REACH REGISTRATION FOR IRON AND IRON SUBSTANCES

Iron Platform substances and nanos

On January 1^st 2020, the amended annexes from the REACH regulation to address nanoforms of substances (commission regulation (EU) 2018/1881, https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32018R1881) entered into force. 

According to this regulation, a nanoform is a form of a natural or manufactured substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm, including also by derogation fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm.

The scope of the nanos information requirements to fulfil by January 2020 covers both intentionally manufactured nanomaterials and fine pure materials or UVCBs with average diameter > 0,1 µm but a nano tail (more than 50 % particles of < 100 nm but > 1 nm). It is therefore important to check the number-based particle-size distributions of fine powders.

In case a substance meets the definition of a nanoform, the nanoform must be characterized by:

1. The number based particle size distribution with indication of the number fraction of constituent particles in the size range within 1 nm – 100 nm.
2. The description of surface functionalization or treatment and identification of each agent including IUPAC name and CAS or EC number.
3. Shape, aspect ratio and other morphological characterization: crystallinity, information on assembly structure including e.g. shell like structures or hollow structures, if appropriate
4. Surface area (specific surface area by volume, specific surface area by mass or both)

ECHA expects that registrants have checked by 1^st of January 2020, the application of the nano definition and that all different nanoforms are addressed in the registration files. Therefore, consortia and individual registrants need to reconsider the relevancy of the definition for the fine materials they cover under the registration and to consider updating their registration files when a nanoform is manufactured or imported for the element they cover.  All registrants should use the ECHA guidance to characterise their nanos.  It must either be justified that all hazard conclusions in the dossiers are also relevant for the nanoforms (i.e. read-across between bulk forms and nano-forms), or specific information on the nanoforms must be included to ensure their safe manufacturing and use.

More information can be found on ECHA website: https://echa.europa.eu/-/get-ready-for-new-reach-requirements-for-nanomaterials  which includes the latest guidance.   The ECHA webinar on 12 November 2019 provided useful guidance and information - copy of the webinar slides can be found here.

Many registrants of iron and iron oxide substances will have received a communication for ECHA in this respect as ECHA has compiled a list of potential nano substances based on publicly available information compiled from REACH registrations, the Cosmetics Regulation as well as French and Belgian national inventories.  The list can be found from this link  https://euon.echa.europa.eu/search-for-nanomaterials - this list includes iron.

Note that to add nano information to your dossier, you will need to upgrade it to IUCLID version 6.4 which includes all the required nano-related fields.