Scientific Committee on Consumer Safety: SCCS: Scientific Advice on: HC Red No. 18: (Colipa No. B124): (CAS No. 1444596-49-9): Submission II

The Scientific Committee on Consumer Safety (SCCS) has issued a preliminary version of scientific advice regarding the use of HC Red No. 18 in cosmetic products. This document assesses the safety, purity, and potential risks associated with the use of this ingredient, particularly in oxidative and non-oxidative hair dye formulations.

• Key Details of the SCCS Advice:
  1. SCCS’s Role:
  The SCCS provides scientific opinions on the health and safety risks of non-food consumer products, ensuring that substances used in cosmetics do not pose a risk to consumer health.
• 2. HC Red No. 18:
  The chemical name and CAS number of HC Red No. 18 are provided to facilitate identification and regulatory monitoring.
• 3. Previous Safety Opinion:
  A previous safety opinion for HC Red No. 18 at a 1.5% concentration in hair dyes was reviewed, offering a historical context for the ingredient’s safety.
• 4. New Submission:
  The latest submission requests a safety assessment of HC Red No. 18 with updated purity data, reflecting changes in the formulation or sourcing.
• 5. Purity and Impurities:
  The submission includes details on the impurities present in the ingredient, including their quantification and the potential toxicological risks associated with these impurities.
• 6. Structural Analysis and Mass Spectrometric Data:
  The submission includes structural analysis and mass spectrometric data to further assess the chemical composition of HC Red No. 18, aiding in a comprehensive safety evaluation.
• 7. In Silico Tools:
  The SCCS utilized in silico tools to predict any toxicological concerns related to HC Red No. 18, applying computational models to assess potential risks without the need for extensive in vivo testing.

This preliminary advice will guide regulatory decisions regarding the safe use of HC Red No. 18 in cosmetic products, ensuring consumer safety while considering the latest scientific data.

Region: EU Harmonized (27 Markets)
Source: https://health.ec.europa.eu/document/download/e921f990-7a44-4825-a15e-cd8e6a6bbc15_en?filename=sccs_o_295.pdf