EWG Skin Deep® | What is POLYSORBATE 61

HOW WE DETERMINE SCORES Learn more About EWG VERIFIED™

Data: Limited

Polysorbate 61

Products with the EWG VERIFIED mark have met the program’s impurity and use restrictions based on EWG's review of the company's data.

IMAGE SOURCE: PubChem

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Other Concerns

Use restrictions (low), Non-reproductive organ system toxicity (low), Irritation (skin, eyes, or lungs) (low), and Contamination concerns (high)

SYNONYMS

POLYSORBATE 61

Restricted

Restricted: EWG VERIFIED products cannot contain this ingredient without adequate substantiation

Polysorbate 61 is a mixture of stearate esters of sorbitol and sorbitol anhydrides, consistingpredominantly of the monoester, condensed with approximately 4 moles of ethylene oxide.

Common concerns

See how this product scores for common concerns.

LOW

Cancer
LOW

Allergies & Immunotoxicity
LOW

Developmental and Reproductive Toxicity
LOW

Use Restrictions

Ingredient concerns

CONCERNS
DATA SOURCES

Products with this Ingredient

daily use with SPF	6 products
CC cream	1 products
recreational sunscreen	1 products

Contamination concerns

Chemical
ETHYLENE OXIDE
1,4-DIOXANE

Organ system toxicity (non-reproductive)

CONCERN	REFERENCE
Limited evidence of sense organ toxicity	Scorecard.org Toxicity Information
Classified as not expected to be potentially toxic or harmful	Environment Canada Domestic Substance List
Classified as a low human health priority	Environment Canada Domestic Substance List

Use restrictions

CONCERN	REFERENCE
Determined safe for use in cosmetics, subject to concentration or use limitations - any	Open scientific literature

Irritation (skin, eyes, or lungs)

CONCERN	REFERENCE
any irritation - weight of evidence unknown/unassessed	Open scientific literature

Data gaps

CONCERN	REFERENCE
Risk assessment method deficiencies and data gaps - Maximum reported "as used" concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product	Cosmetic Ingredient Review Assessments
2 studies in PubMed science library may include information on the toxicity of this chemical	NLM PubMed

Multiple, additive exposure sources

CONCERN	REFERENCE
Designated as safe for general or specific, limited use in food	FDA Everything Added to Food
Designated as safe for general or specific, limited use in food	FDA Food Additive Status

Ecotoxicology

CONCERN	REFERENCE
Not suspected to be an environmental toxin	Environment Canada Domestic Substance List

Informational

CONCERN	REFERENCE
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - any	Cosmetic Ingredient Review Assessments

ED (Environmental Defense). 2006. Scorecard _ The Pollution Information Site. http://www.scorecard.org.
EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
Open scientific/peer reviewed literature
CIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
FDA (U.S. Food and Drug Administration). 2008. EAFUS [Everything Added to Food]: A Food Additive Database. FDA Office of Food Safety and Applied Nutrition.
FDA (U.S. Food and Drug Administration) 2006. Food Additive Status List. Downloaded from http://www.cfsan.fda.gov/%7Edms/opa-appa.html, Oct 16, 2006.

Understanding scores

Cosmetics and personal care products are not required to be tested for safety before being allowed on the market. The Skin Deep® scoring system was designed to help the public understand whether a product is safe to use or whether it contains ingredients of concern.

Every product and ingredient in Skin Deep gets a two-part score – one for hazard and one for data availability. The safest products score well by both measures, with a low hazard rating and a fair or better data availability rating.

HOW WE DETERMINE SCORES

Hazard score

The Skin Deep ingredient hazard score, from 1 to 10, reflects known and suspected hazards linked to the ingredients. The EWG VERIFIED™ mark means a product meets EWG’s strictest criteria for transparency and health.

Data availability

The Skin Deep data availability rating reflects the number of scientific studies about the product or ingredient in the published scientific literature.

NONE LIMITED FAIR GOOD ROBUST

Low Availability

Moderate Availability

High Availability