Prostaglandins and prostaglandin-analogues in eyelash growth treatments
The European Commission requested the SCCS to carry out a safety assessment for prostaglandin-analogues used in cosmetic products. Prostaglandin as well as synthetic prostaglandin-analogues (e.g. Bimatoprost und Tafluprost) are used in drugs to reduce ocular hypertension and treat glaucoma. Increased eyelash growth has been observed as a side effect, and furthermore, other adverse effects have been found, e.g. irreversible changes in iris pigmentation, inflammations, macular edema, or morphological changes in the periorbital region. Additionally, adverse effect to the female reproductive system have been described for Bimatoprost and Tafluprost. Therefore, these substances must not be administered to pregnant women.
The SCCS has received data on Isopropyl cloprostenate and Ethyl tafluprostamide. The available data on other prostaglandin analogues were insufficient for assessment.
Experimental data showed that Isopropyl cloprostenate significantly reduced intra-ocular pressure at dose levels which are typically applied when using lash growth products. Therefore, 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).
Essential oils and other plant extracts
Essential oils are mostly complex mixtures of terpenes, sequiterpenes, aromatic compounds, etc.
Some constituents (e.g. Methyl eugenol, which is contained in rose oil) are restricted in their use in cosmetics. Be aware of possibly critical compounds already during product development.
We support your product development by preparing ingredient profiles (e.g. to determine maximum use concentrations in different product types).
As manufacturer of cosmetic products you may be indirectly concerned by the REACH regulation. Essential oils, resins, concretes, absolutes and other plant extracts (termed Natural Complex Substances, NCS; further Information may be found here: CFCS – Natural Complex Substances) are to a large extent affected by the 2018 registration deadline.
If not registered, some raw materials may disappear from the market. To ensure your future supply and to be able to react to changes on the market by choosing alternative ingredients, ask your supplier if he plans to register.
In case you directly import raw materials from non-EU countries, you may even be required to register. For more information on REACH please visit: CFCS – REACH.