- FDA regulates the use of so-called “indirect” food additives. In general, these are substances that may come into contact with food as part of packaging or processing equipment, but are not intended to be added directly to food. Many indirect additives are the subject of FDA regulatory clearances in 21 CFR Parts 175, 176, 177, and 178.
- On January 4, 2016, FDA published a final rule amending the food additive regulations to no longer permit the use of three perfluoroalkyl ethyl containing food-contact substances (FCSs) as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods because new data are available as to the toxicity of substances structurally similar to these compounds that demonstrate there is no longer a reasonable certainty of no harm from the food-contact use of these FCSs. The Agency implemented the ban in response to a petition filed by the Natural Resources Defense Council, the Center for Food Safety, the Breast Cancer Fund, the Center for Environmental Health, Clean Water Action, the Center for Science in the Public Interest, Children’s Environmental Health Network, Environmental Working Group, and Improving Kids’ Environment.
- The Society of the Plastics Industry (SPI), a leading trade association in the food-contact materials industry, has indicated that the three chemicals subject to FDA’s ban are no longer manufactured and have been replaced by newer alternative technologies in present-day food-contact materials. SPI thus supports the removal of these substances from FDA regulations on the basis of abandonment. The groups who filed the petition with FDA have indicated that they intend to file similar petitions requesting that the Agency remove the clearances associated with a number of FCSs. Many of the future targets of these petitions are anticipated to be substances that are indeed safe and still used. Industry will need to stay aware of the new petitions to respond to these challenges and to ensure that FDA has the relevant data it needs to make a science-based decision on the safety of these cleared materials.
Keller and Heckman LLP has extensive experience in the food-contact material area. For more information on this area of our Food & Drug practice, please visit our newly redesigned PackagingLaw website by clicking here.