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- Opinion on Ethylhexyl Methoxycinnamate (EHMC) (CAS No. 5466-77-3/83834-59-7, EC No. 226-775-7/629-661-9)Publication . European Comission. Scientific Committee on Consumer SafetyThe SCCS concludes the following: 1. In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Ethylhexyl Methoxycinnamate, does the SCCS consider Ethylhexyl Methoxycinnamate safe when used as UV-Filter in cosmetic products up to a maximum concentration of 10%? The SCCS has noted that the available evidence shows that EHMC is an endocrineactive substance due to estrogenic activity and weak anti-androgenic activity both in vitro and in vivo. Having considered the data provided, and the concerns relating to potential endocrine disrupting properties of EHMC, the SCCS is of the opinion that EHMC is safe when used as a UV filter up to a maximum concentration of 10% in sunscreen lotion, face and hand cream, lipstick, sunscreen propellant spray and pump spray, when used separately or in combination. The SCCS is of the opinion that these products are also safe for children due to the high Margin of Safety, which precludes any difference between internal exposures in children that might be higher due to a different surface/body weight ratio than in adults. 2. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Ethylhexyl Methoxycinnamate in cosmetic products? 3. Does the SCCS have any further scientific concerns with regard to the use of Ethylhexyl Methoxycinnamate in cosmetic products? The SCCS mandate does not address environmental aspects. Therefore, this assessment did not cover the safety of EHMC for the environment.
- Scientific advice on the safety of Diethylamino Hydroxybenzoyl Hexyl Benzoate – DHHB -S83 (CAS/EC No. 302776-68-7/443-860-6)Publication . European Comission. Scientific Committee on Consumer SafetyThe SCCS concludes the following: 1. Considering the recent concerns over the presence of DnHexP as a contaminant in the production of Diethylamino Hydroxybenzoyl Hexyl Benzoate (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 Considering the health concerns associated with DnHexP, the SCCS calculated a maximum safe level of 0.026% (260 ppm) for this impurity 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. 2. Does the SCCS have any further scientific concerns regarding the presence of DnHexP in DHHB as a UV-filter in cosmetic products? The SCCS has noted from the available information that DnHexP was below the level of detection in several DHHB containing sunscreen products and other DHHB sources, provided that a specific manufacturing process is applied. The information also showed that it is technically possible to lower the levels of DnHexP in DHHB down to 1 ppm. Considering the existence of such alternative manufacturing process for DHHB, the SCCS is of the opinion that a trace level of 1 ppm should be the target for the maximal level of DnHexP as an impurity in DHHB.
- Scientific advice on the safety of Benzophenone-2 (BP-2) (CAS No. 131-55-5, EC No. 205-028-9) and Benzophenone-5 (BP-5) (CAS No. 6628-37-1, EC No. 613-918-7) as substances with potential endocrine disrupting properties in cosmetic productsPublication . European Comission. Scientific Committee on Consumer SafetyThe SCCS concludes the following: In light of technical and scientific progress, available scientific literature, relevant in silico tools and the SCCS’ expert judgement and taking under consideration in particular the concerns related to potential endocrine disrupting properties, the SCCS is requested: 1. to identify and justify whether there are specific concerns regarding the use of Benzophenone-2 and Benzophenone-5 in cosmetic products. Benzophenone 2 (BP-2): Having considered all the available data, and the concerns relating to potential endocrine disrupting properties, the SCCS cannot conclude on the safety of Benzophenone-2 because genotoxicity potential cannot be excluded. The data on repeated dose toxicity and reproductive toxicity of Benzophenone-2 are also either limited or not available. The available evidence shows that BP-2 is an endocrine-active substance, due to a clear demonstration of estrogenic activity both in vitro and in vivo. Benzophenone 5 (BP-5): Due to the scarcity of information for Benzophenone-5, the SCCS has considered that data from a close analogue BP-4 can be used for read-across for the safety assessment of BP-5. Thus, considering the toxicological data on Benzophenone-4, including the potential endocrine disrupting properties, the SCCS is of the opinion that BP-5 is safe when used as a UV filter up to a maximum concentration of 5% in sunscreen, face and hand cream, lipstick, sunscreen propellant spray and pump spray, when used separately or in combination (based on deterministic aggregated exposure of BP-4). 2. to highlight if there is a potential risk for human health from the use of Benzophenone-2 and Benzophenone-5 in cosmetic products. The SCCS considers that the use of Benzophenone-2 in cosmetic products may pose a risk to the consumer because of the indications for genotoxicity and endocrine activity. The assessment of safety of BP-2 in cosmetic products also requires appropriate data on repeated dose toxicity and reproductive toxicity. The SCCS mandate does not address environmental aspects. Therefore, this assessment has not covered the safety of BP-2 and BP-5 for the environment.