Q&A LoAs and co-registration

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December 2017 - Rare Earth Consortium and nano

The members of the REC consortium are aware of the placing on the market of some rare earth substances covered by the consortium as nanomaterial (NM) and have already started to work on them. However, the work is hampered by the current review of the definition of NM and the on-going consultation on certain important pieces of guidance regarding the registration of NM. Consequently, by May 2018, no registration dossiers falling under the scope of the REC Consortium and submitted by the members of the consortium will be fit as NM. Work on the nano part of the registration dossiers will go on after May 2018 as soon as more clarity is obtained (on the definition and on the registration guidance). Based on the above, a list of dossiers subject to a nano-update will be derived and communicated.
For the NM falling under this list, the REC consortium will perform the update of the registration dossiers and will inform the SIEF-members in due time.
The consortium will also reflect on ways to ensure a fair, transparent and non-discriminatory cost-sharing among the non-nano and nano-forms of the same substance.

May 2017 - new LoAs available

The new LoAs for the substances with the registration deadline 2010 and 2013 are now avaiable for sale.  Please refer to the substance specific page of our website or the relevant SIEF communication. The initial prices of the LoAs per tonnage band is mentionned in this SIEF communication (sent in May 2017). 

March 2017 - Characterisation of nanomaterials

The Consortium members have been extensively discussing methodologies as well as their in-house/externally generated data, but concluded that method optimisation work (both on sample preparation and particle size distribution) is needed to allow the establishment of recommended methods for different types of nanomaterials represented within the Consortium. Such work is scheduled for 2017. Before finalisation of this method optimisation work, the Consortium will not recommend any specific methodology.

As soon as the method optimisation work is finalised, the Consortium will release a communication on this topic.

For an overview and discussion of the available methodologies for the determination of primary particle size distribution, secondary particle size distribution (aggregates, agglomerates), and volume specific surface area, we refer to the following documents:

• JRC reports (2011, 2012, 2014, 2015);
• The recent reply of the JRC to a comment on the application of the VSSA concept (potential issues with e.g. polydisperse/porous materials) (see Gibson et al., 2016, as an answer to Lecloux, 2015);
• A publication from Wohlleben et al., 2013 (BASF) in which ZrO2 samples are characterised together with many other materials.

Additionally, we would like to highlight a publication* on the use of VSSA to characterize nanomaterials. This is an important outcome of the EU NanoDefine project, in which several materials have been characterized. A correlation has been found between the volume specific surface area (VSSA) and the median diameter (D50) on a number basis as derived from electron microscopy. The results of this work have been translated into a paper which has just been accepted for publication in the Journal of Nanoparticle Research. This will most likely allow to make some clarifications regarding VSSA during the public consultation on the recommended definition of nanomaterials.

Moreover, we have been informed that the JRC is supposed to provide guidance on methodologies for characterizing nanomaterials by the end of 2017.

* Wohlleben et al. (2017), Reliable nanomaterial classification of powders using the volume-specific surface area method, J Nanopart Res (2017) 19:61.

Lanthanum trinitrate dossier upgrade to full dossier

The lanthanum trinintrate has been registered as an intermediate under SCC in 2013 and will be updated to an Annex VIII dossier for 2018