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Annex II Entry 210 15/10/2010

Hyoscyamine, its salts and derivatives

Hyoscyamine, 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: 210

Chemical identity and properties

PubChem 2D chemical structure for CAS 101-31-5
CAS 101-31-5PubChem CID 154417

Benzeneacetic acid, alpha-(hydroxymethyl)-, (3-endo)-8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester, (alphaS)-

(S)-atropine is an atropine with a 2S-configuration. It is functionally related to a (S)-tropic acid. It is a conjugate base of a (S)-atropinium. — ChEBI

IUPAC name
[(1R,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl] (2S)-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
3

Also known as

Benzeneacetic acid, .alpha.-(hydroxymethyl)-, (3-endo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester, (.alpha.S)-Benzeneacetic acid, alpha-(hydroxymethyl)-, (3-endo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester, (alphaS)-BENZENEACETIC ACID, .ALPHA.-(HYDROXYMETHYL)-, (3-ENDO)-8-METHYL-8-AZABICYCLO(3.2.1)OCT-3-YL ESTER, (.ALPHA.S)-RefChem:562898Benzeneacetic acid, .alpha.-(hydroxymethyl)-, (3-endo)-8-methyl-8-azabicyclo3.2.1oct-3-yl ester, (.alpha.S)-Benzeneacetic acid, alpha-(hydroxymethyl)-, (3-endo)-8-methyl-8-azabicyclo3.2.1oct-3-yl ester, (alphaS)-hyoscyamineL-Hyoscyamine
16 more reported names
Daturine(-)-HyoscyamineDuboisine(-)-AtropineL-Tropine tropate(S)-(-)-HyoscyamineCystospazl-Atropine(S)-AtropineHyoscyamine (L)LevsinBellafolineHyoscyaminumAtropine, (s)-ENDO-ATROPINETropine, (-)-tropate
Open full PubChem recordPubChem annotations3D structure image
External database identifiers

Evidence from additional scientific databases

EMBL-EBI ChEBI
Exact identifier matchCHEBI:17486

(S)-atropine

An atropine with a 2S-configuration.

Formula
C17H23NO3
Average mass
289.375 g/mol
Monoisotopic mass
289.16779 Da
Formal charge
0
  • tropan-3α-yl 3-hydroxy-2-phenylpropanoate — is a (CHEBI:78734)
  • (S)-tropic acid — has functional parent (CHEBI:30766)
  • tropan-3α-yl 3-hydroxy-2-phenylpropanoate — is a (CHEBI:78734)
  • (S)-atropinium — is conjugate base of (CHEBI:58164)
Additional curated names
(3-endo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl (2S)-3-hydroxy-2-phenylpropanoatetropan-3alpha-yl (2S)-3-hydroxy-2-phenylpropanoate[3(S)-endo]-alpha-(hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester(-)-atropineDaturineDuboisinel-hyoscyamine(-)-hyoscyaminehyoscyamine(S)-(-)-hyoscyamineL-HyoscyamineL-Tropine tropatetropine, (-)-tropate
Cross-references from this source
  • CAS: 101-31-5 — KEGG COMPOUND
  • CAS: 101-31-5 — ChemIDplus
  • CAS: 101-31-5 — NIST Chemistry WebBook
  • MANUAL_X_REF: 1402 — DrugCentral
  • MANUAL_X_REF: C00002293 — KNApSAcK
  • MANUAL_X_REF: C02046 — KEGG COMPOUND
  • MANUAL_X_REF: D00147 — KEGG DRUG
  • MANUAL_X_REF: DB00424 — DrugBank
  • MANUAL_X_REF: OIN — PDBeChem
  • REGISTRY_NUMBER: 91259 — Reaxys

Mapped by: Exact CAS cross-reference in the ChEBI compound record. Source updated: 2017-02-22. Retrieved: 2026-08-31. Open source record

NIH PubChem PUG-View
Exact identifier match154417

Attributed physical-property, hazard, environmental and use annotations.

Mapped by: Existing checksum-valid CAS to unique PubChem CID match. Retrieved: 2026-08-31. Open source record

Scientific classifications and hazard annotations provide context and do not replace the market-specific regulatory decision shown above.

Additional source coverage and match status
SourceResultChecked
EMBL-EBI ChEBIExact match2026-08-31
NIH PubChem PUG-ViewExact match2026-08-31

A recorded no-match is useful evidence that the source was checked; it is not a claim that the substance does not exist elsewhere.

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

Hyoscyamine, its salts and derivatives

Chemical / IUPAC name

Benzeneacetic acid, alpha-(hydroxymethyl)-, (3-endo)-8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester, (alphaS)-

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

Key data

CAS
101-31-5
EC
202-933-0
Annex
II
Entry number
210

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

Annex II 213
Nearby record in the same annex

Iodine

CAS: 7553-56-2
EC: 231-442-4

What Annex II means for Hyoscyamine, its salts and derivatives

Hyoscyamine, 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. Hyoscyamine, 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 101-31-5 is the unique numerical identifier assigned to Hyoscyamine, 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 Hyoscyamine, its salts and derivatives

This page summarizes one Annex II record for Hyoscyamine, 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 Hyoscyamine, its salts and derivatives, but confirm any final regulatory decision against the current official annex wording and source files.

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