FDA: Regulations to Ensure Safety of the Food Supply Congress, in 1958 enacted the Food Additives Amendment to the Federal Food, Drug and Cosmetic Act (FFDCA). This action gave the U. S. Food and Drug Administration (FDA) authority to ensure the safety of food by regulating food additives that may be either directly or indirectly added to food.
The FDA publishes lists of allowed food contact substances in the Code of Federal Regulations (CFR) Section 21, Parts 170-199 including some generally recognized as safe (GRAS) substances. In 1997, the (FFDCA) was amended (FDAMA) to permit the submission of data supported food contact notifications (FCN) for new substances. Notably, the FDA has 120 days to issue a written objection, or the proprietary submitter and its customers may begin marketing.
Within the FFDCA, a food additive is defined as “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in becoming a component of, or otherwise affecting the characteristics of any food including any substance intended for use in packing, packaging or holding food.”
1. Two Types of Food Additives
FDA recognizes direct and indirect food additives. Direct food additives are substances that are intended to be consumed as ingredients of foods. Indirect additives are substances used in the processing, packaging, holding and transporting of food, and as such may be reasonably expected to become a component of food. Under this definition printing inks and coatings, as potential indirect food additives, are subject to FDA regulation..
2. Three Types of Food Contact
Three types of food contact are categorized by the FDA. Substances that directly contact food are direct contact substances. Substances that might come into contact with food, perhaps on the outside of a carton, bag or pouch are indirect contact substances. Incidental contact substances are those where contact is not intended nor is it continuous, such as involving food processing equipment. Food packaging printing inks and coatings may be indirect food additives as they could have direct, indirect or incidental contact with food.
3. Barrier Coatings Stop Migration
FFDCA recognizes that a functional barrier can prevent a substance from migrating into and becoming a component of food. Under 21 CFR 170.3(e) “If there is no migration of a packaging component from the package to the food, it does not become a component of the food and thus is not a food additive.” Under these criteria the substance is not subject to regulation, however, packaging end-users are responsible for extraction testing to assure compliance.
4. Regulation Occurs when Substance becomes a Component of Food
When an ink, coating or other substance may be reasonably expected to become a component of food, FDA regulates it, and clearances must be obtained per indirect food additive regulations. These are listed as:
- Substances permitted by regulation in 21 CFR Parts 175, 176, 177, and 178.
- GRAS substances determined suitable by FDA and published or listed in 21 CFR Parts 182, 184, and 186.
- GRAS substances determined by qualified experts without FDA approval and submitted thru the FCN process.
- Substances permitted thru an effective Food Contact Notification (FCN)
- Substances that were approved for use before the FFDCA in 1958 by letter from the FDA or USDA.
A number of regulations are applicable directly to inks and coatings. 21 CFR Part 175, Indirect Food Additives: Adhesives and Components of Coatings.
- 175.105: Adhesives for use as components of articles intended for use in packaging, transporting or holding food.
- 175.125: Pressure-sensitive adhesives for use as the food contact surface of labels and/or tapes applied to food.
- 175.300: Resinous and polymeric coatings intended as the food contact surface of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting or holding food.
- 175.320: Resinous and polymeric coatings for polyolefin films listing substances that may be used as continuous coatings over polyolefin films otherwise listed in the CFR.
21 CFR Part 176, Indirect Food Additives: Paper and Paperboard Components.
- 176.170: Components of Paper and Paperboard in Contact with Aqueous and Fatty Foods.
- 176.180: Components of Paper and Paperboard in Contact with Dry Food.
5. FDA Compliance Steps
Several defining steps can be taken by ink and coating manufacturers to determine FDA status. Determine when an acceptable functional barrier is present, so that a packaging component substance is not subject to FDA regulation. In the case where there is food contact, or the potential for food contact, all components of the substance, (formulated product) must be reviewed to establish that they are permitted under the specified use conditions pertinent to the food type, and the substrate.
The regulations provide detailed information divided into five categories defining compliance.
- Allowed applications
- List of raw materials that can be used
- A definition of food type
- The extraction test permitted
- The maximum extractables and the analytical methods allowed
6. Check for Proper FDA Compliance Wording
The proper way to indicate that a product is satisfactory from an FDA regulatory view is for the formulator-supplier to state that it conforms with, or is in compliance not approved but compliant, with FDA requirements. Some do not realize that the FDA does not “approve” food-contact materials and it is up to the formulator–supplier to make that determination.
For example, Corks’ aqueous coating CK-83LS-1 is in compliance with 176.170 and 176.180, allowing its use both in direct contact with aqueous and fatty foods as well as dry foods. The USDA also follows these guidelines considering the packaging of fish, meat, poultry and dairy products.
7. Check with the Experts at Cork Industries
Ensure success for your next project and stay in compliance with the best in Direct and Indirect Food Contact Coatings. Expert help is just a click or call away.