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Annex II Entry 258 15/10/2010

Noscapine (INN) and its salts

Noscapine (INN) and its salts is listed in Annex II as a prohibited substance for cosmetic products placed on the EU market.

Prohibited substance— Annex II, EU Regulation 1223/2009
Entry: 258

Chemical identity and properties

PubChem 2D chemical structure for CAS 128-62-1
CAS 128-62-1PubChem CID 275196

Noscapine

(-)-noscapine is a benzylisoquinoline alkaloid that is 1,2,3,4-tetrahydroisoquinoline which is substituted by a 4,5-dimethoxy-3-oxo-1,3-dihydro-2-benzofuran-1-yl group at position 1, a methylenedioxy group at positions 6-7 and a methoxy group at position 8. Obtained from plants of the Papaveraceae family, it lacks significant painkilling properties and is primarily used for its antitussive (cough-suppressing) effects. It has a role as an antineoplastic agent, an antitussive, an apoptosis inducer and a plant metabolite. It is a benzylisoquinoline alkaloid, an organic heterotricyclic compound, an organic heterobicyclic compound, an aromatic ether, a tertiary amino compound, an isobenzofuranone and a cyclic acetal. It is functionally related to a (-)-noscapine hemiacetal. ChEBI

IUPAC name
(3S)-6,7-dimethoxy-3-[(5R)-4-methoxy-6-methyl-7,8-dihydro-5H-[1,3]dioxolo[4,5-g]isoquinolin-5-yl]-3H-2-benzofuran-1-one
Molecular formula
C22H23NO7
Molecular weight
413.4 g/mol
Exact mass
413.14745207 Da
XLogP3
2.7
Topological polar surface area
75.7 Ų
Hydrogen-bond donors
0
Hydrogen-bond acceptors
8
Covalent units
1
Defined stereocentres
2

Also known as

NARCOTINETusscapineMethoxyhydrastineTerbenolCoscopinNarcomprenNarcosineVadebex
16 more reported names
NoscapalinLongatinOpianine(-)-NarcotineNarcotinNarcotussinNectadonNicolaneNoscapinLyobexNipaxonOpianinOpianCoscotabsalpha-NarcotineKey-tusscapine
External database identifiers

Evidence from additional scientific databases

NIH PubChem PUG-View
Exact identifier match275196

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

  • Signal: Warning Source: European Chemicals Agency (ECHA)
  • GHS Hazard Statements: H302 (100%): Harmful if swallowed [Warning Acute toxicity, oral] Source: European Chemicals Agency (ECHA)
  • Precautionary Statement Codes: P264, P270, P301+P317, P330, 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 140 reports by companies from 4 notifications to the ECHA C&L Inventory.; 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)
  • Signal: Warning Source: NITE-CMC
  • GHS Hazard Statements: H302: Harmful if swallowed [Warning Acute toxicity, oral] Source: NITE-CMC
  • Precautionary Statement Codes: P264, P270, P301+P317, P330, and P501 (click each P-code to see the statement) Source: NITE-CMC
  • Uses: MEDICATION Source: Hazardous Substances Data Bank (HSDB)
  • Uses: Use (kg; approx.) in Germany (2009): >1000; Consumption (g per capita; approx.) in Germany (2009): 0.0122; Excretion rate: 1; Calculated removal (%): 46.5 Source: NORMAN Suspect List Exchange

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

Noscapine (INN) and its salts

Chemical / IUPAC name

1(3H)-Isobenzofuranone, 6,7-dimethoxy-3-(5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo(4,5-g)-isoquinolin-5-yl), (S-(R*,S*))-

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

Key data

Annex
Entry number
258

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

Annex II 261
Nearby record in the same annex

Oleandrin

CAS: 465-16-7
EC: 207-361-5

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

Noscapine (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. Noscapine (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 128-62-1 is the unique numerical identifier assigned to Noscapine (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.

Source note for Annex II record Noscapine (INN) and its salts

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

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