SCCS publishes Scientific Opinion on Prostaglandin Analogues (SCCS/1680/25)
Ingredients: Prostaglandin Analogues - MDN, IPCP and DDDE

Date of publication: 6 June 2025

The SCCS has concluded that none of the three prostaglandin analogues evaluated can be considered safe for use in eyelash and eyebrow cosmetic products, citing potent pharmacological activity and lack of adequate reproductive/developmental toxicity data.

What’s new?

On June 6 2025, the Scientific Committee on Consumer Safety (SCCS) published a Scientific Opinion on prostaglandin analogues used in cosmetic products.

The current Opinion specifically addresses three prostaglandin analogues submitted by industry for safety evaluation: Methylamido-Dihydro-Noralfaprostal (MDN), Isopropyl Cloprostenate (IPCP), and Dechloro Dihydroxy Difluoro Ethylcloprostenolamide (DDDE). These substances are synthetic analogues designed to mimic natural prostaglandins and are primarily used in eyelash and eyebrow growth products.

This assessment was prompted by ongoing industry efforts to demonstrate the safety of prostaglandin analogues following the German Federal Institute for Risk Assessment (BfR) alert in 2018, which highlighted health risks associated with eyelash growth treatments containing these substances. This assessment represents a continuation of the Committee’s evaluation of these controversial ingredients following concerns raised in previous Opinion SCCS/1635/21 from February 2022.

Key Provisions

The SCCS evaluated industry-proposed concentration limits for three specific prostaglandin analogues when used in eyelash and eyebrow products:

  • Ethyl Tafluprostamide: 0.018%
  • Methylamido-Dihydro-Noralfaprostal: 0.03%
  • Isopropyl Cloprostenate: 0.005%

The SCCS concluded that none of the three prostaglandin analogues can be considered safe for use in cosmetic products intended for promoting eyelash and eyebrow growth, regardless of the proposed concentrations.

SCCS’s safety concerns included potent pharmacological activity at low concentrations, lack of acceptable reproductive/developmental toxicity data, primary users are likely to be young women and the application proximity to the eyes.

What now?

Deadline for submitting comments on the preliminary Opinion is 18 August 2025.

  • SCCS will review industry submissions and finalize the Opinion based on additional evidence
  • European Commission expected to initiate regulatory amendment process following final Opinion
  • Market surveillance authorities likely to increase enforcement of existing products

Regulatory Timeline: Following the final Opinion publication, the European Commission will likely prohibit these specific prostaglandin analogues through amendment to Annex II (Prohibited Substances) of the European Cosmetics Regulation, with implementation timelines typically providing 12-18 months for industry compliance.

References

SCCS (Scientific Committee on Consumer Safety), Opinion on prostaglandin analogues used in cosmetic products, preliminary version of 28 May 2025, SCCS/1680/25

other REGULATORY UPDATES

SCCS Preliminary Opinion on Sodium Bromothymol Blue (C186) as hair dyeing

Ingredients: SODIUM BROMOTHYMOL BLUE (C186)

Date of publication: 28/10/2022

Following the request from the EU Commission for a scientific opinion on the hair dye Sodium Bromothymol Blue (C186), on October 2022 the Scientific Committee on Consumer Safety (SCCS) issued a preliminary opinion. In light of the data provided, when used in non-oxidative hair colouring products up to a maximum on-head concentration of 0.5%, the SCCS is of the opinion that the complete safety of Sodium Bromothymol Blue could not be assessed.

Read More »

Regulation (EU) 2022/692 – OMNIBUS ACT VI – New and Updated Classification of Cosmetic Ingredients

Ingredients: BENZOPHENONE, TEOPHYLLINE, MELAMINE, AZADIRACHTA EXTRACTS, TRIMETHYLOLPROPANE TRIACRYLATE, PENTETIC ACID, PENTASODIUM PENTETATE

Date of publication: 03/05/2022

Date of application: 01/12/2023

The Commission Delegated Regulation (EU) 2022/692 includes new or updated classification for 12 chemicals that may be used as cosmetic ingredients. Seven out of these 12 are now classified as carcinogenic, mutagenic or toxic to reproduction (CMR) and are banned from cosmetic products marketed in the EU.

Read More »
Any REGULATORY QUESTION?

SCCS Revision of the Scientific Opinion on Vitamin A

Ingredients: RETINOL, RETINYL PALMITATE, RETINYL ACETATE, RETINYL LINOLEATE, RETINAL

Date of publication: 25/10/2022

The Scientific Committee on Consumer Safety has issued a final version of the Scientific Opinion on Vitamin A, concluding that exposure to Vitamin A derived from cosmetics can be a concern for higher exposure consumers, and since cosmetics alone do not exceed the upper limit the SCCS cannot suggest maximum concentration limits that take into account contributions from other sources.

Read More »

Regulation (EU) 2022/1531 – OMNIBUS ACT V – applicable as of 17 December 2022

Ingredients: METHYL SALICYLATE, SODIUM HYDROXYMETHYLGLYCINATE, DBMC, MIBK

Date of publication: 15/09/2022

Date of application: 17/12/2022

The European Commission has published the Commission Regulation (EU) 2022/1531, which amends the Regulation (EC) No 1223/2009 as regards the use in cosmetic products of certain substances classified as CMR, by adding new entries to Annex II and Annex III and revising an entry in Annex V.

Read More »

UK Responsible Person Labelling Deadline Extension

RESPONSIBLE PERSON

Date of application: 31/12/2025

The UK Office for Product Safety and Standards (OPSS) have reviewed the requirement to label the product with the UK Responsible Person and have decided to extend this transitional provision for a total period of five years, until 31 December 2025.

Read More »