FDA Grants FVA Petition to Remove 25 Phthalates No Longer Used; Finds Current Exposure to Phthalates in Food Contact Applications to Be Safe

ARLINGTON, Va., May 20, 2022  /PRNewswire/ -- Today the U.S. Food and Drug Administration (FDA) granted the Flexible Vinyl Alliance's (FVA) petition to abandon the use of 25 ortho-phthalate substances. These substances are no longer used in the manufacture of food packaging and other food-contact applications in the U.S. FDA's granting of FVA's petition will update the food additive regulations to remove unnecessary listings for chemicals no longer used in these applications.

FVA is a coalition of trade organizations, materials suppliers, compounders, formulators, molders, and fabricators of polyvinyl chloride (PVC). FVA provides messaging and information on the proven safety, economy, and utility of flexible PVC, a material used in a wide range of health care, recreational, military, wire and cable, automotive, building, flooring, construction, and packaging applications. FVA is an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA). FVA submitted its petition to remove these substances from the list of food additive clearances in November of 2018.

FVA members requested that FDA remove these substances because they are "simply no longer employed in food contact or packaging applications," said Kevin Ott, FVA's Executive Director. To succeed with this petition, FVA demonstrated a long history of non-use of all 25 phthalates in food packaging by working with FVA members and other industry organizations to survey real-life use of phthalates in food packaging. The removal of these phthalates from the regulations will help to assure consumers that unnecessary chemicals are no longer used in contact with food. 

A key role of FDA's food additive regulations is to provide specific safety standards for substances used in food packaging. FDA recognizes the importance of maintaining an accurate and effective regulatory framework, and through the petition process updates its regulations to reflect the economic realities of US food packaging. Where substances are permanently abandoned for use in food packaging, i.e., they are no longer manufactured or imported for use in food-contact applications, FDA may remove those substances from the regulations in response to petitions to do so.

"We are pleased that FDA has decided to update the food additive regulations to reflect real-life uses of phthalates in food packaging," said Ott. "Beginning many years ago, industry permanently moved on to manufacturing next generation substances for food packaging that are supported by science demonstrating safety." 

In a second filing released today, FDA denied a food additive petition submitted by several NGOs requesting removal of all clearances for phthalates used in food contact applications.  After a careful review of the data provided by the NGOs in their petition, FDA determined that the petition provided an insufficient basis for changing the current clearances. FDA specifically stated in their response that they believe current dietary exposures to phthalates are safe. 

"We are pleased that FDA has relied on the most up-to-date data on these substances, including data provided by FVA members, in their evaluation of these substances," said Ott. "We will continue to ensure the safe use of these materials in accordance with FDA's food contact regulations."

SOURCE Flexible Vinyl Alliance

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