Toxicology of phthalic acid esters used in food-packaging material.

Phthalic acid esters may be used as plasticizers in food-packaging materials that have direct contact with food. Under normal conditions of use small amounts of the plasticizers would be expected to migrate into the food. The safe use of the phthalic acid esters under these conditions is based on available toxicity data, as well as regulations which, in general, specify the maximum extractable fraction of plasticizer that may enter food. Before the enactment of the Food Additives Amendment to the Federal Food, Drug and Cosmetic Act in 1958, sanctions were granted for the use of five phthalates in food-packaging material (diethyl phthalate, butylphthalyl butyl glycolate, ethylphthalyl ethyl glycolate, diisooctyl phthalate, and di-2-ethylhexyl phthalate), with the limitations that they be used in accordance with good manufacturing practice for food packaging materials, and that di-2-ethylhexyl phthalate and diisooctyl phthalate be used with foods of high water content. Foods of high water content were defined as those from which no fat would be extractedwhen the food was pressed against filter paper; under the conditions of this test, if a water spot was formed the food was considered aqueous and if a fat spot was formed the food was considered fatty. The restriction was applied to di-2-ethylhexyl phthalate and to diisooctyl phthalate because the available toxicological data would not support un-