SCCS Publishes Preliminary Opinions on Prostaglandin Analogues and Tea Tree Oil
On 6th June 2025, the EU's SCCS (Scientific Committee on Consumer Safety) published its Preliminary Opinion on Prostaglandin Analogues. The substances considered in this Opinion were Methylamido-Dihydro-Noralfaprostal (MDN) (CAS 155206-01-2), Isopropyl Cloprostenate (IPCP) (CAS 157283-66-4) and Dechloro Dihydroxy Difluoro Ethylcloprostenolamide (DDDE) (CAS 1185851-52-8). These are currently used in eyelash and eyebrow serums to promote growth. When asked whether the prostaglandin analogues were considered safe at concentrations of 0.03%, 0.005% and 0.018% respectively, the SCCS concluded none can be considered safe for use in such cosmetic products. The Committee concluded that potential adverse effects resulting from reproductive/developmental toxicity cannot be excluded. Since prostaglandin analogues are pharmaceutically active compounds used for the treatment of certain eye conditions requiring prescription by qualified medical staff, SCCS expressed concern that, when made freely available for cosmetic use, there is no safeguard against inappropriate use. The Committee also noted a lack of data per se to cosmetic safety assessment and insufficient read-across. From the available data, concerns were expressed for the endpoints of developmental and reproductive toxicity and adverse effects on the eyes/periorbital tissue.
The Opinion on prostaglandin analogues may be found here.
On 6th June, the SCCS also published its Preliminary Opinion on Tea Tree Oil (CAS 68647-73-4). It was concluded that Tea Tree Oil is safe as an anti-seborrheic and anti-microbial agent up to maximum concentrations of 2% in shampoo, 1% in shower gel, 1% in face wash and 0.1% in face cream. This is only applicable to Tea Tree Oil that conforms to ISO 4730:2017 and excludes aerosolised or sprayable products. Tea Tree Oil was found to be a moderate skin sensitiser and with a possible classification of Repr.1B under the EU CLP regulation being considered, the data for which was taken into account when forming the Opinion.
The Opinion on tea tree oil may be found here.
Both Opinions are open for comments until 18th August 2025.
Indonesia's Food and Drug Agency Updates Regulation Concernig Cosmetics
On 18th June 2025, Indonesia's National Agency of Food and Drug Control published a final version of the Decision of the Director of Standardisation of Traditional Medicines, Health Supplements and Cosmetics. Amendments include changes to the information submitted to notify cosmetics and the introduction of a fast-track assessment process.
You may read the regulation here.
