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Annex II Entry 158 20/10/2010

Benzatropine (INN) and its salts

Benzatropine (INN) and its salts 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: 158

Chemical identity and properties

PubChem 2D chemical structure for CAS 86-13-5
CAS 86-13-5PubChem CID 1201549

med.21724, Compound Benztropine

Benzatropine is tropane in which a hydrogen at position 3 is substituted by a diphenylmethoxy group (endo-isomer). An acetylcholine receptor antagonist, it is used (particularly as its methanesulphonate salt) in the treatment of Parkinson's disease, and to reduce parkinsonism and akathisia side effects of antipsychotic treatments. It has a role as a oneirogen, an antiparkinson drug, a muscarinic antagonist, a parasympatholytic and an antidyskinesia agent. — ChEBI

IUPAC name
(1R,5S)-3-benzhydryloxy-8-methyl-8-azabicyclo[3.2.1]octane
Molecular formula
C21H25NO
Molecular weight
307.4 g/mol
Exact mass
307.193614421 Da
XLogP3
4.5
Topological polar surface area
12.5 Ų
Hydrogen-bond donors
0
Hydrogen-bond acceptors
2
Covalent units
1
Defined stereocentres
2

Also known as

RefChem:1088905benztropineBenzatropineCobrentinTropine benzohydryl etherBenzatropinaBenzatropinumBenztropinum
16 more reported names
CogentineAkitan3endo-benzhydryloxytropaneBenzatropinum [INN-Latin]Benzatropina [INN-Spanish]Cogentinol3alpha-(diphenylmethoxy)tropaneHSDB 3014NK 021NHL2J4X8KApo Benztropine3alpha-(Diphenylmethoxy)-1alphaH,5alphaH-tropaneNK-02Benzatropine (INN)Benzatropine [INN]Benzhydryl 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ether
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External database identifiers

Retrieved from NIH PubChem on 2026-09-02 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

Record details

Chemical name

Benzatropine (INN) and its salts

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

Key data

CAS
86-13-5
EC
—
Annex
II
Entry number
158

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

What Annex II means for Benzatropine (INN) and its salts

Benzatropine (INN) and its salts 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. Benzatropine (INN) and its salts 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 86-13-5 is the unique numerical identifier assigned to Benzatropine (INN) and its salts 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 Benzatropine (INN) and its salts

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

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