Although it is not expected that a cosmetic product would cause harm to the consumer under reasonable and foreseeable use conditions, some ingredients may have properties that can impact its safety. For ingredients of concern, the Scientific Committee on Consumer Safety (SCCS) may be requested to assess their safety and one of the ingredients currently under scrutiny is Diethylamino Hydroxybenzoyl Hexyl Benzoate.
Diethylamino Hydroxybenzoyl Hexyl Benzoate is an organic compound highly valued for its ability to absorb UV radiation, particularly UVA rays, being used as a key ingredient in many cosmetic formulations including sunscreens and other skincare and makeup products.
This ingredient is reported to function in cosmetics as a UV filter, UV absorber and light stabiliser agent and is currently authorised for use in cosmetics as a UV filter under Annex VI to Regulation (EC) No. 1223/2099.
Diethylamino Hydroxybenzoyl Hexyl Benzoate has been extensively evaluated by past scientific committees, such as the Scientific Committee on Cosmetic Products and Non-food products intended for Consumers (SCCNFP) and the Scientific Committee on Consumer Products (SCCP). In the last scientific opinion, issued by the SCCP in 2008, this ingredient was concluded to be safe when used as a UV-filter in cosmetic products up to a maximum concentration of 10%, a limit that is still in force today.
Recently, the German authorities informed the European Commission on the detection of the degradation product of a plasticizer in urine samples of children, that is mono-n-hexyl phthalate (MnHexP) which can be a metabolite from various phthalates, including di-n-hexyl phthalate (DnHexP) which is prohibited in cosmetic products. In particular, the assessment from the German Authorities reported that the presence of this contaminant could be from potential exposure to sunscreens.
The German Federal Institute for Risk Assessment (BfR) assessed whether cosmetic products containing a UV filter, such as Diethylamino Hydroxybenzoyl Hexyl Benzoate, potentially contaminated with DnHexP could pose a health risk to consumers. Although they concluded that there is a sufficient margin of safety in the use of sunscreen products containing up to 10% of a UV filter contaminated with up to 0.3 % DnHexP, they noted that the removal of this contaminant requires special manufacturing and purification processes to ensure its lowest possible presence.
Given the concerns raised over the presence of DnHexP as a contaminant in the production of Diethylamino Hydroxybenzoyl Hexyl Benzoate and the possible health risks associated, the European Commission has requested the SCCS to reevaluate the safe use of this ingredient in cosmetic products and provide scientific advise on the maximum safe level of DnHexP as a contaminant in Diethylamino Hydroxybenzoyl Hexyl Benzoate preparations.
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