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Polysorbate 65

Polysorbate 65
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Overall Polysorbate 65 is of lower concern in food.

The overall ingredient concern is determined by using a weight of evidence evaluation of the known safety or hazards. In calculating an overall ingredient score multiple findings of low concern may lead to an overall moderate concern rating, or multiple moderate concerns may lead to a high concern rating. For more details read EWG's ingredient concern methodology.

Specific concerns for Polysorbate 65

Concern
 
 
Source
The Japanese Food Safety Commission reports this substance causes gastrointestinal effects at high doses.
 
Food Safety Commission, Japan. 2007. Evaluation Report of Food Additives Polysorbates (Polysorbates 20, 60, 65 and 80).
The Cosmetic Ingredient Review panel concludes this substance is safe for use when formulated to be non-irritating.
 
Cosmetic Ingredient Review (CIR): CIR Assessments

Concerns from impurities

Concern
 
 
Source
Impurity: 1,4-DIOXANE
Suspected of causing cancer
 
EU GHS Hazard Labeling Codes: GHS Hazard Codes
Impurity: 1,4-DIOXANE
Known to cause cancer
 
California OEHHA (Office of Environmental Health Hazard Assessment): Proposition 65 List (2020 Update)
Impurity: ETHYLENE OXIDE
May cause genetic defects
 
EU GHS Hazard Labeling Codes: GHS Hazard Codes
Impurity: ETHYLENE OXIDE
May cause cancer
 
EU GHS Hazard Labeling Codes: GHS Hazard Codes
Impurity: ETHYLENE OXIDE
Known to cause cancer
 
California OEHHA (Office of Environmental Health Hazard Assessment): Proposition 65 List (2020 Update)
Impurity: ETHYLENE OXIDE
Known to cause reproductive toxicity (to females)
 
California OEHHA (Office of Environmental Health Hazard Assessment): Proposition 65 List (2020 Update)
Impurity: ETHYLENE OXIDE
Known to cause reproductive toxicity (to males)
 
California OEHHA (Office of Environmental Health Hazard Assessment): Proposition 65 List (2020 Update)
Impurity: ETHYLENE OXIDE
Known to cause reproductive toxicity
 
California OEHHA (Office of Environmental Health Hazard Assessment): Proposition 65 List (2020 Update)
Impurity: ETHYLENE OXIDE
Carcinogenic to humans
 
International Agency for Research on Cancer (IARC): Agents classified by the IARC Monographs (through Volume 127)
Impurity: ETHYLENE OXIDE
Known To Be Human Carcinogen
 
National Toxicology Program (NTP): NTP 14th Report on Carcinogens
Impurity: 1,4-DIOXANE
Reasonably Anticipated To Be Human Carcinogen
 
National Toxicology Program (NTP): NTP 14th Report on Carcinogens
Impurity: 1,4-DIOXANE
Causes cancer
 
Centers for Disease Control and Prevention (CDC): NIOSH Pocket Guide to Chemical Hazards
Impurity: ETHYLENE OXIDE
Causes reproductive effects
 
Centers for Disease Control and Prevention (CDC): NIOSH Pocket Guide to Chemical Hazards
Impurity: ETHYLENE OXIDE
Causes leukemia
 
Centers for Disease Control and Prevention (CDC): NIOSH Pocket Guide to Chemical Hazards
Impurity: ETHYLENE OXIDE
Causes peritoneal cancer
 
Centers for Disease Control and Prevention (CDC): NIOSH Pocket Guide to Chemical Hazards
Impurity: 1,4-DIOXANE
Possibly carcinogenic to humans
 
International Agency for Research on Cancer (IARC): Agents classified by the IARC Monographs (through Volume 127)
 

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