Ref: KL-615 and Food Contact Regulations

The FDA is the governing body that regulates chemicals that either indirectly or directly come in contact with food. These regulations are specified in 21 CFR.

21 CFR 178 – Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers

Of relevance is Subpart B – Substances Utilized to Control the Growth of Microorganisms. Much of this section outlines the limitations imposed on the use of the more complex and/or exotic compounds available for microbial control on surfaces that come in contact with food. These surfaces would be in primary and secondary food processing facilities.

Some of the ingredients of Keylate Solution products are listed in this CFR out of concern that excess of “maximum allowable” concentrations of some “sanitizers” may have a negative impact on food. Maximum allowable of some of Keylate Solution  ingredients are not to exceed 200 ppm. Given that the present application of Keylate Solution products do not exceed 20 ppm of specific compounds that are of concern to the FDA, this ameliorates concern that the application of Keylate Solution products around food products would either cause harm to food products or may violate FDA guidelines on the use of chemicals near or on food products.

21 CFR 184 – Direct Food Substances Affirmed as Generally Recognized as Safe

All of the ingredients of Keylate Solution products are listed in Part B of this regulation. Though there are “maximum allowable” concentrations of these GRAS compounds, Keylate Solution products achieve its effective concentration far below concentrations that may cause a concern. What is unique about Keylate Solution products is that they do not contain complex or exotic compounds. It contains simple compounds that readily break down, mimic nature in managing microbes, and its byproducts become trace metabolites for plants and animals.

In trace quantities Keylate Solution products may will have the following GRAS compounds

1191 1193 1205 1210 1230 1297
1307 1307b 1315 1375 1426 1428
1431 1443 1446 1461 1563 1619
1622 1631 1643 1742 1763 1807