SCCS/1684/25: Hair Dye Basic Brown 16 Assessed as Not Safe

On 10 February 2026, the SCCS (Scientific Committee on Consumer Safety, the scientific committee of the EU Commission for consumer safety) published its scientific assessment of the hair dye Basic Brown 16. The result is unambiguous: the committee does not consider the use of the substance in non-oxidative hair dye formulations to be safe. The reason is a potential mutagenic risk.

Which substance is concerned

The substance assessed is the hair dye Basic Brown 16, listed under the internal reference C009. The chemical name is 8-[(4-Aminophenyl)diazenyl]-7-hydroxy-N,N,N-trimethylnaphthalen-2-aminium chloride. The identification numbers are:

• CAS Number: 26381-41-9
• EC Number: 247-640-9

The assessment was carried out as part of Submission V ter, i.e. a repeated submission of data to the committee. It is based on Regulation (EC) No 1223/2009, the European Cosmetics Regulation. The request for assessment came from the European Commission.

What the SCCS examined

The Commission put two questions to the committee. First: Does the SCCS consider Basic Brown 16 safe when used as an ingredient at a concentration of 2% in non-oxidative hair dye formulations? Non-oxidative hair dyes are colouring agents that work without a chemical oxidation process, such as direct dyes that apply the colourant directly to the hair.

Second: Does the SCCS have any further scientific concerns regarding the use of Basic Brown 16 in cosmetic products? The published summary does not provide a substantive statement on this second question.

The result of the assessment

After evaluating the data submitted, the committee reaches a clear conclusion. The SCCS does not consider the use of Basic Brown 16 in non-oxidative hair dye formulations to be safe. The reasoning: the overall weight of evidence indicates a mutagenic potential of the substance.

Mutagenicity refers to a substance's ability to alter genetic material. For cosmetic ingredients, this finding is of central importance, because such properties fundamentally call safe use into question. The SCCS assessment refers explicitly to the tested concentration of 2% in non-oxidative formulations.

An SCCS opinion is initially a scientific statement and not yet a legal rule. The European Commission decides, on the basis of such assessments, whether and how to adapt the annexes of the Cosmetics Regulation. Whether and when a corresponding amendment to the Regulation will follow is not evident from the present document.

Procedural data at a glance

Who is affected and what to check now

Manufacturers and distributors of hair dye products that use Basic Brown 16 or plan to use it are affected. Anyone using this substance in formulations should closely monitor further developments. The SCCS's scientific assessment is often the first step before a regulatory adaptation.

Specifically, it is advisable to review your own formulations: Does a product contain the substance with CAS Number 26381-41-9 or EC Number 247-640-9? If so, an early review of possible alternatives and dialogue with the raw material supplier is worthwhile. The complete opinion is available for download as a PDF (sccs_o_305.pdf) on the website of the European Commission.

At REGULARUS, we continuously monitor SCCS opinions and the subsequent amendments to the Cosmetics Regulation. As part of the safety assessment (CPSR under Annex I) and through our change monitoring service for formulation and legislative changes, we assess what consequences may arise for individual formulations. This does not replace a case-specific legal assessment.

Context and further sources

The assessment of Basic Brown 16 forms part of a series of recent SCCS opinions on cosmetic ingredients. It is important for manufacturers to understand the difference between scientific assessment and applicable law. Only an amendment to the annexes of Regulation (EC) No 1223/2009 creates binding requirements. Until then, the SCCS opinion provides a solid technical basis for forward-looking planning.

The complete opinion can be found on the website of the European Commission. An overview of all SCCS opinions is provided on the SCCS Opinions page of the Commission.