The Scientific Committee has published its final Opinion on prostaglandins and their analogues. It was adopted by written procedure on 3 February 2022.
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 recorded in many EU countries due to the use of cosmetic products containing prostaglandins or their analogues. In December 2019 the sub-working group on borderline products assessed this topic and considered that an SCCS opinion would be useful to assess the safety (lack of) of those products. Finally, as a result of a call for data conducted in 2020, a number of contributions were provided on the safety of some substances belonging to this chemical family:
- 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’; additional cosmetic ingredients relevant to the mentioned chemical family were also found using the keyword ‘prost’ (see Table 1 above and Paragraph 3.1.1 2018 BfR Health assessment). 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 are not otherwise restricted in cosmetic products. Therefore, the Commission requests the SCCS to carry out a safety assessment on Prostaglandins or their analogous in view of the information provided.
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 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.