Technical and Scientific Reports
ECHA publishes reports on scientific and technical issues. Some of these reports summarise the discussion of workshops organised by ECHA on topical issues in regulatory science. The Agency may also commission work by consultants, such as survey projects or state of the art reviews, and the reports here present their findings. Therefore, these reports do not represent the views or position of ECHA.
|Title||Description||Date of publication|
|The report on the regulatory applicability of non-animal approaches reviews their current status under the EU chemicals legislation.||It describes the main types of non-animal approaches, adaptation rules, information requirements and needs for relevant (eco)toxicological properties. For each relevant information requirement, the report describes the potential non-animal approaches, the challenges and future perspectives.||November 2017||Download|
|Segmentation of potential SME Market for ECHA Cloud Services for REACH Registration||This study on the segmentation of the small and medium-sized enterprise (SME) market confirms uncertainties regarding the SMEs’ intentions to register their substances by the 31 May 2018 deadline. The main hurdle seems to be the cost of data needed for registration. It also makes recommendations for the Agency on how to convince SMEs to use and benefit from the ECHA Cloud Services.||October 2017||Download|
|Insights on the impact of REACH & CLP implementation on industry’s strategies in the context of sustainability||Several large corporations (e.g. stock-listed companies) have for a number of years included focuses on sustainable development, Responsible Care and corporate social responsibility in their business activities. Sustainability is often mentioned as a key goal by organisations and many of them are actively integrating sustainability principles into their business models. |
Today, social trends around sustainability as well as emerging regulatory requirements are seen to create both pressure and opportunities for companies. When it comes to compliance with chemical regulations, some companies see it only as a burden, whereas others try to turn the compliance obligations into business opportunities.
|Socio-economic impacts of REACH authorisations||One new element of the REACH Regulation is the authorisation title. It aims to ensure a sufficiently high level of protection for human health and the environment whilst allowing firms to continue the use of specific substances of very high concern (SVHCs), if the risks are adequately controlled. Otherwise, uses may still be authorised if the socio-economic benefits from the use of the substance are shown to outweigh the risks connected with its use and there are no suitable alternative substances or technologies that are economically and technically viable. Taking into account the good functioning of the internal market, the European Commission would grant an authorisation for the continued use.||September 2017||Download|
|Scientific review on the link between the narcotic effects of solvents and (developmental) neurotoxicity.||This scientific report summarises the current evidence on adverse neurological effects exerted by organic solvents with narcotic properties. Information on neurotoxicity in both adults and developing organisms are presented. It has been acknowledged that neurotoxicity in adult animals is a particular concern for developmental neurotoxicity. The question whether narcosis in adult animals should be considered as a concern for developmental neurotoxicity is addressed.||June 2017||Download|
|Study on the effects of the process of applying for authoristation for chemicals on the athorisation list.||14 Finnish companies and a national competent authority were interviewed by Aalto University students to find out how the process of applying for authorisation to continue using chemicals that are on the authorisation list of REACH affected them. The study, commissioned by ECHA, identified improved networking of companies who participated in consortiums, improved worker protection, accelerated substitution and increased awareness of the safety aspects of alternatives in some of the companies. The report highlights the importance of an effective flow of information between all relevant actors (applicants, suppliers, customers, consultants, sector associations and authorities). The report also gives an overview of the time and cost distribution companies had to invest in their applications. According to the report companies have not passed on the costs of applications for authorisation to their customers.||May 2017||Download|
|Read-across assessment framework (RAAF) - considerations on multiconstituent substances and UVCBs||This document describes the additional key issues for the ECHA experts assessing such cases. Such considerations may also be relevant for registrants in the justification of read-across cases. However, due to the case-specific nature of read-across cases for multi-constituent substances and/or UVCBs, the document does not provide considerations on how to deal with the identified issues when adaptations using read-across are developed.||March 2017||Download|
|How ECHA identifies the design for the extended one-generation reproductive toxicity study (EOGRTS) under dossier evaluation||The document explains how ECHA identifies and concludes on the design of EOGRTS under dossier evaluation and discusses the crucial information sources for defining the EOGRTS design and triggering the study itself. |
The EOGRTS is a modular test method for reproductive toxicity. Its different modules cover the basic study design and separate modules for breeding and assessing a second filial generation, testing for developmental neurotoxicity and developmental immunotoxicity. The appropriate study design needs to be defined, justified and documented. For deciding the need and the study design, a multitude of scientific information needs to be searched and evaluated.
|Improving the Identification, Evaluation, Adoption and Development of Safer Alternatives||Chemical substitution is commonly defined as “the replacement or reduction of hazardous substances in products or processes by less hazardous or non-hazardous substances, or by achieving an equivalent functionality via technological or organisational measures.” It is a longstanding risk management approach in Europe and is a goal of the European Union (EU), Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. In particular, the authorisation and restriction processes are two important regulatory drivers of substitution within REACH. Substances of very high concern (SVHC) that are made subject to authorisation require an analysis of alternatives to ensure that these highly hazardous substances are progressively replaced by safer alternative substances or technologies where economically and technically feasible. Member State or European Chemical Agency (ECHA) proposals seeking to restrict substances that pose an unacceptable risk to human health and the environment are also required to undergo a Socio Economic Impact evaluation that contains a similar analysis of alternatives process. |
In order to improve current working practices in the EU in identifying, evaluating and adopting safer alternatives and to more broadly enhance support for substitution among Member States and the European Commission, ECHA commissioned the Lowell Center for Sustainable Production to undertake a landscape analysis of current capacity and needs. The goal of this project is to identify specific priorities that ECHA and other public authorities could support in the near term in order to advance substitution programs and practices among Member States. A review of select applications for authorisation and restrictions proposals, in addition to surveys and interviews involving industry, Member State and Commission authorities, and NGOs were undertaken to obtain critical insights needed for this research.
|Analysis of the relevance and adequateness of using Fish Embryo Acute Toxicity test (FET) Test Guideline (OECD 236) to fulfil the information requirements and addressing concerns under REACH||ECHA has commissioned a study to gather and analyse the publically available data on fish embryo toxicity (FET), to compare it with available data on standard acute fish toxicity (AFT), and to set up the parameters defining the applicability domain and limitations of a FET test in comparison to AFT. The analysis focused mainly on chemical structure, mode of action and several key physico-chemical characteristics of tested compounds (e.g. solubility, lipophilicity). |
The outcome of this analysis constitutes a basis to understand how currently the FET test might be used in the regulatory context of REACH.
|Willingness to pay to avoid certain health impacts||This study examines the economic benefits of avoiding selected adverse human health outcomes due to exposure to chemicals.||May |
|Cost and benefit assessments in the REACH restriction dossiers||This study describes the costs and benefits of the restrictions included or proposed to be included in Annex XVII of REACH. It summarises and aggregates the information on costs and human health and environmental benefits provided in the restriction dossiers and opinions of the Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC).||April |
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|Usage of (eco)toxicological data for bridging data gaps between and grouping of nanoforms of the same substance. Elements to consider||Nanomaterials based solutions have a lot to offer for a wide range of industry sectors from pharmaceuticals to surface technologies. Nanomaterials may be manufactured in several different shapes, sizes and/or with a wide range of surface treatments. Changes made to the particles may not only provide a new function for the nanomaterial but also influence its (eco) toxicological behaviour. |
Therefore, a need was identified in 2014 to develop a pragmatic approach for how to ensure safe use of the potentially numerous nanoforms of the same substance under REACH. A nanoform is defined in this document as a composition of a substance that meets the requirements of the EC definition of a nanomaterial. Different nanoforms may differ with regard to size distributions, shape and/or surface chemistry.
Together with RIVM and JRC, ECHA initiated and led a project over 2015 to develop a scientific reference paper to explore the scientific aspects of justifying when and how to use test data from an (eco)toxicity study on one nanoform to cover other nanoforms of the same substance
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|Analysis of capacities and capabilities of laboratories to conduct OECD TG 443 extended one-generation reproductive toxicity study||ECHA has commissioned a study on global laboratory capacities to conduct extended one-generation reproductive toxicity studies (EOGRTS). In total, 22 laboratories were identified as capable to conduct the studies. Compared with a similar study in 2012, the global laboratory capacity to conduct EOGRTS has increased.||January 2016||Download the report|
|Identification and preliminary analysis of update needs for EUSES||ECHA has commissioned RIVM to make a preliminary analysis of the needs for update and improvement of EUSES. The aim of this analysis was to collect, describe and rank various corrections, improvements and extensions of EUSES developed in different contexts over the past years since EUSES 2.1 was released. The report describes possible extensions of the applicability domain for different types of chemicals and model improvements that affect a wider range of chemicals. A ranking for priority of implementation is proposed as part of the report.||September 2015||Download the report|
|Assessment of Reliability of SpERCs|| |
Commissioned by ECHA, this report sets the basis of a framework for assessing the reliability and plausibility of Specific Environmental Release Categories (SpERCs) in the context of REACH information requirements related to the Chemical Safety Assessment. ECHA wants to share the outcome of the project with interested stakeholders and initiate a discussion with industry and Member States competent authorities on the further development of the Best Practice Format proposed by the consultant.
In this report, the consultant proposes Best Practice Format for SpERC factsheets. SpERC factsheets should be streamlined and explanatory information and justifications be provided in a separate background document. The conclusion of the report anticipates the need for further discussion with industry and the Member States to clarify open remaining issues and finalise the Best Practice Format.
The first phase of the project included a thorough overview of the general quality of existing SpERCs and the definition of requisites indicating good quality SpERC factsheet. On this basis a draft Best Practice Format was proposed that has been tested by four industry associations in the second phase of the project. The resulting SpERC factsheet examples are still drafts and therefore are not published in annex to the report. However, as pointed out by the consultant, these factsheets may be further developed by industry and discussed with ECHA and Member States Competent Authorities to provide illustrative examples of factsheets and background documents.
|March 2015|| |
|2014 CMR Report|| |
In the EU, substances with carcinogenic, mutagenic or reprotoxic properties (CMR substances) should normally have a harmonised classification. At the moment, about 1 400 substances (including substances of unknown or variable composition, complex reaction products or biological materials (UVCB)) and 23 groups of substances (group entries) have a harmonised classification and labelling (CLH) for CMR and are listed in Annex VI to the CLP Regulation.
This report has two aims. Firstly, to see the extent to which registrants and notifiers have classified CMR substances in line with the harmonised classification included in Annex VI (part A) and secondly to see which substances on the EU market are classified for CMR properties by at least some notifiers or registrants but do not currently have a harmonised classification (part B).
|Report on non-standard methods for assessment of chemicals||The Joint Research Centre has published a state-of-the art review of non-animal methods and non-testing (computational) approaches that help promote replacement, reduction, and refinement of animal experiments in the safety assessment of chemicals. The report includes also many "non-standard" methods, e.g. in vitro methods and QSAR modelling that are not included in current regulatory guidelines. The report is of interest for companies that produce or market chemicals and consumer products. It provides a valuable resource for regulatory bodies and non-governmental organisations interested in the use of non-standard methods for enhanced safety testing. The review was completed by the JRC-based European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) within a collaboration agreement with ECHA.||September 2014||Download the report|
|Workshop on Compliance Check 2014-2018 – contributing to high quality information for the safe manufacture and use of chemicals|| |
Proceedings of Workshop on Compliance Check, Helsinki, 31 March - 1 April 2014.
At the workshop, compliance check (CCH) and its strategic direction for the period of 2014-2018 was discussed. The participants included representatives from the Member States and EEA countries; Member State Committee members; two members of the ECHA Management Board Working Group on Planning and Reporting; Member State Committee accredited stakeholder observers representing industry; workers and public interest NGOs; the European Commission; and the ECHA Secretariat.
The workshop found a general agreement that the revised CCH strategy should concentrate on the right substances of concern, those relevant for safe use – both in the selection of substances for compliance checks and for other measures. Furthermore, enhancing interaction with the Member States must be continued to improve efficiency of the CCH process, including its follow-up phase and reporting.
Based on the Workshop conclusions, ECHA will present the key elements for an updated strategy for discussion in the July 2014 CARACAL meeting and will inform the ECHA Management Board meeting accordingly in September.
|June 2014||Download the proceedings|
|Principles for Environmental Risk Assessment of the Sediment Compartment|| |
Proceedings of the Topical Scientific Workshop, Helsinki, 7-8 May 2013
The proceedings reflect the primary objective of the workshop to review the state of art and to contribute to developing updated scientific principles and guidelines for assessing the ecological risks of chemical substances for freshwater and marine sediments. It confirms the significant progress in the last decade that both scientific and regulatory actions have achieved in the scientific understanding of the impact of chemicals on the sediment community.
In the workshop, fruitful discussions on existing gaps and limitations were held; these are addressed and summarised as specific recommendations in the proceedings for each of the three subtopics: Problem definition and conceptual model for sediment risk assessment, exposure and effect assessment.These recommendations are highly relevant as scientific background in improving the approaches used in different regulatory frameworks both in the EU and internationally, as well as in contributing to the emergence of new or improved approaches that may be applied in the implementation of the REACH, CLP and Biocidal Products Regulations at EU level.
|May 2014||Download the proceedings|
|Service Request on a critical review of the environmental and |
physicochemical methodologies commonly employed in the environmental risk assessment of petroleum substances in the context of REACH registrations
|This project aimed to provide information on the scientific validity and the general applicability of the Petrotox and Hydrocarbon Block Method tools as developed by CONCAWE for predicting the environmental hazards, exposure and subsequently the environmental risks associated with petroleum hydrocarbons in the context of REACH registrations. The tools are intended to be applicable to any (petroleum) hydrocarbon substance. RIVM was asked by the European Chemicals Agency to review the validity and implementation of the underlying theories and the validity and quality of the QSAR models used to estimate effect and exposure properties of all representative hydrocarbon structures (the so-called CONCAWE library) used to establish reference hydrocarbon blocks.||October 2013||Download the report|
|Mapping Study on Academic Courses Relevant to REACH and CLP||The aims of this study are two-fold. Firstly, it aims to identify the number and type of available graduate courses in the fields of REACH and CLP across Europe. Secondly, it is conducted to indicate areas in which input could be provided in order to improve training opportunities for regulatory scientists in the field of chemicals. |
The study aims to identify the deficiencies in the current market in terms of REACH and CLP training, and to analyse the duration of the courses that are REACH and CLP specific. It is believed that risk assessment courses should aim to be multidisciplinary in order to cover main areas such as toxicology, environmental fate, ecotoxicology and exposure, as well as provide practical training programmes with hands-on experience.
|April 2013||Download the report|
|Characterisation, chemical representation and modelling of UVCB substances||Substances of unknown or variable composition, complex reaction products or biological materials, collectively called UVCBs under REACH, pose the greatest challenge in a number of REACH processes, in particular in the context of dossier and substance evaluation but also in the priority setting activities of the Agency. The purpose of this contract is to develop a computational methodology for generating representative structures likely to be present in the UVCB and to perform a preliminary screening of their hazardous properties using non-testing methods. The outcome of the project will assist in assessing the homogeneity of UVCBs as far as the likely presence or absence of hazardous constituents is concerned, which can be subsequently applied in dossier and substance evaluation processes but also used by Industry in designing a comprehensive testing strategy of UVCB substances. |
The link provides more information on the project, compiled by the developers of the methodology in the Laboratory of Mathematical Chemistry at the Prof. As. Zlatarov University of Bourgas, Bulgaria.
|March 2013||Download the report|
|Report on Survey of Worldwide CROs|| |
Analysis of the results of a survey of 50 CROs which were identified as being potentially able to perform the OECD 443 extended one generation reproductive toxicity study and/or the OECD 488 transgenic rodent somatic and germ cell mutation assay..
|September 2012||Download the report|
|The status of industrial vegetable oils from genetically modified plants||The main aims of this report are to: explain the reasons behind the genetic modification of plant oils and explain chemical and biological differences between oils from GMOs and non-GMOs and establish whether it is possible to distinguish them analytically.||April 2012||Download the report|