FDA to Consider Petition to Abandon 26 Ortho-Phthalates

ARLINGTON, Va., Nov. 14, 2018 /PRNewswire/ -- The Flexible Vinyl Alliance (FVA) has submitted a petition with the U.S. Food and Drug Administration to update its regulations by removing the clearances for 26 ortho-phthalates that are no longer used in food contact applications. Phthalates are a class of "plasticizers" used to provide vinyl products with flexibility and engineered performance attributes. The actions of the FVA specifically help FDA to remove the listings for 26 ortho-phthalates that have not been used for many years.

FDA allows petitioners to request the repeal of existing clearances that are no longer relied upon and where use in specified applications have been abandoned. FDA today published FVA's petition in the Federal Register. The public has 60 days to comment before a final decision is made by FDA.

The petition was submitted on behalf of the FVA Ortho-Phthalates Coalition, a group of companies and associations focused on the safety of materials that use phthalates. The group includes phthalate users and manufacturers of four ortho-phthalate plasticizers that are still used in limited food-contact applications such as conveyor belts, gaskets, tubing and sealing products.

"The 26 ortho-phthalates covered in the petition are simply no longer employed in food contact or packaging applications," said Kevin Ott, FVA Executive Director. "Extensive survey information from industry seen in today's Federal Register Notice supports the removal of these substances."

Concurrently, the FVA also provided exposure data to FDA on four ortho-phthalates that remain relevant in food contact applications: DIDP, DINP, DEHP and DCHP.  Exposure assessments and safety data on these four plasticizers was provided in confidence to FDA in an accompanying document.

"We encourage FDA to assess the exposure data on these four plasticizers in order to re-affirm their decades of safe use in food contact areas," said Devon Hill, Counsel to FVA. "We look forward to their decision and working with them on this issue moving forward."

The FVA is a coalition of trade organizations, materials suppliers, compounders, formulators, molders and fabricators of PVC. The 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, automotive, building, flooring, construction and packaging applications. FVA is an affiliate of SOCMA. 

SOURCE Flexible Vinyl Alliance