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FDA Files Petitions to Ban Several Substances in Food-Contact Materials

The U.S. Food and Drug Administration (FDA) announced through two Federal Register notices published on Monday, March 16, 2015, that it has filed two Food Additive Petitions submitted by the Natural Resources Defense Council and eight other organizations requesting that the agency take action on the use of perchlorates and substances containing perfluoroalkyl ethyl in certain food-contact applications.

One petition proposes that FDA amend Title 21 Code of Federal Regulations (C.F.R.) Part 176.170 to remove existing clearances for the use of three perfluoroalkyl ethyl containing food-contact substances as oil and water repellants for paper and paperboard intended to contact aqueous and fatty foods. The three substances are:

  1. Diethanolamine salts of mono- and bis (1 H, 1 H, 2 H, 2 H perfluoroalkyl) phosphates where the alkyl group is even-numbered in the range C8-C18 and the salts have a fluorine content of 52.4 percent to 54.4 percent as determined on a solids basis;
  2. Pentanoic acid, 4,4-bis [(gamma-omega-perfluoro-C8-20-alkyl)thio] derivatives, compounds with diethanolamine (CAS Reg. No. 71608-61-2); and
  3. Perfluoroalkyl substituted phosphate ester acids, ammonium salts formed by the reaction of 2,2-bis[([gamma], [omega]-perfluoro C4-20 alkylthio) methyl]-1,3-propanediol, polyphosphoric acid and ammonium hydroxide. (See 80 Fed. Reg. 13508 (3/16/15).)

The other petition requests that FDA:

  1. Remove potassium perchlorate as a permitted additive in sealing gaskets for food containers in 21 C.F.R. Part 177.1210;
  2. Revoke the 2005 "Threshold of Regulation" (TOR) exemption No. 2005-006, which permits the use of sodium perchlorate monohydrate as a conductivity enhancer in the manufacture of antistatic agents in dry food packaging; and
  3. Promulgate a new regulation under 21 C.F.R. Part 189, Subpart D to prohibit the use of perchlorate in antistatic agents for use in food-contact articles. (See 80 Fed. Reg. 13508 (3/16/15).)

Comments on these proposals are due by May 15, 2015.