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Annex II Entry 1371 08/05/2013

Phytonadione [INCI], phytomenadione [INN]

Phytonadione [INCI], phytomenadione [INN] 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: 1371

Chemical identity and properties

PubChem 2D chemical structure for CAS 81818-54-4
CAS 81818-54-4PubChem CID 4812

2-Methyl-3-(3,7,11,15-tetramethyl-2-hexadecen-1-yl)-1,4-naphthoquinone

2-Methyl-3-(3,7,11,15-tetramethylhexadec-2-enyl)-1,4-naphthoquinone has been reported in Brassica oleracea, Homo sapiens, and other organisms with data available. LOTUS - the natural products occurrence database

IUPAC name
2-methyl-3-(3,7,11,15-tetramethylhexadec-2-enyl)naphthalene-1,4-dione
Molecular formula
C31H46O2
Molecular weight
450.7 g/mol
Exact mass
450.349780706 Da
XLogP3
10.9
Topological polar surface area
34.1 Ų
Hydrogen-bond donors
0
Hydrogen-bond acceptors
2
Covalent units
1
Defined stereocentres
0

Also known as

RefChem:2632272-methyl-3-(3,7,11,15-tetramethylhexadec-2-en-1-yl)naphthalene-1,4-dioneEINECS 279-833-9Vitamin K1-d7ProkayvitoralPhytomenadione)C31H46O22-Methyl-3-(3,7,11,15-tetramethylhexadec-2-enyl)-1,4-naphthoquinone
13 more reported names
Vitamin K1 (Phytonadione Impurity 32Vitamin K1 Impurity 66Dry Vitamin K1 5% SDphylloquinone;2-METHYL-3-PHYTYL-1,4-NAPHTHOQUINONEMBWXNTAXLNYFJB-UHFFFAOYSA-NHMS3259K20HMS3372D04s4698Phytomenadione/Vitamin K1 Impurity 95Vitamin K1 (Phylloquinone) (E-Isomer)DB-0568231,4-Naphthalenedione, 2-methyl-3-(3,7,11,15-tetramethyl-2-hexadecen-1-yl)-
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.

PubChem 2D chemical structure for CAS 84-80-0
CAS 84-80-0PubChem CID 5284607

Phylloquinone

Phylloquinone is a member of the class of phylloquinones that consists of 1,4-naphthoquinone having methyl and phytyl groups at positions 2 and 3 respectively. The parent of the class of phylloquinones. It has a role as a cofactor, a plant metabolite and a human metabolite. It is a member of phylloquinones and a vitamin K. ChEBI

IUPAC name
2-methyl-3-[(E,7R,11R)-3,7,11,15-tetramethylhexadec-2-enyl]naphthalene-1,4-dione
Molecular formula
C31H46O2
Molecular weight
450.7 g/mol
Exact mass
450.349780706 Da
XLogP3
10.9
Topological polar surface area
34.1 Ų
Hydrogen-bond donors
0
Hydrogen-bond acceptors
2
Covalent units
1
Defined stereocentres
2

Also known as

VITAMIN K1phytonadionePhytomenadionePhytylmenadioneMephyton3-PhytylmenadioneMonodionSynthex P
16 more reported names
PhyllochinonKinadionKephtonMono-KayCombinal K1FitomenadionaKativ Nalpha-Phylloquinonetrans-PhylloquinoneK-Ject2-Methyl-3-phytyl-1,4-naphthoquinoneAntihemorrhagic vitaminPhyllochinonumPhytomenadionumPhytonadionumOrakay
External database identifiers

Retrieved from NIH PubChem on 2026-08-31 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

Record details

Chemical name

Phytonadione [INCI], phytomenadione [INN]

Chemical / IUPAC name

2-methyl-3-(3,7,11,15-tetramethylhexadec-2-enyl)-1,4-naphthoquinone; Vitamin K1

Regulatory information

Key data

CAS
84-80-0 -- 81818-54-4
EC
201-564-2 -- 279-833-9
Annex
Entry number
1371

Inventory links for Phytonadione [INCI], phytomenadione [INN]

Inventory Restriction reference
Ref 36556

PHYTONADIONE

CAS: 84-80-0 / 81818-54-4
EC: 201-564-2 / 279-833-9

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

What Annex II means for Phytonadione [INCI], phytomenadione [INN]

Phytonadione [INCI], phytomenadione [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.

This record is linked to 1 CosIng inventory ingredient 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. Phytonadione [INCI], phytomenadione [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 84-80-0 -- 81818-54-4 is the unique numerical identifier assigned to Phytonadione [INCI], phytomenadione [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.

Source note for Annex II record Phytonadione [INCI], phytomenadione [INN]

This page summarizes one Annex II record for Phytonadione [INCI], phytomenadione [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 Phytonadione [INCI], phytomenadione [INN], but confirm any final regulatory decision against the current official annex wording and source files.

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