SCCS - Prostaglandin Analogues: Methylamido-Dihydro-Noralfaprostal (MDN), Isopropyl Cloprostenate (IPCP), Dechloro Dihydroxy Difluoro Ethylcloprostenolamide (DDDE)

SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), J. Ezendam (Rapporteur), E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers (Rapporteur), Ch. Rousselle, M. Stepnik (Rapporteur), T. Vanhaecke, S. Wijnhoven
SCCS external experts: E. Benfenati, N. Cabaton, E. Corsini, Ch. Delmaar, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz, 
Contact: SANTE-SCCSec [dot] europa [dot] eu (SANTE-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1680/25
Adopted on: 28 May 2025

Conclusion of the opinion:

(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, Norbimatoprost 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 young women.

More details on the SCCS concerns regarding safety of the PGAs are given in the section 8.

(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Ethyl Tafluprostamide, Methylamido-Dihydro-Noralfaprostal and Isopropyl Cloprostenate, respectively, in eyelash and eyebrow products?

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(3) Does the SCCS have any further scientific concerns regarding the use of Ethyl Tafluprostamide, Methylamido-Dihydro-Noralfaprostal and Isopropyl Cloprostenate in cosmetic products?

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Keywords:

SCCS, scientific opinion, prostaglandin analogues, PGAs, Ethyl Tafluprostamide, Methylamido-Dihydro-Noralfaprostal, Isopropyl Cloprostenate, Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on prostaglandin analogues used in cosmetic products, preliminary version of 28 May 2025, SCCS/1680/25.