SCCS Issued Scientific Advice on the Safety of DHHB

On February 17, 2025, the European Union’s Scientific Committee on Consumer Safety (SCCS), released its latest scientific guidance (SCCS/1678/25) concerning Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB) (CAS No. 302776-68-7). The consultation period remains open until April 25, 2025.

The SCCS concludes the following:

Considering the recent concerns over the presence of DnHexP as a contaminant in the production of DHHB, used as a UV- filter in cosmetic products, as well as in view of technical and scientific progress and taking under consideration in particular the various health concerns, the SCCS is requested to identify the maximum safe level of DnHexP as a contaminant in DHHB preparations.

Taking into account the health concerns associated with DnHexP, the SCCS calculated a maximum level of 0.026% (260 parts per million (ppm)) for this contaminant in the UV filter DHHB. This applies when DHHB is used up to 10% in cosmetic products and only if DnHexP is an unavoidable impurity.

The SCCS has noted available information showing that DnHexP was below the level of detection in several DHHB containing sunscreen products and DHHB sources. The SCCS has also noted the available information showing that the levels of DnHexP in DHHB can be lowered to 1ppm. Therefore, the SCCS is of the opinion that this trace level (1 ppm) should be the target for the maximal level of DnHexP as an unavoidable trace impurity in DHHB.

Hydroxybenzoyl Hexyl Benzoate (DHHB)

The Chinese Cosmetic Ingredient Regulatory Database (ChinaCosIng), independently developed by CIRS Group, indicates that Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB) is used as a light stabilizer, UV absorber, and UV filter in cosmetics. DHHB has been included in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021) and the List of Allowed Sunscreen Agents in the Safety and Technical Standards for Cosmetics in China, with the maximum allowable concentration of 10% when used in cosmetics.

About CIRS

The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet the stringent regulatory standards around the globe. It can provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.

Cosmetic services in the EU and UK:

• Pre-clinical and clinical safety trials: design and realize in vitro tests, providing reports with analysis and conclusion.
• Hazard profiles and risk assessments: comprehensive risk-based safety assessments of cosmetic ingredients and products.
• Regulatory monitoring: a survey of cosmetic ingredients based on EU and UK cosmetic regulations, other local regulations, and international rules.
• Product information file (PIF): provide a cosmetic product safety report (CPSR) and ensure the completeness of PIF.
• Labeling and communication: validate the text and regulatory notices on the packaging in French, Spanish, and English. Compile the regulatory documents necessary for import/export. Notify cosmetic products on the European portal (CPNP).

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

SCCS/1678/25