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Citizen Petition Requests FDA Ban Certain Phthalates; Revoke Clearances for Others

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The Environmental Defense Fund, nine other nongovernmental organizations, and an independent consultant submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA) on April 19, 2016, requesting that the Agency remove the prior sanction of five ortho-phthalates and ban eight other ortho-phthalates.

 The five ortho-phthalates (butylphthalyl butyl glycolate, diethyl phthalate, ethylphthalyl ethyl glycolate, di-(2-ethylhexyl) phthalate (use on foods of high water content only), and diisooctyl phthalate (use on foods of high water content only)) are currently allowed as prior-sanctioned substances under Title 21 of the Code of Federal Regulations (C.F.R.) Section 181.27. With respect to the eight ortho-phthalates (diisobutyl phthalate, di-n-butyl phthalate, butyl benzyl phthalate, dicyclohexyl phthalate, di-n-hexyl phthalate, diisooctyl phthalate, di(2-ethylhexyl) phthalate, and diisononyl phthalate), the petitioners requested that FDA add a new section to Title 21 C.F.R. Part 189 prohibiting their use.

 The NGOs originally filed a Food Additive Petition with these requests, in addition to requesting that FDA revoke the regulatory clearances for 30 other ortho-phthalates when used as components of food-contact articles. The Agency filed a petition with respect to the 30 ortho-phthalates (see the article, FDA Files Petition to Revoke Clearances for Certain Phthalates), but did not accept for consideration the request to remove the prior sanction of five ortho-phthalates and ban the eight ortho-phthalates discussed above, noting that they did not fall within the scope of a food additive petition.