Whether an eyelash serum is a cosmetic or a drug is one of the sharpest borderline questions in the European beauty market, and it stopped being theoretical in February 2026. The Scientific Committee on Consumer Safety concluded that the prostaglandin analogues most lash growth products are built around cannot be considered safe for cosmetic use — which leaves a large, fast-growing category with a formula problem, a claims problem, or both.
If you sell, import or are developing a lash or brow serum for the EU, the classification question determines everything downstream: whether you need a CPSR or a marketing authorisation, whether you can notify through CPNP at all, and whether your best-selling SKU can legally stay on the shelf. This guide sets out how EU law draws the line, what the SCCS actually said, and how to build a lash serum that stays firmly on the cosmetic side of it.
Key takeaways
- A lash serum is a cosmetic if it acts on the appearance of the lashes and surrounding skin; it becomes a medicinal product if it is presented or functions as treating or modifying a physiological process.
- In its final opinion of 2 February 2026, the SCCS concluded that Methylamido-Dihydro-Noralfaprostal, Isopropyl Cloprostenate and Dechloro Dihydroxy Difluoro Ethylcloprostenolamide cannot be considered safe for lash and brow growth applications.
- These ingredients are not yet formally prohibited in an Annex, but a negative SCCS opinion makes a compliant CPSR effectively impossible — and Annex II listing usually follows.
- Documented adverse effects include periorbital fat atrophy, permanent iris pigmentation change, eyelid hyperpigmentation and ocular irritation.
- Canada banned isopropyl cloprostenate from cosmetics in 2019; France’s ANSM has issued public warnings about lash growth products.
- “Grows lashes” is a physiological claim. “Appears longer, looks fuller” is a cosmetic claim. The wording is not marketing polish — it is the classification test.
- Peptide, panthenol and conditioning-based serums remain a viable compliant category with the right claims and eye-area safety data.
How the EU decides: cosmetic or medicinal?
Two definitions collide here, and where a product falls is decided by the national competent authority on a case-by-case basis.
Article 2(1)(a) of Regulation (EC) No 1223/2009 defines a cosmetic as a substance intended to be placed in contact with the external parts of the body — expressly including hair — with a view exclusively or mainly to cleaning, perfuming, changing appearance, protecting, keeping in good condition or correcting body odours. Eyelashes are hair, and the eyelid is external skin, so a lash product is capable of being a cosmetic.
Article 1 of Directive 2001/83/EC defines a medicinal product two ways, and a product only has to satisfy one:
- By presentation — presented as having properties for treating or preventing disease in humans.
- By function — may be used with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action.
Article 2(2) of the Directive settles ties: where a product may fall under both definitions, the medicinal product rules apply. There is no “choose the easier route” option. Our broader guide to cosmetic vs medicinal vs biocide classification covers how this test is applied across categories.
The word “serum” carries no legal weight. Neither does “cosmeceutical”, which is a marketing term with no status in EU law. Authorities look at the mechanism and the claims, not the product descriptor.
Why prostaglandin analogues are the problem
The lash growth category exists because of an accident of ophthalmology. Prostaglandin analogues such as bimatoprost and latanoprost are prescribed to lower intraocular pressure in glaucoma, and clinicians noticed patients growing conspicuously longer, darker, thicker lashes. That side effect became a product category.
The cosmetic industry did not use the licensed drugs themselves. It used structurally related analogues — isopropyl cloprostenate, methylamido-dihydro-noralfaprostal (often abbreviated MDN), dechloro dihydroxy difluoro ethylcloprostenolamide and similar molecules — on the argument that they were different substances not covered by medicines law.
The regulatory difficulty is that this argument works against the brand. If the ingredient genuinely lengthens the anagen phase of the hair follicle by binding prostaglandin receptors, that is a pharmacological action modifying a physiological function — the textbook definition of a medicinal product by function. If it does not work that way, the growth claim is unsubstantiated. Either the product is a drug or the claim is false; there is not much space between.
What the SCCS concluded
The Commission referred the class to the SCCS, which adopted its final opinion on 2 February 2026. The committee concluded that the prostaglandin analogues assessed — Methylamido-Dihydro-Noralfaprostal, Isopropyl Cloprostenate and Dechloro Dihydroxy Difluoro Ethylcloprostenolamide — cannot be considered safe for use in cosmetic products intended to promote eyelash and eyebrow growth.
The safety concerns behind that conclusion are well documented in the ophthalmic literature:
| Effect | Nature | Reversibility |
|---|---|---|
| Iris pigmentation change (heterochromia) | Increased melanin in iris stroma | Generally considered permanent |
| Periorbital fat atrophy (PAP) | Loss of orbital fat, sunken/hollow eye appearance | Partially reversible on discontinuation; not always |
| Eyelid skin hyperpigmentation | Darkening of lid margin and surrounding skin | Usually reversible over months |
| Conjunctival hyperaemia | Persistent eye redness | Reversible |
| Ocular irritation, itching, dryness | Surface irritation | Reversible |
| Intraocular pressure effects | Pharmacological action on aqueous outflow | Clinically significant in some users |
Canada reached a similar conclusion earlier, banning isopropyl cloprostenate from cosmetics in 2019 and adding it to its Cosmetic Ingredient Hotlist. France’s ANSM has publicly warned consumers about the risks of certain eyelash growth products. The EU is now aligned with that direction of travel.
These ingredients are not currently listed in Annex II, and some brands are reading that as permission to continue. It is not. Article 3 requires a cosmetic product to be safe for human health under normal and reasonably foreseeable use, and the CPSR must demonstrate that safety. After a formal negative opinion from the EU’s own scientific committee, no competent safety assessor can reasonably sign off on these substances — and an Annex II entry following a negative SCCS opinion is the usual next step, not a remote possibility.
The claims side of the line
Even with a perfectly benign formula, claims alone can reclassify your product. This is the “medicinal by presentation” limb, and it does not require the product to do anything at all — an average consumer merely needs to be given the impression that it treats or modifies a physiological process.
| Reclassifies as medicinal | Stays cosmetic |
|---|---|
| “Grows your lashes” | “Lashes appear longer” |
| “Stimulates the hair follicle” | “Conditions and protects lashes” |
| “Extends the anagen growth phase” | “Helps reduce the appearance of breakage” |
| “Treats hypotrichosis / lash loss” | “For sparse-looking lashes” |
| “Regrows lashes after chemotherapy” | “Softens and smooths” |
| “Clinically proven to increase lash count” | “93% agreed lashes looked fuller (consumer study, n=52, 4 weeks)” |
The distinction is not cosmetic hair-splitting — it is precisely the line national authorities draw. And note the last row: an appearance claim still needs substantiation under Regulation (EU) No 655/2013 and its six common criteria, with the evidence filed in your PIF. Our guide to permitted cosmetic claims in the EU covers what adequate substantiation looks like.
Claims made by your influencers, affiliates and marketplace listings are your claims. A brand that has scrubbed “grows lashes” from its packaging but pays creators who say it on camera has not solved the problem — under the Unfair Commercial Practices framework, commercial communications you commission are attributable to you.
Building a compliant lash serum
A viable EU lash category still exists. It just runs on conditioning and appearance rather than pharmacology.
Ingredient direction
Peptides (including biotinoyl tripeptide-1 and myristoyl pentapeptide-17), panthenol, biotin, hyaluronic acid, amino acids, botanical conditioning extracts and film-forming polymers all support genuine appearance and conditioning claims without a pharmacological mechanism. Caffeine and similar actives sit in a more nuanced position depending on the claim attached to them.
Eye-area safety data
The eye area is the most demanding site in cosmetics, and a lash serum applied to the lash line with a fine brush, daily, indefinitely, is about as exposed as it gets. Expect your safety assessor to require more than a standard face-cream dataset:
- Ocular tolerance — an in vitro eye irritation assessment (HET-CAM, EpiOcular or equivalent) is effectively expected for the eye area.
- Ophthalmological compatibility — a dermatological/ophthalmological use test under supervision if you want to make a “suitable for sensitive eyes” or “ophthalmologically tested” claim.
- Preservation — eye-area products are high risk for microbial contamination, so preservative efficacy testing to ISO 11930 and microbiological limits to ISO 17516 are essential. See our guide to which cosmetic tests you actually need.
- Applicator hygiene — a brush repeatedly returned to the bottle is a contamination vector, which affects PAO determination and stability design.
Documentation
Standard cosmetic file: a CPSR signed by a qualified safety assessor covering the eye-area exposure scenario specifically, a full PIF, CPNP notification before market entry, and an EU-based Responsible Person. Our guides to the documents needed to order a CPSR and who can sign a CPSR set out what your assessor will ask for.
If you are already selling a prostaglandin serum
Three practical steps, in order.
Audit your INCI lists. These ingredients hide behind names that are not obviously prostaglandin-related: Isopropyl Cloprostenate, Methylamido-Dihydro-Noralfaprostal, Dechloro Dihydroxy Difluoro Ethylcloprostenolamide, Trifluoromethyl Dechloro Ethylprostenolamide. Check every SKU and every supplier formula, including private label.
Reassess the CPSR. Article 5 obliges the Responsible Person to keep the safety assessment current and to take corrective measures where a product does not conform. A CPSR signed before February 2026 on the basis that no negative opinion existed no longer reflects the available evidence. Go back to your assessor.
Decide and document. Reformulate onto a peptide or conditioning base, or withdraw. Either way, record the decision, the date and the reasoning. Enforcement authorities ask what you knew and when — and after a published SCCS opinion, “we did not know” is not available.
Do not assume your contract manufacturer has handled this. The Responsible Person named on the pack carries the obligation under Article 4, regardless of who formulated the product. If you are the RP for a private-label lash serum, the exposure is yours.
Bringing it all together
The eyelash serum category was built on an ambiguity, and that ambiguity has now closed from both ends. On the safety side, the SCCS has said the prostaglandin analogues cannot be considered safe for cosmetic lash and brow use. On the classification side, the more convincingly an ingredient grows lashes, the more clearly it is acting pharmacologically and the harder it is to defend as a cosmetic at all.
What survives is a real and commercially healthy category: conditioning serums with peptides and humectants, honest appearance claims backed by consumer and instrumental data, and a safety file built around genuine eye-area exposure. Brands that make that transition now — before an Annex II entry forces it — keep their listings, their retail relationships and their reputation.
Lexora assesses borderline products and prepares eye-area safety documentation, including the ocular tolerance and claim substantiation review these products need. Talk to us about a CPSR for your lash or brow serum, or have the claims and artwork checked with a cosmetic label review before you print.
Frequently asked questions
Are eyelash growth serums banned in the EU?
Not by an explicit Annex II prohibition, at least not yet. But the SCCS concluded on 2 February 2026 that the main prostaglandin analogues used for lash growth cannot be considered safe for cosmetic use, which makes a compliant CPSR effectively impossible for those ingredients. Products based on peptides and conditioning agents remain lawful.
Which ingredients should I check my formula for?
Isopropyl Cloprostenate, Methylamido-Dihydro-Noralfaprostal (MDN), Dechloro Dihydroxy Difluoro Ethylcloprostenolamide and related prostaglandin analogues such as Trifluoromethyl Dechloro Ethylprostenolamide. They are not always obviously identifiable from the INCI name, so check supplier documentation rather than scanning the list by eye.
Can I say my serum makes lashes look longer?
Yes — appearance claims are cosmetic claims and are permitted, provided you can substantiate them. “Lashes appear longer and fuller” backed by a consumer perception study or instrumental measurement is defensible. “Grows lashes” or “stimulates the follicle” describes a physiological effect and pushes the product toward medicinal product classification.
What extra testing does an eye-area product need?
Beyond the standard set, expect an in vitro ocular tolerance assessment such as HET-CAM or EpiOcular, robust preservative efficacy testing to ISO 11930, and microbiological limits to ISO 17516. If you want to claim “ophthalmologically tested”, you need a supervised use test on file. See our overview of which cosmetic tests you actually need.
Who decides whether my product is a cosmetic or a medicine?
The national competent authority in each Member State, case by case, looking at composition, mechanism, presentation and claims. Because Article 2(2) of Directive 2001/83/EC gives medicinal product law priority where both definitions could apply, a product can be treated as a medicine in one market even if you have notified it as a cosmetic. Our guide to borderline product classification explains the assessment.
I sell a private-label lash serum. Is this my problem?
If you are named as the Responsible Person on the packaging, yes. Article 4 of Regulation (EC) No 1223/2009 places the compliance obligation on the RP regardless of who developed or manufactured the formula, and Article 5 requires corrective action where a product does not conform. Ask your manufacturer for the full formula and check it yourself.
Is periorbital fat atrophy really a risk from a cosmetic?
It is a documented effect of prostaglandin analogues, first characterised in glaucoma patients and subsequently reported in cosmetic lash serum users. It produces a hollowed, sunken appearance around the eye and is not reliably reversible on stopping the product. Alongside permanent iris pigmentation change, it is one of the effects underpinning the SCCS conclusion.
