Revision of REACH Annexes for Nanomaterials – Position Paper

The document analyzes proposed changes to the EU's REACH regulation to ensure nanoforms of substances are properly characterized and assessed. It argues for mandatory separate documentation of nanoforms, stricter requirements for physicochemical and toxicological data—especially for consumer products—and the necessity of full characterization before grouping materials for hazard assessment.

• The inclusion of a nanomaterial definition in REACH Annex VI is supported for providing legal certainty, but the author argues it should be placed in the main body text to be binding for all stakeholders.
• Nanoforms of a substance must be assessed and documented separately from non-nanoforms to ensure risks are adequately controlled, particularly within registration dossiers, chemical safety reports (CSR), and safety data sheets.
• The author recommends that physicochemical and (eco-)toxicological information be mandatory in registration dossiers for phase-in substances if nanoforms are used in consumer articles or preparations to close a risk assessment loophole.
• Registrants should be required to justify the selection of test materials and methods, and explain if results are applicable across multiple forms, to ensure the quality of read-across results.
• For human health hazards, the author argues that inhalation or dermal studies should be mandatory instead of or in addition to oral tests when they are the more appropriate exposure route, and that the discrete nano-object should be tested rather than its aggregates.
• The author contends that nanoforms must be fully characterized before they can be grouped for (eco-)toxicological assessment, as grouping uncharacterized materials is described as scientific nonsense.

APA

Center for International Environmental Law (2015). Revision of REACH Annexes for Nanomaterials – Position Paper. https://www.ciel.org/wp-content/uploads/2015/10/Position-Paper-REACH-Annexes-Final.pdf

Chicago

Center for International Environmental Law. Revision of REACH Annexes for Nanomaterials – Position Paper. 2015. https://www.ciel.org/wp-content/uploads/2015/10/Position-Paper-REACH-Annexes-Final.pdf.

Wikipedia

{{cite press release |author=Center for International Environmental Law |title=Revision of REACH Annexes for Nanomaterials – Position Paper |date=September 2015 |url=https://www.ciel.org/wp-content/uploads/2015/10/Position-Paper-REACH-Annexes-Final.pdf |access-date=17 August 2026 |via=Climate Insights Directory}}

BibTeX

@misc{centerforinternationalenvironmentallaw2015revision, author = {{Center for International Environmental Law}}, title = {{Revision of REACH Annexes for Nanomaterials – Position Paper}}, publisher = {Center for International Environmental Law}, year = {2015}, month = sep, url = {https://www.ciel.org/wp-content/uploads/2015/10/Position-Paper-REACH-Annexes-Final.pdf}, urldate = {2026-08-17}, note = {Indexed by Climate Insights Directory} }