European commision's SCCS Scientific Advice on the Safety of Hair Dye Basic Brown 16 (C009) – Submission V ter

"On November 17, 2025, the Scientific Committee on Consumer Safety (SCCS) issued a preliminary opinion open for comments regarding hair dye ‘Basic Brown 16’ (C009) (CAS No. 26381-41-9, EC No. 247-640-9) Submission V ter. The SCCS concluded that, based on the data provided, Basic Brown 16 is not considered safe for use as an ingredient at 2% in non-oxidative hair dye formulations, as the weight of evidence indicates its potential for mutagenicity. The SCCS also raised further scientific concerns about the use of Basic Brown 16 in cosmetic products, noting that the available evidence does not rule out genotoxicity and that there are uncertainties regarding the exact composition and impurity profile of the substance.
1) Safety Assessment: The SCCS does not consider Basic Brown 16 safe for use in non-oxidative hair dye formulations at 2%, due to concerns about mutagenicity and the lack of robust toxicological data for current batch specifications.
2) Composition and Impurity Profile: The committee noted significant variability in the composition of Basic Brown 16 batches and highlighted the presence of impurities that may contribute to genotoxic risk. The impurity profile has not been fully characterized, and the toxicological relevance of some impurities remains unclear.
3) Genotoxicity and Mutagenicity: The SCCS emphasized that the weight of evidence supports concerns about mutagenicity and potential genotoxicity, which cannot be ruled out for Basic Brown 16. The available studies do not provide sufficient reassurance regarding these endpoints.
4) Further Scientific Concerns: The committee identified additional uncertainties, including the potential for skin sensitization and the lack of reliable data on dermal absorption and long-term exposure effects. The SCCS stressed the need for further clarification and supporting data to address these concerns.Overall, the SCCS’s opinion underscores significant safety and scientific concerns regarding Basic Brown 16, highlighting the need for comprehensive data and rigorous evaluation before considering its use in cosmetic products"