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Annex II Entry 1710 24/08/2023

Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione

Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione 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: 1710

Chemical identity and properties

PubChem 2D chemical structure for CAS 58-55-9
CAS 58-55-9PubChem CID 2153

Theophylline

Theophylline is a dimethylxanthine having the two methyl groups located at positions 1 and 3. It is structurally similar to caffeine and is found in green and black tea. It has a role as a bronchodilator agent, a vasodilator agent, a drug metabolite, an anti-asthmatic drug, an EC 3.1.4.* (phosphoric diester hydrolase) inhibitor, an immunomodulator, a muscle relaxant, an anti-inflammatory agent, an adenosine receptor antagonist, a fungal metabolite and a human blood serum metabolite. — ChEBI

IUPAC name
1,3-dimethyl-7H-purine-2,6-dione
Molecular formula
C7H8N4O2
Molecular weight
180.16 g/mol
Exact mass
180.06472551 Da
XLogP3
0.0
Topological polar surface area
69.3 Ų
Hydrogen-bond donors
1
Hydrogen-bond acceptors
3
Covalent units
1
Defined stereocentres
0

Also known as

1,3-DimethylxanthineElixophyllinTheophyllinTheolairNuelinTheophylline anhydrousElixophyllineLanophyllin
16 more reported names
PseudotheophyllineRespbidSolosinTheocinTheo-durLiquophyllineOptiphyllinParkophyllinTheofolTheogradAcet-theocinSlo-phyllinArmophyllineSlo-bidDoraphyllinElixicon
Open full PubChem recordPubChem annotations3D structure image
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

Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione

Regulatory information

Regulation

(EU) 2023/1490

See every entry this act set

Key data

CAS
58-55-9
EC
200-385-7
Annex
II
Entry number
1710

Inventory links for Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione

Inventory Shared CAS number
Ref 38578

THEOPHYLLINE

CAS: 58-55-9
EC: 200-385-7

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

What Annex II means for Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione

Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione 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. Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione 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 58-55-9 is the unique numerical identifier assigned to Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione 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 Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione

This page summarizes one Annex II record for Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione 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 Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione, but confirm any final regulatory decision against the current official annex wording and source files.

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