The European Commission has amended Annex II to REACH, which gives the requirements for compiling safety data sheets used to provide safety information on hazardous chemical substances and mixtures in the EU. The regulation will apply from 1 January 2021 with a transitional period until 31 December 2022.

The amended provisions for nanoforms are:

1. The word “nanoform” must be used if the safety data sheet relates to one or more nanoforms or substances that include nanoforms.

2. Particle characteristics that specify the nanoform must be indicated if the substance is:

a. registered and covers a nanoform

b. a nanoform used in a mixture and is registered or covered by a downstream user chemical safety report

3. Particle characteristics that impact the safety of the substance must be indicated if the substance is:

a. not registered, but the safety data sheet covers nanoforms

4. Particle characteristics that impact the safety of the mixture must be indicated if the substance is:

a. a nanoform used in a mixture and is not registered or covered by a downstream user chemical safety report

5. The dissolution rate in water or other relevant biological or environmental media must be indicated in addition to the water solubility; and

6. For substances where the n-octanol/water partition coefficient does not apply, the dispersion stability in different media must be indicated.

If the nanomaterial is registered, the corresponding information will be published from the registration dossiers unless claimed confidential, following the REACH provisions for dissemination. This information on nanoforms is available through ECHA’s chemicals database and the EUON’s search for nanomaterials.

The amendments also align the annex with the sixth and seventh revisions of the United Nations’ Globally Harmonised System (GHS).

Reference:https://euon.echa.europa.eu/view-article/-/journal_content/title/new-safety-data-sheet-requirements-for-nanomaterials