SCCS/1673/24: HC Red No. 18 in Hair Dye Products Assessed as Safe

The Scientific Committee on Consumer Safety (SCCS) has re-assessed the hair dye substance HC Red No. 18. In its opinion SCCS/1673/24, the Committee concludes that the substance is considered safe under defined conditions. The opinion was adopted on 22 January 2025 and published on 23 January 2025.

What substance is involved

HC Red No. 18 is a hair dye substance. It carries the Colipa number B124 and the CAS number 1444596-49-9. The CAS number (Chemical Abstracts Service) is an internationally unique identifier for chemical substances. The Committee assessed the substance as part of the so-called Submission II. This means that the applicants provided supplementary data for a second submission.

The assessment was carried out in the context of Regulation (EU) No 1223/2009 on cosmetic products. Hair dyes are subject to special regulation there: substances used to dye hair must be scientifically evaluated and included in the relevant annexes before they are authorised.

What the SCCS examined

The European Commission had asked the Committee for scientific advice. Specifically, two questions were at stake:

• Does the SCCS consider HC Red No. 18 safe when the substance is used as an ingredient in a concentration of 1.5 percent in oxidative hair dye products and of 0.5 percent in non-oxidative hair dye products?
• Does the SCCS have any further scientific concerns regarding the use of HC Red No. 18 in cosmetic products?

Oxidative hair dye products develop their colour through a chemical reaction, usually with the addition of an oxidising agent. Non-oxidative hair dye products deposit the colour directly, without this reaction. Different maximum concentrations apply to each type of application.

The result of the assessment

The Committee reaches a clear conclusion. Based on the data provided, the SCCS considers HC Red No. 18 safe when the substance is used as an ingredient in the following concentrations:

Regarding the second question on further scientific concerns, the SCCS does not raise any additional points. The published conclusion contains no additional note in this regard.

Important for context: a positive SCCS assessment is a scientific opinion. It is not equivalent to a legal authorisation. Whether and when the Commission includes the substance with these conditions in an annex to Regulation (EU) No 1223/2009 is decided by a separate legislative process. The source material does not specify a timeline or a transitional period for this.

Who the opinion affects

The assessment is particularly relevant for manufacturers and distributors of hair dye products. Anyone who intends to use, or already uses, HC Red No. 18 in formulations should monitor further developments in the legislative process. What will be decisive is which conditions and maximum concentrations the Commission ultimately incorporates into the binding annex.

The concentrations of 1.5 percent and 0.5 percent stated by the SCCS are tied to the respective type of application. A formulation that complies with these limits corresponds to the Committee's scientific assessment. However, binding obligations and permitted uses only arise once this is legally anchored in the Regulation.

What manufacturers should check now

Several practical steps can be derived from the opinion:

• Check whether HC Red No. 18 is present in your current or planned formulations, and in what concentration.
• Clearly assign each formulation to a type of application: oxidative or non-oxidative. This determines the relevant maximum concentration.
• Document the concentration used in a traceable manner in your Product Information File (PIF).
• Monitor upcoming changes to the annexes of Regulation (EU) No 1223/2009. Binding requirements will only be established there.

For any formulation containing hair dyes, the safety assessment under Annex I of the Regulation is a central component. The CPSR (Cosmetic Product Safety Report, safety report under Annex I) must take into account the specific concentration, the type of application and the underlying data. We support manufacturers in preparing the CPSR, the PIF and the INCI labelling. If the legal situation changes due to the substance being included in the annexes, we assist with the necessary adjustment of the documentation as part of our amendment service.

Where to find the opinion

The full SCCS opinion is publicly available. It carries the number SCCS/1673/24 and was adopted in its final version on 22 January 2025. The corresponding PDF file (sccs_o_295.pdf) and further details are available on the European Commission's publication page. An overview of all SCCS opinions can be found in the Committee's opinion database.