SCCS/1678/25: Safe Maximum Level for DnHexP Impurity in UV Filter DHHB

The EU Commission's scientific advisory committee (SCCS, Scientific Committee on Consumer Safety) has issued an opinion on the safety of the UV filter Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB). The focus is not on the filter itself, but on an impurity: Di-n-hexyl phthalate (DnHexP), which can arise during the manufacturing of DHHB. The opinion SCCS/1678/25 was adopted on 26 June 2025.

What it is about

DHHB (CAS/EC number 302776-68-7 / 443-860-6) is a UV filter used in cosmetic products such as sunscreens. The assessment was prompted by recent concerns regarding the presence of DnHexP as an impurity in the DHHB production process. The EU Commission asked the SCCS to determine the maximum safe level of this impurity in DHHB preparations.

DnHexP is a phthalate and is associated with health concerns. The SCCS took these concerns into account in its calculation. Importantly, the assessment concerned the impurity, not the general permissibility of DHHB as a filter.

The calculated maximum level

The SCCS calculated a maximum safe level for DnHexP as an impurity in the UV filter DHHB. The key data of the opinion:

According to the SCCS, the value of 260 ppm applies when DHHB is used at up to 10% in the cosmetic product, and only if DnHexP represents an unavoidable impurity.

The target value of 1 ppm

In its second conclusion, the SCCS goes beyond the pure safety value. The information available showed that DnHexP was below the detection limit in several sunscreen products containing DHHB and other DHHB sources, provided a specific manufacturing process is applied.

The data also showed that it is technically possible to reduce the DnHexP content in DHHB to 1 ppm. Because such an alternative manufacturing process exists, the SCCS is of the opinion that a trace value of 1 ppm should be the target for the maximum DnHexP content in DHHB. The committee thus clearly distinguishes between the value that is just about safe and what the state of the art allows.

Who is affected by the opinion

Affected are manufacturers and distributors of cosmetics who use DHHB as a UV filter, in particular in sunscreens and day care products with sun protection factor. The opinion is also relevant for anyone purchasing raw materials containing DHHB, since the DnHexP content arises during the manufacturing process of the filter and is therefore often present at the raw material supplier's stage.

Importantly, an SCCS opinion is a scientific assessment, not yet applicable law. Only once the EU Commission amends the annexes of the Cosmetics Regulation (EC) No 1223/2009 accordingly will binding obligations with specific deadlines arise. The source material does not yet mention a transition period or a legal act in this regard.

What manufacturers can check now

Even without a binding regulation, the opinion provides technical guidance. Useful steps:

• Check raw material specification: Does the data sheet of your DHHB raw material include information on the DnHexP content? Ask your supplier specifically.
• Compare use concentration: The SCCS value refers to DHHB up to 10% in the product. Document the concentration at which you use DHHB.
• Question the supplier's manufacturing process: Since DnHexP can be reduced to 1 ppm or below the detection limit with the appropriate process, it is worth asking about the process applied.
• Keep the safety assessment up to date: Impurity profiles belong in the safety report (CPSR, Cosmetic Product Safety Report under Annex I) and in the Product Information File (PIF).

The full text of the opinion can be found in the SCCS publication SCCS/1678/25. An overview of all opinions is available on the SCCS Opinions page of the EU Commission.

Practical implications

The assessment shows a recurring pattern: not only the active substance but also its impurities determine the safety of a cosmetic product. For sunscreens containing DHHB, the DnHexP content will become a review point that manufacturers should keep in mind going forward. Those who document their raw material suppliers' data early on are prepared for a possible future amendment of the Cosmetics Regulation. If you need support in assessing impurities in your formulation or updating your documentation, we are happy to assist you.