The European Commission Publishes an Amendment to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation to include SDS Requirements for Nanoforms.

The European Commission (EC) has published a regulation in the Official Journal of the European Union that amends Annex II of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The Annex II amendments require that safety data sheets (SDS):

1. Indicate if one or more nanoforms, or substances containing nanoforms, are listed by identifying them using the word “nanoform”;

2. If the substance is registered and includes a nanoform, particle characteristics as described in Annex VI must be indicated;

3. If the substance is not registered and includes a nanoform, the particle characteristics of the substance which will impact the safety of the substance must be noted;

4. The dissolution rate in water or in other relevant biological or environmental media must be noted in addition to the water solubility;

5. The dispersion stability in different media must be indicated for nanoforms of a substance for which the n-octanol/water partition coefficient does not apply.

6. If the substance is used in a mixture and is in nanoform, the particle characteristics that specify nanoforms (as described in Annex VI) must be noted if the substance is registered or addressed by the downstream user chemical safety report. If not registered, characteristics that impacts the safety of the mixture must be provided; and

7. Align SDSs with the sixth and seventh editions of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).

The Annex II amendments will apply beginning January 1, 2021. SDSs which do not comply with the amended Annex II requirements may be used until December 31, 2022.