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Posted on July 27, 2022 by Marc Hirsch
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With one of my past companies, food contact was an issue with several of the polymers and additives we manufactured since the application was adhesives. I have also had the occasion to work with coatings materials that also come in contact with food. One thing that has occurred over the past is the refinement of regulations due to better testing and understanding of the materials used. It is too much to cover here but a separate article could be written on food preparation, sanitization, etc. Although not universally well-known, the topic of Food and Drug Administration (FDA) regulations regarding indirect and direct food contact, is extremely important. With UV and EB more widely used, it seems apropos to discuss the fundamentals for coatings and adhesives at this time.
The U.S. enacted the Food Additives Amendment to the Federal Food, Drug and Cosmetic Act (FFDCA) in 1958. This act gave the U. S. Food and Drug Administration (FDA) power 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 permitted food contact substances in the Code of Federal Regulations (CFR) Section 21, Parts 170-199 including some generally recognized as safe (GRAS) substances. The (FFDCA) was amended in 1997 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.”
There are two types of food additives. The FDA recognizes direct and indirect food additives. 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. Direct food additives are substances that are intended to be consumed as ingredients in foods. A manufacturer of an adhesive formulation, therefore, may use any substance listed under Section 175.105 (c) in its adhesive formulation subject to any limitations on the use of that substance provided in the regulation. What makes Section 175.105 somewhat unique is that it also places physical limitations on how the manufacturer of finished food packaging may use adhesive formulations in the finished food contact articles.
There are three types of food contact categorized by the FDA. 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. 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. Section 175.105(a)(2), manufacturers of finished food packaging must ensure that adhesives either:
(a) Are separated from food by a functional barrier or
(b) Are used subject to the following additional limitations:
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.
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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:
A number of regulations are applicable directly to inks and coatings. 21 CFR Part 175, Indirect Food Additives: Adhesives and Components of Coatings.
As was indicated in the beginning of this article, there are a lot of intricacies of the regulations for food contact, food handling and sanitization. This article just scratches the surface of the topic. Anyone who is working with ingredients that directly or indirectly come in contact with food should consult with an expert in the area and not assume that by reading the regulations they are an expert.
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Mr. Hirsch is a Senior Development Scientist and Principal Consultant at M&M Hirsch & Associates from 2011 to present. In his career, he has formulated architectural, industrial, military and specialty coatings. He has also worked with and formulated adhesives, inks, and construction products and in general is a material science generalist.
He was a Developmental Scientist in the Advanced Materials group at Luna Labs (LunaLabs) 2004-2008, formulating military coatings and adhesives. Previously, he was at Dow Chemical (1995-2004) as the applications and development manager in Core R&D in the Coatings & Functional Polymers Group. He also managed the TS&D group for coatings while at Dow (1995-99) and held positions at Rhodia (Laboratory Manager, Latex & Specialty Polymers (1989-95)) and was the Development Chemist, exterior latex paints at Benjamin Moore & Co. (1979-89).
Mr. Hirsch is a Director with the ChemQuest group, (chemquest.com) June 2021-present, has served in a consultancy capacity at OmniTech (omnitechintl.com) (2015-2022) for soy-based adhesives and coatings, Daikin America (daikin-america.com) (2011-2015) fluoropolymers and materials, and also with organizations that provide formal mentoring (TORCH), coaching and leadership training, as well as the facilitation of problem-solving teams. He has several granted patents, many patent applications and internal disclosures for trade secrets.
