We produce enzymes that can be used to manufacture food additives. Are the facilities in which these enzymes are manufactured/processed, packed or held subject to these regulations?

In this document, for the purposes of food facility registration, the definition of
“food” excludes food contact substances (21 CFR 1.227). If an enzyme produced by the facility
is added to food and is intended to have a technical effect in the food, the facility is required to
register. If the manufactured enzymes are used to manufacture a substance that will be a food
contact substance (or component of a food contact substance), the facility is not required to
register