Several scientific bodies have expressed concerns about the safety of prostaglandins when they are applied close to the eye. The first warnings date back to 2018, when the German Federal Institute for Risk Assessment, the “Bundesinstitut für Risikobewertung” (BfR), informed the European Commission of the increasing presence of prostaglandin derivatives in cosmetic products intended to promote eyelash growth. In its assessment, the agency emphasised that these substances have a powerful pharmacological activity which may lead to undesirable biological effects, even at very low concentrations.
Following this alert, the European Commission mandated the Scientific Committee on Consumer Safety (SCCS) to assess the safety of several prostaglandin analogues used in cosmetic products. An initial opinion published in 2022 indicated that the available data were insufficient to reach a conclusion on the safety of substances such as isopropyl cloprostenate or ethyl tafluprostamide. The Committee particularly highlighted the absence of robust toxicological data that would allow certain potential risks to be ruled out. As new data were submitted by industry, the SCCS re‑evaluated these substances in a more recent opinion published in 2025.
After examination of the available data, the committee concluded that none of the prostaglandin analogues assessed could be considered safe for use in cosmetic products intended to promote eyelash and eyebrow growth, including isopropyl cloprostenate, ethyl tafluprostamide and methylamido-dihydro-noralfaprostal.
At this stage, however, these scientific conclusions have not yet resulted in an official amendment to Regulation (EC) No 1223/2009 on cosmetic products, which governs the placing of cosmetics on the market in the European Union. Nevertheless, in light of the SCCS opinions, the European authorities could decide to include these substances in Annex II of the Regulation, which lists ingredients prohibited in cosmetic products, or to restrict their use. Final regulatory decisions are still pending.
In the meantime, certain national agencies have chosen to inform the public about the potential risks associated with these substances. In France, Anses thus issued in 2025 a warning concerning cosmetics containing prostaglandin derivatives. Anses points out that these adverse effects are already well known in ophthalmology, but that patients treated with eye drops containing prostaglandin analogues are informed of these risks as part of a necessary medical treatment. In the case of cosmetic products, however, these effects are not mentioned on the packaging, which limits the information available to consumers.
Pending any potential changes to European regulations, the agency therefore recommends that users remain alert to the onset of unusual symptoms, such as a change in iris colour or persistent eye irritation. In the event of an adverse effect, it is advisable to stop using the product, to consult a healthcare professional and to report the event via the national portal for reporting undesirable health effects. Reports arising from cosmetovigilance indeed play an important role in identifying new risks and in adapting safety measures designed to protect consumers.