Guidance
OECD
The Organisation for Economic Co-operation and Development (OECD, www.oecd.org) is an international intergovernmental organisation that works towards shaping policies that foster prosperity, equality, opportunity and well-being for all.
In its programme on Chemical Safety and Biosafety, the OECD assists countries in developing and implementing policies and instruments that make their systems for managing chemicals as efficient and robust as possible, while protecting human health and the environment. The Mutual Acceptance of Data (MAD) system helps to avoid conflicting or duplicative national requirements, provides a common basis for co-operation among national authorities and avoids creating non-tariff barriers to trade. OECD countries and full adherents have agreed that a safety test carried out in accordance with the OECD Test Guidelines and Principles of Good Laboratory Practice in one OECD country must be accepted by other OECD countries for regulatory assessment purposes. This is the concept of “tested once, accepted for assessment everywhere”. Apart from saving large amounts of test animals, this saves the chemicals industry the expense of duplicate testing for products which are marketed in more than one country. The OECD test guidelines may be complemented by ISO or CEN standards that give precise instructions, e.g. for executing part of such testing or for testing individual chemicals.
In the OECD Test Guideline Programme, the Test Guidelines for the Mutual Acceptance of Data (MAD) system are continuously expanded and updated to ensure they reflect the state-of-the-art science and techniques to meet member countries regulatory needs. The Guidelines are elaborated with the assistance of experts from regulatory agencies, academia, industry, environmental and animal welfare organisations.
The OECD Guidelines for the Testing of Chemicals are a unique tool for assessing the potential effects of chemicals on human health and the environment. They are split into five sections: Section 1: Physical-Chemical properties; Section 2: Effects on Biotic Systems; Section 3: Environmental fate and behaviour; Section 4: Health Effects and Section 5: Other Test Guidelines (with a focus on pesticides and their residues). Accepted internationally as standard methods for safety testing, the Guidelines are used by professionals in industry, academia and governments involved in the testing and assessment of chemicals (industrial chemicals, pesticides, personal care products, etc.). as such they former a cornerstone under the OECD Mutual Acceptance of Data (MAD) system.
OECD Series on Testing and Assessment The OECD Series on Testing and Assessment includes publications related to testing and assessment of chemicals. Documents include but are not limited to Guidance Documents to (further) support the use of Test Guidelines, Case Study Reports on Integrated Approaches to Testing and Assessment (IATAs), Validation Study Reports in support of newly developed Test Guidelines, but also other Study Reports or Dedicated Review Papers.
OECD Series on the Safety of Manufactured Nanomaterials The purpose of the OECD Series on the Safety of Manufactured Nanomaterials is to provide up-to-date information on the OECD activities on manufactured nanomaterials that are related to human health and environmental safety. Documents include but are not limited to Guidance Documents to (further) support the assessment of nanomaterials, workshop reports on applicability of Test Guidelines for nanomaterials, overviews of activities on nanomaterials in the different member countries (so called Tour de Table documents), or outputs from the OECD Testing Programme on nanomaterials.
ISO
The International Organisation for Standardisation ISO is an independent, non-governmental international organization. ISO develops and publishes standards for any conceivable aspect of measuring and describing nanotechnologies, except regulatory methods. Methods for regulatory testing are developed by OECD, although the OECD test guidelines may be complemented by ISO standards that give precise instructions e.g. for executing part of such testing or for testing individual chemicals. ISO standards are internationally agreed by experts.
International Standards An International Standard provides rules, guidelines or characteristics for activities or for their results, aimed at achieving the optimum degree of order in a given context. It can take many forms. Apart from product standards, other examples include: test methods, codes of practice, guideline standards and management systems standards.
Technical Specification A Technical Specification addresses work still under technical development, or where it is believed that there will be a future, but not immediate, possibility of agreement on an International Standard. A Technical Specification is published for immediate use, but it also provides a means to obtain feedback. The aim is that it will eventually be transformed and republished as an International Standard.
Technical Report A Technical Report contains information of a different kind from that of the previous two publications. It may include data obtained from a survey, for example, or from an informative report, or information of the perceived “state of the art”.
Publicly Available Specification A Publicly Available Specification is published to respond to an urgent market need, representing either the consensus of the experts within a working group, or a consensus in an organization external to ISO. As with Technical Specifications, Publicly Available Specifications are published for immediate use and also serve as a means to obtain feedback for an eventual transformation into an International Standard. Publicly Available Specifications have a maximum life of six years, after which they can be transformed into an International Standard or withdrawn.
International Workshop Agreements An International Workshop Agreement is a document developed outside the normal ISO committee system to enable market players to negotiate in an “open workshop” environment. International Workshop Agreements are typically administratively supported by a member body. The published agreement includes an indication of the participating organizations involved in its development. An International Workshop Agreement has a maximum lifespan of six years, after which it can be either transformed into another ISO deliverable or is automatically withdrawn.
Guides Guides are just that. They help readers understand more about the main areas where standards add value. Some Guides talk about how, and why, ISO standards can make it work better, safer, and more efficiently. Full list of Guides available in the ISO Catalogue.
ISO is subdivided in different technical committees, which are dedicated to specific topics.
ISO/TC 229 Nanotechnologies The technical committee ISO/TC 229 Nanotechnologies works towards standards applicable to nanomaterials. Specific tasks include developing standards for terminology and nomenclature, metrology and instrumentation, including specifications for reference materials, test methodologies, modelling and simulations, and science-based health, safety, and environmental practices.
European Committee for Standardization (CEN)
The European Committee for Standardization is one of three European Standardization Organizations that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level. CEN works close in a liaison with ISO , and as such CEN develops and publishes standards for any conceivable aspect of measuring and describing nanotechnologies, except regulatory methods. Nevertheless, CEN standards may complement OECD Test Guidelines by giving precise instructions e.g. for executing part of such testing or for testing individual chemicals. An overview of standards can be found here: standards.cencenelec.eu/dyn/www/f?p=CEN:105::RESET
Here we focus on the Technical Committees that are most relevant for nanomaterials.
CEN/TC 352 Nanotechnologies CEN/TC 352 develops standards on classification, terminology and nomenclature, metrology and instrumentation, test methods modelling and simulation and more, related to nanotechnologies and nanomaterials. The TC works closely with the international committee ISO/TC 229 Nanotechnologies and has published more than 15 EN ISO documents, addressing topics of global relevance and avoiding the duplication of work at European and international level.
CEN/TC 195 Cleaning equipment for air and other gases The scope of CEN/TC 195 is standardization in the fields of terminology, classification, characteristics, and test and performance methods for air and gas cleaning equipment for general ventilation and industrial applications.
CEN/TC 137 Assessment of workplace exposure to chemical and biological agents CEN /TC 137 focusses on the standardization in the field of assessment of exposure to agents at the workplace including the planning and performing of measurement but excluding the establishment of limit values.
Search for guidelines
| Name ↕ | Website ↕ | Description ↕ |
|---|---|---|
| OECD | www.oecd.org/ | The Organisation for Economic Co-operation and Development (OECD) is an international intergovernmental organisation that works towards shaping policies that foster prosperity, equality, opportunity and well-being for all. The MAD system helps to avoid conflicting or duplicative national requirements, provides a common basis for co-operation among national authorities and avoids creating non-tariff barriers to trade. OECD countries and full adherents have agreed that a safety test carried out in accordance with the OECD Test Guidelines and Principles of Good Laboratory Practice in one OECD country must be accepted by other OECD countries for assessment purposes. This is the concept of “tested once, accepted for assessment everywhere”. This saves the chemicals industry the expense of duplicate testing for products which are marketed in more than one country. |
| OECD Test Guideline Programme | www.oecd.org/chemicalsafety/testing/oecd-guidelines-testing-chemicals-related-documents.htm | The OECD Guidelines for the Testing of Chemicals is a collection of most relevant internationally agreed testing methods used by government, industry and independent laboratories to identify and characterise potential hazards of chemicals. They are a set of tools for professionals, used primarily in regulatory safety testing and subsequent chemical and chemical product notification, chemical registration and in chemical evaluation. They can also be used for the selection and ranking of candidate chemicals during the development of new chemicals and products and in toxicology research. |
| OECD Test Guidelines | ||
| OECD Guidelines for the Testing of Chemicals - Library | www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals_72d77764-en | |
| OECD Section 1: Physical Chemical Properties | www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-1-physical-chemical-properties_20745753 | |
| OECD TG 124: Determination of the Volume Specific Surface Area of Manufactured Nanomaterials | www.oecd-ilibrary.org/environment/test-no-124-determination-of-the-volume-specific-surface-area-of-manufactured-nanomaterials_abb72f8f-en | This Test Guideline (TG) describes a harmonised procedure to determine the Volume Specific Surface Area (VSSA) of powdered solid manufactured nanomaterials (MNs). The VSSA (in m²/cm³) of a material is calculated by multiplying its mass specific surface area (in m²/g) with its skeletal density (in g/cm³). The determination of the external and internal (mass) specific surface area (SSA) of powdered solid MNs is done by the Brunauer, Emmett and Teller (BET) method. This TG also provides instructions on how to determine the skeletal density (ρ) of the MN by gas pycnometry. |
| OECD TG 125: Nanomaterial Particle Size and Size Distribution of Nanomater | www.oecd-ilibrary.org/environment/test-no-125-nanomaterial-particle-size-and-size-distribution-of-nanomaterials_af5f9bda-en | This Test Guideline, covering nanomaterials spanning from 1 nm to 1000 nm, is intended for particle size and particle size distribution measurements of nanomaterials. The TG includes the following methods: Atomic Force Microscopy (AFM), Centrifugal Liquid Sedimentation (CLS)/Analytical Ultracentrifugation (AUC), Dynamic Light Scattering (DLS), Differential Mobility Analysis System (DMAS), (Nano)Particle Tracking Analysis (PTA/NTA), Small Angle X-Ray Scattering (SAXS), Scanning Electron Microscopy (SEM), and Transmission Electron Microscopy (TEM). For measuring the diameter and length of fibres, analysing images captured with electron microscopy is currently the only method available. |
| OECD Section 2: Effects on Biotic Systems | www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-2-effects-on-biotic-systems_20745761 | |
| OECD Section 3: Environmental Fate and Behaviour | www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-3-degradation-and-accumulation_2074577x | |
| OECD TG 318: Dispersion Stability of Nanomaterials in Simulated Environmental Media | www.oecd-ilibrary.org/environment/test-no-318-dispersion-stability-of-nanomaterials-in-simulated-environmental-media_9789264284142-en | This test guideline describes a test procedure to gain information on dispersion stability of manufactured nanomaterials in simulated environmental media. The main purpose of this guideline is to assess the ability of a nanomaterial to attain a colloidal dispersion and to conserve this dispersion under environmentally relevant conditions. The test procedure involves a dispersion of the nanomaterial with the aid of a calibrated sonication procedure and the determination of the mass concentration of the nanomaterial in a set of test vials while the particles undergo homoagglomeration and settling in environments of different hydrochemistry. |
| OECD Section 4: Health Effects | www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-4-health-effects_20745788 | |
| OECD TG 412: Subacute Inhalation Toxicity: 28-Day Study | www.oecd-ilibrary.org/environment/test-no-412-subacute-inhalation-toxicity-28-day-study_9789264070783-en | This revised Test Guideline 412 (TG 412) has been designed to fully characterize test article toxicity by the inhalation route following repeated exposure for a limited period of time (28 days), and to provide data for quantitative inhalation risk assessments. It was updated in 2017 to enable the testing and characterisation of effects of nanomaterials tested. Groups of at least 5 male and 5 female rodents are exposed 6 hours per day for 28 days to a) the test chemical at three or more concentration levels, b) filtered air (negative control), and/or c) the vehicle (vehicle control). Animals are generally exposed 5 days per week but exposure for 7 days per week is also allowed. Males and females are always tested, but they may be exposed at different concentration levels if it is known that one sex is more susceptible to a given test article. This guideline allows the study director the flexibility to include satellite (reversibility) groups, bronchoalveolar lavage (BAL), lung burden (LB) for particles, neurologic tests, and additional clinical pathology and histopathological evaluations in order to better characterize the toxicity of a test chemical. |
| OECD TG 413: Subchronic Inhalation Toxicity: 90-day Study | www.oecd-ilibrary.org/environment/test-no-413-subchronic-inhalation-toxicity-90-day-study_9789264070806-en | This revised Test Guideline 413 (TG 413) has been designed to fully characterize test article toxicity by the inhalation route following repeated exposure for a period of 90 days, and to provide data for quantitative inhalation risk assessments. It was updated in 2017 to enable the testing and characterisation of effects of nanomaterials tested. Groups of at least 10 male and 10 female rodents are exposed 6 hours per day for 90 days to a) the test chemical at three or more concentration levels, b) filtered air (negative control), and/or c) the vehicle (vehicle control). Animals are generally exposed 5 days per week but exposure for 7 days per week is also allowed. Males and females are always tested, but they may be exposed at different concentration levels if it is known that one sex is more susceptible to a given test chemical. The results of the study include measurement and daily and detailed observations (haematology and clinical chemistry), as well as ophthalmology, gross pathology, organ weights, and histopathology. This Test Guideline allows the flexibility to include satellite (reversibility) groups, interim sacrifices, bronchoalveolar lavage (BAL), lung burden (LB) for particles, neurologic tests, and additional clinical pathology and histopathological evaluations in order to better characterize the toxicity of a test chemical. |
| OECD Guidance documents | ||
| OECD Series on Testing and Assessment | www.oecd.org/chemicalsafety/testing/series-testing-assessment-publications-number.htm | This Series includes publications related to testing and assessment of chemicals. |
| OECD Series on Testing and Assessment No. 1: Guidance Document for the Development of OECD Guidelines for the Testing of Chemicals | https://one.oecd.org/document/ENV/JM/MONO(2006)20/REV1/en/pdf | This Guidance Document describes in detail the process of Test Guideline development, including the structure of the Test Guidelines Programme (TGP) and the responsibilities of those involved. |
| OECD Series on Testing and Assessment No. 39: Second Edition - Guidance Document on Inhalation Toxicity Studies | www.oecd.org/officialdocuments/ displaydocument/?cote=env/jm/mono(2009)28/rev1&doclanguage=en |
The main purpose of this document is to assist the regulated community and regulators in selecting the most appropriate acute inhalation TG so that particular data requirements can be met while reducing animal usage and suffering. This Guidance Document also contains additional supporting information on the conduct and interpretation of studies performed using the inhalation test guidelines: TG 403, TG 436, TG 433, TG 412, and TG 413. |
| OECD Series on Testing and Assessment No. 317: Guidance Document on Aquatic and Sediment Toxicological Testing of Nanomaterials | www.oecd.org/officialdocuments/ publicdisplaydocumentpdf/?cote=env/jm/mono(2020)8&doclanguage=en |
This document provides guidance for aquatic (including sediment) ecotoxicity testing of MNs for the purposes of determining their hazard. |
| OECD Series on Testing and Assessment No. 318: Guidance Document for the Testing of Dissolution and Dispersion Stability of Nanomaterials, and the Use of the Data for Further Environmental Testing and Assessment | www.oecd.org/officialdocuments/ publicdisplaydocumentpdf/?cote=env/jm/mono(2020)9&doclanguage=en |
This document provides guidance for the methods to address dissolution rate and dispersion stability for nanomaterials with focus on environmental aqueous media. |
| OECD Series on Testing and Assessment No. 340: Study Report on a test for removal in wastewater treatment plants of gold manufactured nanomaterial (MN): activated sludge sorption isotherm | www.oecd.org/officialdocuments/ publicdisplaydocumentpdf/?cote=ENV-CBC-MONO(2021)15%20&doclanguage=en |
This document includes a detailed description of a procedure for measuring the net removal extent (NR) to which a MN distributes between activated sludge and water in wastewater treatment systems. The goal of this test is to provide sufficient information to predict the removal of a test MN in a wastewater treatment facility through association with sludge. |
| OECD Series on Testing and Assessment No. 342: Guidance Document on testing Nanomaterials using OECD TG No. 312 “Leaching in soil columns" | www.oecd.org/officialdocuments/ publicdisplaydocumentpdf/?cote=ENV-CBC-MONO(2021)17%20&doclanguage=en |
This document provides specific guidance for test preparation, implementation, performance, analysis and reporting using the OECD TG No. 312 for testing the mobility and retention of NMs in different types of soils. The GD is likely also relevant for colloidal materials of greater size ranges, because transport of these materials occurs via the same kinetically dominated processes that determine the fate of NMs. The document informs on necessary modifications and additions to the standard test protocol including preparation and application of the test materials, analytics and data reporting. |
| OECD Series on the Safety of Manufactured Nanomaterials | www.oecd.org/chemicalsafety/nanosafety/ publications-series-safety-manufactured-nanomaterials.htm |
The purpose of the OECD Series on the Safety of Manufactured Nanomaterials is to provide up-to-date information on the OECD activities related to human health and environmental safety. |
| OECD Series on the Safety of Manufactured Nanomaterials No. 86 Assessment of the durability of Nanomaterials and their Surface Ligands | www.oecd.org/officialdocuments/ displaydocument/?cote=env/jm/mono(2018)11&doclanguage=en |
In this document, the in vitro and in vivo systems that are used to measure biodurability in biological and environmental systems, are presented for the pristine NMs of the OECD sponsorship programme. |
| OECD Series on the Safety of Manufactured Nanomaterials No. 101- Evaluation of Tools and Models for Assessing Occupational and Consumer Exposure to Manufactured Nanomaterials; Part III: Performance testing results of tools/models for consumer exposure | www.oecd.org/officialdocuments/ publicdisplaydocumentpdf/?cote=ENV-CBC-MONO(2021)29%20&doclanguage=en |
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| OECD Series on the Safety of Manufactured Nanomaterials No. 100 - Evaluation of Tools and Models for Assessing Occupational and Consumer Exposure to Manufactured Nanomaterials; Part II: Performance testing results of tools/models for occupational exposure (Annex 1) | www.oecd.org/officialdocuments/ publicdisplaydocumentpdf/?cote=ENV/CBC/MONO(2021)28&docLanguage=En |
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| OECD Series on the Safety of Manufactured Nanomaterials No. 99 - Evaluation of Tools and Models for Assessing Occupational and Consumer Exposure to Manufactured Nanomaterials; Part I: Compilation of tools/models and analysis for further evaluation | www.oecd.org/officialdocuments/ publicdisplaydocumentpdf/?cote=ENV-CBC-MONO(2021)27%20&doclanguage=en |
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| OECD Series on the Safety of Manufactured Nanomaterials No. 98 - Evaluation of Tools and Models Used for Assessing Environmental Exposure to Manufactured Nanomaterials; Functional Assessment and Statistical Analysis of Nano-Specific Environmental Exposure Tools and Models; Annex 1 | www.oecd.org/officialdocuments/ publicdisplaydocumentpdf/?cote=ENV-CBC-MONO(2021)23%20&doclanguage=en |
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| OECD Series on the Safety of Manufactured Nanomaterials No. 91 - Guiding Principles for Measurements and Reporting for Nanomaterials: Physical Chemical Parameters | http://www.oecd.org/officialdocuments/ publicdisplaydocumentpdf/?cote=env/jm/mono(2019)13&doclanguage=en |
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| OECD Series on the Safety of Manufactured Nanomaterials No. 90 - Physical-Chemical Decision Framework to inform Decisions for Risk Assessment of Manufactured Nanomaterials | http://www.oecd.org/officialdocuments/ publicdisplaydocumentpdf/?cote=env/jm/mono(2019)12&doclanguage=en |
This document provides guidance on which test methods are (or are not) appropriate to measure a given physico-chemical parameter considered key to characterization and identification, for a given type of nanomaterial. It is important to note that this document is not intended for risk assessment per se but rather presents an approach to gather fit-for-purpose physico-chemical information to more fully understand the behaviour of nanomaterials in biotic and abiotic systems. |
| OECD Series on the Safety of Manufactured Nanomaterials No. 88 - Investigating the Different Types of Risk Assessments of Manufactured Nanomaterials | http://www.oecd.org/officialdocuments/ displaydocument/?cote=env/jm/mono(2018)24&doclanguage=en |
The outcome of this project is an increased understanding of the details and scope of different regulatory risk assessments for manufactured nanomaterials by comparing and contrasting the conditions, assumptions, and levels of uncertainties of approaches utilised in different jurisdictions. Best practices could be identified that could be adopted by other countries |
| OECD Series on the Safety of Manufactured Nanomaterials No. 85 - Evaluation of in vitro methods for human hazard assessment applied in the OECD Testing Programme for the Safety of Manufactured Nanomaterials | http://www.oecd.org/officialdocuments/ publicdisplaydocumentpdf/?cote=ENV/JM/MONO(2018)4&doclanguage=en |
The present report summarises the information extracted from dossiers, presents the evaluation of the information extracted from the dossiers, and identifies potential next steps (e.g. where modification of existing TGs, or proposals of new TGs or Guidance Documents (GDs) could be appropriate). The recommendations and observations presented in this report are only based on the information extracted from the dossiers and recent publications on specific TGs. |
| OECD Series on the Safety of Manufactured Nanomaterials No. 76 - Grouping and Read-Across for the Hazard Assessment of Manufactured Nanomaterials | http://www.oecd.org/officialdocuments/ displaydocument/?cote=env/jm/mono(2016)59&doclanguage=en |
This report summarize the outcomes of a meeting having the purpose to have a common understanding of which specific aspects are to be considered in a regulatory context when applying grouping and read-across for hazard assessment of manufactured nanomaterials (MNs). |
| ISO 21505:2017 | www.iso.org/standard/63578.html | ISO 21505:2017 describes the context in which the governance of projects, programmes and portfolios is conducted and provides guidance for the governance of projects, programmes and portfolios. ISO 21505:2017 can also be used for assessment, assurance or verification of the governance function for projects, programmes or portfolios. ISO 21505:2017 is intended for governing bodies and executive and senior management who influence, impact or make decisions regarding the governance of projects, programmes and portfolios. It is also intended to provide guidance to those who direct projects, programmes and portfolios, such as sponsors, steering committees, portfolio owners and the project management office. It also can be used by project, programme and portfolio managers, as well as stakeholders involved in the development and implementation of projects, programmes and portfolios. Other audiences who can have an interest in this topic include those advising, informing, assisting or working within projects, programmes and portfolios. |
| ISO/TR 13329-2013 | www.iso.org/standard/53705.html | This Technical Report provides guidance on the development of content for, and consistency in, the communication of information on safety, health and environmental matters in safety data sheets (SDS) for substances classified as manufactured nanomaterials and for chemical products containing manufactured nanomaterials. It provides supplemental guidance to ISO 11014:2009[1] on the preparation of SDSs generally, addressing the preparation of an SDS for both manufactured nanomaterials with materials and mixtures containing manufactured nanomaterials. |
| ISO/TS 12901-2:2014 | www.iso.org/standard/53375.html | ISO/TS 12901-2:2014 describes the use of a control banding approach for controlling the risks associated with occupational exposures to nano-objects, and their aggregates and agglomerates greater than 100 nm (NOAA), even if knowledge regarding their toxicity and quantitative exposure estimations is limited or lacking. The ultimate purpose of control banding is to control exposure in order to prevent any possible adverse effects on workers' health. The control banding tool described here is specifically designed for inhalation control. Some guidance for skin and eye protection is given in ISO/TS 12901‑1. ISO/TS 12901-2:2014 is focused on intentionally produced nano-objects such as nanoparticles, nanopowders, nanofibres, nanotubes, nanowires, as well as of aggregates and agglomerates of the same. As used in ISO/TS 12901-2:2014, the term "NOAA" applies to such components, whether in their original form or incorporated in materials or preparations from which they could be released during their lifecycle. ISO/TS 12901-2:2014 is intended to help businesses and others, including research organizations engaged in the manufacturing, processing or handling of NOAA, by providing an easy-to-understand, pragmatic approach for the control of occupational exposures. |
| CEN/TS 16937:2016 | statnano.com/standard/cen/760/CENTS-16937-2016 | This Technical Specification provides a guidance for the responsible development of nanotechnologies taking into account: - Board Accountability; - Stakeholder Involvement; - Worker Health and Safety; - Benefits to and Risks for Public Health, Safety and the Environment; - Wider Social and Ethical Implications and Impacts; - Engagement with Business Partners; - Transparency and Disclosure. NOTE 1 This Technical Specification contributes to social responsibility as defined in ISO 26000:2010. NOTE 2 Nanotechnology activities include industrial production, R&D, services, and marketing of products. This Technical Specification neither covers labelling and advertising aspects nor is it intended for certification purposes, nor does it imply any legally binding agreements. This Technical Specification intends to cover nanotechnology activities involving manufactured nanomaterials, and where relevant incidental nanomaterials. |
| Other guidance documents | ||
| Guidance on the GRACIOUS Framework for grouping and read-across of nanomaterials and nanoforms | zenodo.org/record/5534466#.YzRbknZBw2x | The Framework streamlines the process for assessing the risk associated with Nanomaterials by logically grouping them thereby allowing extrapolation between (read-across) nanomaterials and reducing the need to assess exposure to and toxicity on a case by case basis. |
| Australian cost benefit analysis guidance | obpr.pmc.gov.au/sites/default/files/2021-09/cost-benefit-analysis.pdf | cost–benefit analysis (CBA) to assess regulatory proposals in order to encourage better decision making. A CBA involves a systematic evaluation of the impacts of a regulatory proposal, accounting for all the effects on the community and economy, not just the immediate or direct effects, financial effects or effects on one group. It emphasises, to the extent possible, valuing the gains and losses from a regulatory proposal in monetary terms |
| ECHA | ||
| ECHA - Guidance on information requirements and chemical safety assessment chapter R.8 | echa.europa.eu/documents/10162/17224/ information_requirements_r8_en.pdf/e153243a-03f0-44c5-8808-88af66223258?t=1353935239897 |
This guidance document describes the hazard assessment procedure of chemicals |