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26 July 2026 Update

SCCS/1683/25: Hair Dye Basic Blue 99 (C059) Deemed Not Safe

SCCSHaarfarbstoffBasic Blue 99Genotoxizität

Unlabeled cosmetic bottles with blue color pigment next to laboratory glassware and pigment powder

The Scientific Committee on Consumer Safety (SCCS) adopted a scientific opinion on the hair dye Basic Blue 99 (C059) on 2 February 2026. The committee concludes that the use of the substance in non-oxidative hair dye products is not considered safe. This is based on Submissions IV & V, published on 10 February 2026 under the number SCCS/1683/25.

What the SCCS Assessed

Basic Blue 99 is a hair dye designated as 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride. The substance carries the CAS number 68123-13-7 and the EC number 268-544-3. The European Commission had asked the SCCS to assess whether the substance is safe when used at 1 percent in non-oxidative hair dye formulations. Non-oxidative hair dyes are products that change hair color without the oxidation reaction typical of permanent dyeing.

The SCCS evaluated all available data. Two questions were at the center: safety at 1 percent in non-oxidative formulations, and any further scientific concerns regarding use in cosmetic products.

The Key Finding: Indications of Genotoxicity

On the first question, the SCCS reaches a clear conclusion. Based on the data submitted, the committee does not consider the use of Basic Blue 99 as an ingredient in non-oxidative hair dye products to be safe. The reason: the totality of the evidence points to a potential for genotoxicity. Genotoxicity describes the ability of a substance to damage genetic material.

Where a genotoxicity potential has been identified, a safe concentration limit generally cannot be derived. This explains why the SCCS does not consider the use safe even at the tested concentration of 1 percent.

Further Concerns: Skin Sensitization

The SCCS also raises concerns regarding the second question. The committee refers to cases of immediate-type hypersensitivity reactions, some of which were severe. Although the SCCS notes uncertainty about the exact composition of the batch that triggered these reactions, the committee considers this a warning signal for a corresponding risk under the batch specifications currently under consideration. The SCCS also classifies Basic Blue 99 as a skin sensitizer. A skin sensitizer is a substance that can trigger allergic skin reactions upon repeated contact.

Who the Opinion Affects

The assessment is directed at manufacturers and placers of hair dye products who use, or intend to use, Basic Blue 99 (C059). This particularly concerns non-oxidative hair dye products, as the assessment focused on this area of use and a concentration of 1 percent.

Important context: an SCCS opinion is a scientific assessment. It is not yet an amended legal provision. Amendments to the annexes of Regulation (EU) 1223/2009 on cosmetic products are made by the European Commission through a separate procedure. The source material does not specify a concrete timeline or legal act in this regard. Whether and when the Commission will act on the basis of this opinion is not stated in the publication.

What Manufacturers Can Check Now

Anyone using Basic Blue 99 in their formulations can assess their own situation based on the opinion. Useful starting questions include:

  • Does any of my formulations contain Basic Blue 99 (CAS 68123-13-7, EC 268-544-3)?
  • In which product types and at what concentration is the substance used?
  • Is current information from raw material suppliers on batch specification available?
  • Is the safety assessment (CPSR, Cosmetic Product Safety Report under Annex I of Regulation 1223/2009) up to date with current scientific knowledge?

The full opinion is available as a PDF (SCCS/1683/25, document sccs_o_304.pdf) on the European Commission's website. It contains the complete data basis and the reasoning behind the conclusions. You can find the original text of the opinion here. An overview of all SCCS opinions is available on the Commission's SCCS Opinions page.

In Brief

The SCCS has assessed Basic Blue 99 (C059) in non-oxidative hair dye products at 1 percent as not safe, because the available data indicate a potential for genotoxicity. In addition, the committee classifies the substance as a skin sensitizer and sees a risk of immediate-type hypersensitivity reactions. The opinion was adopted on 2 February 2026 and published on 10 February 2026. Whether this will lead to a legal amendment cannot be determined from the source material.

Sources

This article provides general information on regulatory developments and does not replace legal advice for individual cases.