Nano rules in REACH: There is a need for adjustment

29.08.2025
Ein Nanoteilchen im Gewebe
The outcome after five years of nano-specific information requirements in the REACH Regulation: The nano-specific information requirements were a first step towards obtaining the data needed for risk assessment

Report on the assessment by the higher federal authorities of the enforceability of the rules for nanomaterials in REACH – review five years after ent

Five years after the nano-specific information requirements in the REACH Regulation came into force, the Federal Environment Ministry asked the Federal Office for Chemicals (BfC) to take stock. It became clear that the nano-specific information requirements were a first step towards obtaining the data needed for risk assessment. However, based on their experience, the authorities have come to the conclusion that many registration dossiers for nanomaterials do not currently provide the required data. Further adjustments are needed before the promise of ‘no data, no market’ can truly be fulfilled.

Substance identities and properties remain unclear

The authorities repeatedly find that registration dossiers do not describe the identity of the nanoforms covered and their properties in a comprehensible manner. The creation of categories of similar nanoforms also presents registrants and authorities with difficulties that have not yet been resolved. Another problem is that the necessary internationally standardized test methods are not available and/or are not adapted to the requirements of substances in nanoform. The full report, including specific proposals for amendments to REACH, can be found under “Further information.”

29.08.2025 | Report Nanotechnology
https://www.bundesumweltministerium.de/ME11444-1

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