Good Active Ingredient Sensitization Data

Shellac

INCI: SHELLAC

Shellac (CAS 9000-59-3) is a cosmetic active ingredient functioning as Film-forming agent; binding agent; coating agent. EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in food safety data.

View industrial chemical safety profile for CAS 9000-59-3 →

Auto-generated CPSR Part A draft with source citations
Function
Film-forming agent; binding agent; coating agent
Safety Rating
GOOD

Chemistry & Identifiers

Regulatory Status

EU EU Status permitted
US US Status permitted
US Notes FDA GRAS status under 21 CFR 184.1715 as a direct food additive; also listed as indirect food additive under 21 CFR 175.105, 175.300, and 176.170. Permitted in cosmetics with no FDA concentration restrictions. CIR Expert Panel reviewed and reaffirmed safety conclusion (safe up to 6% in cosmetic formulations) in 2008.

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Shellac.

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

Contact sensitization data for Shellac based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
botanical
EU Allergen Listed
no
Patch Test Positive Rate
0.3%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis

Source: IVDK; ESSCA; NACDG

Additional Ingredient Properties

4 property records from structured ingredient metadata.

allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "botanical", "patch_test_frequency_pct": "0.3", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "IVDK; ESSCA; NACDG"}
ecotoxicity
{"biodegradable": "yes", "biodegradation_days": "60-120", "bioaccumulative": "no", "aquatic_toxicity_level": "low", "coral_reef_safe": "yes", "marine_toxicity": "low aquatic toxicity", "freshwater_toxicity": "minimal impact", "endocrine_disruptor": "no", "persistent_organic_pollutant": "no", "microplastic": "no", "nano_particle": "no", "hawaii_banned": "no", "eu_restricted_environmental": "no", "p…
polymer
{"cas_number": "9000-59-3", "ingredient_class": "film_former/nail_film_former/hair_fixative", "polymer_type": "natural_polysaccharide", "chemical_backbone": "ester", "ionic_character": "nonionic", "pH_viscosity_sensitivity": "moderate", "salt_tolerance": "moderate", "electrolyte_effect_on_viscosity": "moderate", "temperature_viscosity_sensitivity": "moderate", "film_flexibility": "semi_flexible", …
sensory
{"silky": "waxy", "smooth, glides easily": "smooth, glossy", "dry-touch, non-greasy": "protected, shiny", "instant": "moderate", "low": "medium", "w/o": "w/o", "very-high": "moderate", "no": "no", "yes": "yes", "light-diffusing": "high-shine", "1.40": "1.16", "transparent": "translucent", "colorless": "amber", "excellent": "fair", "light": "medium", "synthetic": "botanical"}

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Anti-caking agent Binder Drier Film former Hair fixative Humectant Pigment Processing aids not otherwise specified Softener and conditioner Surface modifier
Regulatory List Membership (2)
EU Regulated in Personal Care FDA Substances Added to Food (EAFUS)

Expert Verdict

Expert safety assessment and concern-level summary for Shellac.

Regulatory Flags

eu-unrestricted cir-approved no-sccs-opinion gras-fda sensitizer fda_food_additive

Chemical Function

Softener and conditioner Film former Viscosity modifier Hair fixative Binder

Regulatory Lists

inert_ingredient; non_food_use; Pesticides Europe; Personal care Europe; Personal care food_additive; Substances Added to Food (formerly EAFUS) (2/2019)

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in food safety data.

SOURCE EFSA / FDA GRAS food_additives

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name
Shellac
E Number
E904
ADI
0.4 mg/kg bw
Food Category
preservative
View full food safety profile →

Frequently Asked Questions

Is Shellac safe in cosmetics?

Shellac has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted.

Is Shellac allowed in the EU?

Shellac EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Shellac do in cosmetics?

Shellac functions as: Film-forming agent; binding agent; coating agent. It is classified as a Active Ingredient in our database. CAS number: 9000-59-3.

Is Shellac used outside cosmetics?

Shellac also appears in food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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