Request for a scientific opinion on Prostaglandins analogues used in cosmetic products.

In 2018, according to the German Federal Institute for Risk Assessment (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.

In December 2019, the sub-working group on borderline products (“Borderline products” are products having combined characteristics of medicines along with foods, medical devices or cosmetics) assessed this topic and considered that an SCCS safety evaluation of such ingredients would be useful.

During the call, contributions were provided on the safety of the following substances:

  • Ethyl Tafluprostamide CAS 1185851-52-8 (also known as Dechloro Dihydroxy Difluoro Ethylcloprostenolamide or DDDE) and
  • Isopropyl cloprostenate CAS 157283-66-4.

The Commission database for information on cosmetic substances and ingredients (CosIng) contains 14 cosmetic ingredients, each described as ‘a synthetic analogue of a prostaglandin’.

In addition, the EU cosmetic products notification portal (CPNP) contains notifications of cosmetic products containing prostaglandins and their analogues placed on the EU market.

Prostaglandins and their analogues are not listed in the Annexes to the Cosmetic Regulation (EC) No. 1223/2009 and their use is not otherwise restricted in cosmetic products.

Terms of reference

      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).
      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?
      3. In light of the available data, does the SCCS consider that the use in cosmetic products of prostaglandins analoguesraises safety concerns and might pose a risk to human health?

Deadline: 9 months

The SCCS approved this mandate by written procedure on 18 January 2021.