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Annex II Entry 245 20/10/2010

Neostigmine and its salts (e.g. neostigmine bromide (INN))

Neostigmine and its salts (e.g. neostigmine bromide (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: 245

Chemical identity and properties

PubChem 2D chemical structure for CAS 114-80-7
CAS 114-80-7PubChem CID 8246

Neostigmine Bromide

Neostigmine bromide is the bromide salt of neostigmine. It contains a neostigmine. — ChEBI

IUPAC name
[3-(dimethylcarbamoyloxy)phenyl]-trimethylazanium bromide
Molecular formula
C12H19BrN2O2
Molecular weight
303.20 g/mol
Exact mass
302.06299 Da
Topological polar surface area
29.5 Ų
Hydrogen-bond donors
0
Hydrogen-bond acceptors
3
Covalent units
2
Defined stereocentres
0

Also known as

Neoserine bromideKirkstigmine bromideEustigmin bromideLeostigmine bromideVagostigminSyntostigmin bromideneo-ProserinProserine bromide
16 more reported names
Stigmanol bromideSynstigmin bromideNeostigmini bromidumPhilostigmin bromideNeo proserineBromure de neostigmineBromuro de neostigminaNeostigmine methyl bromideNeoproserine3-Dimethylcarbamoxyphenyl trimethyl ammonium bromide(m-Hydroxyphenyl)trimethylammonium bromide dimethylcarbamateNSC-757233CHEBI:179557005SYP50G53-Hydroxyphenyltrimethylammonium bromide dimethylcarbamic esterBenzenaminium, 3-(((dimethylamino)carbonyl)oxy)-N,N,N-trimethyl-, bromide
Open full PubChem recordPubChem annotations3D structure image
External database identifiers

Evidence from additional scientific databases

NIH PubChem PUG-View
Exact identifier match8246

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

  • Signal: Danger Source: European Chemicals Agency (ECHA)
  • GHS Hazard Statements: H300 (95.1%): Fatal if swallowed [Danger Acute toxicity, oral]; H310 (95.1%): Fatal in contact with skin [Danger Acute toxicity, dermal]; H315 (97.6%): Causes skin irritation [Warning Skin corrosion/irritation]; H317 (95.1%): May cause an allergic skin reaction [Warning Sensitization, Skin]; H319 (97.6%): Causes serious eye irritation [Warning Serious eye damage/eye irritation]; H330 (95.1%): Fatal if inhaled [Danger Acute toxicity, inhalation]; H334 (95.1%): May cause allergy or asthma symptoms or breathing difficulties if inhaled [Danger Sensitization, respiratory]; H335 (95.1%): May cause respiratory irritation [Warning Specific target organ toxicity, single exposure; Respiratory tract irritation] Source: European Chemicals Agency (ECHA)
  • Precautionary Statement Codes: P233, P260, P261, P262, P264, P264+P265, P270, P271, P272, P280, P284, P301+P316, P302+P352, P304+P340, P305+P351+P338, P316, P319, P320, P321, P330, P332+P317, P333+P317, P337+P317, P342+P316, P361+P364, P362+P364, P403, P403+P233, P405, and P501 (click each P-code to see the statement) Source: European Chemicals Agency (ECHA)
  • ECHA C&L Notifications Summary: Aggregated GHS information provided per 41 reports by companies from 4 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.; Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown. For more detailed information, please visit ECHA C&L website. Source: European Chemicals Agency (ECHA)

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

Record details

Chemical name

Neostigmine and its salts (e.g. neostigmine bromide (INN))

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

Key data

CAS
114-80-7
EC
204-054-8
Annex
II
Entry number
245

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

Annex II 247
Nearby record in the same annex

Amyl nitrites

CAS: 110-46-3
EC: 203-770-8
Annex II 241
Nearby record in the same annex

2-Naphthol

CAS: 135-19-3
EC: 205-182-7
Annex II 249
Nearby record in the same annex

Nitrobenzene

CAS: 98-95-3
EC: 202-716-0

What Annex II means for Neostigmine and its salts (e.g. neostigmine bromide (INN))

Neostigmine and its salts (e.g. neostigmine bromide (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. Neostigmine and its salts (e.g. neostigmine bromide (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 114-80-7 is the unique numerical identifier assigned to Neostigmine and its salts (e.g. neostigmine bromide (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 Neostigmine and its salts (e.g. neostigmine bromide (INN))

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

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