Even when the wrapping comes off, you inevitably ingest some of the container... l the European Food Safety Authority (EFSA) was asked to look into the matter.
Plastic, rubber, cardboard, metal, and glass packaging act as a barrier against all sorts of contamination, but they are also a source of contamination. Speak with anyone who produces, studies, or regulates packaging, and you will hear this point repeated: It is not a question of whether packaging components will leach into a product, it’s a question of how much.
“If you have a material in contact with food, and if it’s not completely inert—and there are no completely inert materials—something in the packaging will end up in the food,” says Dimitrios Spyropoulos, a regulator at EFSA.
The same holds true for pharmaceuticals. “You will always have leachables,” says Guirag Poochikian, a retired U.S. Food & Drug Administration regulator who used to evaluate leachables from inhaler devices. “The question is ‘What are they, and what is their safety margin’ ” in humans?
As analytical technology improves—in some cases allowing parts-per-trillion levels of detection—trace, and sometimes not-so-trace, levels of thousands of different leachables can be measured in food and pharmaceuticals. More challenging is tracking down the source of migrating compounds and figuring out what levels are harmful to human health.
Controversies over what migration levels constitute harmful human exposure continue to simmer. And even as researchers come up with new strategies for reducing leachables, cases of unexpected packaging chemicals migrating into food or drug formulations point to the need for further diligence.
...Only after leachables have been identified, quantified, and sourced does the most critical step occur: determining what levels of leachables in food or drugs pose a risk to human health. Regulatory agencies have entirely different approaches to assessing the risk in food versus pharmaceuticals.
Sometimes the limits of known leachables set by regulators are controversial, as illustrated by the debate over BPA. Scientists such as biomedical researcher Wade Welshons of the University of Missouri, Columbia, argue that their data show that both FDA’s and the European Commission’s allowable level of the molecule in food can cause endocrine disruption in humans and that regulators have been basing their decisions on just four industry-sponsored studies. Regulators and industry continue to argue that BPA is present in food packaging at levels that are safe and that they base their evaluation on sound science.
Others say that regulators approach the study of risk too narrowly. In particular, regulators evaluate the risk associated with individual leachable chemicals in isolation. This approach neglects the possibility that if humans are exposed to low doses of several chemicals that affect the same organ in the body, the combination may induce harmful effects, even if they are present below their “no-effect concentration” as individual chemicals, says Jane Muncke, a toxicologist at Switzerland-based glass-container supplier Emhart Glass. “New approaches need to be put in place to characterize whole-packaging toxicity—including printing inks, adhesives, and secondary packaging—to understand what consumers are actually being exposed to and whether there is a safety issue,” Muncke notes.
At the same time, those producing packaging are looking at ways to reduce leachables....
Please read full from American Chemical Society
