A New Online Database on Chemicals in Accordance with REACH Regulation

The need for comprehensive and reliable risk management of chemicals requires appropriate information, data integration, and sharing, as suggested in Europe by Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. REACH requires more sharing of responsibilities among authorities, chemical manufacturers, importers, and users to manage the risks that chemicals can pose to human health and the environment throughout their life cycle. This has obviously enlarged the audience of people who could be interested in gathering this information. A major bottleneck is that information sources on chemicals are frequently sparsely distributed, collected, and managed by different institutions, with different aims, resulting in several practical problems. This article describes the conceptual design and implementation of a free online access database (DESC) as an integrated information system on chemical substances in compliance with the REACH regulation. An interdisciplinary approach was applied by involving several experts from different disciplines (ecotoxicologists, chemists, information technology specialists, regulators). DESC contains relevant environmental and toxicological data (physico-chemical and ecotoxicological data, inclusion in priority lists, current classification and labeling, etc.) on more than 651 chemicals, which can be easily consulted by people with different degrees of expertise interested in knowing the risk from exposure to chemicals and their safe use.     

Introduction to the EU REACH legislation

FRAME initiatives on the European Union REACH (Registration, Evaluation and Authorisation of Chemicals) system for the safety testing and risk assessment of chemicals, first proposed as a White Paper in 2001, are summarised. These initiatives considered the scientific and animal welfare issues raised by the REACH proposals, and resulted in a number of suggestions for improvement, many of which seem to have been adopted during the current progress of the legislation through the European Council and European Parliament.     

The agro-production chain environmental management in the agricultural production-consumption chain

After promoting environmental certification of companies in a chain perspective (Udo de Haes & De Snoo, 1996) now the agro-production chain is worked out as a case study. The role of the different links in the chain, such as agricultural producers, processing industry, wholesale companies and retailers is discussed. Also the role of consumers and authorities is described. For every company in the chain the advantages of a company based approach will be a better image and a guaranteed-sale and/or supply. In comparison with a product based approach (ecolabelling) the steering forces in the agro-production chain will be the retailers and not the consumers. Because consumers only get information at company level the approach is less dependent on consumers behaviour in the shop.     

Improving structure and transparency in reliability evaluations of data under REACH: suggestions for a systematic method

Abstract

The goal of identifying hazardous chemicals registered under the Registration, Evaluation, Authorization and restriction of CHemicals (REACH) Regulation and taking appropriate risk management measures relies on robust data registrations. However, the current procedures for European chemical manufacturers and importers to evaluate data under REACH neither support systematic evaluations of data nor transparently communicate these assessments. The aim of this study was to explore how using a data evaluation method with predefined criteria for reliability and establishing principles for assigning reliability categories could contribute to more structured and transparent evaluations under REACH. In total, 20 peer-reviewed studies for 15 substances registered under REACH were selected for an in-depth evaluation of reliability with the SciRAP tool. The results show that using a method for study evaluation, with clear criteria for assessing reliability and assigning studies to reliability categories, contributes to more structured and transparent reliability evaluations. Consequently, it is recommended to implement a method for evaluating data under REACH with predefined criteria and fields for documenting and justifying the assessments to increase consistency of data evaluations and transparency.     

Integrated decision-tree testing strategies for acute systemic toxicity and toxicokinetics with respect to the requirements of the EU REACH legislation

Liverpool John Moores University and FRAME conducted a joint research project, sponsored by Defra, on the status of alternatives to animal testing with regard to the European Union REACH (Registration, Evaluation and Authorisation of Chemicals) system for the safety testing and risk assessment of chemicals. The project covered all the main toxicity endpoints associated with REACH. This paper focuses on the use of alternative (non-animal) methods (both in vitro and in silico) for acute systemic toxicity and toxicokinetic testing. The paper reviews in vitro tests based on basal cytotoxicity and target organ toxicity, along with QSAR models and expert systems available for this endpoint. The use of PBPK modelling for the prediction of ADME properties is also discussed. These tests are then incorporated into a decision-tree style, integrated testing strategy, which also includes the use of refined in vivo acute toxicity tests, as a last resort. The implementation of the strategy is intended to minimise the use of animals in the testing of acute systemic toxicity and toxicokinetics, whilst satisfying the scientific and logistical demands of the EU REACH legislation.     

Assessment of local wood species used for the manufacture of cookware and the perception of chemical benefits and chemical hazards associated with their use in Kumasi,Ghana

Background

Historical proven wood species have no reported adverse health effect associated with its past use. Different historical proven species have traditionally been used to manufacture different wooden food contact items. This study uses survey questionnaires to assess suppliers’, manufacturers’, retailers’ and consumers’ (end-users’) preferences for specific wood species, to examine the considerations that inform these preferences and to investigate the extent of awareness of the chemical benefits and chemical hazards associated with wooden food contact material use.

Methods

Through the combined use of a cross sectional approach and a case study design, 25 suppliers, 25 manufacturers, 25 retailers and 125 consumers (end-users) of wooden food contact materials in four suburbs in Kumasi Metropolitan Area (Anloga junction, Ahinsan Bus Stop, Ahwia-Pankrono and Race Course) and Ashanti Akyim Agogo in the Ashanti Akyim North District of the Ashanti Region were administered with closed ended questionnaires. The questionnaires were prepared in English, but local language, Twi, was used to translate and communicate the content of the questionnaire where necessary.

Results

Suppliers’, manufacturers’ and retailers’ preferences for specific wood species for most wooden cookware differed from that of consumers (end-users). But all respondent groups failed to indicate any awareness of chemical benefits or chemical hazards associated with either the choice of specific wood species for specific wooden cookware or with the general use of wooden food contact materials. The lack of appreciation of chemical benefits or hazards associated with active principles of wooden cookware led to heavy reliance of consumers (end-users) on the wood density, price, attractive grain pattern and colour or on the judgement of retailers in their choice of specific species for a wooden cookware.

Conclusion

This study contributes some practical suggestions to guide national policy development on improvement in quality of available wooden food contact materials in Ghana.

     

Smartphone repairability indexes in practice: Linking repair scores to industrial design features

Policymaking mediates the relationships between manufacturers and consumers, thus defining the boundaries for the philosophies of production set forth by major companies. Research states that policymaking falls short in addressing the waste issues, natural resources consumption, greenhouse gas emissions, and other negative impacts posed by premature obsolescence; only recently have the “right-to-repair” guidelines demanded by environmental organizations and communities of citizens been included in policymaking. The introduction of the Index of Repairability in France as information at the point of sale aims to inform consumers and support their decision-making in purchasing more repairable products. In this paper, we consider the two Indexes of Repairability publicly available to consumers—in the French legislation and iFixit—and assess their application to smartphones from three manufacturers. The study establishes links between the scores and the industrial design features that promote or hinder repairability, service factors and information for self-repair, authorized repair, and independent repair. Data collection considers the available information for consumers and citizens by using netnography and secondary data from manufacturers, policymakers, and communities of users. Our findings suggest that higher scores that indicate easier repairability are not limited to product architectures that follow design for disassembly guidelines. Smartphones that are difficult to repair can still score high, and thus be perceived as easier to repair, if manufacturers provide high quality and affordable service. This paper discusses the results of the ongoing development of repairability scores for smartphones, thus suggesting paths for future research to improve methods and policies to support a longer lifetime of products.     

Product Chain Actors' Potential for Greening the Product Life Cycle

The challenge in working with environmental improvements is to select the action offering the most substantial progress. However, not all actions are open to all actors in a product chain. This study demonstrates how life cycle assessment (LCA) may be used with an actor perspective in the Swedish postfarm milk chain. The potential measures were identified, applied by the dairy, retailer, and household, that gave the most environmental improvement in a life cycle perspective. Improved energy efficiency, more efficient transport patterns, reduced milk and product losses, and organic labeling were investigated. Milk, yogurt and cheese were considered. After LCAs of the products were established, improvement potentials of the actors were identified and quantified. The quantification was based mostly on literature studies but also on assumptions. Then the LCAs were recalculated to include the estimated improvement potential. To find the action with the greatest potential, the environmental impacts of the modified and original LCAs were compared for each actor. No action was superior to any other from the dairy perspective, but reduced wastage lowered most impacts for all three products. For retailers, using less energy is the most efficient improvement. From the household perspective, reducing wastage gives unambiguously positive results. When households choose organic products, reductions in energy use and greenhouse gases are even larger, but eutrophication increases. Overall, households have greatest potential for improvement while yogurt is the product offering the most improvement potential.     

Collection and Dissemination of Exposure Data Throughout the Chemical Value Chain: A Case Study from a Global Consumer Product Industry

The human and environmental safety of chemicals in formulated consumer products has for decades been important for product manufacturers and ingredient suppliers. However, prior to the mid-1990s, the underlying product safety data were largely not publicly available. The U.S. Environmental Protection Agency's Chemical Right-to-Know Program and a related program of the Organization of Economic Cooperation and Development have since been the catalysts for the broad dissemination of standardized hazard datasets for thousands of high production volume (HPV) chemicals in commerce around the globe. The formulated consumer products industry took the additional step of developing and summarizing the science around exposure to their products, largely cleaning products and personal care products, in order to be able to characterize and communicate the safety of their products. Perhaps even more significant was the collection and circulation of information surrounding the habits and practices of product use, and ingredient concentrations in products. The objective of this article is to detail the methods used for collection of this information by the American Cleaning Institute (ACI), and the process by which hazard and exposure information may be used in screening-level risk assessments. These data and methods appear in a number of ACI's publications (http://www.aciscience.org).     

The new EU REACH regulation has finally been adopted: is this the end of the campaign trail... or just the beginning?

The final EU REACH legislation has recently been adopted. This article considers the progress that has been made toward reducing the numbers of animals likely to be required to fulfil the testing requirements, and also considers the benefits to animal welfare and science that have arisen since the original REACH system proposals were published in 2003. Several positive changes have been made, including: the use of exposure-based testing; the requirement for scientific justification of any proposed animal testing; mandatory data sharing; and the fact that the EU is to take responsibility for the development and validation of alternative methods. While these changes are to be commended, there is still much room for improvement, particularly with respect to the adoption of integrated testing strategies that make maximum use of non-animal approaches to expedite the risk assessment process of existing chemicals, with the use of refined and updated animal tests only as a last resort.     

Trends in Risk Assessment of Chemicals in the European Union

Current legislation in the European Union (EU) requires a risk assessment for industrial chemicals. The underlying procedures and paradigms of such EU risk assessment for new and existing chemicals are explained. The risk assessment is performed according to a harmonised methodology, laid down in the Technical Guidance Documents (TGD). Important new, technical risk assessment aspects covered in a recent revision round of the TGD are highlighted. The most prominent change in the environmental TGD part is the addition of the marine risk assessment, including a Persistent Bioaccumulation and Toxicity (PBT) assessment. In the human health part a significant change is the new data requirement for reproductive toxicity. The performance of both the risk assessment and the risk reduction phase of EU existing chemicals have been evaluated. An important conclusion was that our a priori knowledge on possible risks of chemicals is poor. The European Commission has recently launched a proposal (REACH) for drastically changing the risk management process of industrial chemicals in the EU. Major changes are a shift in responsibility from authorities to industry (including downstream users) for the safe use of chemicals, an acceleration of data collection for ‘non-assessed’ chemicals, and an authorization step for substances of very high concern.     

A review of the status of alternative approaches to animal testing and the development of integrated testing strategies for assessing the toxicity of chemicals under REACH--a summary of a DEFRA-funded project conducted by Liverpool John Moores University and FRAME

Liverpool John Moores University and FRAME were recently awarded a DEFRA tender to conduct a review of the status of alternative approaches to animal testing, and to recommend further research with regard to the forthcoming European Union REACH (Registration, Evaluation and Authorisation of Chemicals) system for the safety testing and risk assessment of chemicals. The outcome of the project is summarised, including the prospects for in vitro and in silico testing, areas where reduction and refinement could be applied, and how decision-tree integrated testing strategies could be used to reduce the number of animals needed to fulfil the testing requirements of the REACH system. This paper is a prelude to a series of individual papers on detailed suggestions for applying non-animal methods to each of the major toxicity endpoints in REACH.     

Developing sustainable food supply chains

This paper reviews the opportunities available for food businesses to encourage consumers to eat healthier and more nutritious diets, to invest in more sustainable manufacturing and distribution systems and to develop procurement systems based on more sustainable forms of agriculture. The important factors in developing more sustainable supply chains are identified as the type of supply chain involved and the individual business attitude to extending responsibility for product quality into social and environmental performance within their own supply chains. Interpersonal trust and working to standards are both important to build more sustainable local and many conserved food supply chains, but inadequate to transform mainstream agriculture and raw material supplies to the manufactured and commodity food markets. Cooperation among food manufacturers, retailers, NGOs, governmental and farmers' organizations is vital in order to raise standards for some supply chains and to enable farmers to adopt more sustainable agricultural practices.     

An unexpected challenge: ionizable compounds in the REACH chemical space

Purpose  

About 143,000 industrial chemicals have been pre-registered at the European Chemical Agency for registration according to REACH. The tools, models, and regressions employed for the chemical safety assessment of the registered compounds have limited applicability domains. Thus, it is an important question which fraction of the pre-registered compounds falls into these applicability domains.     

In vitro tests within the REACH information strategies

Tonnage-based information requirements are specified in the proposal on the regulation on the Registration, Evaluation and Authorisation of Chemicals (REACH) in the European Union. The hazard assessment for toxic endpoints should be performed by using a tiered approach, i.e. as an information strategy (IS), starting with an evaluation of all of the data already available, including animal in vivo and in vitro data, and human evidence and case reports, as well as data from (Quantitative)-Structure Activity Relationships ([Q]SARs) or read-across, before any further testing is suggested. To contribute to the implementation of the REACH system, the Nordic countries launched two projects: 1) a review of currently used testing strategies, including a comparison with the REACH requirements; and 2) the development of detailed ISs for skin and eye irritation/corrosion. The review showed that the ISs and classification criteria for the selected endpoints are inconsistent in many cases. In the classification criteria, human data and in vivo test results are usually the prerequisites. Other types of information, such as data from in vitro studies, can sometimes be used, but usually as supportive evidence only. This differs from the REACH ISs, where QSARs, read-across and in vitro testing are important elements. In the other part of the project, an IS for skin and eye irritation/corrosion was proposed. The strategy was "tested" by using four high production volume (HPV) chemicals: hydrogen peroxide, methyl tertiary-butyl ether (MTBE), trivalent chromium, and diantimony trioxide, but only MTBE and trivalent chromium are dealt with in this paper. The "test" revealed that in vivo data, human case reports and physical-chemical data were available and could be used in the evaluation. Classification could be based on the proposed IS and the existing data in all cases, except for the eye irritation/corrosion of trivalent chromium. Weight-of-evidence analysis appeared to be a useful step in the ISs proposed, and including it in the REACH strategies should be considered. For these chemicals, few in vitro and (Q)SAR data were available--more of these data would be generated, if the relevant guidance and legislation on classification were updated.     

Risk Assessment Using EUSES; Refinement Options to Estimate Atmospheric Transportation by its Operational Priority Substances Model (OPS)

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.     

A Statistical Approach for Estimation of Process Flow Data from Production of Chemicals of Fossil Origin (6 pp)

Goal, Scope and Background The life cycles of many products including textiles contain chemicals for which process flow data are not known or are too time consuming to collect. Although each chemical may not contribute significantly to the LCA results of the product, which might justify excluding them, but together their contribution could be significant. Similarly, rough estimates of the process flows for the production of a single chemical may be very uncertain and considered meaningless, while the estimates of the cumulative data of process flows for several chemicals may be less uncertain and be a meaningful contribution to the quality of the LCA results. There are methods for estimation of process flows for different types of products, with varying demands regarding input data and time and with varying accuracy of the results. This work contributes to the available methods, focusing on simple estimations for production of chemical substances. The goal was to create a fast method for estimation of emissions, resource and energy flows (process flows) for the production of chemicals, based on easily available data on the properties of the chemicals. The process flows investigated were limited to those normally associated with process industries and contributing most to depletion of resources, to global warming, acidification, eutrophication and photochemical ozone production, i.e. use of energy, crude oil, coal, natural gas, uranium in ore and emissions of CO2, SOx, NOx, NMVOC, methane, BOD, COD and total N. Toxic substances were excluded, since toxic emissions are substance specific and cannot be included in a generalization. Method Available data for the process flows for the production of chemicals of mainly fossil origin were correlated to properties of chemicals such as amount of carbon in the molecule, heat of formation and average number of chemical reaction steps in the production. The production procedures were found in readily available literature. Up to about six reaction steps were evaluated in the correlation study. The variations in the process flows among the chemicals studied were calculated. Results and Discussion There were weak correlations between average number of chemical reaction steps in the production and energy use, COD measured in water emissions, and SOx and NOx emissions to air. For the remaining properties of chemicals and process flows, there were only weak correlations for share of double bonding in the molecule if only molecules containing double bondings were included. Conclusions The precision in estimation of the process flows increases non-significantly when adding information on the number of reaction steps or share of double bonding for chemicals containing double bonding is added. Recommendations and Outlook It seems reasonable to start with a simple grouping method to estimate the process flows for the production of a chemical of fossil origin. Further investigations might investigate whether there is a correlation between process flows and the costs of chemicals, and further study the correlations between process flows and share of double bonding for chemicals containing double bondings.