Certification Report - The certification of equivalent diameters of a mixture of silica nanoparticles in aqueous solution: ERM®-FD102

This report describes the production of ERM®-FD102, silica nanoparticles in an aqueous solution certified for different equivalent diameters. The material was produced following ISO Guide 34:2009. The certified reference material (CRM), which has been produced by the Institute for Reference Materials and Measurements (IRMM) of the European Commission's Joint Research Centre (JRC), is a mixture of two monomodal populations of silica nanoparticles with distinct nominal particle sizes of 20 nm and 80 nm. These nominally 20 nm and 80 nm particle populations are further referred to as size class A and size class B, respectively. The CRM was prepared from two commercially available silica sols, moderately diluted in an aqueous solution and bottled in 10 mL pre-scored amber glass ampoules. Between unit-homogeneity was quantified and stability during dispatch and storage were assessed in accordance with ISO Guide 35:2006. The minimum sample intake for the different methods was determined from the results and information provided by the laboratories that participated in the interlaboratory comparison (ILC) exercises of the characterisation study. The material was characterised, for size classes A and B, by an intercomparison amongst laboratories of demonstrated competence and adhering to ISO/IEC 17025. Technically invalid results were removed but no outlier was eliminated on statistical grounds only. Uncertainties of the certified values were calculated in accordance with the Guide to the Expression of Uncertainty in Measurement (GUM) and include uncertainty contributions related to possible inhomogeneity and instability and to characterisation. The material is intended for quality control and assessment of method performance. As any reference material, it can also be used for control charts or validation studies. In addition, ERM®-FD102 can be used for calibration of electron microscopy methods. The CRM is available in amber glass ampoules containing about 9 mL of suspension. The CRM was accepted as European Reference Material (ERM®) after peer evaluation by the partners of the European Reference Materials consortium.JRC.D.2-Standards for Innovation and sustainable Developmen

CERTIFICATION REPORT: The certification of particle size distribution of corundum: ERM-FD066

This report describes the production of ERM-FD066FD066, which is a corundum material certified for the particle size distribution as determined by laser diffraction (ISO 13320) and scanning electron microscopy (ISO 13322). This material was produced following ISO Guide 34:2009 and is certified in accordance with ISO Guide 35:2006. Commercial corundum was ground mixed, riffled and packed into glass bottles. These bottles are equipped with glass slides to allow homogenisation of the individual sample. Between unit-homogeneity was quantified and stability during dispatch and storage were assessed in accordance with ISO Guide 35:2006.The minimum sample intake was determined as the lowest amount that gave repeatable results in the characterisation study. The material was characterised by an interlaboratory comparison of laboratories that demonstrated competence and adhering to ISO/IEC 17025. Technically invalid results were removed but no outlier was eliminated solely on statistical grounds. Uncertainties of the certified values were calculated in accordance with the Guide to the Expression of Uncertainty in Measurement (GUM) and include uncertainties related to possible inhomogeneity, instability and characterisation. The material is intended for the quality control and assessment of method performance. As with any reference material, it can be used for establishing control charts or validation studies. The CRMs is available in glass bottles containing at least 40 g of corundum powder. The minimum amount of sample to be used is 70 mg.JRC.F.6-Reference Material

The certification of the absorbed energy (25 J nominal) of Charpy V-notch reference test pieces for tests at 20 °C: ERM®-FA013bt

This certification report describes the processing and characterisation of ERM®-FA013bt, a batch of Charpy V-notch certified reference test pieces certified for the absorbed energy (KV). Sets of five of these test pieces are used for the verification of pendulum impact test machines according to ISO 148-2 (Metallic materials - Charpy pendulum impact test – Part 2: Verification of testing machines . The absorbed energy (KV) is procedurally defined and refers to the impact energy required to break a V-notched test piece of standardised dimensions, as defined in ISO 148-1. The certified value of ERM®- FA013bt is made traceable to the SI, via the SI-traceable certified value of the master batch ERM®-FA013ba, by testing samples of ERM®- FA013bt and ERM®-FA013ba under repeatability conditions on an impact pendulum verified and calibrated with SI-traceably calibrated tools. The certified value is valid only for strikers with a 2 mm tip radius. The certified value is valid at (20 ± 2) °C.JRC.D.2-Standards for Innovation and sustainable Developmen

The certification of the absorbed energy (25 J nominal) of Charpy V-notch reference test pieces for tests at 20 °C: ERM®-FA013bs

This certification report describes the processing and characterisation of ERM®-FA013bs, a batch of Charpy V-notch certified reference test pieces certified for the absorbed energy (KV). Sets of five of these test pieces are used for the verification of pendulum impact test machines according to ISO 148-2 (Metallic materials - Charpy pendulum impact test – Part 2: Verification of testing machines [1]). The absorbed energy (KV) is procedurally defined and refers to the impact energy required to break a V-notched test piece of standardised dimensions, as defined in ISO 148-1 [2]. The certified value of ERM®- FA013bs is made traceable to the SI, via the SI-traceable certified value of the master batch ERM®-FA013ba, by testing samples of ERM®- FA013bs and ERM®-FA013ba under repeatability conditions on an impact pendulum verified and calibrated with SI-traceably calibrated tools. The certified value is valid only for strikers with a 2 mm tip radius. The certified value is valid at (20 ± 2) °C.JRC.D.2-Standards for Innovation and sustainable Developmen

CERTIFICATION REPORT: The certification of particle size distribution of corundum: ERM-FD069

This report describes the production of ERM-FD069, which is a corundum material certified for the particle size distribution as determined by laser diffraction (ISO 13320) and optical microscopy (ISO 13322). This material was produced following ISO Guide 34:2009 and is certified in accordance with ISO Guide 35:2006. Two grades of commercial corundum were mixed, repeatedly riffled and packed into glass bottles. These bottles are equipped with glass slides to allow thorough homogenisation of the material inside the bottle. Between unit-homogeneity was quantified and stability during dispatch and storage was assessed in accordance with ISO Guide 35:2006. The minimum sample intake was determined as the lowest amount that gave repeatable results in the characterisation study. The material was characterised by an interlaboratory comparison of laboratories of demonstrated competence and adhering to ISO/IEC 17025. Technically invalid results were removed but no outlier was eliminated on statistical grounds only. Uncertainties of the certified values were calculated in accordance with the Guide to the Expression of Uncertainty in Measurement (GUM) and include uncertainties related to possible inhomogeneity, instability and characterisation. The material is intended for the quality control and assessment of method performance. As with any reference material, it/they can be used for establishing control charts or be used in validation studies. The CRMs is available in glass bottles containing at least 40 g of corundum powder. The minimum amount of sample to be used is 100 mg.JRC.F.6-Reference Material

CERTIFICATION REPORT: The certification of equivalent diameters of silica nanoparticles in aqueous solution: ERM®-FD101b

This report describes the production of ERM®-FD101b, silica nanoparticles suspended in an aqueous solution, certified for different equivalent particle diameters. The material was produced following ISO Guide 34:2009. The certified reference material (CRM) was produced by the Directorate F - Health, Consumers and Reference Materials of the European Commission’s Joint Research Centre (JRC) in Geel (Belgium). The CRM was produced from a diluted and pH adjusted commercial colloidal silica slurry. Between unit-homogeneity was quantified and stability during dispatch and storage were assessed in accordance with ISO Guide 35:2006. The minimum sample intake for the different methods was determined from the results and information provided by the laboratories that participated in the interlaboratory comparison (ILC) exercises of the characterisation study. The material was characterised for several equivalent particle diameters based on an interlaboratory comparison amongst laboratories of demonstrated competence and adhering to ISO/IEC 17025. Technically invalid results were removed but no outlier was eliminated on statistical grounds only. Uncertainties of the certified values were calculated in accordance with the Guide to the Expression of Uncertainty in Measurement (GUM) and include uncertainty contributions related to possible inhomogeneity and instability and to characterisation. The material is intended for quality control and assessment of method performance. The method-defined certified values are regarded as reliable estimates of the true values and ERM-FD101b can therefore be used for calibration purposes. The CRM is available in 10 mL pre-scored amber glass ampoules each containing about 9 mL of suspension. The CRM was accepted as European Reference Material (ERM®) after peer evaluation by the partners of the European Reference Materials consortium.JRC.F.6-Reference Material

Certification of Equivalent Spherical Diameters of Silica Nanoparticles in Water - Certified Reference Material ERM®-FD100

This report describes the certification of the equivalent spherical diameters of silica nanoparticles suspended in aqueous solution, Certified Reference Material (CRM) ERM-FD100®. The CRM has been certified by the European Commission, Joint Research Centre, Institute for Reference Materials and Measurements (IRMM), Geel, BE. The intended use of this ERM-FD100 is to check the performance of instruments and methods that determine the particle diameter of nanoparticles (particle size ranging from approximately 1 nm to approximately 100 nm) suspended in a liquid medium. It is available in 10 mL pre-scored amber glass ampoules containing approximately 9 mL of suspension. The CRM was prepared from commercially available colloidal silica (Koestrosol 1530, Chemiewerk Bad Koestritz GmbH, DE). Certification of the CRM included testing of the homogeneity and stability of the ampouled diluted raw material, as well as the characterisation using an intercomparison approach. The material has been certified for the equivalent diameter of the silica nanoparticles in aqueous suspension using different methods. Certified values are the cumulants dynamic light scattering (DLS) intensity-weighted harmonic mean particle diameter, the line-start centrifugal liquid sedimentation (CLS) intensity-based modal (Stokes) particle diameter, the electron microscopic (transmission electron microscopy (TEM)/ scanning electron microscopy (SEM)) number-based modal particle diameter and the small angle X-ray scattering (SAXS) intensity-weighted average particle diameter. Indicative values have been established for the volume-weighted mean equivalent spherical diameter via the SAXS method and for the zeta potential via the electrophoretic mobility (ELM) method. Additional informational values are given for the volume-weighted mean diameter via the DLS method, and the pH value of the ERM-FD100 suspension. Uncertainties are expanded uncertainties estimated in accordance with the Guide to the expression of uncertainty in measurement (GUM) with a coverage factor of k = 2, corresponding to a confidence interval of about 95 %. An exception is the mean equivalent volume-weighted diameter determined by the SAXS method which has a coverage factor of 2.8.JRC.DG.D.2-Reference material

An overview of concepts and terms used in the European Commission's definition of nanomaterial

This report supports the implementation of the European Commission’s Recommendation on a definition of nanomaterial (2011/696/EU). It addresses its key concepts and terms and discusses them in a regulatory context. Corresponding to the broad scope of the definition the considerations in this report can be applied across all relevant legislative areas; they are not specific to any particular piece of legislation. The report provides recommendations for a harmonised and coherent implementation of the nanomaterial definition in any specific regulatory context at European Union and national level.JRC.F.2-Consumer Products Safet

Identification of nanomaterials through measurements

This report addresses identification of nanomaterials according to the European Commission's Recommendation on the definition of nanomaterial (2011/696/EU) by measurements and discusses options and points to consider when assessing whether a particulate material is a nanomaterial or not. The primary criterion to identify nanomaterials is the median of the number-based distribution of the constituent particles’ external dimensions, regardless of whether these particles appear separate from one another or are parts of aggregates or agglomerates. The main steps in the nanomaterial identification process are collecting information on the material, acquiring knowledge of the measurement method(s), matching method(s) and material, sample preparation, measurement/analysis and decision (nanomaterial / no nanomaterial). Assessment of particle size measurements requires specification of the measurand, the physical principle of the measurement technique, the applied sample preparation protocol, the covered size range and the data analysis procedure to allow a reliable classification of a material according to the EC nanomaterial definition. A variety of screening and confirmatory techniques is available to analyse particle size distributions. Screening techniques do not measure directly the number-based distribution of the external particle dimensions, but they are fast and inexpensive and still allow to positively identify a material as a nanomaterial. Confirmatory techniques are usually more costly and time-intensive, but may provide a more reliable classification and allow resolving doubts or disputes. The volume specific surface area can serve as proxy to identify nanomaterials, provided that certain requirements are fulfilled. For a correct classification whether a material is a nanomaterial or not, a thorough knowledge of the applied measurement method is needed to correctly interpret the outcome of a measurement and to understand whether a specific technique is fit for the purpose. Reliable measurement results can be obtained if a reference measurement system is implemented, which is typically based on documented and validated methods and reference materials. Best practices should be applied when reference measurement systems are not available. This report provides examples and practical options for consideration, including a flowchart that can assist users with relevant technical knowledge in the identification of nanomaterials.JRC.F.2-Consumer Products Safet

CERTIFICATION REPORT: The certification of electrophoretic mobility/zeta potential of silica particles in aqueous solution: ERM-FD306/SRM 1993

This report describes the production of ERM-FD306/SRM 1993, silica particles suspended in a borate buffer, certified for electrophoretic mobility and zeta potential by electrophoretic light scattering (ELS). This material was produced following ISO 17034:2016 and is certified in accordance with ISO Guide 35:2017. The certified reference material (CRM) was jointly produced by the Directorate F - Health, Consumers and Reference Materials of the European Commission’s Joint Research Centre (JRC) in Geel (Belgium) and the US National Institute of Standards and Technology (NIST), Gaithersburg (USA). The CRM was produced from a buffer-modified and diluted commercial colloidal silica slurry. Between-ampoule homogeneity was quantified and stability during dispatch and storage were assessed in accordance with ISO Guide 35:2017. The minimum sample intake for the ELS method was determined from the results and information provided by the laboratories that participated in the interlaboratory comparison (ILC) exercise. The material was characterised by an interlaboratory comparison between laboratories of demonstrated competence and adhering to ISO/IEC 17025. Technically invalid results were removed but no outlier was eliminated solely on statistical grounds. Uncertainties of the certified values were calculated in accordance with the Guide to the Expression of Uncertainty in Measurement (GUM) and include uncertainties related to possible inhomogeneity, instability and characterisation. The material is intended for quality control and assessment of method performance. The method-defined certified values are regarded as reliable estimates of the true values and ERM-FD306/SRM 1993 can therefore be used for calibration purposes. The CRM is available in 25 mL pre-scored amber glass ampoules each containing approximately 25 mL of suspension.JRC.F.6-Reference Material