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Monday, February 1, 2021Regulation

Prostaglandin analogues: request for the SCCS Opinion

Substances analogues aux prostaglandines : demande d'Opinion au CSSC

Following the alert of the German BfR and the subsequent call for data, prostaglandin analogues used in cosmetic products will be subject to a safety assessment by the SCCS. The request was made by the European Commission and was published on 19 January 2021. The Scientific Committee accepted this mandate by written procedure on 18 January 2021.

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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 eyelash growth treatments contain substances such as prostaglandins or their analogues.
According to the BfR’s Health assessment of eyelash growth treatments, the use of prostaglandins and their analogues as components of cosmetic products may include health risks for consumers. Prostaglandin analogues are also used in drugs to reduce ocular hypertension. Increased eyelash growth has been observed as a side effect, and furthermore, other adverse effects have been found.

As a result of this communication, EU countries’ competent authorities were invited in 2019 to participate in a survey on products for eyelash growth containing prostaglandins and their analogues. The information collected helped to identify an uneven situation in terms of applicable regulatory framework (e.g. cosmetic products or medicinal products). Furthermore, several cases of serious undesirable health effects were reported in many EU countries due to the use of cosmetic products containing prostaglandins analogues.

In December 2019, the sub-working group on borderline products assessed this topic and considered that an SCCS safety evaluation of such ingredients would be useful. Following …

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