Two main categories of epoxy applications in the food industry may be subject to FDA requirements established under Title 21 of the Code of Federal Regulations (CFR):

• Resinous and polymeric coatings — 21 CFR 175.300.
• Adhesives — 21 CFR 175.105

Because resinous and polymeric coatings are complex materials that are often cross-linked and may not have a single, clearly defined chemical composition, 21 CFR 175.300 identifies substances that may be used in the manufacture of resinous and polymeric coatings intended for food-contact applications. Similarly, 21 CFR 175.105 identifies substances that may be used in the manufacture of food-packaging adhesives.

Compliance depends not only on the individual components but also on the finished formulation, the intended application, the conditions of use, and all applicable extractive and migration limitations.

An epoxy system that meets the applicable requirements may be described as “used in accordance with” or “used in compliance with” Title 21 CFR 175.300 or 175.105. It should not be described as “FDA approved,” because the FDA does not generally approve specific formulated coating systems marketed by individual companies.

The manufacturer is responsible for determining whether a specific epoxy system, as a finished and fully cured product, complies with the applicable FDA requirements and conditions of use. This assessment should consider all applicable food-contact regulations and authorizations published under Title 21 of the Code of Federal Regulations.

For additional information, please consult:

• Title 21 of the Code of Federal Regulations
• FDA guidance on determining the regulatory status of food-contact materials
• U.S. Government Publishing Office

The following section lists Dura-Coat epoxy coatings intended for use in applications subject to 21 CFR 175.300 and/or 21 CFR 175.105, within the applicable conditions and limitations of use.