Assessment of the use of substances in hydraulic fracturing of shale gas reservoirs under REACH

Hydraulic fracturing is a technique that has been applied for stimulation of conventional oil and gas wells in the US since many years. The recent developments in high volume hydraulic fracturing combined with directional/horizontal drilling techniques have made the gas trapped into unconventional reservoirs such as shale formations economically exploitable. In the US, shale gas has become an important energy resource. In the EU, there is limited experience in the use of these techniques and research/experimental drilling activities have been performed in some Member States where shale gas reservoirs are present. In this context, the EC's Joint Research Centre’s Institute for Health and Consumer Protection (JRC-IHCP) was asked by EC's DG Environment to perform an assessment of REACH registration dossiers of certain selected substances that may be connected with the use in hydraulic fracturing of shale gas reservoirs. The main goal of this task was to understand whether this type of use has been registered under REACH and eventually how industry is dealing with related exposure scenarios and exposure assessments. The present document reports and discusses the results of the analysis of the selected REACH registration dossiers.JRC.I.4-Nanobioscience

Considerations on a Definition of Nanomaterial for Regulatory Purposes

The recent EU Cosmetic Products Regulation includes a labelling obligation for nanomaterials in the list of ingredients, in order to allow consumers to make a choice. Similar provisions are now being considered for other regulations/directives, e.g. the Novel Foods Regulation. Also the European chemicals legislation REACH may need adjustments to address and control the potential risk of nanomaterials. The introduction of these provisions specific to nanomaterials requires the adoption of a definition of the term "nanomaterial". This need is also acknowledged by the European Parliament which has called for a comprehensive science-based definition in Community legislation. This report reviews and discusses issues and challenges related to a definition of "nanomaterial". It gives a short overview about what may be considered as nanomaterials, their novel properties and applications. The need for a definition of nanomaterial is discussed, and the question of what should be achieved by a definition is addressed. The report gives an overview of definitions by international, national and European institutions, and lists approaches used in European legislation. It summarises the advantages and shortcomings of different elements typically used in available definitions, regarding their applicability in a regulatory context. The following three key elements are identified as being crucial in achieving a single, enforceable definition of nanomaterial: (i) the term "material", (ii) the nanoscale, and (iii) specific nanoscale properties. Material and nanoscale should both preferably be defined precisely in order to ease enforceability. This implies the introduction of precise nanoscale limits and instructions on how such limits can be applied to nanoscale materials with size distributions. Size-derived properties, nanostructured features, nanoscale materials incorporated in a matrix and the origin of the material are also issues to be considered. Key words: nanomaterial, definition, nanoscale, physico-chemical properties, Cosmetic Products Regulation, REACH.JRC.DG.I.5-Nanobioscience

Towards a review of the EC Recommendation for a definition of the term "nanomaterial": Part 3: Scientific-technical evaluation of options to clarify the definition and to facilitate its implementation

This report provides the JRC's scientific-technical evaluation of options to clarify the EC Recommendation on a definition of nanomaterial, published in 2011 (EC Recommendation 2011/696/EU). It is a follow-up report of two previous JRC publications, which compiled feedback on the experiences of stakeholders with the EC nanomaterial definition collected by JRC in 2013 and early 2014 (EUR 26567 EN, 2014), and provided an assessment of the collected information (EUR 26744 EN, 2014). The three JRC reports are part of the review process foreseen in the 2011 EC Recommendation. The evaluation shows that the scope of the definition regarding the origin of nanomaterials should remain unchanged, addressing natural, incidental as well as manufactured nanomaterials. Moreover, because of the regulatory purpose of the definition, there is little evidence to support deviating from size as the sole defining property of a nanoparticle or from the range of 1 nm to 100 nm as definition of the nanoscale. Besides the need for clarification of some terms used in the definition additional implementation guidance would be useful. The role of the volume specific surface area deserves clarification and a method to prove that a material is not a nanomaterial would be helpful. A strategy how to avoid unintended inclusion of materials and the list of explicitly included materials deserve also attention.JRC.I.4-Nanobioscience

Towards a review of the EC Recommendation for a definition of the term "nanomaterial" Part 2: Assessment of collected information concerning the experience with the defintion

This report provides the JRC assessment of feedback on the experiences of stakeholders with the EC nanomaterial definition, published in 2011 (EC Recommendation 2011/696/EU). The report is a follow-up report of the previous JRC report (EUR 26567 EN, 2014), which compiled feedback collected by JRC in 2013 and early 2014, partly through a dedicated survey. Based on the current report, JRC will prepare a set of recommendations for the revision of the EC nanomaterial definition, as part of the review process foreseen in the 2011 EC Recommendation.JRC.D.2-Standards for Innovation and sustainable Developmen

Basic comparison of particle size distribution measurements of pigments and fillers using commonly available industrial methods

The Nanobiosciences Unit of the Joint Research Centre’s Institute for Health and Consumer Protection and Eurocolour, the association of European pigments, dyes and fillers industry, have carried out a program of work to evaluate a number of instrumental methods of measuring particle size distributions as required for assessing compliance versus the EU Recommendation for the definition on nanomaterials. The study has examined the use of five instrumental methods applied to a range of eight widely different but industrially relevant powder pigments. The techniques examined were Laser Diffraction (LD), Dynamic Light Scattering (DLS), Centrifugal Liquid Sedimentation (CLS), Volume Specific Surface Area (VSSA) and Electron Microscopy (EM). This report describes the materials studied and the preparative and analytical methods used. Individual chapters provide an overview of the single analytical methods used together with a summary of the results obtained using each particular method. In considering the results of this study it is important to note that the aim was not to determine the optimum conditions for every individual sample but rather to produce and evaluate data which could be considered representative of that obtainable in industrial laboratories using existing instrumental facilities operated by experienced but not specialised operators. The report discusses the challenges of using these instrumental methods to obtain a simple unambiguous classification of the test materials according to the EC definition.JRC.I.4-Nanobioscience

Towards a review of the EC Recommendation for a definition of the term "nanomaterial"; Part 1: Compilation of information concerning the experience with the definition

In October 2011 the European Commission (EC) published a Recommendation on the definition of nanomaterial (2011/696/EU). The purpose of this definition is to enable determination when a material should be considered a nanomaterial for regulatory purposes in the European Union. In view of the upcoming review of the current EC Definition of the term 'nanomaterial' and noting the need expressed by the EC Environment Directorate General and other Commission services for a set of scientifically sound reports as the basis for this review, the EC Joint Research Centre (JRC) prepares three consecutive reports, of which this is the first. This Report 1 compiles information concerning the experience with the definition regarding scientific-technical issues that should be considered when reviewing the current EC definition of nanomaterial. Based on this report and the feedback received, JRC will write a second, follow-up report. In this Report 2 the JRC will provide a detailed assessment of the scientific-technical issues compiled in Report 1, in relation to the objective of reviewing the current EC nanomaterial definition.JRC.I.4-Nanobioscience

The European Chemicals Bureau: an Overview of 15 Years Experience in EU Chemicals Legislation

From its creation in 1993, the European Chemicals Bureau (ECB) has played a vital role in the conception, development, implementation and monitoring of European Union (EU) legislation on chemicals and in contributing to the European Commission¿s participation in international chemicals programmes. The ECB has housed much of the European Commission¿s experience, capacity and historical memory in chemical risk assessment and safe chemical management. The contribution of ECB to the drafting, development and implementation of the REACH regulation has been an important one. The provision of scientific/technical expertise to the start-up phase of the newly born European Chemicals Agency (ECHA) has been essential for a swift and effective implementation of REACH. The ECB has contributed to that effort not only by selecting, recruiting and training ECHA staff but also by seconding part of its own key staff to the agency. And finally, during 2008 the ECB is completing the hand-over files and transmitting them to the ECHA, which is taking over responsibility for the operational implementation of EU legislation on chemicals.JRC.I-Institute for Health and Consumer Protection (Ispra

EU management of risks associated to the use of nanoparticles

This extended abstract summarised the EU legal framework covering nanomaterials.JRC.I.4-Nanobioscience

Screening of EU New Chemicals Database concerning an Aquatic Exposure Threshold of No Concern

This 'Letter to the Editor' is the reaction to the paper "Mode of action and aquatic exposure thresholds of no concern" by de Wolf et al. published in Environmental Toxicology and Chemistry. The paper refers to a personal communication concerning an analysis of the EU New Chemicals Database: "Sokull-Kluettgen and Vollmer reported that based on their analysis, which did not make a distinction between MODs, no evidence suggests that an ETNCaqMOD1-3 of 0.1 µg/L is an unacceptable value". This is in contrast to the reaction of the European Chemicals Bureau (ECB) on the approach in the discussion with some of the authors back in 2003. This letter presents the ECB data analysis, which was available to the authors of the paper, to avoid misinterpretation. It does not comment in detail on the suggest approach of an aquatic exposure threshold of no concern.JRC.I.3-Toxicology and chemical substance

Engineered Nanomaterials: Hazard, Exposure and Safety Assessment - Regulation and Legislation

This book chapter summarises the legislation applicable to nanomaterial in the US and in EuropeJRC.I.4-Nanobioscience