What is changing?
The European Commission has adopted a revision to the REACH information requirements for nanomaterials1 which will come into force 1st January 2020. The update defines the terms “nanoform” and “sets of similar nanoforms” and provides guidance on nanoform identification and characterisation. The revision also clarifies what data are required from companies manufacturing or importing nanoforms of substances within the scope of REACH.2 This will enable companies registering a nanoform (and relevant regulatory authorities assessing the registration) to evaluate:
the hazardous properties of a given nanomaterial
safe manufacturing / consumer use
the potential hazard(s) posed to human health and/or the environment
the need for any further risk management measures
The revised Annexes are:
Annex VI: Characterisation of nanoforms or sets of nanoforms covered by the registration
Annex I: The chemical safety assessment
Annexes III and VII-XI: Registration information requirements
Annex XII: Downstream user obligations
IUCLID will also be updated with new data fields for reporting nanoforms on 30th October 2019. Companies manufacturing or importing any nanomaterial at or above the one tonne REACH threshold per calendar year will be required to register their material.
Why are these changes required?
With the ongoing increase in nanomaterial manufacture and commercial use and the analytical challenges presented by nanoforms, a revision of the REACH “nanoform” requirements was necessary to ensure that data provided for new registrations will enable a comprehensive safety assessment to be made.3
What is the impact of these changes?
If you are a registrant of a nanoform substance, you will need to review and potentially update your dossiers with any additional nanoform-specific information by 1st January 2020. While there is concern that the information requirements and test methods in REACH for nanomaterials that are currently on the market, may not be sufficient for safety assessment of next generation nanomaterials, ECHA judge that it is likely that most registrations will be from companies registering first generation nanomaterials (i.e. passive nanostructures including simple organic and carbon-based nanomaterials).4
How can we help you?
The registration of nanoform substances introduces significant technical considerations and challenges compared with non-nanoform substances. If you are considering a nanoform registration, or are in the process of registering a nanoform substance, Cambridge Environmental Assessments can assist and help you navigate your way through any safety challenges or regulatory requirements for your materials, products or technologies.
For further advice on the above or any other chemical regulatory concern, please contact firstname.lastname@example.org
1 Commission Regulation (EU) 2018/1881: amending REACH Annexes to address nanoforms of substances. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R1881&from=EN
2 ECHA Newsletter: September 2018. https://newsletter.echa.europa.eu/home/-/newsletter/entry/are-the-new-reach-information-requirements-for-nanos-relevant-for-you-
3 ChemicalWatch: September 2019 https://newsletter.echa.europa.eu/home/-/newsletter/entry/are-the-new-reach-information-requirements-for-nanos-relevant-for-you-
4 The European Union Observatory for Nanomaterials (EUON). Information note on nanomaterials in the EU: https://euon.echa.europa.eu/documents/23168237/24095696/190919_background_note_next_gen_materials_en.pdf/b9178324-5a69-2e4b-1f2b-aac2c2845f45
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