IMIDAZOLIDINYL UREA
Commonly Found In
Overview
Imidazolidinyl urea is a formaldehyde-releasing preservative marketed under the trade name Germall 115. It releases lower levels of formaldehyde than diazolidinyl urea, providing broad-spectrum antimicrobial activity. The EU permits it at up to 0.6% with a mandatory 'contains formaldehyde' label if released formaldehyde exceeds 0.05%.
Also known as: Germall 115, N,N'-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxo-4-imidazolidinyl]urea]
Key Benefits
Preservative only; no direct skin-conditioning benefit. Studies suggest lower formaldehyde release and allergenicity compared to diazolidinyl urea, making it a somewhat milder formaldehyde-releasing option.
Supporting Research
- β’ CIR Expert Panel: Assessed imidazolidinyl urea as safe at concentrations up to 0.6%
- β’ Frosch PJ et al. (1995): Comparative patch testing data show lower sensitization rate than diazolidinyl urea
Skin Compatibility Ratings
Comedogenic Rating
Non-comedogenic; widely used water-soluble preservative at low concentrations.
Source: CIR Expert Panel safety assessment
Irritancy Rating
Moderate sensitization/irritation risk due to formaldehyde release; EU labeling required if released formaldehyde >0.05%
Source: CIR Expert Panel; patch-test literature
Typical Use Concentration
Range
0.1β0.6%
Optimal
0.2β0.5%
EU Annex V entry 27: max 0.6% with labeling. US: allowed, assessed safe at β€0.6% by CIR.
Works Well With / Avoid
Works Well With
Use With Caution
EU Annex V max 0.6%; 'contains formaldehyde' label required if released formaldehyde >0.05%. CIR-assessed safe at permitted levels.
Commonly Found In
Global Regulation Summary
Overview of current status across major international markets.
Detailed Regional Status
| Region | Status | Max Conc. | Conditions | Source |
|---|---|---|---|---|
| πͺπΊ EU | Allowed | - | - | Official β |
| πΊπΈ USA | Allowed | - | - | Official β |
| π―π΅ Japan | Allowed | - | - | Official β |
| π°π· Korea | Unknown | - | - | Official β |
| π¬π§ UK | Banned | - | Follows EU regulations (V/27) | Official β |
π Why Regulations Differ
Both EU and US allow imidazolidinyl urea as a preservative at 0.6% with EU labeling requirements. Lower formaldehyde release than diazolidinyl urea means slightly lower sensitization rate; US has no formal limit but CIR review set safety benchmark.
Regulation Analysis
Regional Agreement
Banned in UK but allowed in EU, USA, Japan.
Category Comparison
There are 157 ingredients in the PRESERVATIVE category. 99% are banned in at least one major market.
Strictness Ranking
πΏ Natural Sources
Synthetic only. Does not occur in nature.
π How It's Made
Synthesized by condensation of allantoin with formaldehyde and urea under alkaline conditions. The process creates N,N'-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxo-4-imidazolidinyl]urea], a formaldehyde-releaser.
π Uses in Cosmetics
Used at 0.1-0.6% as a preservative in creams, lotions, and cosmetics. Works by releasing a small amount of formaldehyde to prevent bacterial and mold growth. The EU allows up to 0.6% with a required label warning.
π¬ Other Applications
Used in some pharmaceutical preparations and industrial formulations requiring mild preservation at neutral pH.
π‘ Fun Facts
- β’ Marketed under the trade name Germall 115 when introduced by Sutton Labs in the 1970s
- β’ It releases less formaldehyde than diazolidinyl urea, making it less allergenic but also less effective as a preservative
- β’ EU's Cosmetic Regulation requires products containing imidazolidinyl urea to state 'Contains formaldehyde' if formaldehyde concentration exceeds 0.05%
Data Sources
- β’ EU Cosmetics Regulation 1223/2009 Annex V entry 27
- β’ CIR Expert Panel β Safety Assessment of Imidazolidinyl Urea
- β’ Frosch PJ et al. (1995) β Comparative patch-test sensitization data
Last data verification: 2026-04-16
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Frequently Asked Questions
What is IMIDAZOLIDINYL UREA used for in cosmetics?
IMIDAZOLIDINYL UREA is primarily used for preservative in cosmetic products. The ingredient is commonly found in various cosmetic products to prevent microbial growth.
Which countries regulate IMIDAZOLIDINYL UREA?
IMIDAZOLIDINYL UREA is banned in UK. The ingredient is freely allowed in EU, JP, US.
Are there alternatives to IMIDAZOLIDINYL UREA?
Due to regulatory restrictions on IMIDAZOLIDINYL UREA, cosmetic manufacturers often use alternative ingredients with similar functions. For preservative, alternatives may include other approved ingredients in the same category. Consult product labels for specific formulations, and look for products compliant with your region's regulations.
Where can I find official regulation information about IMIDAZOLIDINYL UREA?
Official information about IMIDAZOLIDINYL UREA regulations can be found on government websites: EU CosIng database, US FDA Cosmetics page, Japan MHLW cosmetics standards, UK Government cosmetics guidance, and Korea MFDS. Always verify regulatory status with these official sources before making formulation decisions.
Disclaimer
The information on this website is for educational and informational purposes only and is not intended as medical advice. While we strive for accuracy based on official government databases, cosmetic regulations change frequently. Always consult with a qualified professional or refer to the latest official regulatory documents for compliance. We are not responsible for any actions taken based on the information provided here.