The European Commission has published a regulation amending Annex II of REACH legislation to extend nanoforms terminology into Safety Data Sheets within the wider REACH Annexes which came into force in January.
Nanoforms are mentioned in key areas, with introductory text "The safety data sheet shall mention in each relevant section whether and which different nanoforms it covers and link the relevant safety information to each of those nanoforms. As provided for in Annex VI, the term “nanoform” in this Annex refers to a nanoform or a set of similar nanoforms."
Section 1.1 Product identifier
"If the safety data sheet pertains to one or more nanoforms, or substances that include nanoforms, this shall be indicated by using the word “nanoform”."
Section 2.2 Mixtures
if the substance as used in the mixture is in nanoform and is as such registered or addressed by the downstream user chemical safety report, the particle characteristics that specify the nanoform, as described in Annex VI, shall be indicated. If the substance as used in the mixture is in nanoform but is not registered or addressed by the downstream user chemical safety report, the particle characteristics which have impact on the safety of the mixture, shall be provided.
Section 3.1 substances
If the substance is registered and it covers a nanoform, the particle characteristics that specify the nanoform, as described in Annex VI, shall be indicated.
If the substance is not registered, but the safety data sheet covers nanoforms, the particle characteristics of which have impact on the safety of the substance, those characteristics shall be indicated.
Section 9.1. Information on basic physical and chemical properties
- Solubility
As regards nanoforms, the dissolution rate in water or in other relevant biological or environmental media shall be indicated in addition to the water solubility.
- Partition coefficient n-octanol/water (log value)
As regards nanoforms of a substance for which the n-octanol/water partition coefficient does not apply, the dispersion stability in different media shall be indicated.
- Particle characteristics
If the substance is in nanoform or if the mixture supplied contains a nanoform, those characteristics shall be indicated in this subsection, or referred to if already specified elsewhere in the safety data sheet.
SDS' must be modified by the end of 2022.
The full text can be accessed HERE.
