Is Lanolin safe in cosmetics?
Lanolin has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted.
Lanolin
Also known as: Caswell No. 518, EINECS 232-348-6, EPA Pesticide Chemical Code 031601, Fats and Glyceridic oils, lanoline, Wollfett (+15 more)
INCI: LANOLIN
Lanolin (CAS 8006-54-0) is a cosmetic emollient functioning as Complex mixture of esters, diesters, and hydroxy esters derived from sheep wool. EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical and food safety data.
Function
Complex mixture of esters, diesters, and hydroxy esters derived from sheep wool wax. Highly effective occlusive emollient mimicking skin sebum lipid complexity. Modern ultra-refined pharmaceutical grades achieve allergen levels below detectable thresholds. Functions as emollient, occlusive, and skin-conditioning agent.
Editorial assessment
MODERATE
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
FDA-approved OTC active ingredient: skin protectant at 12.5-50% (21 CFR 347.10(k)); anorectal products (21 CFR 346.14); ophthalmic products (21 CFR 349.14). Inactive ingredient: ophthalmic ointments up to 10% (Lanolin Alcohol), topical creams/lotions/ointments up to 6% (Lanolin Alcohol). Permitted food additive in chewing gum base (21 CFR 172.615). CIR 2024: safe as used.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Lanolin.
Calculate MoS for your specific formulation with the MoS Calculator.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Lanolin, relevant to systemic exposure and MoS calculations.
Absorption %
2-6%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum
Molecular Weight
Variable Da
Log P
n/a
Systemic Absorption
minimal
Topical Bioavailability
1-4%
Safety Margin Factor
low
Vehicle Dependent
Yes — absorption varies by formulation
Source: CIR Expert Panel
HRIPT Human Patch Test Studies
1 human repeat insult patch test aggregated from dermatological literature.
| Test Type | N | Sensitized | Dose µg/cm² | NESIL µg/cm² | Potency |
|---|---|---|---|---|---|
| HMT | - | 0 | 15517.24 | - | - |
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
Additional Jurisdictional Restrictions (1)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| GCC | halal_restricted | - | All cosmetics |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Face Cream | 1–5 | 20 | CIR Safety Assessment |
| Lip Balm | 5–20 | 40 | CIR Safety Assessment |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-static agent
Binder
Emulsifier
Film former
Flavouring and nutrient
Fragrance
Humectant
Softener and conditioner
Solvent
Stabilizing agent
Regulatory List Membership (4)
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
FDA Substances Added to Food (EAFUS)
Consumer Product Chemical
Editorial summary
Preliminary editorial summary for Lanolin — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
eu-unrestricted
cir-approved
no-sccs-opinion
animal-derived
allergen
sensitizer
eu_children_restricted
fda_food_additive
Known Synonyms
Caswell No. 518
EINECS 232-348-6
EPA Pesticide Chemical Code 031601
Fats and Glyceridic oils, lanoline
Wollfett
Adeps lanae
Adeps Lanae ahydricus
Lanae cera
UNII-7EV65EAW6H
Lantrol 1674
Lantrol 1673
Lanor crystal
Dewaxed lanolin
Jeelan oil
Ivarlan 3100
Yofco liquid lanolin
Wool oil
Vigilan
UNII-OVV5IIJ58F
Ovis aries hair oil
Chemical Function
Softener and conditioner
Humectant
Surfactant (surface active agent)
Anti-static agent
Regulatory Lists
active_ingredient; Europe; Pesticides
inert_ingredient; Pesticides
inert_ingredient; non_food_use; Pesticides
Cleaning products and household care - shoes; Europe
Cleaning products and household care - shoes; Europe
active_ingredient; animal_products; Europe; pharmaceutical; residue
Europe; Personal care
children; Europe; Personal care
children; Europe; Personal care - general moisturizing - hand/body lotion
Europe; Personal care - make-up and related
Europe; Personal care - make-up and related
Europe; Personal care - liniment
Europe; Personal care
Europe; Personal care
Europe; Personal care
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Canada; pharmaceutical
consumer_product
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA count match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Adverse Event Associations
10
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Lanolin (Wool Fat/Grease)
Food Category
oils_fats
Frequently Asked Questions
Is Lanolin allowed in the EU?
Lanolin EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Lanolin do in cosmetics?
Lanolin functions as: Complex mixture of esters, diesters, and hydroxy esters derived from sheep wool wax. Highly effective occlusive emollient mimicking skin sebum lipid complexity. Modern ultra-refined pharmaceutical grades achieve allergen levels below detectable thresholds. Functions as emollient, occlusive, and skin-conditioning agent.. It is classified as a Emollient in our database. CAS number: 8006-54-0.
Is Lanolin used outside cosmetics?
Lanolin also appears in pharmaceutical and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Lanolin compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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