title: Dietary exposures for the safety assessment of seven emulsifiers commonly added to foods in the United States and implications for safety.
abstract: Dietary exposure assessment using food-consumption data and ingredient-use level is essential for assessing the safety of food ingredients. Dietary exposure estimates are compared with safe intake levels, such as the acceptable daily intake (ADI). The ADI is estimated by applying a safety factor to an experimentally determined no-observed-adverse-effect level of a test substance. Two food ingredients classified as emulsifiers, carboxymethylcellulose (CMC) and polysorbate 80 (P80), received attention recently due to their putative adverse effects on gut microbiota. Because no published dietary exposure estimates for commonly used emulsifiers exist for the US population, the current investigation focused on the estimation of dietary exposure to seven emulsifiers: CMC, P80, lecithin, mono- and diglycerides (MDGs), stearoyl lactylates, sucrose esters, and polyglycerol polyricinoleate. Using maximum-use levels obtained from publicly available sources, dietary exposures to these emulsifiers were estimated for the US population (aged 2 years and older) for two time periods (1999-2002 and 2003-10) using 1- and 2-day food-consumption data from the National Health and Nutrition Examination Survey, and 10-14-day food-consumption data from NPD Group, Inc.'s National Eating Trends - Nutrient Intake Database. Our analyses indicated that among the emulsifiers assessed, lecithin and MDGs have the highest mean exposures at about 60 and about 80 mg kg-1bw day-1, respectively, whereas the exposure to CMC is half to one-third that of lecithin or MDGs; and the exposure to P80 is approximately half that of CMC. The review of available safety information such as ADIs established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), in light of our updated dietary exposure estimates for these seven emulsifiers, did not raise safety concerns at the current specified levels of use. Additionally, by examining two time periods (1999-2002, 2003-10), it was concluded that there is no evidence that exposure levels to emulsifiers have substantially increased.
authors.affiliation: a Office of Food Additive Safety/Center for Food Safety and Applied Nutrition , Food and Drug Administration (USFDA) , College Park , MD , USA.
authors.forename: Romina
authors.identifier: http://orcid.org/0000-0002-2540-2386
authors.initials: R
authors.lastname: Shah
authors.affiliation: a Office of Food Additive Safety/Center for Food Safety and Applied Nutrition , Food and Drug Administration (USFDA) , College Park , MD , USA.
authors.forename: Renata
authors.identifier: http://orcid.org/0000-0002-5150-6410
authors.initials: R
authors.lastname: Kolanos
authors.affiliation: a Office of Food Additive Safety/Center for Food Safety and Applied Nutrition , Food and Drug Administration (USFDA) , College Park , MD , USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: DiNovi
authors.affiliation: a Office of Food Additive Safety/Center for Food Safety and Applied Nutrition , Food and Drug Administration (USFDA) , College Park , MD , USA.
authors.forename: Antonia
authors.identifier: http://orcid.org/0000-0002-7430-5179
authors.initials: A
authors.lastname: Mattia
authors.affiliation: a Office of Food Additive Safety/Center for Food Safety and Applied Nutrition , Food and Drug Administration (USFDA) , College Park , MD , USA.
authors.forename: Kotaro J
authors.identifier: http://orcid.org/0000-0002-3195-5294
authors.initials: KJ
authors.lastname: Kaneko
mesh_terms: D004032:Diet / Q000009:adverse effects*; D045703:Emulsifying Agents / Q000032:analysis*; D005503:Food Additives / Q000032:analysis*; D059022:Food Safety; D006801:Humans; D009749:Nutrition Surveys; D018570:Risk Assessment; D014481:United States
chemical_list: D045703:Emulsifying Agents; D005503:Food Additives
keywords: ADI; Emulsifiers; NHANES; NPD NET-NID; dietary exposure; polysorbate 80 (P80); sodium carboxymethylcellulose (CMC)