Is a Substance Cleared in Section 175.300 Permitted for use in Adhesives Complying with Section 175.105?

October 16, 2012

If a substance is listed for food contact application in 21 CFR 175.300 and not listed in 175.105, may it still be used in adhesives by reference to 175.105(c)(5)?


Generally speaking, yes. Coatings made from substances listed in Title 21 of the Code of Federal Regulations (C.F.R.) Section 175.300 may usually be used in adhesive applications under Section 175.105. Coatings cleared under 175.300 are permitted for use directly in contact with food, while coatings (adhesives) that are cleared under 175.105 are required to be separated from food by a functional barrier. Specifically, manufacturers of finished food packaging must ensure that adhesives are either: 1) separated from food by a functional barrier, or 2) the quantity of adhesive contacting packaged dry food does not exceed the limits of good manufacturing practices (GMP) and the quantity of adhesive contacting aqueous and fatty foods does not exceed trace amounts at the seams and edges of packaging laminates that may occur within the limits of GMP. Consequently, a coating cleared under 175.300 may be used in an adhesive under 175.105 since it is already cleared for direct use with food.

For more information, see the article, FDA Regulation of Adhesives in Food Packaging.