CosIng Checker
CosIng Checker
EU cosmetic ingredients, restrictions and safety
Login
Annex II Entry 385 20/10/2010

11-alpha-Hydroxypregn-4-ene-3,20-dione and its esters

11-alpha-Hydroxypregn-4-ene-3,20-dione and its esters is listed in Annex II as a prohibited substance for cosmetic products placed on the EU market.

Search similar Back to annex Compare
Prohibited substance— Annex II, EU Regulation 1223/2009
Entry: 385

Record details

Chemical name

11-alpha-Hydroxypregn-4-ene-3,20-dione and its esters

Chemical / IUPAC name

11alpha-Hydroxyprogesterone; Pregn-4-ene-3,20-dione, 11-hydroxy-, (11alpha)-

Regulatory information

Regulation

(EC) 2009/1223

SCCS opinions

Key data

CAS
80-75-1
EC
201-306-9
Annex
II
Entry number
385

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

What Annex II means for 11-alpha-Hydroxypregn-4-ene-3,20-dione and its esters

11-alpha-Hydroxypregn-4-ene-3,20-dione and its esters is listed as a prohibited substance under Annex II of EU Cosmetics Regulation 1223/2009. No concentration limit applies — the presence of this substance in any cosmetic product placed on the EU market is not permitted regardless of use level.

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. 11-alpha-Hydroxypregn-4-ene-3,20-dione and its esters is listed in Annex II of EU Cosmetics Regulation 1223/2009 as a prohibited substance. It must not be present in any cosmetic product placed on the EU market at any concentration.

CAS 80-75-1 is the unique numerical identifier assigned to 11-alpha-Hydroxypregn-4-ene-3,20-dione and its esters 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.
Open INCI Checker

Source note for Annex II record 11-alpha-Hydroxypregn-4-ene-3,20-dione and its esters

This page summarizes one Annex II record for 11-alpha-Hydroxypregn-4-ene-3,20-dione and its esters 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 11-alpha-Hydroxypregn-4-ene-3,20-dione and its esters, but confirm any final regulatory decision against the current official annex wording and source files.

View sourcesView updates

Tools & next steps

Check your formula

Paste a full INCI list to detect 11-alpha-Hydroxypregn-4-ene-3,20-dione and its esters and other flagged EU annex records in one pass.

INCI Checker

Compare entries

Compare 11-alpha-Hydroxypregn-4-ene-3,20-dione and its esters side by side with another annex record to review differences in restrictions, concentrations and annex placement.

Compare

Browse the annex

See all records in Annex II and compare regulatory conditions across substances in this annex.

Open Annex II