US FDA to de-authorize 26 phthalates

On November 14, 2018, the Department of Health and Human Services (HHS) of the U.S. Food and Drug Administration (FDA) notified of a proposed rule to amend several sections in the Code of Federal Regulations (CFR) based on the “petition, submitted by the Flexible Vinyl Alliance (FVA) [on July 3, 2018], requesting that we amend our food additive regulations to no longer provide for the use of 26 ortho-phthalates [(or substances identified as ‘ortho-phthalates’ in the petition)] in various food-contact applications because these uses have been permanently abandoned.”

In particular, the amendments are proposed for the §§175, 176, 177, and 178 of the 21 CFR “to revoke the approvals for 26 substances that the petition identifies as ortho-phthalates” because “the food additive uses have been permanently abandoned.” FDA notes that some of these 26 substances are “subject of approvals in multiple food additive regulations for different uses.” Therefore, the FDA provides a list of “the regulations that would be affected by this FAP [(food additive petition)],” identifying “the specific ortho-phthalates that the regulation authorizes,” and specifically asks for comments on whether all of the identified uses have indeed been abandoned.



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