SCCS Prostaglandin Analogues Opinion Finds Lash Growth Ingredients Unsafe

The ruling has significant implications for cosmetic manufacturers, formulators, brand owners and regulatory compliance teams operating under Regulation (EC) No 1223/2009.

SCCS Prostaglandin Analogues Opinion: Key Findings

The SCCS evaluated data submitted by industry in response to earlier concerns raised in Opinion SCCS/1635/21. The substances assessed were:

• Methylamido-Dihydro-Noralfaprostal (MDN)
• Isopropyl Cloprostenate (IPCP)
• Dechloro Dihydroxy Difluoro Ethylcloprostenolamide (DDDE, also known as Ethyl Tafluprostamide)

Despite new submissions, the Committee concluded that none of the three prostaglandin analogues can be regarded as safe for use in cosmetic products applied near the eye.

The primary concern relates to their potent pharmacological activity, even at very low concentrations, combined with insufficient data to exclude potential reproductive and developmental toxicity risks.

Reproductive Toxicity Concerns In Lash Serums

The SCCS highlighted that users of eyelash growth products are most likely to be women of child-bearing age. In the absence of robust reproductive and developmental toxicity data, the Committee stated that safety cannot be adequately demonstrated.

Although available evidence did not indicate genotoxicity for the assessed prostaglandin analogues, the possibility of non-genotoxic carcinogenicity cannot be excluded due to the lack of long-term experimental data.

For regulatory professionals, this distinction is critical. A negative genotoxic profile does not equate to overall safety, particularly for biologically active substances used chronically near sensitive tissues such as the eye.

Regulatory And Commercial Impact Across The Value Chain

The SCCS prostaglandin analogues opinion increases compliance pressure on cosmetic brands marketing lash-enhancing products in the EU.

Stakeholders affected include:

• Raw material suppliers of prostaglandin analogues
• Contract manufacturers producing lash and brow serums
• Responsible Persons under EU cosmetics legislation
• Retailers and distributors placing such products on the EU market

Companies currently using MDN, IPCP or DDDE must reassess product safety files and toxicological risk assessments. Given the clear safety conclusion, reformulation may be necessary to maintain EU market access.

Regulatory teams should monitor potential Commission follow-up, including possible Annex amendments under Regulation 1223/2009.

What Businesses Should Do Now

Companies should immediately:

• Audit portfolios for the presence of prostaglandin analogues
• Engage toxicologists to reassess safety documentation
• Evaluate alternative lash-conditioning ingredients with established safety profiles
• Prepare for potential enforcement or market surveillance actions

Proactive compliance planning will reduce disruption if regulatory restrictions follow.

Summary

The SCCS prostaglandin analogues opinion concludes that MDN, IPCP and DDDE are not safe for use in eyelash and eyebrow cosmetics due to pharmacological potency and unresolved reproductive toxicity concerns. The decision places immediate compliance and reformulation pressure on cosmetic manufacturers operating in the EU.