ECHA: REACH and nanoforms

REACH Annexes containing the modifications concerning the references to nanomaterials have been voted and approved by the REACH Committee.

The modified Annexes are published on the Eurlex website at the following link

The documents will now be forwarded to Parliament and the Council for a 3-month scrutiny period.

From a first Cefic analysis, the most relevant changes are:

  • Dissolution rate will have to be considered for endpoints that consider solubility.
  • For water solubility in Annex VII, the following sentence is included: For nanoforms the potential confounding effect of dispersion shall be assessed when conducting the study.
  • In Annex VII, the text on acute toxicity via oral route is replaced by acute toxicity via inhalation route.
  • The concept “set of nanoforms” is included.
  • The requirements previously in Annex IX for further physchem properties to consider, or to be required by the Agency is moved to Annex VIII.

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