Ingredient Directory
Low ConcernVegan

Azadirachta Indica Leaf Extract

Neem leaf extract

Safety Flags
CMR: None for leaf extract; seed extracts proposed CMR2 by ECHA (Repr. 2 suspected reprotoxic) Allergen: Botanical sensitivity possible - skin sensitization reported; Skin Sens. 1 proposed classification applies to seed extract not leaf extract
Safety Notes

CRITICAL: Regulatory concern for neem SEED extract (proposed CMR2/Repr. 2 by ECHA 2019) does NOT apply to neem LEAF extract which has different safety profile. Leaf extract considered low hazard. Traditional Ayurvedic use well established.

Function & Common Use

Function

Skin conditioning, antimicrobial, antioxidant, anti-inflammatory

Category

Botanical Extract

Common In

Acne treatments, Ayurvedic skincare, scalp care, antimicrobial formulations

Origin

Plant derived

Concentration Limits

India (CDSCO)

Not verified in source checked

EU Cosmetics Reg.

No limit for leaf extract; seed extract restrictions under review

US FDA (21 CFR)

No limit established for leaf extract

Korea (MFDS)

Not verified in source checked

Baby restriction: None for leaf extract

Pregnancy: No specific restriction for topical leaf extract; seed extract use should be avoided in pregnancy due to proposed Repr. 2 classification

Frequently Asked Questions

Is Azadirachta Indica Leaf Extract safe to use in skincare?

Azadirachta Indica Leaf Extract has a Low concern rating from The Clean Sheet. CRITICAL: Regulatory concern for neem SEED extract (proposed CMR2/Repr. 2 by ECHA 2019) does NOT apply to neem LEAF extract which has different safety profile. Leaf extract considered low hazard. Traditional Ayurvedic use well established.

Is Azadirachta Indica Leaf Extract allowed in India?

Azadirachta Indica Leaf Extract is currently classified as "Not specifically restricted in source checked - traditional Ayurvedic ingredient; no known CDSCO restriction for leaf extract" under Indian cosmetics regulations. The maximum permitted concentration is Not verified in source checked.

What is Azadirachta Indica Leaf Extract used for in cosmetics?

Azadirachta Indica Leaf Extract functions as: Skin conditioning, antimicrobial, antioxidant, anti-inflammatory. It is commonly found in: Acne treatments, Ayurvedic skincare, scalp care, antimicrobial formulations.

Can Azadirachta Indica Leaf Extract cause an allergic reaction?

Yes. Azadirachta Indica Leaf Extract has an allergen flag (Botanical sensitivity possible - skin sensitization reported; Skin Sens. 1 proposed classification applies to seed extract not leaf extract). If you have sensitive skin or known fragrance/contact allergies, patch-test products containing this ingredient before full use.

Is Azadirachta Indica Leaf Extract safe for babies?

Azadirachta Indica Leaf Extract has baby/child restrictions: None for leaf extract. Avoid using products containing this ingredient on infants unless specifically formulated and labelled for baby use.

TCS Assessment
Low Concern
Data Confidence
High
Based on peer-reviewed safety data, regulatory status, and expert review by The Clean Sheet panel.

Regulatory Status

India (CDSCO)
Not specifically restricted in source checked - traditional Ayurvedic ingredient; no known CDSCO restriction for leaf extract
EU
Permitted for leaf extract - listed in EU CosIng; not in Annex II or Annex III. IMPORTANT: Neem seed extracts are subject to separate CMR2 classification proposal (Repr. 2, Skin Sens. 1) - this does NOT apply to leaf extract
US FDA
Permitted for cosmetic use (leaf extract); no restriction identified for leaf extract form
Korea (MFDS)
Not specifically restricted in source checked - general cosmetic ingredient under MFDS negative list system
Australia (TGA)
Permitted as cosmetic ingredient under AICIS; no specific restriction for leaf extract found
Canada (NHPID)
Not verified in source checked

EU Annex: None for leaf extract; seed extracts subject to proposed CMR2 classification

Identifiers

CAS84696-23-1
EC283-644-9

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