Nanomaterials in reach

• Several critical differences between the “nano” forms of substances and their “bulk” counterparts may necessitate additional considerations in regulatory frameworks to adequately address potential risks posed by nanomaterials (NMs). The aim of this presentation is to address the problematics of assessing and managing risks of NMs by the means of EU chemicals regulation REACH (Registration, Evaluation, and Authorization of Chemicals). It is based on the results of the SKEP-ERA net project “Nanomaterials in REACH”, which during year 2010 gathered international expertise on chemicals regulation, physico-chemical properties and toxicity of NMs, and environmental and technology policy. Analysis and discussion points cover following topics: definitions concerning nanomaterials, REACH provisions for registration of NMs as substances, and in articles (including “phase-in”/“non-phase-in” status, mass based tonnage thresholds, “prioritization” criteria, classification as hazardous, percentage thresholds in articles), substance identification, scope of data requirements, standardization and methodology for human and environmental hazards identification and risk characterisation. Examples of resulting recommendations include: (1) adopt a single overarching definition of NMs for regulatory purposes; (2) treat “nano” forms as different from their “bulk” counterparts and as “non-phase in” substances; (3) differentiate “nano” forms with the same core chemistry using differences in the physicochemical parameters; (4) introduce mandatory list of physicochemical properties for substance identification; (5) introduce alternatives to the tonnage triggers; (6) develop register of comprehensive information on the presence of NMs in articles; (7) extend a scope of data requirements with nano-specific data requirements; (8) develop nano-specific criteria for inclusion in the SVHC list.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)

Keyword

Toxicology

Toxikologi

Publication and Content Type

vet (subject category)

art (subject category)