Guidance on the Safety Assessment of Nanomaterials in Cosmetics

Policy Details

Policy Details

Originating Entity
Last Action
Adopted by the Scientific Committee on Consumer Safety.
Date of Last Action
Oct 30 2019
Date Introduced
Oct 30 2019
Publication Date
Nov 7 2019
Date Made Public
Oct 30 2019

SciPol Summary

The Scientific Committee on Consumer Safety has created an updated guidance on evaluating the safety of nanomaterial ingredients in cosmetics. Because nanomaterials may behave differently than other materials, specific guidelines are needed to ensure risks associated with exposure are properly measured.  This is a revision of the original 2012 guidance, updated to include new materials and techniques.  The guidance lays out the following:

  • Requirements for safety assessments-Premarket notifications are required for all nanomaterials in cosmetics. Conventional risk assessment strategies should apply to nanomaterials, but nanomaterial specific characterization may be required.
  • Physicochemical characterization-Must cover variation due to production techniques. Characterization of material must include the material as manufactured, the material after addition to final cosmetic product, and the form used for toxicology investigations.Parameters include size and size distribution, aggregation states, shape, and solubility.
  • Exposure assessment-Must investigate the amount and routes (i.e. oral or inhalation) of exposure to nanomaterials by cosmetics consumers.
  • Hazard identification and dose-response characterization- Starts with review of relevant literature to prevent repeating studies that have already been done. Specific considerations for nanomaterials include solubility/dispersion, surface interactions, coatings, nano-carriers and nano-encapsulated materials, immunotoxicity, genotoxicity, carcinogenicity, and developmental and reproductive toxicity.
  • Risk assessment-Ban on animal testing to determine toxicity of cosmetics ingredients means alternative methods may be required; however, there is not yet a standardized framework for these tests.
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