by Dr. Martina Schneider and Caroline Miller, CIH, CSP
On December 3, 2018, the EU amended the REACH Regulation via Commission Regulation (EU) 2018/1881 to address the nanoforms of substances (see also previous blog article here). Annexes I, III, VI, VII, VIII, IX, X, XI and XII were amended at this time.
The amendment introduced the requirement that for nanoforms, specific characterization information should be provided as part of the substance composition information. The nanoform should be considered in the Chemical Safety Assessment. Registrants in the 1-10 tonnage band would have to consider inhalation toxicity instead of the oral route as inhalation is the more appropriate route of exposure. In addition, there are requirements to inform downstream users. All new and previous submissions of registrations for nanoforms are covered by the amendments. The additional information requirements to update dossiers with nano-specific information apply from 1 January 2020.
Registrants should be ready to update their dossiers and to do so, an update for the IUCLID software will be available as of October 30, 2019 which will introduce new data fields relevant for the nanoform. Please note that the updated version of the IUCLID software must be used for nanoform submissions as the submission will not be complete with earlier versions of the software. In addition, the new guidance, that is currently still in draft version will be finalized soon. The new guidance includes advice on utilization of read-across between various forms of nanomaterials and how to comply with changes to Annex VI.
In addition to updating IUCLID and issuance of new guidance, ECHA is supporting companies that are required to provide new submissions on nanoforms by hosting a webinar on 12 November 2019 to provide information on the new amendments for nanoforms, in which webinar participants will be able to participate in a question and answer session with ECHA’s experts. Also, ECHA’s helpdesk is prepared to support companies that are preparing new nanoform submissions.
- Review your chemical inventory for nanoform materials that are or will be manufactured or imported into the EU.
- Compare your nanoform materials to the EU’s recommended definition of nanomaterial.
- For those nanoform materials that meet EU;s recommended definition, be prepared to update your dossier by 1 January 2020.
ECHA Sponsored Webinar “Revised REACH Information Requirements for Nanoforms. Are you ready?”: https://echa.europa.eu/support/training-material/webinars
Commission regulation (EU) 2018/1881: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2018.308.01.0001.01.ENG&toc=OJ:L:2018:308:TOC
ECHA news on nanomaterials: https://echa.europa.eu/-/get-ready-for-new-reach-requirements-for-nanomaterials?_cldee=bWFydGluYS5zY2huZWlkZXJAdWwuY29t&recipientid=lead-1e7879735ce6e8118107005056952b31-b69c11d98a5b4355ae937c96b0f2e114&esid=e1f24b9e-70ea-e911-8113-005056b9310e
- IUCLID software
- European Union
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