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Posted: August 5, 2010
Newly released 'Nanomaterials in IUCLID 5.2' industry user manual
(Nanowerk News) The Nanomaterials in IUCLID 5.2 Industry User User Manual gives practical instruction to REACH registrants on how to include information on different forms of a substance in a IUCLID 5.2 dossier.
The manual introduces a book-keeping principle where each form gets a specific label that enables it to be tracked throughout the dossier: instructions are given on how to create labels for form-specific Reference substances, composition blocks, Endpoint study records and analytical data. In particular, the manual gives instructions that will enable registrants to consistently create and label Endpoint study records such that it is clear which composition or form was used as the test substance for that study.
The technical manual will ensure that industry can have a coherent approach on how information on nanoforms is structured in a dossier. This will also simplify the retrieval of information on the forms of a substance that are included in a given dossier.
Nanomaterials are covered under the substance definition in REACH and may be considered to be distinct substances or forms of a substance (CA/59/2008). The sole purpose of this document is to provide registrants with information on how to technically prepare their IUCLID dossiers for nanomaterials. It is the responsibility of the registrant to identify the substance and this document does not provide any information that will aid the registrant deciding when a nanomaterial can be considered to be a distinct substance or a nanoform. Moreover, following the technical advice given in this document does not imply that a dossier would be compliant with REACH requirements should it be selected for evaluation.
The preparation of a IUCLID dossier for nanomaterials is in principle not different from the preparation of a dossier for any other substance with the exception that internationally agreed naming and identification conventions are not yet available for nanomaterials. This can potentially create issues with consistency in the identification information included in the dossier. For cases where the registrant has concluded that the nanomaterial is a nanoform of a substance, it is suggested to include information on the nanoform in the dossier analogously to any other composition of a substance (e.g. substances with compositions that have different impurity profiles, metals and metal powders).1 Specific examples will be given here on how to prepare the IUCLID dossier to avoid potential inconsistencies and complete the two new specific fields for nanomaterials in IUCLID 5.2.
This document also aims to provide registrants with practical instructions on how to include information on nanomaterials so that that the dossiers are better structured and facilitate the retrieval of information via the currently available search functionalities in IUCLID 5.2. This should also facilitate a coherent approach in the preparation of joint registration dossiers. Although there are no specific information requirements for nanomaterials under REACH, registrants are encouraged to include any information they consider relevant to better describe the substance and to demonstrate its safe use. For example, registrants may wish to take advantage of (preliminary) guidance of the OECD Working Party on Manufactured Nanomaterials (WPMN) on testing, exposure measurements and mitigation of nanomaterials and include specific information relating to the current recommendations.