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Food Addit Contam Part A 2017 Jun;34(6):905-17

Dietary exposures for the safety assessment of seven emulsifiers commonly added to foods in the United States and implications for safety.

Shah R, Kolanos R, DiNovi MJ, Mattia A, Kaneko KJ


Dietary exposure assessment using food consumption data and ingredient use level is essential for assessing safety of food ingredients. Dietary exposure estimates are compared to safe intake levels, such as Acceptable Daily Intake (ADI). 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, sodium 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 United States population, the current investigation focused on the estimation of dietary exposure to seven emulsifiers: CMC, P80, lecithin, mono- and diglycerides (MDG), 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 United States population (aged 2 years and older) for two time periods (1999-2002 and 2003-2010) using one- and two-day food consumption data from the National Health and Nutrition Examination Survey, and 10-14 day food consumption data from NPD Group, Inc. National Eating Trends-Nutrient Intake Database. Our analyses indicated that among the emulsifiers assessed, lecithin and MDG have the highest mean exposures at ~60 and ~80 mg/kg bw/day, respectively, whereas the exposure to CMC is one-half to one-third of lecithin or MDG; and the exposure to P80 is approximately one-half of CMC. The review of available safety information such as ADIs established by the Joint FAO/WHO Expert Committee on Food Additives, 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) and (2003-2010), it was concluded that there is no evidence that exposure levels to emulsifiers have substantially increased.

Category: Journal Article
PubMed ID: #28346062 DOI: 10.1080/19440049.2017.1311420
Includes FDA Authors from Scientific Area(s): Food
Entry Created: 2017-03-28 Entry Last Modified: 2017-07-25