HEXAMIDINE PARABEN
Official label name (INCIInternational name of cosmetic ingredients: the one printed on the pack. name, EU glossary of cosmetic ingredient names), No 11860
- Preservative allowed under conditions (Annex V)
HEXAMIDINE PARABEN: Preservative allowed under conditions, maximum 0.1% in the ready-for-use preparation (Annex V, entry 47), under Regulation (EC) No 1223/2009. Annexes of the Regulation consulted on 23 October 2026.
Who it concerns
What official classifications and rules say for each group. A classification describes the hazard of the pure substance, not the risk of a product that contains it, which depends on the dose and the exposure.
Prohibition or serious classificationThe text prohibits the substance for this use, or ranks it among the most serious hazards (known or presumed carcinogenic, mutagenic or reprotoxic, identified endocrine disruptor).Worth watchingThe text sets a condition or flags a hazard worth knowing: allergen, suspected effect, condition for children, hazard to the aquatic environment.For informationOfficial information with no condition on a finished product: warning to read, irritation of the pure substance.
Pregnancy and breastfeeding
No classification harmonised by the European Union covers reproduction, the unborn child or breastfeeding for this substance. This does not mean it has been judged to have no effect during pregnancy.
Babies and children
The Cosmetics Regulation sets no age-related condition for this ingredient.
Skin, eyes and allergies
No harmonised classification for sensitisation, irritation or eye damage, and no obligation to label it as an allergen.
Environment
No harmonised classification as hazardous to the aquatic environment, and it is not on ECHAEuropean Chemicals Agency.'s Candidate List as an endocrine disruptor for the environment.
Read on the label
The Cosmetics Regulation requires no warning to be printed for this ingredient.
In plain words
What it is used for
Functions declared by manufacturers:
Preservative: inhibits primarily the development of micro-organisms in cosmetics.
Functions declared in the CosIngThe European Commission's database of cosmetic ingredients. inventory. CosIng, inventory of cosmetic ingredients (INCI names, CAS, EC, functions), retrieved 21 October 2026.
Definitions of functions (decision repealed on 8 May 2020, cited for information). Decision 2006/257/EC, inventory of cosmetic ingredients (definitions of functions), retrieved 22 October 2026.
What the rules say
An ingredient can be used as a preservative only if it appears on the list of Annex V. HEXAMIDINE PARABEN is on it with a maximum concentration.
CosIng, Annex V of Regulation (EC) No 1223/2009 (allowed preservatives), retrieved 23 October 2026, source updated 13 October 2026.
The text of the annexes
Preservative allowed under conditions
- Maximum concentration
- 0.1%
- Entry
- Annex V, No 47
- Substance
- Benzenecarboximidamide, 4,4'-(1,6-hexanediylbis(oxy))bis-, and its salts (including isothionate and p-hydroxybenzoate)
- Glossary names
- HEXAMIDINE / HEXAMIDINE DIISETHIONATE / HEXAMIDINE DIPARABEN / HEXAMIDINE PARABEN
- CAS
- 3811-75-4 / 659-40-5 / 93841-83-9 / -
- EC
- - / 211-533-5 / 299-055-3 / -
Regulation (EC) No 1223/2009, Annex V, entry 47. CosIng, Annex V of Regulation (EC) No 1223/2009 (allowed preservatives), retrieved 23 October 2026, source updated 13 October 2026.
Entry from Regulation (EC) No 1223/2009, adopted on 30 November 2009.
SCCSEU Scientific Committee on Consumer Safety: it assesses cosmetic ingredients. opinions cited: Opinion concerning Restrictions on Materials listed in annex VI of Directive 76/768/EEC on Cosmetic Products; Opinion on Hexamidine and its salts.
What has changed, and what will change
Dates of the texts that cover this ingredient. A text date may cover several substances: the details of each entry are below.
Annex V, entry 47: introduced or replaced by Regulation (EC) No 1223/2009
Annex V, entry 47: applies from this date
Identity
- CosIng identifier
- 34261
- Declared functions
- Preservative
CosIng cites no CAS number for this name.
CosIng inventory. CosIng, inventory of cosmetic ingredients (INCI names, CAS, EC, functions), retrieved 21 October 2026.
Elsewhere in the world
Information on other jurisdictions, with no effect on sale in France. What is covered, and what is not yet.
Comparison between countries
Most restrictive status in each country, and the maximum concentration cited. The details and the source of each rule follow.
| Country | Rule | Maximum concentration cited |
|---|---|---|
| European Union | Preservative allowed under conditions | 0.1% |
| United Kingdom | Preservative allowed under conditions | 0.1% |
| Switzerland | EU Regulation applies | 0.1% |
| United States (federal) | No federal rule recorded | not cited |
| Japan | No entry in the lists recorded | not cited |
| South Korea | No entry in the lists recorded | not cited |
| China | Not on the prohibited lists recorded (lists of allowed substances are not recorded) | not cited |
| Australia | No entry in the lists recorded | not cited |
| Brazil | No entry in the lists recorded | not cited |
United Kingdom (Great Britain)
- Preservative allowed under conditions (Annex V)
Same entries as in the European Union. Their maximum concentrations are compared in the “Comparison between countries” table; other conditions (product types, warnings) may differ.
Annexes II to VI in force. United Kingdom, Annexes II to VI of Regulation (EC) No 1223/2009 as retained and amended, retrieved 21 October 2026.
Contains public sector information licensed under the Open Government Licence v3.0.
Northern Ireland applies EU law.
Switzerland
Regulation (EC) No 1223/2009 applies in Switzerland (Article 54 of the Ordinance on Foodstuffs and Utility Articles).
Switzerland, FDHA Ordinance on Cosmetic Products (OCos, SR 817.023.31), consolidated version, retrieved 22 October 2026.
United States, federal rules
None of the integrated sections of the federal code (21 CFR 700.11 to 700.27 and 250.250) targets this name. The FDA does not publish a list of allowed ingredients.
United States, 21 CFR part 700 and section 250.250 (FDA rules on cosmetic ingredients), eCFR, retrieved 21 October 2026.
The eCFR is not an official legal edition of the Code of Federal Regulations.
Glossary: Commission Implementing Decision (EU) 2025/1175. Page updated on 23 October 2026.