By EAS Senior Consultant Thomas Dunn
A food additive is defined in Section 201(s) of the Food, Drug & Cosmetic Act (FD&C Act) as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use); if such substance is not GRAS or sanctioned prior to 1958 or otherwise excluded from the definition of food additives.
For regulatory purposes, FDA divides food additives into two main categories: direct and indirect. Indirect food additives are food additives that come into contact with food as part of packaging, holding, or processing, but are not intended to be added directly to, become a component, or have a technical effect in or on the food. Indirect food additives mentioned in Title 21 of the U.S. Code of Federal Regulations (21 CFR) used in food-contact articles, include adhesives and components of coatings (Part 175), paper and paperboard components (Part 176), polymers (Part 177), and adjuvants and production aids (Part 178). Prior to 1997, all food additives, direct and indirect, were subject to approval via a petition process.
Section 409 of the FD&C Act defines a Food Contact Substance (FCS) as any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food. Examples of food contact substances include polymers (plastic packaging materials), pigments and antioxidants used in polymers, can coatings, adhesives, materials used during the manufacture of paper and paperboard, slimicides and biocides (antimicrobial agents), and sealants for lids and caps.
In 1997, the Food and Drug Administration Modernization Act (FDAMA) amended Section 409 of the FD&C Act establishing a “Food Contact Notification” (FCN) process that allows for alternative review of FCSs. The FCN process, administered by the Center for Food Safety and Nutrition (CFSAN), differs from the older food additive petition process in many ways. Most significant is the new program’s scientific approach to managing risk. With no sacrifice to public visibility or information access, the FDA has established specific process guidelines proactively detailing objective data requirements for manufacturing, chemistry, toxicology, and environmental aspects of the production and use of the proposed FCS that applicants must provide. When the applicant has provided FDA with all of the necessary data (the data requirements are described in guidelines published by FDA and are available on FDA’s website), the agency has a 120-day review period to evaluate the safety of the food contact substance as proposed. If there are no identified concerns, the FCN automatically becomes effective on the 120th day. Unlike approved food additive petitions where a regulation is entered into title 21 CFR, the FCN is then added to an Inventory of Effective Premarket Notifications for Food Contact Substances that is posted on CFSAN’s web page.
It is important to note that a food contact notification (FCN) is only effective for the manufacturer or supplier identified in the notification. Anyone who markets a food contact substance (FCS) based on an effective notification must be able to demonstrate that the notification is effective for their food contact substance. All persons who purchase a food contact substance manufactured or supplied by a manufacturer or supplier identified in an effective notification may rely on that notification to legally market or use the food contact substance for the use that is the subject of the notification, consistent with any limitations in the notification
FDA suggests that an FCN applicant discuss the proposal with agency scientists early in the application process. This allows the applicant and agency scientists to discuss the critical data requirements, test protocols, and validation procedures before either dedicates resources to activities potentially inadequate to support FDA’s assessment of public health risk posed by the FCS. Months of chemical and toxicological testing may well precede the 120 day FDA review.
In more than 14 years of existence, the FCN program has processed and listed almost 1,300 substances. The listing includes the FCS, the supplier’s name, the manufacturer of the FCS, the intended use, the limitations on the conditions of use for the FCS and its specifications, the effective date, and FDAs environmental decision. Successful completion of all the data requirements for complete submission involves a thorough understanding of FDA’s administrative process and the data needs of the agency’s scientific risk assessment.
EAS Consulting Group can assist you in preparing and submitting FCNs to FDA. EAS has a large group of professionals on its staff with years of previous experience working for FDA and other government agencies and industries. Please feel free to contact us to discuss your needs and our services.