Registration, Evaluation, Authorisation And Restriction Of Chemicals Regulation Research Articles

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.

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.

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.

Quantification of preservatives in tattoo and permanent make-up inks in the frame of the new requirements under the REACH Regulation.

According to the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) restriction, tattoo and permanent make-up (PMU) inks placed on the European Union market after January 4, 2022, shall not contain methylisothiazolinone, benzisothiazolinone (BIT), octylisothiazolinone (OIT), or other skin sensitizers in concentrations of 10 mg/kg or higher and phenoxyethanol (PE) or other eye irritants or damaging substances in concentrations of 100 mg/kg or higher. In addition, preservatives and other substances enlisted in Annex II to Cosmetic Product Regulation shall not be present in concentrations of 0.5 mg/kg or higher. This study aims to quantify 14 preservatives in 99 tattoo and 39 PMU inks from the Italian market and presents a comparison with concentration limits set by the REACH restriction. Inks were analysed by applying validated analytical methods based on liquid chromatography techniques. About 24.0%, 15.2% and 1.5% of the overall samples contained BIT, PE and OIT, respectively, at concentrations exceeding REACH concentration limits. The number of noncompliant tattoo inks (49.5%) would be significantly greater than that of the PMU inks (17.9%). About 40.6% of the samples would be noncompliant with the restriction for the presence of preservatives above the permitted level. Additional concentration limits will apply to skin sensitizing preservatives for proper labelling of inks under CLP (Classification, Labelling and Packaging) Regulation.

Effects of calcium cyanamide on Collembola in a standardized field test: Part 1. Rationale and performance of the study

BackgroundA field study lasting one year was performed to study the effects of a calcium cyanamide fertiliser (trade name: Perlka®) on Collembola in order to support the terrestrial risk assessment under the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation. Due to the lack of an appropriate guidance document, the design of the study was based on the ISO Guideline 11268–3, originally developed for earthworm field studies. However, the sampling procedure was adapted accordingly by applying ISO Guideline 23611–2, i.e. taking soil core and pitfall trap samples. Two groups of four plots each were treated with 200 kg/ha and 400 kg/ha Perlka®, respectively. A third group served as a fertiliser control, i.e. it was treated with a standard urea fertiliser (172.9 kg Piagran®/ha) at the same total nitrogen rate (79.5 kg/ha) as provided by the high Perlka® application rate. The fourth group served as negative control without any fertiliser treatment and the fifth group was treated with the reference item Agriclor® (480 g a.i./L chlorpyrifos), known to be toxic to springtails.ResultsIn total 16 different Collembola species were determined. For seven species, covering all life form types, a reliable statistical evaluation was possible, which was reflected in correspondingly low MDD values in the study. A statistically significant decrease of the abundance (at least 50%) on the reference item plots compared to the untreated control was observed for six species, thus demonstrating the sensitivity of the Collembola community.ConclusionNo long-lasting effects of the Perlka® application rates could be observed for any of the Collembola species. In order to support risk assessors in both industry and authorities in the interpretation of large and complex data sets typical for field studies with chemicals, further guidance on implementation and data interpretation is urgently needed.

Environmental Risk Assessment of Technical Mixtures Under the European Registration, Evaluation, Authorisation and Restriction of Chemicals—A Regulatory Perspective

The European Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation has been in force since 2007 and is intended to ensure a high level of protection for human health and the environment. The REACH regulation is based on the principle that manufacturers, importers, and downstream users take responsibility for their chemicals. Currently about 23 000 single chemicals are registered within the REACH legislation. A large proportion of substances registered under REACH end up in technical mixtures, intentionally manufactured as such, or generated mixtures containing byproducts of processes. Such mixtures that contain a number of different components are, for example, ink, paint, lacquer, mortar, or cleaning agents. However, REACH focuses on single substances and addresses the safe use of substances as such (e.g., bisphenol A) or substances in mixtures (e.g., bisphenol A used as an antioxidant in mixtures) and in articles (e.g., bisphenol A used as a monomer for polycarbonate production from which greenhouse sheets may be made). In contrast to other substance regulations, under REACH the registrants and downstream users of chemicals are responsible for the risk assessment. According to the REACH regulation, they also have the obligation to derive and communicate safe use conditions for their technical mixtures. Currently, no guidance document and no distinct obligations for an assessment of technical mixtures exist. In light of the available evidence for the joint exposures and effects of chemicals due to co-exposures, the need for approaches for a mixture assessment and improved data communications were highlighted by various stakeholders from industry, European member states, and the European Chemicals Agency (ECHA). The lead component identification (LCID) methodology and the safe use of mixtures information (SUMI) tool were proposed by the European Chemical Industry Council (Cefic) as working tools for the evaluation of the hazard potential, derivation of safe use conditions, and data communication for mixtures along the supply chain. The present paper analyzes the workability and pitfalls of these proposed methodologies from a regulatory perspective, aiming at a safe use of technical mixtures which considers the joint effects and exposures of its components. Integr Environ Assess Manag 2021;17:498-506. © 2021 Umweltbundesamt. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Benefits of Ryegrass on Multicontaminated Soils Part 1: Effects of Fertilizers on Bioavailability and Accumulation of Metals

Effects of three phosphorus fertilizers on the shoot biomass and on the accumulation of alkali, alkaline earth, and transition metals in the shoots and roots of ryegrass were studied with two contaminated garden soils. Phosphates were added in sustainable quantities in order to reduce the environmental availability of carcinogenic metals (e.g., Cd and Pb) and to enhance the bioavailability of alkali and alkaline earth metals as well as micronutrients needed by plants. Addition of Ca(H2PO4)2 was the most convenient way to (i) limit the concentration of Cd and Pb, (ii) keep constant the transfer of macro- and micronutrient from the soil to the ryegrass shoots, (iii) decrease the availability of metals, and (iv) increase the ratio values between potential Lewis acids and Cd or Pb in order to produce biosourced catalysis. For instance, the real phytoavailability was reduced by 27%–57% and 64.2%–94.8% for Cd and Pb, respectively. Interestingly, the real phytoavailability of Zn was the highest in the least contaminated soils. Even if soils were highly contaminated, no visual toxicity symptoms were recorded in the growing ryegrasses. This indicates that ryegrass is suitable for the revegetation of contaminated gardens. To promote the sustainable ryegrass production on contaminated soils for production of new organic fragrance and drugs in green processes according to REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) regulation, two processes should be recommended: assisted phytostabilization of the elements, and then assisted phytoextraction by using chelators.

Compartment-Specific Screening Tools for Persistence: Potential Role and Application in the Regulatory Context.

The persistence assessment under the European Union regulation Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) relies on compartment-specific degradation half-lives derived from laboratory simulation studies with surface water, aquatic sediment, or soil. Although these data are given priority, they are not available for most of the compounds. Therefore, according to the Integrated Assessment and Testing Strategy (ITS) for persistence assessment, results from ready biodegradability tests (RBTs) are used within a persistence screening to decide whether a substance is considered as "not persistent" or "potentially persistent." However, ready biodegradability is currently tested only in water. Consequently, there is a lack of approaches that include the soil and sediment compartments for persistence assessment at the screening level. In previous studies, compartment-specific screening tools for water-sediment (Water-Sediment Screening Tool [WSST]) and soil (Soil Screening Tool [SST]) were developed based on the existing test guideline Organisation for Economic Development and Co-operation (OECD TG 301C [MITI (Ministry of International Trade and Industry, Japan) test]). The test systems MITI, WSST, and SST were successfully applied to determine sound and reliable biodegradation data for 15 test compounds. In the present study, these results are used within the scope of a new alternative persistence screening approach, the Compartment-Specific Persistence Screening (CSPS). Compared to the persistence screening under REACH, the CSPS is a more conservative approach that provides additional reasonable results, particularly for compounds that sorb to sediment and soil, and for which the current standard persistence screening might be insufficient. Thus, the CSPS can be used to identify potentially persistent and nonpersistent compounds in the regulatory context by a comprehensive assessment that includes water, soil, and sediment. Moreover, experimentally determined half-lives from the compartment-specific screening tools can be used as input for multimedia models that estimate, for example, overall persistence (Pov ). The application of fixed half-life factors to extrapolate from water to soil and sediment, which is here demonstrated to be inappropriate, can thereby be avoided. Integr Environ Assess Manag 2019;00:000-000. © 2019 SETAC.

Integrated in silico strategy for PBT assessment and prioritization under REACH

Chemicals may persist in the environment, bioaccumulate and be toxic for humans and wildlife, posing great concern. These three properties, persistence (P), bioaccumulation (B), and toxicity (T) are the key targets of the PBT-hazard assessment. The European regulation for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) requires assessment of PBT-properties for all chemicals that are produced or imported in Europe in amounts exceeding 10 tonnes per year, checking whether the criteria set out in REACH Annex XIII are met, so the substance should therefore be considered to have properties of very high concern. Considering how many substances can fall under the REACH regulation, there is a pressing need for new strategies to identify and screen large numbers fast and inexpensively. An efficient non-testing screening approach to identify PBT candidates is necessary, as a valuable alternative to money- and time-consuming laboratory tests and a good start for prioritization since few tools exist (e.g. the PBT profiler developed by US EPA).The aim of this work was to offer a conceptual scheme for identifying and prioritizing chemicals for further assessment and if appropriate further testing, based on their PBT-potential, using a non-testing screening approach. We integrated in silico models (using existing and developing new ones) in a final algorithm for screening and ranking PBT-potential, which uses experimental and predicted values as well as associated uncertainties. The Multi-Criteria Decision-Making (MCDM) theory was used to integrate the different values. Then we compiled a new set of data containing known PBT and non-PBT substances, in order to check how well our approach clearly differentiated compounds labeled as PBT from those labeled as non-PBT. This indicated that the integrated model distinguished between PBT from non-PBT compounds.

SPERCS-A tool for environmental emission estimation

The European Union (EU) chemicals regulation Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) requires a hazardous substance registration to identify the uses of a substance and the corresponding conditions of safe use. This requirement includes a human and an environmental safety assessment. Exposure scenarios are developed and employed for estimating emissions resulting from the uses of hazardous substances. To support the environmental assessments, the REACH guidance documents define 22 environmental release categories (ERCs) with conservative release factors (RFs) to water, air, and soil. Several industry associations target the ERCs to more specific uses and respective emission scenarios to enable more realistic emission estimations. They have developed more than 190 specific ERCs (SPERCs) as standardized descriptions of operational conditions (OCs) and risk management measures (RMMs). SPERCs reflect the current good practice and are documented in factsheets. These factsheets contain the information necessary for environmental emission modeling. Key parameters are the substance use rate, the efficiency of the risk management measures (if applicable), and the RFs. These parameters can be based on literature or measured company data or are justified by qualitative arguments. The majority of SPERCs have been implemented as realistic worst-case emission values in screening-level chemical safety assessment (CSA) tools. Three regulatory reviews in Europe have established requirements for documenting the SPERCs and for justifying the RFs. In addition, each of the reviews included recommendations for improving the SPERCs. The latest review proposed a condensed factsheet that focuses on the essentials for exposure assessment and subsequent communication in safety data sheets. It is complemented with a background document for providing details on the emission scenarios and justifications. In the EU the SPERCs will be further progressed in a consensus process using the multi-stakeholder expert network on exposure scenarios. The SPERCs have the potential to be used in environmental risk assessments within other regulatory frameworks or in other geographical regions. Integr Environ Assess Manag 2016;12:772-781. © 2015 SETAC.

Rejestracja polimerow wg Rozporzadzenia REACH

According to the Article 2(9) of Regulation (EC) No 1907/2006 of The European Parliament and of The Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), polymers are exempt from registration and evaluation requirement. However, in accordance with the preamble of REACH Regulation "Polymers should be exempted from registration and evaluation until those that need to be registered due to the risks posed to human health or the environment can be selected in apracticable and cost-efficient way on the basis of sound technical and valid scientific criteria”. The article discuss in brief the results of analysis performed for The European Commission, which were presented in The Final Report. It aims to point out, how the registration process of polymers or some types of polymers could appear soon in EU and what producers, importers and downstream users of polymer could expect.

Implementation of the chemicals regulation REACH – Exploring the impact on occupational health and safety management among Swedish downstream users

In the present study we have examined how the European chemicals regulation Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) has influenced occupational risk management of chemicals at Swedish downstream user companies. The data were collected through interviews with occupational health and safety professionals, safety representatives and authority employees. The results show that most of the informants had scarce knowledge about REACH and that REACH implementation has not had any major impacts on downstream users’ occupational risk management, but the impacts the regulation has had were perceived as positive. For instance, clear substance identification and increased hazard information were appreciated improvements of safety data sheets (SDS). However, with regards to identifying how to safely use a substance or product neither the SDSs nor the attached exposure scenarios were perceived as sufficient. REACH was not perceived as a major driver for substitution but has had some impact on substitution, either by requiring it for certain substances as through the authorisation procedure or facilitating the identification of relevant substances to substitute as more information on hazards has become available. The obstacles to REACH implementation are similar to those of occupational health and safety legislation; lack of awareness, understanding and/or incentives to take action. Especially smaller companies with their limited resources lag behind. Reaching the full potential of REACH requires more work on motivating and supporting downstream users to fulfil their REACH obligations.

Consideration of criteria required for assignment of a (skin) sensitiser a substance of very high concern (SVHC) under the REACH regulation

The identification, characterisation, risk assessment and risk management of materials that cause allergic sensitisation is an important requirement for human health protection. It has been proposed that for some chemical and protein allergens, and in particular for those that cause sensitisation of the respiratory tract (associated with occupational asthma), it may be appropriate to regard them as Substances of Very High Concern (SVHC) under the provisions of REACH (Registration, Evaluation, Authorisation and restriction of CHemicals). We have argued previously that categorisation of sensitising agents as SVHC should be used only in exceptional circumstances. In the present article, the subject of SVHC is addressed from another perspective. Here the information that would be required to provide a compelling case for categorisation of a skin sensitising substance as a SVHC is considered. Three skin sensitising chemicals have been identified to serve as working examples. These are chromate, a potent contact allergen, and the skin sensitisers formaldehyde and isoeugenol. The key criterion influencing the decision regarding a skin sensitiser being categorised as SVHC is the extent to which impacts on the quality of life are reversible. Consequently, SVHC categorisation for skin sensitising chemicals should be used only in exceptional circumstances.

Integrated testing strategy (ITS) for bioaccumulation assessment under REACH

REACH (registration, evaluation, authorisation and restriction of chemicals) regulation requires that all the chemicals produced or imported in Europe above 1 tonne/year are registered. To register a chemical, physicochemical, toxicological and ecotoxicological information needs to be reported in a dossier. REACH promotes the use of alternative methods to replace, refine and reduce the use of animal (eco)toxicity testing. Within the EU OSIRIS project, integrated testing strategies (ITSs) have been developed for the rational use of non-animal testing approaches in chemical hazard assessment. Here we present an ITS for evaluating the bioaccumulation potential of organic chemicals. The scheme includes the use of all available data (also the non-optimal ones), waiving schemes, analysis of physicochemical properties related to the end point and alternative methods (both in silico and in vitro). In vivo methods are used only as last resort. Using the ITS, in vivo testing could be waived for about 67% of the examined compounds, but bioaccumulation potential could be estimated on the basis of non-animal methods. The presented ITS is freely available through a web tool.

Semipolar polycyclic aromatic compounds: Identification of 15 priority substances and the need for regulatory steps under REACH regulation

Semipolar polycyclic aromatic compounds (sPACs) are frequently found in association with homocyclic polycyclic aromatic hydrocarbons (PAHs) in substances of unknown or variable composition, complex reaction products, or biological materials (UVCBs) from coal or crude oil and products derived thereof. However, major information deficiencies exist with regard to their prevalence and their toxicological and ecotoxicological potential, persistency, and bioaccumulation characteristics. Therefore, in this work, the environmental concern and relevance of sPACs was addressed in a general, stepwise approach. First, a large list of sPACs was collected and subsequently refined by assessing their persistence, bioaccumulation, and toxicity (PBT) properties by quantitative structure-activity relationship (QSAR) methods and their relevance by determining their respective frequency of occurrence. In this way, 15 priority sPACs were identified. These 15 priority sPACs were further characterized in detail with respect to their ecotoxicological properties, environmental behavior, carcinogenicity, and genotoxicity attributes. All of these 15 substances were quantified in distillate or product samples. In the next step, some principles for nomination of indicator substances, indicative for the overall content of sPACs, are derived. Data gaps on ecotoxicological endpoints preclude final conclusions, but the respective necessary supplemental tests were identified. Five of the 15 sPACs were tentatively characterized as potential substances of very high concern (SVHC) for the environment. The overall results of this study also clearly show that regulatory risk management of homocyclic PAHs within the European Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) does not address the environmental concern created by sPACs within UVCBs from coal or crude oil. The study proves the need for additional regulatory steps under REACH and suggests indicator substances for their enforcement.

Why are nanomaterials different and how can they be appropriately regulated under REACH?

BackgroundFor nanomaterials, not only their chemical composition but also their morphological properties and surface properties determine their characteristics. These properties do not only differ in comparison to the corresponding bulk material but also between different nanoforms of the same substance. Changes in these physico-chemical characteristics can cause changes in chemical properties, reactivity, (photo-) catalytic activities and energetic properties and in turn alter their (eco-) toxicity, fate and behaviour in environmental media and toxico-kinetics. Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) deals with chemical substances in general and although there are no special provisions that explicitly refer to nanomaterials, they are principally covered by REACH. In October 2012, the European Commission published the Second Regulatory Review on Nanomaterials. In February 2013, the REACH Review from the European Commission was published. Both papers address questions about the regulation of nanomaterials in REACH. The Commission proposes to improve the future situation by adaptation of the REACH Regulation. However, the European Commission plans to revise the annexes only and not the main text of the regulation.Results and conclusionsIn this publication, the authors present their considerations and recommendations on how REACH can adequately be adapted to nanomaterials. In the author's view, the bulk form and nanoforms of the same chemical composition should be treated as the same substance in the context of REACH. However, the regulation of nanomaterials under REACH has to meet specific requirements. Taking into account the plurality of physico-chemical characteristics and resulting changes in the hazard profile, an approach must be found to adequately cover nanomaterials under REACH. Accordingly, the REACH information requirements have to be adapted. This includes lower tonnage thresholds for different REACH obligations (e.g. registration, chemical safety report) which are justified by highly dispersed use together with low mass application, linked with the uncertainties regarding (eco-) toxicity, environmental fate and exposure. If the physico-chemical characteristics of different nanoforms of the same substance differ in a relevant manner they have to be considered separately for further test performance and REACH requirements.

A New Online Database on Chemicals in Accordance with REACH Regulation

ABSTRACT 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.

On the development of QSPR models for regulatory frameworks: The heat of decomposition of nitroaromatics as a test case

Many regulatory frameworks, e.g. related to the Transport of Dangerous Goods, the Registration, Evaluation, Authorisation and restriction of chemicals (REACH) or the Classification, Labelling and Packaging of substances and mixtures (CLP), require the characterization of the hazards of chemicals, which could be complex. In particular, the REACH regulation involves an extensive quantity of works, to gather toxicological, eco-toxicological and physico-chemical properties for a large number of compounds. So, the full characterization by experimental way is time-consuming and cost-expensive. Alternative methods are therefore encouraged to complement experimental tests. The Quantitative Structure–Property Relationships (QSPR) approach is one of the recommended methods, provided that they are developed within the rigorous guidelines proposed by the Organization for Economic Co-operation and Development (OECD). In this context, a series of nitroaromatic compounds has been analyzed to achieve new QSPR models for the prediction of their heat of decomposition respecting the requirements for application in regulatory frameworks.Three multilinear models were obtained upon the set of descriptors considered for their development (constitutional, topological or both) that do not need any preliminary time expensive quantum chemical calculations. They were tested by internal and external validation tests. Good performances for the two ones including constitutional descriptors were obtained in particular in terms of predictive power in a well defined applicability domain (RIN2 = 0.81–0.87). They are easier to apply than our previous quantum chemical based model, since they do not need any preliminary calculations.

Risk assessment of nanomaterials in cosmetics: a European union perspective

In Europe, the data requirements for the hazard and exposure characterisation of chemicals are defined according to the REACH regulation and its guidance on information requirements and chemical safety assessment (Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), and its guidance documents; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:396:0001:0849:EN:PDF; and at: http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm). This is the basis for any related risk assessment. The standard reference for the testing of cosmetic ingredients is the SCCP’s ‘Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation’ (The SCCP’s Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (2006); available at: http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_03j.pdf), which refers to the OECD guidelines for the testing of chemicals (The OECD Guidelines for the Testing of Chemicals as a collection of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to assess the safety of chemical products; available at: http://www.oecd.org/topic/0,2686,en_2649_34377_1_1_1_1_37407,00.html). According to the cosmetics directive [76/768/EEC], compounds that are classified as mutagenic, carcinogenic or toxic to reproduction are banned for the use in cosmetic products. Since December 2010, the respective labelling is based on the rules of regulation (EC) No. 1272/2008 (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, Official Journal L 353, 31/12/2008, pages 1–1355; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:en:PDF) on classification, labelling and packaging of substances and mixtures (CLP). There is no further impact from the CLP regulation on cosmetic products, because regulation (EC) No. 1223/2009 on cosmetic products defines its own labelling rules (Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF). Special notification procedures are mandatory for preservatives, colourants and UV-filters where a safety approval from the European ‘Scientific Committee on Consumer Safety’ (SCCS) is needed prior to marketing. The risk assessment of nanomaterials in consumer products still poses a significant challenge as highlighted by the example of UV-filters in sunscreens since nanomaterials cannot be classified as a homogenous group of chemicals but still need to be addressed in risk characterisation on a case by case basis.