IngredientsEuropean Union
Benzalkonium chloride in EU cosmetics: status and maximum concentration
INCI BENZALKONIUM CHLORIDE · CAS 63449-41-2, 68391-01-5, 68424-85-1, 85409-22-9, 61789-71-7, 8001-54-5
EU status: Restrictedpreservative or rinse-off hair
Data from Certo’s regulatory database as of
Some rows corrected against the legal texts on
The short answer
Benzalkonium chloride is restricted in cosmetic products sold in the European Union (preservative or rinse-off hair). The binding limits are set in Regulation (EC) No 1223/2009, Annex III, entry 65; Annex V, entry 54.
EU legal requirements
| Product type or use | Limit | Conditions and label wording | Applies from |
|---|---|---|---|
| EU Cosmetics Regulation, Annex III 65 — Uses other than as a preservative. Benzalkonium chloride, bromide and saccharinate count together. Legal text | |||
| Rinse-off hair products | ≤ 3 % as benzalkonium chloride, for benzalkonium chloride, benzalkonium bromide and benzalkonium saccharinate combined | — | In force |
| Any other product | Not allowed | — | In force |
| Every product type | ≤ 0.1 % as benzalkonium chloride (only the homologues with an alkyl chain of C14 or less), for benzalkonium chloride, benzalkonium bromide and benzalkonium saccharinate combined | — | In force |
| Every product type | — | The product's presentation must show that benzalkonium chloride is used for a purpose other than as a preservative. | In force |
| EU Cosmetics Regulation, Annex V 54 — As a preservative. Benzalkonium chloride, bromide and saccharinate count together. Legal text | |||
| Every product type | ≤ 0.1 % as benzalkonium chloride, for benzalkonium chloride, benzalkonium bromide and benzalkonium saccharinate combined | — | In force |
| EU Cosmetics Regulation, Annex III 65 and Annex V 54 — Every use. Legal text | |||
| Every product type | — | The label must state ‘Avoid contact with eyes’. | In force |
What the texts say
Reference number: 65 Chemical name/INN: Benzalkonium chloride, bromide and saccharinate (8) Name of Common Ingredients Glossary: Benzalkonium bromide CAS number: 91080-29-4 EC number: 293-522-5 Product type, body parts: Rinse-off hair (head) products Maximum concentration in ready for use preparation: 3 % (as benzalkonium chloride) Other: In the final products the concentrations of benzalkonium chloride, bromide and saccharinate with an alkyl chain of C14, or less must not exceed 0,1 % (as benzalkonium chloride) Wording of conditions of use and warnings: Avoid contact with eyes Other: For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product Name of Common Ingredients Glossary: Benzalkonium chloride CAS number: 63449-41-2/68391-01-5/68424-85-1/85409-22-9 EC number: 264-151-6/269-919-4/270-325-2/287-089-1 Name of Common Ingredients Glossary: Benzalkonium saccharinate CAS number: 68989-01-5 EC number: 273-545-7
Reference number: 54 Chemical name/INN: Benzalkonium chloride, bromide and saccharinate (10) Name of Common Ingredients Glossary: Benzalkonium chloride, benzalkonium bromide, benzalkonium saccharinate CAS number: 8001-54-5, 63449-41-2, 91080-29-4, 68989-01-5, 68424-85-1, 68391-01-5, 61789-71-7, 85409-22-9 EC number: 264-151-6, 293-522-5, 273-545-7, 270-325-2, 269-919-4, 263-080-8, 287-089-1 Maximum concentration in ready for use preparation: 0,1 % (as benzalkonium chloride) Wording of conditions of use and warnings: Avoid contact with eyes
Wording of conditions of use and warnings: Avoid contact with eyes
Not to be confused with
- Other “-alkonium” quaternary ammonium compounds (cetalkonium, stearalkonium, olealkonium or tallowalkonium chloride, and others): Not named in Annex III 65 or Annex V 54. Whether a grade falls under these entries depends on its CAS number: check it against the entries.
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.