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FDA Files Petition to Revoke Clearances for 26 Phthalates due to Abandonment

U.S. Capitol Building

The U.S. Food and Drug Administration (FDA) announced on November 14, 2018, that it has filed a Food Additive Petition (FAP) to amend its food additive regulations to remove the clearances for 26 ortho-phthalates due to abandonment by industry. The FAP was filed on July 3, 2018 by the Flexible Vinyl Alliance (FVA).

By way of background, on April 12, 2016, FDA accepted for consideration a separate FAP submitted by a group of nongovernment organizations (NGOs) that called on the Agency to revoke the same clearances for the 26 ortho-phthalates, in addition to four others, because they are not safe for use in food-contact applications. (See the article, FDA Files Petition to Revoke Clearances for Certain Phthalates, for more information on the NGOs’ petition.)

Four of the 30 ortho-phthalates targeted by the NGOs (diisonnyl phthalate (DINP), diisodecyl phthalate (DIDP), (di-(2-exylhexyl) phthalate (DEHP) and dicyclohexyl phthalate) are still used in food-contact applications. Industry has submitted, on a confidential basis, information to FDA regarding the current food-contact uses for those four ortho-phthalates. 

Comments on the petition to revoke the clearances for the 26 ortho-phthalates due to abandonment are due by January 14, 2019. See the November 14 Federal Register notice (83 Fed. Reg. 56750) for more information.