PRAMOXINE HCL
PRAMOXINE HCL is banned in cosmetics in the EU — Annex II, entry 405 of Regulation (EC) No 1223/2009. Review the regulatory details and Safety Gate alerts.
Regulatory data checked on 2026-09-05. The legal status follows Regulation (EC) No 1223/2009 and its annexes; the substance is identified from the European Commission's CosIng database.
About the ingredient
Morpholine, 4-[3-(4-butoxyphenoxy)-propyl]-, hydrochloride
EU regulatory status
Annex of Regulation (EC) No 1223/2009: II/405
What entry II/405 of the Regulation says
Pramocaine (INN)
Source: the European Commission's official CosIng database and Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. How we assess ingredients — full methodology.
- View the entry in the CosIng database (European Commission)
- Open Regulation 1223/2009 in EUR-Lex
- Check the chemical profile in PubChem
Last updated:
Functions in cosmetics
Frequently asked questions
Is PRAMOXINE HCL safe in cosmetics?
PRAMOXINE HCL falls under Annex II to Regulation (EC) No 1223/2009, and under Article 14 a cosmetic product placed on the EU market must not contain a substance prohibited by that annex. This is a legal status, not a toxicity finding about any particular product. Where a non-compliant product is found, the competent authority requires the responsible person to bring it into conformity, withdraw it from the market or recall it, proportionate to the risk; products presenting a serious risk are also notified through the EU Safety Gate.
In which annex of Regulation 1223/2009 does PRAMOXINE HCL fall?
PRAMOXINE HCL falls under reference II/405 in the annexes of Regulation (EC) No 1223/2009 on cosmetic products. An annex entry may name a substance directly or cover it as part of a broader category. The first part (Roman numeral) indicates the annex: II – prohibited substances, III – substances restricted by conditions, IV – permitted colorants, V – permitted preservatives, VI – permitted UV filters.
What functions does PRAMOXINE HCL perform in cosmetics?
According to the European Commission's CosIng database, PRAMOXINE HCL performs the following functions in cosmetics: ANTIOXIDANT. Functions are defined in the CosIng glossary and describe the technological role of a substance in the finished product.
Are there Safety Gate alerts concerning PRAMOXINE HCL?
Our copy of the EU Safety Gate database currently contains no alerts linking PRAMOXINE HCL to a cosmetic recall. The database is refreshed regularly from the European Commission's official Safety Gate system.