US FDA consults on food contact phthalate petition

The US Food and Drug Administration (FDA) has announced a consultation on a food additive petition filed by ten NGOs that asked the agency to revoke regulations that allow the use of 30 ortho-phthalates in food contact materials (FCMs).

In the petition, the NGOs stated there is no longer a reasonable certainty of no harm for the ortho-phthalates' food contact uses. Evidence of various reproductive, developmental and endocrine health effects, they say, warrants further agency safety review of these commonly used substances.

Tom Nelter, chemical policy director at petitioning NGO the Environmental Defense Fund (EDF), pointed out that the announcement of the consultation follows in the wake of a study that shows that fast food intake may increase phthalate exposure.

The FCM uses of the ortho-phthalates being petitioned include:

• adhesives;
• resinous and polymeric coatings, including for polyolefin films;
• components of paper and paperboard in contact with aqueous and fatty foods, and dry foods;
• defoaming agents used in the manufacture of paper and paperboard;
• slimicides;
• acrylic and modified acrylic plastics, semi-rigid and rigid;
• cellophane;
• closures with sealing gaskets for food containers;
• melamine-formaldehyde resins in molded articles;
• polyester elastomers and resins (crosslinked);
• rubber articles, intended for repeated use;
• plasticisers in polymeric substances; and
• surface lubricants used in the manufacture of metallic articles.

If the agency determines that new data is available that justifies amending these specified food additive regulations to no longer provide for the use of the ortho-phthalates, they will publish an amendment of the regulations in the Federal Register.

The consultation closes 19 July.