The US Food and Drug Administration has denied petitions to ban phthalates in materials that come into contact with food. The scientific evidence provided in the petitions does not demonstrate that phthalates are unsafe for food contact uses, the FDA says in a May 12 letter to the petitioners. Environmental and public health groups filed the petitions in 2016.
In its letter, the FDA states that it is granting a petition filed in 2018 by the Flexible Vinyl Alliance, a plastics industry group, to prohibit the use of 25 phthalates in food contact applications. Industry no longer uses those 25 chemicals for such applications, the FDA says. For the 8 phthalates that industry is still using in substances that contact food, the FDA is seeking safety, dietary exposure, and use information, the agency says.
The FDA regulates phthalates that come into contact with food as food additives. The chemicals are not added directly to food, but they can migrate into food from food processing equipment, packaging, and food preparation materials like vinyl gloves.
Phthalates have been associated with adverse effects on male reproductive development. The Consumer Product Safety Commission set a limit of 0.1% for certain phthalates in children’s toys and child care articles in 2017.
Environmental groups that filed the petitions are disappointed it took the FDA 6 years to make a decision. “We submitted these petitions in 2016. The law required a decision several years ago,” Tom Neltner, chemicals policy director at the Environmental Defense Fund (EDF), says in a statement. The EDF and other petitioners sued the FDA in December to force the agency to make a decision on the 2016 petitions.
“Despite the extra time, FDA has continued to ignore the widespread contamination of food” by phthalates and the cumulative effects these chemicals have on children’s health, Neltner says in the statement. “It’s outrageous that FDA decided chemicals banned from children’s toys should remain in the food we eat.”
Phthalates are found in numerous consumer products, including fragrances, cosmetics, pharmaceuticals, and cleaning products. Cumulative exposure to multiple sources of phthalates increases the risks to health, the petitioners say.