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Annex II Entry 335 20/10/2010

Ergocalciferol (INN) and Cholecalciferol (vitamins D2 and D3)

Ergocalciferol (INN) and Cholecalciferol (vitamins D2 and D3) 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: 335

Chemical identity and properties

PubChem 2D chemical structure for CAS 67-97-0
CAS 67-97-0PubChem CID 5280795

Vitamin D3

Calciol is a hydroxy seco-steroid that is (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene in which the pro-S hydrogen at position 3 has been replaced by a hydroxy group. It is the inactive form of vitamin D3, being hydroxylated in the liver to calcidiol (25-hydroxyvitamin D3), which is then further hydroxylated in the kidney to give calcitriol (1,25-dihydroxyvitamin D3), the active hormone. It has a role as a geroprotector and a human metabolite. It is a steroid hormone, a secondary alcohol, a seco-cholestane, a hydroxy seco-steroid and a member of D3 vitamins. — ChEBI

IUPAC name
(1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol
Molecular formula
C27H44O
Molecular weight
384.6 g/mol
Exact mass
384.339216023 Da
XLogP3
7.9
Topological polar surface area
20.2 Ų
Hydrogen-bond donors
1
Hydrogen-bond acceptors
1
Covalent units
1
Defined stereocentres
5

Also known as

cholecalciferolColecalciferolCalciolOleovitamin D3RicketonDeparalArachitolDelsterol
16 more reported names
TrivitanVigorsanEbivitVigantolvitamin d-3ColecalcipherolColecalciferolumCholecalciferolumD3-VicotratD3-VigantolVi-de-3-hydrosolNEO Dohyfral D3ProvitinaRampageVitinc Dan-Dee-3(+)-Vitamin D3
Open full PubChem recordPubChem annotations3D structure image
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

Ergocalciferol (INN) and Cholecalciferol (vitamins D2 and D3)

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

Identified ingredients

Key data

CAS
50-14-6 / 67-97-0
EC
200-014-9 / 200-673-2
Annex
II
Entry number
335

Inventory links for Ergocalciferol (INN) and Cholecalciferol (vitamins D2 and D3)

Inventory Restriction reference
Ref 84565

ERGOCALCIFEROL

CAS: 50-14-6 / 1406-16-2
EC: 200-014-9 / 215-797-2

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

What Annex II means for Ergocalciferol (INN) and Cholecalciferol (vitamins D2 and D3)

Ergocalciferol (INN) and Cholecalciferol (vitamins D2 and D3) 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.

This record is linked to 3 CosIng inventory ingredients for name and identifier cross-reference. 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. Ergocalciferol (INN) and Cholecalciferol (vitamins D2 and D3) 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 50-14-6 / 67-97-0 is the unique numerical identifier assigned to Ergocalciferol (INN) and Cholecalciferol (vitamins D2 and D3) 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 Ergocalciferol (INN) and Cholecalciferol (vitamins D2 and D3)

This page summarizes one Annex II record for Ergocalciferol (INN) and Cholecalciferol (vitamins D2 and D3) 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 Ergocalciferol (INN) and Cholecalciferol (vitamins D2 and D3), but confirm any final regulatory decision against the current official annex wording and source files.

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