CMR substances in EU cosmetics: the ban and the four-part exception
The EU bans CMR substances from cosmetics (Regulation 1223/2009, Article 15). Category 2 can return after an SCCS safety evaluation; category 1A/1B only through a four-part exception including an analysis of alternatives.
Short answer: Regulation 1223/2009 Article 15 bans CMR substances (carcinogenic, mutagenic or toxic for reproduction) from EU cosmetics. Category 2 CMRs may be used only if the SCCS has evaluated them and found them safe; category 1A/1B CMRs only through an exception requiring four cumulative conditions, including a documented analysis of alternatives (consolidated 18.05.2026).
The rules
| CMR category (Reg. 1272/2008, Part 3 of Annex VI) | EU status | Way back in |
|---|---|---|
| Category 2 | Prohibited | SCCS evaluation finding it safe for cosmetic use |
| Category 1A / 1B | Prohibited | All four conditions below, adopted via Commission measure |
The four cumulative conditions for category 1A/1B:
- The substance complies with food-safety requirements (Regulation (EC) No 178/2002);
- No suitable alternative substance is available, documented in an analysis of alternatives;
- The application is for a particular use of the product category with a known exposure;
- The substance has been evaluated and found safe by the SCCS for the particular use.
What this means in practice
Annex II (the banned list) is where CMR decisions land: when a substance is classified as CMR 1A/1B or 2, it moves onto Annex II unless the Article 15 route applies (for category 2) or the four-part exception is satisfied (1A/1B). That is how recent reformulations — for example, the removal of certain fragrance and preservative molecules — became mandatory rather than advisory.
The US has no single equivalent "CMR ban" for cosmetics: ingredients are handled individually (prohibited list, color-additive rules, drug rules when claims apply). A formula that survived a US review can still fail the EU CMR gate on a recent classification.
Common mistakes
- Assuming a supplier's "food-grade" or "cosmetic-grade" statement settles CMR status. Classification changes; Annex II follows it.
- Reading old formulation guides. A substance banned into Annex II after your guide was printed is still banned.
- Treating the category 2 route as automatic. It needs an SCCS evaluation and a Commission measure — not a supplier letter.
Do this now
Take the three newest ingredients in your EU formula and check each against the current Annex II consolidated text. Recent classifications are exactly the ones older dossiers miss.
FAQ
Are CMR substances banned from EU cosmetics?
Yes. Article 15 of Regulation 1223/2009 prohibits substances classified as CMR.
Can a category 2 CMR still be used?
Only where the SCCS has evaluated it and found it safe for cosmetic use.
How can a category 1A or 1B CMR come back?
Only through the four cumulative conditions: food-safety compliance, no suitable alternative documented in an analysis of alternatives, a particular use with known exposure, and an SCCS safety evaluation for that use.
Sources
- Regulation (EC) No 1223/2009, Article 15 — consolidated text 18.05.2026
- Regulation (EC) No 1223/2009, Annex II (prohibited substances list) — consolidated text 18.05.2026
- FDA, prohibited & restricted ingredients (US-side handling) — fda.gov
Last verified: 2026-11-10.
Not legal advice, and not a guarantee of compliance or of acceptance by any authority.
Want this checked against your own formula? Run the free label check. It screens your ingredients against the EU banned list. It returns an issue list, not a print-ready label.
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