Prostaglandins and prostaglandin-analogues used in cosmetic products

SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik (Rapporteur), T. Vanhaecke, S. Wijnhoven
SCCS external experts: A. Koutsodimou, 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/1635/21
Adopted on: 3 February 2022

Conclusion of the opinion:

(1) In light of the data provided, does the SCCS consider Isopropyl cloprostenate (CAS 157283-66-4) and Ethyl Tafluprostamide or DDDE (CAS 1185851-52-8) safe when used up to the concentrations provided in the respective dossiers (0.006% and 0.007% for Isopropyl cloprostenate and 0.018% for Ethyl Tafluprostamide)

Having considered the limited data provided and the available information from published literature, the SCCS is not able to conclude on the safety of isopropyl cloprostenate and ethyl tafluprostamide when used up to the intended use concentrations indicated in the respective dossiers (0.006% and 0.007% for isopropyl cloprostenate and 0.018% for ethyl tafluprostamide).

(2) Does the SCCS have any further scientific concerns with regard to the use of Isopropyl cloprostenate (CAS 157283-66-4) and Ethyl Tafluprostamide / DDDE (CAS 1185851-52-8) in cosmetic products?

The SCCS has noted concerns about the safety of isopropyl cloprostenate and ethyl tafluprostamide when used in cosmetic products - in particular those that are intended for use in the proximity of the eye. These concerns have been highlighted in more detail in Annex 1.

(3) In light of the available data, does the SCCS consider that the use in cosmetic products of prostaglandins analogues (listed in Table 1) raises safety concerns and might pose a risk to human health?

Prostaglandins and synthetic analogues are widely known to be potent pharmacologically active substances. Due to these effects, other regulatory authorities have advised against, or have prohibited, their use in eyelash growth-promoting cosmetics. In view of the potential for causing effects at very low concentrations, and the intended use in the proximity of the eye, the SCCS has noted concerns over the safety of prostaglandin analogues when used in cosmetic products. These have been highlighted in Annex 1 to this Opinion.

Keywords:

SCCS, scientific opinion, prostaglandins, Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on Prostaglandins and prostaglandin-analogues used in cosmetic products, preliminary version of 27 September 2021, final version of 3 February 2022, SCCS/1635/21.