Examen des annexes REACH relatives aux nanomatériaux

This 2015 position paper by the Center for International Environmental Law (CIEL) analyzes proposed changes to the EU's REACH regulation annexes regarding nanomaterials. CIEL advocates for stricter, more specific requirements for the characterization and separate evaluation of nanoforms, arguing that current proposals only cover minimum needs. Key recommendations include mandatory inhalation or dermal testing where appropriate, the removal of certain exemptions for bioaccumulation and long-term toxicity tests, and the requirement that all nanoforms be fully characterized before being grouped for risk assessment.

• CIEL supports the inclusion of a definition for 'nanomaterial' in Annex VI of the REACH regulation to provide legal certainty, but argues that placing this definition within the main body of the text would make it binding for all stakeholders subject to the regulation.
• The document asserts that nanoforms of a substance must be evaluated and documented separately from non-nanoforms to properly control risks. CIEL specifically argues that the phrase 'le cas échéant' (as applicable) in Annex I section 5.2.2 regarding emission estimates for nanoforms should be removed to avoid legal uncertainty.
• CIEL proposes that for substances under a transitional regime (produced between 1 to 10 tonnes), physico-chemical and (eco)-toxicological information must be included in the registration dossier if nanoforms are used in consumer preparations or incorporated into consumer products.
• Regarding material testing, CIEL argues that declarants should not only describe the test material and sample preparation but also provide a scientific justification for the choice of material and the appropriateness of the test method, especially when using read-across data.
• The document argues that inhalation or dermal risk studies should be mandatory instead of or in addition to oral tests if they are more appropriate, and that tests should focus on a single 'nano-object' rather than its aggregates or agglomerates.
• CIEL contends that it is scientifically unsound to group uncharacterized nanomaterials for risk assessment. It insists that full characterization of all nanoforms must occur before they can be grouped for (eco)-toxicological evaluation.

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} }