# Theophylline

URL: https://app.greenveil.ai/ingredients/ingredient_cas_58_55_9
Categories: beauty, food, industrial, pharma
Functions: Humectant, Pharmaceutical, Softener and conditioner
Identifier: 58-55-9

> Theophylline is used as humectant / pharmaceutical. Greenveil chemical-concern score: 100/100 — Critical concern based on regulatory listings.. Assessed from 8 sources.

## Safety assessment

- Chemical concern score: 100/100 — Critical concern based on regulatory listings.
- Confidence: 4
- Rationale: Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione is prohibited in cosmetic products under Annex II of the EU Cosmetics Regulation (EC) 1223/2009.

## Regulatory status

- EU: banned — Annex II of EU Cosmetics Regulation (EC) 1223/2009: substances prohibited in cosmetic products.
- US: commercial use observed — EPA CPDat observed this chemical in 28 composition records across product categories including Personal care, Raw materials, Food and drug. EPA CPDat classifies this chemical for functional uses including Humectant, Softener and conditioner, Pharmaceutical.
- US: marketed drug occurrence — FDA NDC lists this ingredient in 6 active drug products and 6 total products.
- US: marketed drug occurrence — FDA NDC lists this ingredient in 49 active drug products and 49 total products.
- US: listed in openFDA substance — openFDA substance registry classifies this ingredient as chemical.

_Assessed by Greenveil._