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Annex II Entry 239 15/10/2010

Poldine metilsulfate (INN)

Poldine metilsulfate (INN) 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: 239

Chemical identity and properties

PubChem 2D chemical structure for CAS 545-80-2
CAS 545-80-2PubChem CID 11017

Pyrrolidinium, 2-(((2-hydroxy-2,2-diphenylacetyl)oxy)methyl)-1,1-dimethyl-, methyl sulfate (1:1)

IUPAC name
(1,1-dimethylpyrrolidin-1-ium-2-yl)methyl 2-hydroxy-2,2-diphenylacetate;methyl sulfate
Molecular formula
C22H29NO7S
Molecular weight
451.5 g/mol
Exact mass
451.16647344 Da
Topological polar surface area
121.0 Ų
Hydrogen-bond donors
1
Hydrogen-bond acceptors
7
Covalent units
2
Defined stereocentres
0

Also known as

Poldine methylsulfateNactonPoldine methylsulphateAlfalandNactatePoldine methosulfatePoldine metilsulphateMcN-R-726-47
16 more reported names
I.S. 499Poldine methyl methosulfateCLB-499IS-499I.S.-499564C0W9848PYRROLIDINIUM, 2-(((HYDROXYDIPHENYLACETYL)OXY)METHYL)-1,1-DIMETHYL-, METHYL SULFATE (SALT)Nacton ftepoldine methyl sulfatepoldine methyl sulphateRefChem:175023208-894-6Poldine metilsulfateMetilsulfate de poldineMetilsulfato de poldinaPoldine metilsulfate [INN]
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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

Poldine metilsulfate (INN)

Chemical / IUPAC name

Pyrrolidinium 2-(((hydroxydiphenylacetyl)oxy)methyl)-1,1-dimethyl-, methyl sulfate

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

Key data

CAS
545-80-2
EC
208-894-6
Annex
II
Entry number
239

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

Annex II 238
Nearby record in the same annex

Arecoline

CAS: 63-75-2
EC: 200-565-5
Annex II 241
Nearby record in the same annex

2-Naphthol

CAS: 135-19-3
EC: 205-182-7

What Annex II means for Poldine metilsulfate (INN)

Poldine metilsulfate (INN) 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. Poldine metilsulfate (INN) 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 545-80-2 is the unique numerical identifier assigned to Poldine metilsulfate (INN) 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 Poldine metilsulfate (INN)

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

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