European Scientific Committee Finds UV Filter, Skin-Lightening Agent Unsafe
This article was originally published in The Rose Sheet
Executive Summary
UV filter Phenylene Bis-diphenyltriazine and skin-lightening agent deoxyarbutin are not safe for use in sunscreen products (up to 10%) and face creams (up to 3%), respectively, based on submitted and available data, the EC's Scientific Committee on Consumer Safety says. Comments are being accepted through Oct. 23.
Recently released opinions from the European Commission's Scientific Committee on Consumer Safety include evaluations of UV filter S86 and skin-lightening agent deoxyarbutin, both deemed unsafe for use in the cosmetic contexts evaluated.
Cosmetics Europe submitted a safety-assessment dossier for S86 (INCI name Phenylene Bis-diphenyltriazine) in December 2012 to support the ingredient's use in sunscreen products.
Sunscreens are regulated as cosmetics in the European Union, and the EC maintains a list of UV filters
permitted for use in cosmetic products.
In its opinion, adopted by written procedure in July, SCCS lays out safety conclusions based on its review of data provided on a commercial form of the ingredient, noting that its determinations pertain to Phenylene Bis-diphenyltriazine "with median particle size distribution (number-sized) around 130-170 nm or larger."
According to the committee, the UV filter is not safe for use in concentrations up to 10% due to potential genotoxicity and phototoxicity risks.
Further, an adequate physico-chemical characterization is needed, submitted tests on eye irritation and skin sensitization were deemed inconclusive, and insufficient information on chronic or sub-chronic toxicity after inhalation was provided, SCCS says.
The committee notes that bioaccumulation in the environment may be possible as well, owing to "poor biodegradation potential and the very high octanolwater partition coefficient."
Deoxyarbutin (INCI name Tetrahydropyranyloxy Phenol) is a skin-lightening agent synthesized through removal of hydroxyl groups from the glucose side-chain of β-arbutin.
In its request for an opinion on the ingredient, the EC referred to previous assessments of β-arbutin in which the SCCS stated concerns about related ingredients' potential to release or form hydroquinone.
The EC also pointed out that hydroquinone's use in skin-lightening creams is banned in Europe except in certain professional nail and hair applications (Also see "Artificial Nail System Ingredients Approved By EU For Professional Use" - HBW Insight, 13 Oct, 2003.). The prohibition has prompted increased use of deoxyarbutin as a replacement for skin-lightening purposes, according to the EC.
In light of that trend, SCCS was asked to weigh in on the ingredient's use in face creams at a maximum level of 3% or less.
The panel determined during its June 25 plenary meeting that while deoxyarbutin can be considered safe for consumers in those contexts, "hydroquinone will be formed at levels which raise concerns with regard to the safety of such products during life-cycle of the product (e.g. storage conditions and stability under in-use conditions)."
The SCCS's "overall conclusion," therefore, is that deoxyarbutin's use in face creams at the concentrations considered is not safe.
The committee notes that its opinion is based on scientific data submitted to the EC in 2008 by Girindus AG, a company that no longer exists after being purchased by Nitto Denko Avecia and subsequently sold to Merck & Co., Inc.
Meanwhile, updated information has been received from companies working with alpha- and beta-arbutin skin-lightening agents following the SCCS's request in January 2012 for additional data on arbutin and its derivatives, the SCCS says.
Comments on the Phenylene Bis-diphenyltriazine and deoxyarbutin opinions are being accepted through Oct. 23.
Other recent opinions issued by the SCCS, with October deadlines for comment, include assessments of hair-dye ingredients 2,6-Dihydroxyethylaminotoluene; HC Yellow No. 17; and 2,5,6-Triamino-4-pyrimidinol sulfate.