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Tuesday, April 9, 2024Regulation

Prostaglandin analogues: new request for Opinion to SCCS

Analogues aux prostaglandines : nouvelle demande d'Opinion au CSSC

In its assessment at the beginning of 2022, the SCCS was unable to reach a conclusion on the safety of prostaglandin analogues substances. Since the industry has provided new data, the European Commission has just given the Scientific Committee a new mandate.

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Background

In 2018, the German Federal Institute for Risk Assessment (BfR) informed the European Commission that cosmetic products intended to promote the growth of eyelashes were increasingly available on the market. These products contained substances such as prostaglandins or their analogues that may pose risks for consumers.
Prostaglandins and their analogues were not listed in the Annexes to the Cosmetic Regulation (EC) No.1223/2009 and their use was not otherwise restricted in cosmetic products.

In 2019, Member States were invited to participate in a survey on cosmetic products for eyelash growth containing prostaglandins (and analogues) and their potential undesirable health effects, which led to launching a Call for data in 2020 (from June to October 2020).
During the call for data, stakeholders submitted evidence on the safety of prostaglandins and two dossiers on the safety of the analogues “Ethyl Tafluprostamide”(DDDE) (CAS No.1185851-52-8) and “Isopropyl Cloprostenate” (CAS No.157283-66-4), respectively.

In 2021, the Commission services requested the SCCS to carry out a safety assessment on the safety of prostaglandins and their analogues in cosmetic products in view of the information provided.
In the Opinion SCCS/1635/21, the SCCS was not able to conclude on the safety of “Isopropyl Cloprostenate” and “Ethyl Tafluprostamide” in …

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