Revision of REACH Annexes for Nanomaterials – Position Paper

This position paper by the Center for International Environmental Law (CIEL) evaluates proposed amendments to the REACH Annexes intended to improve the registration and risk assessment of nanomaterials in the European Union. CIEL argues that nanoforms must be assessed and documented separately from non-nanoforms and calls for more rigorous characterization, mandatory testing for specific exposure routes, and the closure of loopholes regarding phase-in substances used in consumer products.

• CIEL supports the inclusion of a nanomaterial definition in REACH Annex VI to provide legal certainty, but argues that placing this definition in the main body of the text is necessary to make it binding for all stakeholders.
• The document asserts that 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.
• CIEL proposes that physicochemical and (eco-)toxicological information should be mandatory for phase-in substances (those on the market before 1 June 2008) specifically when nanoforms are incorporated into consumer articles or preparations to close a risk assessment loophole.
• Regarding test materials, CIEL argues that registrants should be required to justify why a specific test material and method were chosen and whether the results are applicable across multiple nanoforms, including for historical data.
• CIEL criticizes the Commission's proposed characterization criteria for nanoforms as being only minimum requirements, noting the absence of data on surface charge, surface chemistry, stability of aggregates, and the crystalline state.
• The paper advocates for mandatory inhalation or dermal studies for nanoforms when they are more appropriate than oral tests, arguing that failing to require these tests effectively results in testing the materials on humans.
• CIEL contends that nanoforms must be fully characterized before they can be grouped for (eco-)toxicological assessment, stating that grouping uncharacterized materials for hazard assessment is 'scientific nonsense'.
• The document supports a new obligation for downstream users to maintain information on the physical state, concentration, and quantities of nanoforms used in mixtures and articles.

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} }