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Annex II Entry 45 15/10/2010

Atropine, its salts and derivatives

Atropine, its salts and derivatives is listed in Annex II as a prohibited substance for cosmetic products placed on the EU market.

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Prohibited substance— Annex II, EU Regulation 1223/2009
Entry: 45

Chemical identity and properties

PubChem 2D chemical structure for CAS 51-55-8
CAS 51-55-8PubChem CID 174174

Npc209773

Atropine is a racemate composed of equimolar concentrations of (S)- and (R)-atropine. It is obtained from deadly nightshade (Atropa belladonna) and other plants of the family Solanaceae. It has a role as an antidote to sarin poisoning, a oneirogen, a bronchodilator agent, an anti-arrhythmia drug, a muscarinic antagonist, a parasympatholytic, a mydriatic agent, an anaesthesia adjuvant and a plant metabolite. It contains a (S)-atropine and a (R)-atropine. — ChEBI

IUPAC name
[(1S,5R)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl] 3-hydroxy-2-phenylpropanoate
Molecular formula
C17H23NO3
Molecular weight
289.4 g/mol
Exact mass
289.16779360 Da
XLogP3
1.8
Topological polar surface area
49.8 Ų
Hydrogen-bond donors
1
Hydrogen-bond acceptors
4
Covalent units
1
Defined stereocentres
2

Also known as

RefChem:1092872ATROPINEdl-HyoscyamineAtropenAtropinTropine tropatedl-TropyltropateAtropinol
16 more reported names
EyesulesIsopto-atropineTroyl tropateAtropinaAtropin-flexiolen(+,-)-Tropyl tropateAtropin [German]Atropina [Italian]hyoscyamine(+/-)-Atropine(+-)-hyoscyamineTropine, tropate (ester)(+-)-atropineTropic acid, ester with tropine(+/-)-HyoscyamineCCRIS 3080
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External database identifiers

Retrieved from NIH PubChem on 2026-08-31 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

Record details

Chemical name

Atropine, its salts and derivatives

Regulatory information

Regulation

(EC) 2009/1223

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Key data

CAS
51-55-8
EC
200-104-8
Annex
II
Entry number
45

Direct matches are limited for this record, so nearby entries from Annex II are shown as well.

Annex II 47
Nearby record in the same annex

Benzene

CAS: 71-43-2
EC: 200-753-7

What Annex II means for Atropine, its salts and derivatives

Atropine, its salts and derivatives is listed as a prohibited substance under Annex II of EU Cosmetics Regulation 1223/2009 and must not be intentionally added. Article 17 separately addresses unintended small quantities that are technically unavoidable under good manufacturing practice and compatible with the Article 3 safety requirement.

Formulators must screen their ingredients and raw materials to ensure none contain this substance. Suppliers should provide documentation confirming absence when requested.

The page also surfaces 12 related annex records with overlapping identifiers, annex logic or naming patterns.

Compliance checklist

  • Verify this substance is absent from all raw materials and finished formulations.
  • Request absence confirmation or CoA from raw material suppliers.
  • Document the screening result in the Product Information File (PIF).

Frequently asked questions

Yes. Atropine, its salts and derivatives is listed in Annex II of EU Cosmetics Regulation 1223/2009 and is prohibited as an intentionally added cosmetic ingredient. Article 17 provides a narrow exception for unintended small quantities that are technically unavoidable under good manufacturing practice, provided the product remains safe under Article 3.

CAS 51-55-8 is the unique numerical identifier assigned to Atropine, its salts and derivatives by the Chemical Abstracts Service. In cosmetic compliance work, the CAS number is used to cross-reference the substance across regulatory databases, raw material specifications and safety assessment reports. Multiple EU annex entries may share the same CAS number if the same substance appears under different conditions or in different annexes.

Use the INCI Checker tool on this site to paste your full ingredient list (INCI) and scan it against all Annex II–VI entries. The tool highlights any ingredients that match restricted, prohibited or allergen-flagged records. This is useful for rapid compliance screening of finished product formulas or raw material declarations.
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Source note for Annex II record Atropine, its salts and derivatives

This page summarizes one Annex II record for Atropine, its salts and derivatives from public European Commission cosmetic materials and adds linked inventory or identifier matches when available.

Use this record page to review Annex II conditions for Atropine, its salts and derivatives, but confirm any final regulatory decision against the current official annex wording and source files.

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