In the coatings industry, there are various applications where the coating must meet regulations for safe use in contact with food. Depending on the specific application, the requirements of the Food and Drug Administration (FDA) may apply. Epoxy coatings are widely used in applications that require contact with food. The regulations regarding the required testing and the approval process for epoxy coatings in each of these areas are different. The purpose of this bulletin is:
- Provide general information about the FDA;
- List the Taurus epoxy coatings that can be used in compliance with current FDA requirements (e.g., 21 CFR 175.105 and 21 CFR 175.300).
There are two main types of epoxy applications in the food industry that may be subject to FDA regulations as outlined in the requirements of Title 21 of the Code of Federal Regulations (CFR):
- Resinous and polymeric coatings (21 CFR 175.300), and
- Adhesives (21 CFR 175.105)
Since resinous and polymeric coatings are extremely complex materials and are often cross-linked without a clearly defined chemical composition, Section 175.300 lists the materials that may be used in the manufacture of polymeric coatings intended for direct food contact applications.
Similarly, Section 175.105 lists the substances that may be used to prepare adhesives. However, formulators must keep in mind that it is the final formulated system that must comply with these FDA regulations, including final use limitations and extractive requirements.
An epoxy system that meets the requirements set forth in these regulations is said to be “used in accordance with” or “used in compliance with Title 21 of the CFR, Parts 175.300 or 175.105.” It is not referred to as “FDA approved” because the FDA does not “approve” specific formulated systems from a company. The responsibility for determining the compliance of a specific epoxy system (final cured product) lies with the manufacturer of the system. The manufacturer must consult the FDA’s food additive regulations, which are published in Title 21 of the Code of Federal Regulations.
For more information on Title 21 of the CFR, please visit:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
For information about the U.S. Government Printing Office, which publishes the CFR, call 202-512-1800 or visit:
https://www.gpo.gov/contact.htm
