ECHA Publishes Technical Manual for Including Nanoforms in an IUCLID Dossier
On June 11, 2010, the European Chemicals Agency (ECHA) announced the availability of a technical manual for including nanoforms in an International Uniform Chemical Information Database (IUCLID) dossier. The Nanomaterials in IUCLID 5.2 Industry User Manual “gives practical instruction to [Registration, Evaluation, Authorization and Restriction of Chemicals (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 Manual states:
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 Manual notes that, although there are no specific information requirements for nanomaterials under REACH, it encourages registrants “to include any information they consider relevant to better describe the substance and to demonstrate its safe use.” The Manual suggests that registrants take advantage of the preliminary guidance of the Organization for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) on testing, exposure measurements, and mitigation of nanomaterials. The Manual is available online. The OECD WPMN materials are available online.