further scientific questions homosalate

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This opinion has an eight-week comment period (November 6, 2020 to January 4, 2021) from its initial publication. SCCS will consider comments received during this period. For this opinion, there have been some changes, notably sections 3.1.1.3, 3.1.6, SCCS general comment under 3.1.9, new

This opinion has an eight-week comment period (November 6, 2020 to January 4, 2021) from its initial publication. SCCS will consider comments received during this period. For this opinion, there have been some changes, notably sections 3.1.1.3, 3.1.6, SCCS general comment under 3.1.9, new research under 3.2.1.1, SCCS comment under 3.2.1.2, SCCS comment under 3.2.2 additional information for . SCCS general comment on toxicokinetics under 3.2.2, calculation of SED under 3.3.2, including information on inhalation-oral and pooled exposures, new information under 3.4.1.1 and SCCS comments under 3.4.4.1 New information under SCCS Commentary, SCCS Commentary Changes per 3.4.5, Sections 3.4.10.1 - 3.4.10.2.4, SCCS Overall Conclusions on Endocrine Disrupting Properties Level 4 Section 3.4.10.2.4, Section 3.4.10.2.4 Section 3.5 and related Discussion section. Most of the conclusions remain unchanged, except for the deletion of the sentence on inhalation toxicity and the addition of a paragraph on joint exposure to salicylic acid. Also added a final sentence on efficacy under Conclusion 3.

1 Based on the data presented and considering the concerns associated with the potential endocrine disrupting properties of homosalate, does the SCCS consider that homosalate is safe for use in cosmetics as a UV filter at a maximum concentration of 10%?
Based on the safety assessment of homosalate, and taking into account concerns related to potential endocrine disrupting properties, the SCCS concluded that homosalate is not safe for use in cosmetics as a UV filter at concentrations up to 10%.
2 Also, according to SCCS, what is the safe maximum concentration of homosalate for use as a UV filter in cosmetics?
The SCCS believes that the use of homosalate as a UV filter in cosmetic products is safe for consumers, with a maximum concentration of 0.5% of homosalate in the final product.
3 Does the SCCS have any further scientific questions homosalate regarding the use of homosalate in cosmetics?
It should be noted that the SCCS considers the currently available evidence for the endocrine disrupting properties of homosalate to be inconclusive and equivocal at best. This applies to all available data from computer modeling, in vitro testing and in vivo studies when considered individually or in combination. The SCCS believes that although some studies have suggested that homosalate may have endocrine effects, the evidence is currently not conclusive enough to draw a specific endocrine-related toxicological starting point for safety assessments.
Exposure to homosalate from products other than those in this opinion was not considered.
This opinion does not consider concomitant exposure to salicylic acid formed from the metabolic transformation of humosalate, other salicylates (eg, methyl salicylate), or salicylic acid derived directly from salicylic acid itself.
The use of lower concentrations of homosalate may affect the efficacy of UV filters, but this is outside the scope of SCCS to assess the efficacy of cosmetic ingredients.

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