On February 10, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued final opinion (SCCS/1680/25) on Prostaglandin Analogues: Methylamido-Dihydro-Noralfaprostal (MDN) (CAS No. 155206-01-2), Isopropyl Cloprostenate (IPCP) (CAS No. 157283-66-4) and Dechloro Dihydroxy Difluoro Ethylcloprostenolamide (DDDE) (CAS No. 1185851-52-8). Compared to the scientific advice issued on June 6, 2025, the final opinion has been updated. The revisions are highlighted in yellow as follows.
Scientific Opinion on Three Prostaglandin Analogues
1. In light of the data provided and taking under consideration the concerns raised by the SCCS in Opinion SCCS/1635/21,
a) does the SCCS consider Ethyl Tafluprostamide safe when used in eyelash and eyebrow products up to a maximum concentration of 0.018 %?
b) does the SCCS consider Methylamido-Dihydro-Noralfaprostal safe when used in eyelash and eyebrow products up to a maximum concentration of 0.03 %?
c) does the SCCS consider Isopropyl Cloprostenate safe when used in eyelash and eyebrow products up to a maximum concentration of 0.005 %?
Having evaluated all the evidence provided by the Applicants to support the safe use of the three prostaglandin analogues (PGAs) - Isopropyl Cloprostenate, Methylamido-DihydroNoralfaprostal and Dechloro Dihydroxy Difluoro Ethylcloprostenolamide - the SCCS is of the opinion that none of them can be considered safe for use in cosmetic products intended for promoting the growth of eyelashes and eyebrows.
The SCCS conclusion is based on the potent pharmacological activity of the PGAs, even at low concentrations, and the lack of acceptable data that would make it possible to exclude any potential adverse effects resulting from reproductive/developmental toxicity. The latter is crucially important for PGAs in view that users of the PGA-containing cosmetic products will most likely be women of child-bearing age.
More details on the SCCS concerns regarding safety of the PGAs are given in the section 8.
2. The available evidence has shown that neither of the 3 PGAs assessed in this Opinion has a potential for genotoxicity, and hence no concern over genotoxic carcinogenicity. However, as indicated in the previous SCCS Opinion (SCCS/1635/21), in the absence of experimental data on carcinogenicity, the possibility of non-genotoxic carcinogenicity cannot be excluded.
Regulatory Requirements Interpretation of Three Prostaglandin Analogues
The Global Cosmetic Ingredient Regulatory Database-Global CosIng, an upgraded version of China CosIng independently developed by CIRS Group indicates that Isopropyl Cloprostenate (IPCP) (CAS No. 157283-66-4) is included in the following key lists globally.
Dechloro Dihydroxy Difluoro Ethylcloprostenolamide (DDDE) (CAS No. 1185851-52-8) is included in the following key lists globally.
While, the above three substances, classified as prostaglandin analogues (PGAs), are not listed in the annexes of the EU Cosmetics Regulation (EC) No. 1223/2009 as well as Inventory of Existing Cosmetic Ingredients in China (IECIC), and there are no specific concentration limits established for their use in cosmetic products.
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