IngredientsEuropean Union
Piroctone olamine in EU cosmetics: status and maximum concentration
INCI PIROCTONE OLAMINE · CAS 68890-66-4
EU status: Restrictedcaps; nitrosamine conditions
Data from Certo’s regulatory database as of
The short answer
Piroctone olamine is restricted in cosmetic products sold in the European Union (caps; nitrosamine conditions). The binding limits are set in Regulation (EC) No 1223/2009, Annex III, entry 61; Annex V, entry 35.
EU legal requirements
| Product type or use | Limit | Conditions and label wording | Applies from |
|---|---|---|---|
| EU Cosmetics Regulation, Annex III 61 — Monoalkylamines, monoalkanolamines and their salts. Legal text | |||
| Every product type | ≤ 0.5 % (secondary amines) | — | In force |
| Every product type | — | The finished product's safety assessment must show that the formula contains no nitrosating system. | In force |
| Every product type | — | The supplier's document must show that the piroctone olamine has a purity of at least 99 %. | In force |
| Every product type | ≤ 0.5 % (secondary amines), in the raw material | — | In force |
| Every product type | ≤ 50 μg/kg (nitrosamines), in the raw material | — | In force |
| Every product type | — | The supplier's document must show that the raw material is kept in nitrite-free containers. | In force |
| EU Cosmetics Regulation, Annex V 35 — Every use, whatever its function. 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt count together. Legal text | |||
| Rinse-off products | ≤ 1 %, for piroctone olamine and piroctone combined | — | In force |
| Other products | ≤ 0.5 %, for piroctone olamine and piroctone combined | — | In force |
What the texts say
Reference number: 61 Chemical name/INN: Monoalkylamines, monoalkanolamines and their salts Maximum concentration in ready for use preparation: Maximum secondary amine content: 0,5 % Other: — Not to be used with nitrosating systems- Minimum purity: 99 % — Maximum secondary amine content: 0,5 % (applies to raw materials) — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers
Reference number: 35 Chemical name/INN: 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt Name of Common Ingredients Glossary: 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon, Piroctone Olamine CAS number: 50650-76-5, 68890-66-4 EC number: 272-574-2 Product type, Body parts: Rinse-off products Maximum concentration in ready for use preparation: 1,0 % Product type, Body parts: Other products Maximum concentration in ready for use preparation: 0,5 %
Sources
This page is general regulatory information, not legal advice. Rely on the legal texts linked above and on your own regulatory experts before making a compliance decision.