Examen des annexes REACH relatives aux nanomatériaux
Summary
The document analyzes proposed changes to the REACH regulation's annexes to ensure nanomaterials are properly documented and assessed. It argues that nanoforms must be evaluated separately from non-nanoforms and that registration dossiers should include detailed physico-chemical and toxicological data, especially for consumer products. The author supports the inclusion of a formal definition of 'nanomaterial' in Annex VI but argues that current characterization requirements are insufficient, omitting critical data on surface chemistry and agglomeration. It further advocates for mandatory inhalation or dermal toxicity studies when more appropriate than oral tests and insists that nanomaterials must be fully characterized before being grouped for risk assessment.
Key insights
- The author supports including a definition of nanomaterials in Annex VI for legal certainty but argues that placing it in the main body of the text would make it binding for all stakeholders under REACH.
- Nanoforms of a substance must be evaluated and documented separately from non-nanoforms to ensure risks are properly controlled, particularly in chemical safety reports (CSR), safety data sheets, and communications with downstream users.
- The author argues that physico-chemical and (eco)-toxicological information should be mandatory in registration dossiers for transitional substances if nanoforms are used in consumer preparations or products.
- The author contends that registrants should be required to perform inhalation or dermal risk studies instead of or in addition to oral tests if those routes are more appropriate, and must provide scientific justification for the chosen route.
- The document argues that grouping nanoforms for (eco)-toxicological assessment is scientifically unsound unless all nanoforms are fully characterized first, as properties like size, coating, and shape significantly influence toxicity.
Cite the original document
- APA
- Center for International Environmental Law (2015). Examen des annexes REACH relatives aux nanomatériaux. https://www.ciel.org/wp-content/uploads/2016/08/Position-Paper-REACH-Annexes-Final-FRENCH-TRANSLATION.pdf
- Chicago
- Center for International Environmental Law. Examen des annexes REACH relatives aux nanomatériaux. 2015. https://www.ciel.org/wp-content/uploads/2016/08/Position-Paper-REACH-Annexes-Final-FRENCH-TRANSLATION.pdf.
- Wikipedia
- {{cite press release |author=Center for International Environmental Law |title=Examen des annexes REACH relatives aux nanomatériaux |date=September 2015 |url=https://www.ciel.org/wp-content/uploads/2016/08/Position-Paper-REACH-Annexes-Final-FRENCH-TRANSLATION.pdf |access-date=17 August 2026 |via=Climate Insights Directory}}
- BibTeX
- @misc{centerforinternationalenvironmentallaw2015examen, author = {{Center for International Environmental Law}}, title = {{Examen des annexes REACH relatives aux nanomatériaux}}, publisher = {Center for International Environmental Law}, year = {2015}, month = sep, url = {https://www.ciel.org/wp-content/uploads/2016/08/Position-Paper-REACH-Annexes-Final-FRENCH-TRANSLATION.pdf}, urldate = {2026-08-17}, note = {Indexed by Climate Insights Directory} }
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