On EU's Heels, UK Seeks Data On UV Filters Suspected Of Endocrine Disruption
Executive Summary
The Cosmetic, Toiletry and Perfumery Association hopes to leverage data submitted for the UK evaluation to defend oxybenzone, homosalate, octocrylene and other ingredients in the EU, partnering with Cosmetics Europe.
The UK’s Office for Product Safety and Standards plans to evaluate the safety of UV filters benzophenone-3 (oxybenzone), octocrylene and homosalate, specifically focusing on their endocrine-disrupting potential, according to a 5 April call for data.
“Please submit data regarding all physicochemical properties, toxicokinetic and toxicological endpoints and assessment of exposure through consumer products," says OPSS, which regulates all consumer products in the UK except for vehicles, medicines and food.
The national regulator also intends to assess the safety of kojic acid and butylated hydroxytoluene (BHT), which function in cosmetic products primarily as a skin-lightening agent and antioxidant, respectively.
OPSS notes that data on each ingredient must be provided as a separate submission.
In 2019, the European Commission listed oxybenzone, octocrylene, homosalate, kojic acid and BHT among 14 cosmetic ingredients prioritized for review by the Scientific Committee on Consumer Safety due to endocrine disruption concerns. (Also see "EU’s SCCS Finds Endocrine-Disrupting Evidence Inconclusive In UV Filter Reassessments" - HBW Insight, 23 Jan, 2021.)
The Commission since has received final opinions from the SCCS regarding the named substances’ safe use in cosmetics and potential hormonal impacts.
In its March 2021 final opinion on oxybenzone, the committee recommended tighter restrictions on the UV filter’s use in body creams, propellant sprays and pump sprays compared with the 10% limit currently set by the EU’s Cosmetic Products Regulation, especially in instances where oxybenzone also is present at concentrations up to 0.5% to protect the cosmetic formulation (see table).
Homosalate, currently permitted by the Cosmetic Products Regulation as a UV filter in sunscreen products at levels up to 10%, is more appropriately capped at 0.5%, according to a final opinion issued by the SCCS in June 2021.
The committee acknowledged that revising EU regulatory requirements in accordance with its opinion could undermine homosalate’s efficacy as a UV filter, but said such considerations were outside its remit.
One month later, “in order to ensure broad availability of UV-filters and consequently adequate sun protection for consumers,” industry submitted a recalculated Margin of Safety based only on homosalate’s use in face products, which led to scientific advice published by the SCCS in December 2021 designating homosalate as safe as a UV filter in face cream and pump spray at concentrations up to 7.34%.
The SCCS characterized available evidence for oxybenzone’s and homosalate’s endocrine-disrupting properties as “inconclusive, and at best equivocal.” While there are indications from some in vivo studies to suggest that octocrylene and homosalate may have endocrine effects, “the evidence is not conclusive enough at present to enable deriving a specific endocrine-related toxicological point of departure for use in safety assessment,” the committee said, taking a similar position on oxybenzone.
The Cosmetic, Toiletry and Perfumery Association alerted its members and wider industry on 6 April to OPSS’ call for data, noting the UK’s Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products will review the data and assess the safety of the ingredients in question.
Data submissions are due to OPSS by 31 May.
CTPA states, “These ingredients have also been under regulatory scrutiny in the EU as part of the Chemical Strategy for Sustainability. CTPA is therefore liaising with Cosmetics Europe, the EU personal care association, to explore the possibility to use the data submitted for defense of these ingredients in the EU.”