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HomeHow to prepare registration dossiers that cover nanoforms
Best practices
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This document has been developed in order to provide advice to registrants preparing registration dossiers that cover “nanoforms”. The advice provided in this document is for registrants, and provides best practices or recommendations. These best practices identify the elements that are recommended as minimum when registering substances that fulfil the Commission Recommendation for the definition of nanomaterial. These elements are considered to be important to understand the nature of the substance that is covered by the registration dossier. The aim of this document is to provide criteria for distinguishing between different nanoforms and to give a set of elements recommended to be reported on the characterization of nanoforms. The hazards posed by all possible forms of the substance covered by a registration, including nanoforms, must be addressed by the toxicological and ecotoxicological information provided in the registration dossier Applying these best practices will ensure consistent reporting in registration dossiers and facilitate registrants to clearly demonstrate fulfilment of their registration obligations for substances that fulfil the EC definition (from here on substances that meet the definition of nanomaterial are referred to as nanomaterials in this document). This document is intended to provide advice specific to nanomaterials and does not preclude the applicability of the general principles given in the Guidance on registration [1]. This document does not aim to give potential registrants advice on how to fulfil their information requirements for the substances they are registering. This is addressed in other guidance material (See Appendices for nanomaterials to Chapters R.6, R.7a, R.7b and R.7c to the Guidance on IR&CSA [2], [3], [4], [5]).
- Utgiven:
- Författare: European Chemicals Agency (EU-organisation eller EU-byrå)
- Ämnen: Kemisk industri
- Ämne: administrativa formaliteter , datakommunikation , dokumentregistrering , handbok , kemikalier , kemisk industri , nanoteknik
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| ISSN | ISBN 978-92-9495-868-6 | DOI 10.2823/128306 | Katalognummer ED-02-17-415-EN-N |
- Released on EU publications website:
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