HYDROLYZED HAIR KERATIN
Commonly Found In
Overview
Hydrolyzed hair keratin is a protein derived from human or animal hair that has been broken down into smaller peptides and amino acids through hydrolysis. It is used in hair care formulations to strengthen hair, improve elasticity, and repair damage. The EU and UK ban it (Annex II/416) due to BSE/TSE (bovine spongiform encephalopathy) concerns associated with animal-derived proteins; Japan and the US permit its use.
Also known as: keratin hydrolysate (hair), hair keratin peptides, hydrolyzed keratin
Key Benefits
Studies suggest hydrolyzed hair keratin peptides may help strengthen hair and improve elasticity by binding to damaged areas of the hair shaft and partially replenishing lost protein. Clinical evidence indicates it may reduce breakage in chemically treated hair. Its small molecular weight after hydrolysis allows partial penetration of the hair cuticle.
Supporting Research
- β’ CIR Expert Panel: Hydrolyzed keratin ingredients are safe for use in cosmetics at concentrations used in practice
- β’ Robbins CR (2012) β Chemical and Physical Behavior of Human Hair: keratin hydrolysates can adsorb onto hair surface and improve combability and tensile strength
Skin Compatibility Ratings
Comedogenic Rating
Non-comedogenic; used primarily in hair care products; not associated with pore-clogging at typical use concentrations
Source: CIR Expert Panel; published hair care literature
Irritancy Rating
Well tolerated; low irritancy and sensitization potential at typical use concentrations in hair care formulations
Source: CIR Expert Panel
Typical Use Concentration
Range
0.5β5%
Optimal
1β3%
Typically used at 1β3% in hair conditioners and treatments. Concentration-dependent efficacy for hair strengthening benefits. Not permitted in EU/UK cosmetics regardless of concentration.
Works Well With / Avoid
Works Well With
EU/UK banned (Annex II/416) due to BSE/TSE concerns from animal origin. Not prohibited on safety grounds β the ban is precautionary. Vegan keratin alternatives (phytokeratin from wheat, soy, or oat) may be substituted in EU/UK formulations.
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 | Banned | - | - | 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 (II/416) | Official β |
π Why Regulations Differ
EU/UK ban (Annex II/416) is precautionary, based on BSE/TSE risk from animal-derived proteins, not direct human safety toxicology. Japan and US permit it provided sourcing meets animal health requirements. The ban mirrors restrictions on other animal-derived proteins in EU cosmetics regulations.
Regulation Analysis
Regional Agreement
Banned in EU, UK but allowed in USA, Japan.
Category Comparison
There are 174 ingredients in the HAIR CONDITIONING category. 99% are banned in at least one major market.
Strictness Ranking
πΏ Natural Sources
Derived from human or animal hair (typically sheep wool or human hair). Keratin is the structural protein in hair, nails, and skin.
π How It's Made
Produced by chemical or enzymatic hydrolysis (breaking down) of hair keratin into smaller peptides and amino acids. Hydrolysis methods include acid, alkaline, or enzymatic treatment to break disulfide bonds and peptide chains.
π Uses in Cosmetics
Used in hair care products to strengthen hair and improve elasticity. Banned in EU/UK (Annex II/416) due to BSE/TSE (mad cow disease) concerns from animal-derived ingredients. Allowed in US and Japan with proper sourcing documentation. Claimed to repair damaged hair by filling in gaps in hair cuticle.
π¬ Other Applications
Biomedical research on protein structure, tissue engineering scaffolds, wound healing materials, and edible film coatings for food preservation.
π‘ Fun Facts
- β’ EU ban stems from 1990s-2000s BSE (mad cow disease) crisis - regulations prohibit animal-derived proteins that could theoretically transmit prion diseases
- β’ Keratin makes up 95% of hair's dry weight and contains high levels of cysteine amino acid, giving hair its strength through disulfide bonds
- β’ Some modern formulations use plant-derived 'vegan keratin' (phytokeratin) as an alternative to animal keratin
Data Sources
- β’ EU Cosmetics Regulation 1223/2009 Annex II entry 416
- β’ CIR Expert Panel β Safety Assessment of Hydrolyzed Proteins
- β’ Robbins CR (2012) β Chemical and Physical Behavior of Human Hair, 6th ed.
Last data verification: 2026-04-12
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Frequently Asked Questions
Why is HYDROLYZED HAIR KERATIN banned in the EU but allowed in the US?
The EU follows a precautionary principle, banning HYDROLYZED HAIR KERATIN under II/416 due to potential safety concerns. The US FDA has not found sufficient evidence to prohibit its use, allowing it under different safety assessment standards. This reflects differing regulatory philosophies between the two regions.
Why is HYDROLYZED HAIR KERATIN banned in the EU but allowed in Japan?
The EU prohibits HYDROLYZED HAIR KERATIN (II/416) based on their strict safety criteria. Japan's Ministry of Health, Labour and Welfare (MHLW) has evaluated the ingredient and permits its use, potentially with different safety data or usage conditions.
What is HYDROLYZED HAIR KERATIN used for in cosmetics?
HYDROLYZED HAIR KERATIN is primarily used for hair conditioning in cosmetic products. It also serves as skin conditioning. The ingredient is commonly found in various cosmetic and personal care products.
Which countries regulate HYDROLYZED HAIR KERATIN?
HYDROLYZED HAIR KERATIN is banned in EU, UK. The ingredient is freely allowed in JP, US.
Are there alternatives to HYDROLYZED HAIR KERATIN?
Due to regulatory restrictions on HYDROLYZED HAIR KERATIN, cosmetic manufacturers often use alternative ingredients with similar functions. For hair conditioning, 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.
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.