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Food Contact Use of Three Substances No Longer Authorized

Tuesday, January 05, 2016
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has issued a final rule amending the food additive regulations to withdraw authorization for the use of the following three perfluoroalkyl ethyl-containing food-contact substances as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods, effective Jan. 4.

- diethanolamine salts of mono- and bis (1H,1H,2H,2H 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

- pentanoic acid, 4,4-bis [(gamma-omegaperfluoro-C8-20-alkyl)thio] derivatives, compounds with diethanolamine

- 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

The FDA explains that new data are available as to the toxicity of substances structurally similar to these compounds that demonstrate there is no longer a reasonable certainty of no harm from the food-contact use of these FCSs.

Objections to this rule and requests for a hearing are due by Feb. 3.

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