The updated REACH Annexes for nanoforms of substances will apply from 1 January 2020 (REGULATION (EU) 2018/1881).
The new requirements apply to both new (now pending) registrations and already registered substances. ECHA believes that there are likely to be more nanoformed substances on the market than are currently registered under REACH. All these dossiers must now be revised in a timely manner in order to meet the new information requirements.
Additional information is not only required in the area of substance description. There are also changed information requirements in Annexes VII to X, which should be taken into account when carrying out new tests.
On October 30, 2019, IUCLID6 has been updated with new data fields for reporting the properties of nanoforms and amounts of nanoforms. Starting this day, registrants wishing to submit registrations for substances in nanoform can provide full information on the characterization of their nanoforms or sets of nanoforms.
Existing dossiers must now be revised and supplemented with the requested information
- For re-submission, the latest IUCLID version must be used.
- An update of IUCLID 5 requires extensive formal adjustments
- Dossiers often include both the bulk material (non-nano forms) and one or more nanomaterials.
- The studies must be clearly assigned to the different forms of the substance (assessment entities).
- This may require a substantial update of the existing exposure and risk assessment
- Existing tests may have been performed on nanomaterials without adequate documentation.
- Some study results may also be applied to nanomaterials – but this must be scientifically justified for different endpoints.
- If there are gaps in the data, it must be checked whether they can also be closed with alternative methods.
Online dossier cannot be used to submit registrations for nanomaterials
The REACH-IT online dossier tool for preparing joint submission member registrations is not being updated with the latest IUCLID version. This may lead to completeness check failures, e.g. when preparing a dossier covering substances in the nanoform.
For new registrations, please consider using one of the other tools offered by the Agency, such as the maintenance-free IUCLID 6 Cloud.
Can additional tests be necessary?
– Yes – some additional nanoform-specific physicochemical parameters (e.g. surface chemistry, Zeta potential, dustiness)
– Depending on material properties (solubility in water and / or biological media, dustiness)
– Depending on the inherent properties of the substance (toxic potential)
– Depending on the uses
Expert knowledge is essential to make the decision on a case-by-case basis and to write the appropriate justifications
- Implementation of the new information for the characterization of nanoforms
- Development of a strategy for grouping different nano-forms
- Here we serve as a “trustee” to ensure that the confidentiality remains granted to the co-registrants
- Assignment of already existing studies (or test materials) to the different nano-forms
- Examination of the existing dossier for new additional data requirements
- Nano-specific data gap analysis
- Development of justifications for the use of existing study results (transfer of results to the bulk material, justification for the read-across between different groups of nanomaterials)
- Holistic exposure and risk assessment for different nanoforms using assessment entity modelling