Elsevier

Reproductive Toxicology

Volume 42, December 2013, Pages 85-94
Reproductive Toxicology

Data gaps in toxicity testing of chemicals allowed in food in the United States

https://doi.org/10.1016/j.reprotox.2013.07.023Get rights and content
Under a Creative Commons license
open access

Highlights

  • For the first time, a searchable list of chemical additives allowed in human food by FDA has been developed and made publicly available with cross-references to supporting toxicology studies.

  • In practice, almost 80% of chemical additives directly—intentionally—added to food lack the relevant information needed to estimate the amount that consumers can safely eat in FDA's own database and 93% lack reproductive or developmental toxicity data, although FDA requires feeding toxicology data for these chemicals.

  • Of the totality of FDA-regulated additives, both directly and indirectly allowed in food, almost two-thirds don’t have publicly available feeding data.

  • In the absence of toxicology data on the majority of chemicals added to food, the scientific basis for determinations of safety to humans may be questioned.

Abstract

In the United States, chemical additives cannot be used in food without an affirmative determination that their use is safe by FDA or additive manufacturer. Feeding toxicology studies designed to estimate the amount of a chemical additive that can be eaten safely provide the most relevant information. We analyze how many chemical additives allowed in human food have feeding toxicology studies in three toxicological information sources including the U.S. Food and Drug Administration's (FDA) database. Less than 38% of FDA-regulated additives have a published feeding study. For chemicals directly added to food, 21.6% have feeding studies necessary to estimate a safe level of exposure and 6.7% have reproductive or developmental toxicity data in FDA's database. A program is needed to fill these significant knowledge gaps by using in vitro and in silico methods complemented with targeted in vivo studies to ensure public health is protected.

Keywords

Food chemicals, Food additives, FDA, GRAS, Safe, Toxicology, Food contact substances, Flavors

Abbreviations

FDA
U.S. Food and Drug Administration
EPA
U.S. Environmental Protection Agency
TOR
Threshold of Regulation
FCS
Food Contact Substances
GRAS
Generally Recognized as Safe
FEMA
Flavor and Extract Manufacturers Association
EAFUS
Everything Added to Food in the United States
CASRN
Chemical Abstract Service Registry Number
PAFA
Priority-based Assessment of Food Additives.

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