ECHA has released the draft Commission Regulation amendments to several Annexes of REACH to clarify the registration requirements for nanomaterials. The drafted amendments are currently subject to the scrutiny of the Parlament and Council for a period of 3 months. This period, in fact, is almost over.
The extra clarity on the requirements was a welcomed move by many and clearly states the obligations of a registrant. The amendments are expected to take effect in January 2019, but are subject to delay. It is expected that all registrants, current or new, must meet the newly outlined obligations for nanomaterials within one year after the Legislation updates have taken effect. Registrants are encouraged to actively start as soon as possible the required updates to their dossiers in order to meet these deadlines.
Some major points within the updates:
Many of the same processes as before apply to nanomaterials which has been previously indicated by ECHA.
It is expected that the current Commission Recommendation for the definition of a nanomaterial (2011/696/EU) will be used to determine if a substance is a nanomaterial. However, there is debate on whether it will be used in its exact form or if there will be subtle modifications.
The term "nanoform" will be adopted. A nanoform is defined as "a form of a substance that meets the requirements of the Commission Recommendation for definition of nanomaterial and has a shape and surface chemistry" (ECHA, 2017).
During submissions of nanomaterials under the bulk or ionic form of the substance the Registrant must provide sufficient scientific justification and experimental and monitoring data to prove substance sameness (physical-chemical, (eco)toxicological and environmental fate etc.). As such for one registration there may be the need for more than one data-set. Furthermore, different nanoforms within the same registration will also need to be addressed seperately. For grouping of nanoforms molecular structural similarities will not be sufficient justification alone.
Substance identification will now include nanosepecific elements, and it will be a legal requirement to supply information about such things as coatings.
It has been indicated that some previous waivers and tests may no longer be applicable to nanomaterials, and that different parameters may trigger testing requirements. For instance acute toxicity should be conducted via the inhalation route as a default, it will not be possible to waive aquatic toxicity testing based on poor solubility and a low dissolution rate of the nanomaterial will trigger the need for long-term testing; such as an OECD 211 (Daphnia reproduction study). Considering environmental fate, during "degradation" studies morphological and chemical transformations will have to be considered and may need to be considered in the hazard and risk assessment.
Furthermore a separate hazard and risk assessment may be required if the nanoform does not fit within a current nanomaterial, bulk or ionic group.
There are still knowledge gaps that need to be addressed by the scientific community but the above amendments go some way to enabling informed regulatory strategies. Some these gaps we will report on soon.
If you would like more information on the changes and how they may affect you or your company please contact us at info@bluefrogscientific.com.
