern hydrodynamic, liquid flow and mass transfer of the species in the tube.It is important to note that the use of CrVI salts has been prohibited since 2017 (except for authorizations for applications without alternatives) by the European regulation REACh (Registration, Evaluation, Authorization and restriction of Chemicals). Indeed, hexavalent chromium is classified in Appendix XIV among SVHC (substances of very high concern), due to its high toxicity (CMR compound : Carcinogenic, Mutagenic and Reprotoxic) and the high danger it represents for coworkers using this compound. The objective of NXCHROME is to find a alternative process with a "REACh compatible" electrolyte based on an innovative trivalent chromium. The modus operandi and the electrochemical mechanisms involved are completely different and less well known, compared to the former electrolyte. Nevertheless, it keeps this low faradic yield and the liquid agitation mode in tubular parts will remains identical.Nevertheless, this change is a good opportunity for a deep investigation in the "bubble induced hydrodynamic" which occurs during plating time, and to collect all reliable information on fluids behavior. Then, two main research axis have been considered. The first one is done via the numerical simulation of the secondary current distribution, i.e. taking into account the electrical phenomena in the electrolyte (ohmic drop), the geometry of the system and the kinetics of the electrochemical reactions. This part is in collaboration with HIVELIX company. The second one trhought the design and elaboration of a large size experimental set-up in stainless steel and PMMA (φ = 40mm, L = 3000mm) Figure 1. This ste-up includes electrochemically active cathode parts (production of bubbles by hydrolysis), and transparent parts (windows of observations of the bubbles, according to the height of the tube). As it is the bubble production which puts in movement the fluid with their vertical displacement towards the surface, informations on their size and behavior are of primary importance. Their speed is determined by their size (depending on the distance covered and the coalescence) and the liquid physical properties.To mimic the chromium electrolyte, a transparent saline solution has been chosen and prepared by adjusting its parameters to be identical to the industrial electrolyte (viscosity, conductivity...), while allowing bubble production on the central electrode surface.Data collection and order of magnitude are done by various means, namely flow rate measurements, gas retention within the liquid and high frequency camera shots (bubble size, bubble velocity, coalescence...). Figure 1

Is there any added value of the second generation in the Extended One-Generation Reproductive Toxicity Study (EOGRTS)? A retrospective analysis of 24 EOGRTS

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.

Occurrence and Regulatory Evaluation of Contaminants in Tattoo Inks

Tattooing has been an enduring form of body art since ancient times, but it carries inherent health risks, primarily due to the complex composition of tattoo inks. These inks consist of complex mixtures of various ingredients, including pigments, solvents, impurities and contaminants. This literature review aims to shed light on the organic and inorganic contaminants present in tattoo inks prior to the implementation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation in 2022. This review shows that the most common contaminants are polycyclic aromatic hydrocarbons (PAHs), with a concentration range of 0.005–201 mg/kg, mainly detected in black tattoo inks, and primary aromatic amines (PAAs), with a concentration range of 0.5–1100 mg/kg, and heavy metals such as lead (0.01–14.0 mg/kg) and chromium(VI) (0.16–4.09 mg/kg) which are detected in almost all tattoo inks. When compared to the new concentration limits outlined in REACH, it is clear that a significant part of these contaminants would be considered non-compliant. However, the results of the review are limited due to the lack of quantitative data on contaminants in tattoo inks. In addition, the future implementation of REACH is expected to lead to changes in the composition of tattoo inks, which will affect the presence of contaminants.

The use of alternatives assessment in chemicals management policies: Needs for greater impact.

Alternatives assessment is a methodology used to identify, evaluate, and compare potential chemical and nonchemical solutions with a substance of concern. It is required in several chemicals management regulatory frameworks, with the objective of supporting the transition to safer chemistry and avoiding regrettable substitutions. Using expert input from symposium presentations and a discussion group hosted by the Association for the Advancement of Alternatives Assessment, four case examples of the use of alternatives assessment in regulatory frameworks were evaluated and compared: (1) the US Environmental Protection Agency Significant New Alternatives Policy (USEPA SNAP), (2) authorization provisions in the EU REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) regulation, (3) the California (CA) Safer Consumer Products (SCP) Program, and (4) the Safer Products for Washington (WA) Program. Factors such as the purpose of the alternatives assessment, the timeline of actions, who completes the assessment, the role of stakeholder engagement, and the regulatory response options for each policy are outlined. Through these presentations and expert discussions, four lessons learned about the use of alternatives assessments in regulatory policy emerged: (1) the goal and purpose of the regulatory framework significantly affects its ability to result in safer substitution, (2) existing frameworks struggle with data access and insufficient stakeholder engagement, (3) some frameworks lack clear decision rules regarding what is a safer and feasible alternative, and (4) regulatory response options provide limited authority for enforcement and do not adequately address options where alternatives are unavailable or limited. Five recommendations address these lessons as well as how the application of alternatives assessment in regulatory settings could have greater impact in the future. This synthesis is not meant to be a comprehensive policy analysis, but rather an assessment based on the perspectives from experts in the field, which should be supplemented by formal policy analysis as policies are implemented over time. Integr Environ Assess Manag 2023;00:1-11. © 2023 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Cosmetic UV filters in the environment-state of the art in EU regulations, science and possible knowledge gaps.

The aim of this work was to review the principals of environmental hazard and risk assessment (ERA) of cosmetic UV filters registered under EU REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). Furthermore, effects as obtained from non-standardized testing methods and organisms from scientific literature were compared against the predicted no effect concentrations (PNECs) as derived based on standardized test methods for the various environmental compartments under REACH. The REACH dossiers at the ECHA webpage were screened for available information related to basic physico-chemical data (i.e. water solubility, octanol-water partitioning coefficient), PNECs and associated data (data basis, assessment factors (AFs)). Scientific literature was screened for available ecotoxicity data and the adverse effect levels were compared against the derived PNECs under REACH. Current approaches for environmental risk assessments of UV filters were evaluated for its applicability for a direct release scenario. Under REACH, PNECs were derived for all hazardous UV filters. Although, PNECs were often derived for various environmental compartments (i.e. freshwater, marine water, sediment, soil), results from literature focused on aquatic data. Effects as observed within scientific literature matches in principle with the hazardous profile of the UV filters. Effects levels both on the acute and the chronic toxicity as retrieved from the non-standardized test organisms (literature) were above the derived PNECs under REACH. Currently, ERAs performed for cosmetic UV filters under REACH are solely tonnage driven and thus do not fully capture the use in sunscreens and associated leisure activities. Existing EU REACH regulation is considered as sufficient to evaluate the environmental safety of UV filters used in sunscreens. To cover the direct release of UV filters due to various leisure activities into the aquatic freshwater and marine environment, an additional application-based ERA is considered necessary.

Analysis of health concerns not addressed by REACH for low tonnage chemicals and opportunities for new approach methodology.

In Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) the criterion for deciding the studies that must be performed is the annual tonnage of the chemical manufactured or imported into the EU. The annual tonnage may be considered as a surrogate for levels of human exposure but this does not take into account the physico-chemical properties and use patterns that determine exposure. Chemicals are classified using data from REACH under areas of health concern covering effects on the skin and eye; sensitisation; acute, repeated and prolonged systemic exposure; effects on genetic material; carcinogenicity; and reproduction and development. We analysed the mandated study lists under REACH for each annual tonnage band in terms of the information they provide on each of the areas of health concern. Using the European Chemicals Agency (ECHA) REACH Registration data base of over 20,000 registered substances, we found that only 19% of registered substances have datasets on all areas of health concern. Information limited to acute exposure, sensitisation and genotoxicity was found for 62%. The analysis highlighted the shortfall of information mandated for substances in the lower tonnage bands. Deploying New Approach Methodologies (NAMs) at this lower tonnage band to assess health concerns which are currently not covered by REACH, such as repeat and extended exposure and carcinogenicity, would provide additional information and would be a way for registrants and regulators to gain experience in the use of NAMs. There are currently projects in Europe aiming to develop NAM-based assessment frameworks and they could find their first use in assessing low tonnage chemicals once confidence has been gained by their evaluation with data rich chemicals.

Implicit Values in the Recent Carbon Nanotube Debate

Carbon nanotubes (CNTs) are one of the first examples of nanotechnology, with a history of promising uses and high expectations. This paper uses the recent debate over their future to explore both ethical and value-laden statements which unsettle the notion of CNTs as a value-free nanotechnology and their regulation as purely a technical affair. A point of departure is made with the inclusion of CNTs on the Substitute-It-Now list by the Swedish NGO ChemSec, an assessment process that anticipates and complements the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation in Europe. An argument map is constructed to illustrate the core contention in the debate—should CNTs be substituted or not—which follows from a systematic literature review and content analysis of sampled journal articles. Nine arguments are articulated that bolster one of two camps: the pro-substitution camp or the contra-substitution camp. Beneath these arguments are a set of three implicit values that animate these two camps in prescribing competing interventions to resolve the dispute: (i) environmental protection and human safety, (ii) good science, and (iii) technological progress. This leads to a discussion around the regulatory problem of safeguarding conflicting values in decision-making under sustained scientific uncertainty. Finally, the study suggests further empirical work on specific nanomaterials in a pivot away from the abstract, promissory nature of nanotechnology and other emerging technologies in science, technology, and innovation policy. The examination of ethics and values is useful for mapping controversies in science and technology studies of regulation, even amongst experts in cognate research fields like nanomedicine and nanotoxicology.

Useful knowledge regarding tattoos

The number of people with tattoos has continued to increase in recent years. In the USA about 23% and in Europe 9-12% of the population have tattoos. In the German media (2019) and by the infoportal Statista (2017), it is assumed that 21-25% of citizens have tattoos and that the trend is increasing (Statista 2018: 36%). Men and women wear tattoos equally. The age group 20-29years dominates with almost 50% having tattoos. The following article describes the new regulations especially the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation, legal basis, and governmental controls on the subject of "tattoos". The composition of tattooing agents and testing options relevant for the user before and for the performance of tattooing are presented. Dermatologically associated diseases and testing procedures are listed. Since 70% of the population denies knowledge of this information even when they have tattoos themselves, this update is written as an overview for treating physicians and users.

ECHA reports progress on reducing animal tests

In vitro tests and other nonanimal methods are on the rise for ensuring the safety of chemicals in the European Union, according to a report from the European Chemicals Agency (ECHA). The report finds that read-across is the most common nonanimal method for assessing chemical risks under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. Read-across uses data from chemicals with known toxicity to assess the safety of other chemicals with similar properties. The report also finds a notable increase since 2019 in the use of in vitro test methods that involve human cells, tissues, or organs. Under REACH, in vitro tests are used primarily to obtain data on skin and eye irritation and skin sensitization. Other nonanimal methods include waiving the need for certain toxicity data and using computational models to predict toxicity based on chemical structures. Testing chemicals on vertebrate animals is permitted under REACH only

The Skin Sensitisation of Cosmetic Ingredients: Review of Actual Regulatory Status.

All cosmetics products must be safe under foreseeable conditions of use. Allergenic responses are one of the most frequent adverse reactions noted for cosmetics. Thus, the EU cosmetics legislation requires skin sensitisation assessment for all cosmetics ingredients, including the regulated ones (for which the full toxicological dossier needs to be analysed by the Scientific Committee on Consumer Safety (SCCS)) and those (perceived as less toxic) which are assessed by industrial safety assessors. Regardless of who performs the risk assessment, it should be carried out using scientifically and regulatory body-accepted methods. In the EU, reference methods for chemical toxicity testing are defined in the relevant Annexes (VII-X) of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation. Recommendations for Skin Sensitization (Skin Sens) testing are provided in Annex VII, and this particular endpoint information is required for all EU-registered chemicals. Historically, in vivo animal and human methods have been used. Both raise ethical doubts, and some of them cause practical problems in the objective analysis of skin sensitising potency. Previous decades of huge effort have resulted in the regulatory acceptance of the alternative Skin Sens IATA (Integrated Approaches to Testing and Assessment) and NGRA (Next Generation Risk Assessment). Regardless of the testing issues, a serious sociological problem are observed within the market: the consumer assumes the presence of strong sensitisers in cosmetics formulations and insufficient risk management tools used by the industry. The present review aims to provide an overview of methods for assessing skin sensitisation. Additionally, it aims to answer the following question: what are the most potent skin sensitisers used in cosmetics? The answer considers the mechanistic background along with the actual regulatory status of ingredients and practical examples of responsible industry solutions in the area of risk management.

Environmental exposure assessment of co-formulants in plant protection products under REACH.

It is a regulatory requirement to assess co-formulants in plant protection products (PPP) under the European Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation. The standard environmental exposure assessment framework for chemicals under REACH is a multicompartmental mass-balanced model and, at the local scale, is designed for use with urban (wide dispersive) or industrial (point source) emissions. However, the environmental release of co-formulants used in PPP is to agricultural soil and indirectly to waterbodies adjacent to a field and, for sprayed products, to the air. The Local Environment Tool (LET) has been developed to assess these specific emission pathways for co-formulants in a local-scale REACH exposure assessment, based on standard approaches and models used for PPP. As such, it closes a gap between the standard REACH exposure model's scope and REACH requirements to assess co-formulants in PPP. When combined with the output of the standard REACH exposure model, the LET includes an estimate of the contribution from other nonagricultural background sources of the same substance. The LET is an improvement over the use of higher tier PPP models for screening purposes because it provides a simple standardized exposure scenario. A set of predefined and conservatively selected inputs allows a REACH registrant to conduct an assessment without requiring detailed knowledge of PPP risk assessment methods or typical conditions of use. The benefit to the co-formulant downstream user (formulators) is a standardized and consistent approach to co-formulant assessment, with meaningful and readily interpretable conditions of use. The LET can serve as an example to other sectors of how to address possible gaps in the environmental exposure assessment by combining a customized local-scale exposure model with the standard REACH models. A detailed conceptual explanation of the LET model is provided here together with a discussion on its use in a regulatory context. Integr Environ Assess Manag 2023;19:1544-1554. © 2023 BASF SE, Bayer AG et al. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Modernizing persistence–bioaccumulation–toxicity (PBT) assessment with high throughput animal-free methods

The assessment of persistence (P), bioaccumulation (B), and toxicity (T) of a chemical is a crucial first step at ensuring chemical safety and is a cornerstone of the European Union’s chemicals regulation REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals). Existing methods for PBT assessment are overly complex and cumbersome, have produced incorrect conclusions, and rely heavily on animal-intensive testing. We explore how new-approach methodologies (NAMs) can overcome the limitations of current PBT assessment. We propose two innovative hazard indicators, termed cumulative toxicity equivalents (CTE) and persistent toxicity equivalents (PTE). Together they are intended to replace existing PBT indicators and can also accommodate the emerging concept of PMT (where M stands for mobility). The proposed “toxicity equivalents” can be measured with high throughput in vitro bioassays. CTE refers to the toxic effects measured directly in any given sample, including single chemicals, substitution products, or mixtures. PTE is the equivalent measure of cumulative toxicity equivalents measured after simulated environmental degradation of the sample. With an appropriate panel of animal-free or alternative in vitro bioassays, CTE and PTE comprise key environmental and human health hazard indicators. CTE and PTE do not require analytical identification of transformation products and mixture components but instead prompt two key questions: is the chemical or mixture toxic, and is this toxicity persistent or can it be attenuated by environmental degradation? Taken together, the proposed hazard indicators CTE and PTE have the potential to integrate P, B/M and T assessment into one high-throughput experimental workflow that sidesteps the need for analytical measurements and will support the Chemicals Strategy for Sustainability of the European Union.

The HBM4EU chromates study - Outcomes and impacts on EU policies and occupational health practices.

Within the EU human biomonitoring initiative (HBM4EU), a targeted, multi-national study on occupational exposure to hexavalent chromium (Cr(VI)) was performed. Cr(VI) is currently regulated in EU under REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and under occupational safety and health (OSH) legislation. It has recently been subject to regulatory actions to improve its risk management in European workplaces. Analysis of the data obtained within the HBM4EU chromates study provides support both for the implementation of these regulatory actions and for national enforcement programs and may also contribute to the updating of occupational limit values (OELs) and biological limit values for Cr(VI). It also provides useful insights on the contribution of different risk management measures (RMMs) to further reduce the exposure to Cr(VI) and may support the evaluation of applications for authorisation under REACH. Findings on chrome platers' additional per- and polyfluoroalkyl substances (PFAS) exposure highlight the need to also pay attention to this substance group in the metals sector. A survey performed to evaluate the policy relevance of the HBM4EU chromates study findings supports the usefulness of the study results. According to the responses received from the survey, the HBM4EU chromates study was able to demonstrate the added value of the human biomonitoring (HBM) approach in assessment and management of occupational exposure to Cr(VI). For future occupational studies, we emphasise the need for engagement of policy makers and regulators throughout the whole research process to ensure awareness, relevance and uptake of the results in future policies.

In silico Genotoxicity Prediction by Similarity Search and Machine Learning Algorithm: Optimization and Validation of the Method for High Energetic Materials

AbstractThe European regulation REACh (Registration, Evaluation, Authorization, and restriction of Chemicals) has placed responsibility on the industry to manage the risk from chemicals since 2006. In order to ensure a high level of protection of human health and environment, toxicity prediction methods are now a widely used tool for regulatory decision making and selection of leads in new substances design. These in silico methods are an alternative to traditional in vitro and in vivo testing methods, which are laborious, time‐consuming, highly expensive, and even involve animal welfare issues. Many computational methods have been employed to predict the toxicity profile of substances, but they are mostly adapted to pharmaceutical molecules and not to High Energetic Materials (HEMs).In line with these restrictions, ArianeGroup set up a collaborative project with the French CNRS to develop optimized tools for the prediction of HEM properties, such as genotoxicity. Several in silico methods can be used to predict the properties of molecules, such as QSAR, Local QSAR or Machine Learning. We already demonstrated that using Local QSAR allows for better predictions with a good reliability [1].We therefore developed a genotoxicity prediction tool based on the structural similarity search coupled with a supervised machine learning algorithm. This tool is composed of 3 predictive models: the Ames test, the Chromosomal Aberration test and the Mouse Lymphoma Assay. The aim of this paper is to evaluate the performance of these models to predict the genotoxicity of HEMs. We also present the methodology we applied to build these models and to optimize their performances. The dimensional reduction of the training set and the hyperparameters tuning of the different algorithms showed a performance acceleration and a significant reduction of the overfitting, which caused a decline in the generalization capacity of the predictive models. The performance of the predictive models was evaluated on a test set of HEMs and compared to the results of other prediction softwares.

Toxicity of Different Chemical Components in Sun Cream Filters and Their Impact on Human Health: A Review

Some chemical components in sun cream filters have endocrine-disrupting activity or can be carcinogenic, neurotoxic, bioaccumulative, allergens, or be toxic for human reproduction. It is important that sunscreens have safety requirements. The objective of this work is to compare sun cream filters used in conventional commercial sunscreens and those that are considered natural products, especially focused on endocrine-disrupting effects. In order to achieve the above objective, the compositions of different conventional and natural sun cream filters were evaluated and compared, taking into account the presence of the different sun cream filters whose effects were evaluated on the website specialized in safety and cosmetics, Environmental Working Group (EWG), and in the Register of chemical substances and mixtures in the EU Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation. The currently available evidence of each sun cream filter and their degree of safety has been summarized. Several organic sun cream filters present a potential risk to health and the environment; however, inorganic sun cream filters such as titanium dioxide and zinc oxide (ZnO and TiO2) show a very low risk in humans as they are not absorbed through intact or damaged tissues. The legislation does not oblige manufacturers to specify the concentration of each substance, which provides qualitative but not quantitative information for the consumer.

Key Properties for the Toxicity Classification of Chemicals: A Comparison of the REACH Regulation and Scientific Studies Trends

In the last half century, the improvements in quality of life owing to the development of the chemical industry are indisputable. However, despite global improvements, there has also been a large increase in pollution at the environmental level and this has caused relevant harmful risks not only to wildlife and the environment but also to human health. In response, governments have begun to regulate and control chemicals to prevent environmental pollution. At the European level, REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) was created with the aim to protect human/animal health and the environment from chemicals. Additionally, this regulation shows the main experimental tests that are needed to classify a chemical from a physicochemical and toxicological point of view. The main objective of this study is to compare the tests or experiments stipulated by the European REACH regulation with the studies carried out by the scientific community. To obtain this comparison, an exhaustive bibliographic review was carried out, analyzing the physicochemical properties and the (eco)toxicological information established by the European REACH regulation and scientific articles published in the Web of Science (WOS) database. The results obtained indicate that, although there are many authors who conducted tests indicated by the regulation, there are others whose essays or studies are not in line with the regulation; this may be because, on many occasions, the purpose of the information to be obtained is quite different.

Semi-automated harmonization and selection of chemical data for risk and impact assessment.

Chemical data for thousands of substances are available for safety, risk, life cycle and substitution assessments, as submitted for example under the European Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation. However, to widely disseminate reported physicochemical properties as well as human and ecological exposure and toxicological data for use in various science and policy fields, systematic methods for data harmonization and selection are necessary. In response to this need, we developed a semi-automated method for deriving appropriate substance property values as input for various assessment frameworks with different requirements for resolution and data quality. Starting with data reported for a given substance and property, we propose a set of aligned data selection and harmonization criteria to obtain a representative mean value and related confidence intervals per chemical-property combination. The proposed method was tested on a set of octanol-water partition coefficients (Kow) for an illustrative set of 20 substances, reported under the REACH regulation as example data source. Our method is generally applicable to any set of substances, and can assess specific distributions in quality and variability across reported data. Further research can likely extend our method for mining information from text fields and adapt it to available data reported or collected from other sources and other substance properties to improve the reliability of input data for risk and impact assessments.

Assessment of the Intestinal Absorption of Higher Olefins by the Everted Gut Sac Model in Combination with In Silico New Approach Methodologies.

To reduce the number of animals and studies needed to fulfill the information requirements as required by Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (EC no. 1907/2006), a read-across approach was used to support approximately 30 higher olefins. This study aimed to assess the absorption potential of higher olefins through the gut wall as the experimentally determined bioavailability which would strengthen the read-across hypothesis and justification, reducing the need for toxicity studies on all of the higher olefins. The absorption potential of a series of higher olefins (carbon range from 6 to 28, with five configurations of the double bond) was determined in the in vitro everted rat small intestinal sac model and subsequently ranked. In addition, in silico approaches were applied to predict the reactivity, lipophilicity, and permeability of higher olefins. In the in vitro model, everted sacs were incubated in “fed-state simulated small intestinal fluid” saturated with individual higher olefins. The sac contents were then collected, extracted, and analyzed for olefin content using gas chromatography with a flame ionization detector. The C6 to C10 molecules were readily absorbed into the intestinal sacs. Marked inter-compound differences were observed, with the amount of absorption generally decreasing with the increase in carbon number. Higher olefins with ≥C14 carbons were either not absorbed or very poorly absorbed. In the reactivity simulation study, the reactivity is well described by the position of the double bond rather than the number of carbon atoms. In the lipophilicity and permeability analysis, both parameter descriptors depend mainly on the number of carbon atoms and less on the position of the double bond. In conclusion, these new approach methodologies provide supporting information on any trends or breakpoints in intestinal uptake and a hazard matrix based on carbon number and position of the double bond. This matrix will further assist in the selection of substances for inclusion in the mammalian toxicity testing programme.