Cleo
Company
Request a demo
Anaelle GuezNaomie Halioua
Request a demo
Cleo

AI-powered regulatory intelligence.

contact@cleolabs.co

Solutions

  • Product Compliance

Company

  • About
  • Research
  • Blog
  • Compliance Guides

Jurisdictions

  • 🇪🇺 European Union
  • 🇫🇷 France
  • 🇩🇪 Germany
  • 🇬🇧 United Kingdom
  • 🇺🇸 United States

Legal

  • Privacy
  • Terms
  • Security

Events

  • VivaTech ParisJun 11–14, 2026

© 2026 Cleo Labs. All rights reserved.

GDPREU DataSOC 2 Type IIISO 27001
Blog/Product Compliance
Product Compliance2026-04-27·6 min read
Naomie Halioua

Naomie Halioua

Co-founder & CRO, AI Research

When a lipstick becomes a legal risk: what 2025's cosmetic recalls reveal about product compliance

When a lipstick becomes a legal risk: what 2025’s cosmetic recalls reveal about product compliance.

In 2024, cosmetics accounted for 36% of all alerts on Safety Gate, the EU rapid alert system for dangerous non-food products. The leading category — ahead of toys, ahead of clothing, ahead of electronics. For an industry that sells itself on the promise of skincare, that number is worth pausing on.

36%

Of 2024 Safety Gate alerts

#1

Category, ahead of toys

1223/2009

EU regulation in force

Three recent recalls, three lessons

Case 1 — The moisturiser that burns

Several brands were pulled from the market in 2025 for using a methylchloroisothiazolinone (MCI) and methylisothiazolinone (MI) blend in leave-on products. Both preservatives are authorised in rinse-off products, but explicitly banned in a cream you leave on the skin. The reason has been documented for years: burn risk, eye lesions, severe allergic reactions.

The trap? The exact same formula can be perfectly legal in a shower gel and entirely banned in a day cream. Compliance does not hinge on the product itself — it hinges on its end use.

Case 2 — Heavy-metal makeup

A makeup palette flagged by Ireland contained arsenic, lead, nickel and chromium VI. According to health authorities, that is a cocktail that is simultaneously carcinogenic, neurotoxic and allergenic.

Contamination of this kind almost never originates in a marketing decision. It comes from the pigments themselves — minerals extracted, in some cases, in conditions where traceability is weak. Put plainly: the non-compliance starts at the other end of the supply chain, often at a tier-3 supplier the brand has never audited.

Case 3 — PFAS, where the rule changes overnight

French law n°2025-188 of 27 February 2025 banned certain perfluoroalkyl substances (PFAS) in cosmetics. Several products were recalled in the immediate aftermath — not because they had changed, but because the regulation had.

This is probably the most instructive of the three. The product was compliant on a Monday. It was no longer compliant on the Tuesday.

Compliant on Monday. Recalled on Tuesday. The product did not change — the rulebook did.

Why cosmetic compliance has three stacked layers of complexity

Compared to other sectors, cosmetic product compliance is hard on three distinct fronts at once.

Three layers · One product

01

Ingredient

Living annexes II, III, IV, V, VI of EU 1223/2009

02

Dossier

PIF + CPSR signed by qualified assessor, kept 10 years

03

Claim

EU 655/2013: fairness, truthfulness, evidence, equity

The ingredient layer

Regulation (EC) 1223/2009 governs a set of living annexes: banned substances (Annex II), restricted substances (Annex III), authorised preservatives (Annex V), UV filters (Annex VI), colourants (Annex IV). Those annexes are amended several times a year. A formula validated 18 months ago may very well not be compliant today.

The dossier layer

Every product placed on the EU market must hold an up-to-date Product Information File (PIF), including a Cosmetic Product Safety Report (CPSR) signed by a qualified assessor. That file must be kept available to authorities for 10 years after the last placing on the market of the relevant batch. That is exactly what inspectors come to verify.

The claim layer

Saying a cream is "hypoallergenic", "natural" or "paraben-free" is not an editorial choice. It is a regulated statement, framed by Regulation (EU) 655/2013 on cosmetic claims, which requires fairness, truthfulness, evidence and equity. A blog post claiming "100% natural" without an evidentiary file is a non-compliance dossier writing itself.

Why this is different from textile or electronics

In textile, a non-compliance can often be fixed by switching supplier. In electronics, by a firmware update. In cosmetics, an ingredient or claim non-compliance generally triggers:

  • an immediate market withdrawal
  • a Safety Gate (RAPEX) notification — therefore EU-wide visibility
  • fines that can reach several hundred thousand euros
  • and, for retail-distributed brands, listings compromised for years

And often, all of that because a 4-page text was amended in Brussels three months earlier.

What the brands that get it right do differently

They stop treating compliance as an event (annual audit, product launch) and start treating it as a flow. They know what changed in the annexes this month, what changes next month, and what is in the pipeline at every market they distribute to.

Compliance as event

Annual audit. Re-checked at launch. Reactive — only revisited after a complaint, an inspection, or a recall.

Compliance as flow

Live monitoring of every annex amendment, per market. Alerts before the rule changes, not after the recall.

Because in cosmetics, more than anywhere else, non-compliance does not show up in the product. It shows up in the regulatory calendar.

Get in touch

Track the annexes. Not the recalls.

Cleo Labs builds the product compliance infrastructure for brands that sell internationally. See how we monitor the annexes of EU 1223/2009 in real time across 106 countries.

Book a demo →

Frequently asked questions

Why are cosmetics the leading category in EU Safety Gate alerts?

Because cosmetic compliance hinges on three constantly moving layers — ingredients (annexes II, III, IV, V, VI of EU 1223/2009 are amended several times a year), the Product Information File and Cosmetic Product Safety Report, and claim regulation (EU 655/2013). A formula validated 18 months ago can be illegal today, and recalls follow regulator updates more than product changes.

What changed with French law n°2025-188 on PFAS in cosmetics?

French law n°2025-188 of 27 February 2025 banned certain perfluoroalkyl substances (PFAS) in cosmetics. Several products were recalled immediately after, not because they had been reformulated, but because the rule had changed. It is the textbook case where a product is compliant on Monday and recalled on Tuesday.

What is the difference between Annex II, III, V and VI of EU Regulation 1223/2009?

Annex II lists substances banned in cosmetics. Annex III lists substances allowed only under restrictions (e.g. concentration limits, specific use cases). Annex IV lists authorised colourants. Annex V lists authorised preservatives. Annex VI lists authorised UV filters. All five annexes are amended several times a year via Commission regulations, which is why brands need continuous monitoring rather than periodic audits.

Related resources

Product Compliance · 2026-03-11

Cosmetic Regulation by Country: EU vs US vs Japan vs Brazil vs China

Product Compliance · 2026-03-12

Global Chemical Product Compliance: CAS Numbers, Formulations & Multi-Country Regulations

Company · 2026-04-17

Global Product Compliance in 2026: Why We Won the Pitch by Deel

Try Cleo: free regulatory risk scan

See your regulatory landscape mapped in minutes. No signup, no credit card.

Start free scan
Book a call
Anaelle GuezNaomie Halioua
Request a demo