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Scopolamine

CAS 51-34-3 · 100/100 · High conf.

Also registered as 6 other CAS numbers

14797-94-5 · 28901-63-5 · 58670-87-4 · 65319-33-7 · 97991-84-9 · 226562-00-1

Concern score

100/100Critical concern based on regulatory listings.
High confidence

Scopolamine in plain language

What it is

Also known as Hyoscine · Hyoscine, its salts and derivatives · See · Scop

What it does

Used in food as a naturally occurring toxicant, food contaminant.

  • Naturally occurring toxicant, food contaminant
Is it a concern?
Critical concern: no hazard classifications on record. It is banned in EU cosmetics.

Why it's flagged

Hyoscine, its salts and derivatives is prohibited in cosmetic products under Annex II of the EU Cosmetics Regulation (EC) 1223/2009.

RestrictedEU EC — banned

The score describes this ingredient's chemical identity — its hazard profile from published classifications and regulatory status — not the safety of any product it appears in.

Regulation

Restrictions first, then routine listings from published regulatory sources.

  • In marketed US drugs
  • EU Annex II — prohibited
  • EU prohibited in cosmetics

Recorded in these product areas

  • Found in consumer products
  • Industrial
  • EUEC

    Annex II of EU Cosmetics Regulation (EC) 1223/2009: substances prohibited in cosmetic products.

    banned
    View source →
  • EUEFSAEFSA opinion2 entries
    • Scientific Opinion on Tropane alkaloids in food and feed (EFSA CONTAM)Source →
    • Tropane alkaloids (from Datura sp)as undesirable substances in animal feed (EFSA CONTAM)Source →
  • EUCosIngActiveCosmetics Regulation annex II / ref 295.
    • Cosmetics Regulation annex II / ref 295.Source →
  • GLOBALJECFAEvaluatedJECFA evaluation record. Functional class: naturally occurring toxicant, food contaminant.
    • JECFA evaluation record. Functional class: naturally occurring toxicant, food contaminant.Source →
  • USEPAcommercial use observedEPA CPDat observed this chemical in 0 composition records across product categories including unclassified products.
    • EPA CPDat observed this chemical in 0 composition records across product categories including unclassified products.Source →
  • USFDAlisted in openFDA substanceopenFDA substance registry classifies this ingredient as chemical.
    • openFDA substance registry classifies this ingredient as chemical.Source →
  • USFDAmarketed drug occurrenceFDA NDC lists this ingredient in 20 active drug products and 21 total products.
    • FDA NDC lists this ingredient in 20 active drug products and 21 total products.Source →

Expert safety opinions

Independent scientific assessments cited by the records we hold, with the year and link where the record gives one.

  • JECFA

    Joint FAO/WHO Expert Committee on Food Additives

    • JECFA evaluation record. Functional class: naturally occurring toxicant, food contaminant.

      Year not recorded · GLOBAL JECFA listing · Read the source →

  • EFSA

    European Food Safety Authority

    • Scientific Opinion on Tropane alkaloids in food and feed (EFSA CONTAM)

      2013 · EU EFSA listing · Read the source →

    • Tropane alkaloids (from Datura sp)as undesirable substances in animal feed (EFSA CONTAM)

      2008 · EU EFSA listing · Read the source →

Evidence & sources

No graded research studies for Scopolamine yet. This record is compiled from the published data sources below — registries and regulatory listings, not study findings.

9 data sources

Where this comes from

  • CosIng

    regulatory · updated 2026-09-23

    Open →
  • EU CosIng Cosmetics Regulation Annexes

    regulatory · updated 2010-10-15

    Open →
  • EFSA OpenFoodTox

    regulatory · updated 2026-10-04

    Open →
  • EPA Chemical and Products Database

    exposure · updated 2020-08-31

    Open →
  • EPA DSSTox Identifiers

    chemistry · updated 2025-12-29

    Open →
  • FDA National Drug Code Directory

    regulatory · updated 2028-06-30

    Open →
  • FDA GSRS UNII

    registry · updated 2026-02-26

    Open →
  • WHO JECFA Database

    regulatory · updated 2026-10-04

    Open →
  • openFDA Substance

    registry · updated 2026-05-24

    Open →
Reference links (1)
Openfda substance

clinicalkey.com

Suitability

Context-specific fit derived from published classifications and the current ingredient evidence profile.

Food use

Food-use source coverage is present in the current record.

Good fit

The ingredient appears in food-oriented source coverage or allowed-use references, which makes food use easier to support than a context with no domain signal at all.

Fragrance avoidance

No fragrance-linked caution surfaced in the current profile.

Good fit

This ingredient does not currently read as a fragrance-linked driver in the published evidence and hazard profile.

Where it has been recorded

How often FDA National Drug Code directory has listed Scopolamine in a product composition. These are source records, not Greenveil catalog products.

Source records

21

Typical roles

Naturally occurring toxicant, food contaminant
See products using Scopolamine →

Catalog

Found in these products

Their ingredient lists include Scopolamine; each product's own rating depends on its whole formula, so it is shown on the product page, not here.