New safety data sheet requirements for nanomaterials

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:

• The word “nanoform” must be used if the safety data sheet relates to one or more nanoforms, or substances that include nanoforms.
• Particle characteristics that specify the nanoform must be indicated if the substance is:
  • registered and covers a nanoform
  • a nanoform used in a mixture and is registered or covered by a downstream user chemical safety report
• Particle characteristics that impact the safety of the substance must be indicated if the substance is:
  • not registered, but the safety data sheet covers nanoforms
• Particle characteristics that impact the safety of the mixture must be indicated if the substance is:
  • a nanoform used in a mixture and is not registered or covered by a downstream user chemical safety report
• The dissolution rate in water or in other relevant biological or environmental media must be indicated in addition to the water solubility; and
• 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).

Background
REACH information requirements for nanomaterials

Updated REACH information requirements for nanoforms of substances have applied since 1 January 2020. Beyond this date, companies must have a REACH registration compliant with these requirements to manufacture or import nanoforms of substances that need to be registered under REACH. The purpose of the new requirements is to make sure companies provide adequate data to show the safe use of their nanoforms for human health and the environment.

Safety data sheets

Safety data sheets include information about the properties of hazardous substances or mixtures containing hazardous substances, its hazards and instructions for handling, disposal and transport and also first-aid, firefighting and exposure control measures. The format and content of the safety data sheets are specified in REACH. A safety data sheet must be provided to downstream users for:

• A substance or mixture that is classified as hazardous according to the Classification, Labelling and Packaging (CLP) Regulation.
• A substance that is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB).
• A substance that is included in the Candidate List of substances of very high concern (SVHCs).

The information normally found in a safety data sheet will be published from all REACH registration dossiers regardless of whether the substance requires a safety data sheet or not – unless the information is claimed confidential.

Source: EUON – New safety data sheet requirements for nanomaterials

Commission Regulation of the European Commission: Commission Regulation (EU) 2020/878 of 18 June 2020 amending Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance)