Date: Jan 01, 2004
Your product is shipped to the paper mill, a few hours later your telephone rings and it's the regulatory manager from the mill. He asks: "Thanks for the shipment. We have one question, however. We have been asked by one of our customers if the paper we are providing complies with FDA's food additive regulations. We can't separate our paper into food and non food-contact use for each customer, so what I need to know from you is whether your product can be used in food-contact applications."
There is a brief pause; your thoughts are many: "They're using the paper in contact with food?" "Does our product comply with FDA regulations?" "With which food additive regulation must our product comply?"
Before you can respond to your own questions, your customer asks you the bottom line: "Does your product comply with Section 176.170?" Your only response, for now, "I'll call you right back."
The 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (the Act), provided the U.S. Food and Drug Administration (FDA) with authority over all substances used in food packaging that are classified as "food additives." A "food additive" is defined in Section 201(s) of the Act as a substance that is reasonably expected to become a component of food under the intended conditions of use. Under the Act, a substance that meets the Act's "food additive" definition will be considered "unsafe" and deemed adulterated, unless it is used in accordance with an applicable FDA food additive regulation or an effective food-contact notification (FCN).1 Since the 1958 Food Additives Amendment, substances used in all types of food packaging materials that are reasonably expected to migrate into food, e.g., adhesives, coatings, plastic bottles and films, and paper and paperboard, are subject to FDA pre-clearance authorization. The purpose of this article is to provide an overview of FDA's food additive regulations regarding components that may be used in paper and paperboard in contact with food.
FDA's regulation of paper and paperboard can be found at 21 Code of Federal Regulations (C.F.R.) Part 176, titled "Indirect Food Additives: Paper and Paperboard Components." This Part lists substances that may be used in paper and paperboard in contact with different types of food having various functions in the papermaking process.
Section 176.170, the specific regulation cited by most people in the paper industry as their criteria for compliance, identifies those substances that are regulated for use as components of the uncoated or coated surface of paper and paperboard intended for use in packaging aqueous and fatty foods. Section 176.180 identifies those substances that are regulated for use as components of the uncoated or coated surface of paper and paperboard intended for use in packaging dry foods. However, these are not the only regulations that clear substances for use in paper or paper coatings. In fact, any substance listed in Part 176 is permitted to be used in paperboard production. By way of example, Sections 176.200 and 176.210 regulate defoaming agents used in paper production. Specifically, Section 176.200 lists those substances which may be used for defoamers for coatings, while Section 176.210 lists substances that may be used in the wet-end manufacture of paper.
It is important to remember that, although other substances listed outside of Sections 176.170 and 176.180 may be used in contact with fatty, aqueous, or dry foods, and can be said to be in compliance with Sections 176.170 and 176.180, such substances can only be said to comply with Sections 176.170 and 176.180, provided that the underlying clearances do not restrict the use of the substance in the application of interest. For example, defoamers listed under Section 176.210 are not permitted for use in paper coatings, and paper made with such a coating would not be in compliance with the regulations, unless the substance is also listed under Section 176.200. This is because wet-end defoamers are not expected to be present in the finished paper product at significant levels, and if the defoamer is used in paper coatings, migration may be much higher; such levels may not have been contemplated by FDA when the defoamer was initially cleared for wet-end use under Section 176.200. However, it may be possible to use a Section 176.210 defoamer in paper coatings if one can establish that the defoamer is not a "food additive" when used as intended. This type of evaluation is based on the demonstrated or calculated migration of the substance to food, the resulting dietary exposure to the substance, and its toxicity. For this reason, such evaluations must be conducted on a case-by-case basis.
On the other hand, a substance cleared for use as a defoamer in coatings under Section 176.200 may generally be used in the wet-end manufacture of paper, even though it is not specifically listed under Section 176.210. This can be said because, generally, the use of a Section 176.200 defoamer in the wet-end of the manufacturing process is not expected to be present in the finished paper product at significant levels, and, therefore, will typically be found not to migrate to food when made the subject of extraction studies utilizing a methodology of suitable analytical sensitivity. If migration is not detected at the appropriate analytical sensitivity, such defoamer is not reasonably expected to become a component of food under the intended conditions of use and, thus, is not a food additive and may be used without any further clearance or approval by FDA. Such evaluations, however, must be conducted on a case-by-case basis.
It is also important to recognize that the substances listed in Part 176 are not the only substances that can be used in paper and paperboard. Notably, Section 181.30 and Section 182.90 list substances that are prior sanctioned and generally recognized as safe (GRAS), respectively, for use in paper.2
In addition, Sections 176.170 and 176.180, as well as other food additive regulations in Part 176, permit by reference the use of substances that are the subject of other food additive regulations. Such cross-referencing is typically to substances cleared in stand-alone regulations (e.g., polyolefins under Section 177.1520 and acrylics under Section 177.1010), provided the substance conforms with any specifications and limitations set forth in the regulation being used as the basis for the cross-reference.
The basis for using substances listed in other regulations is found in paragraph (a)(4) of Section 176.170, which permits the use of substances "that by regulation in parts 170 through 189 'may be safely used' as components of the uncoated or coated food-contact surface of paper and paperboard in contact with aqueous or fatty food, subject to the provisions of such regulation." A similar cross-reference provision exists in Section 176.180(b)(1), which explicitly permits the use of any substance listed in Section 176.170, provided it is used within the limitations and specifications of its clearance in Section 176.170.
It is important to note, however, that this language does not permit any substance listed in any other regulation to be used under Part 176; it only allows those that are not limited by terms of the underlying regulation to be used. For example, substances cleared for use under Section 177.1210, "Closures with Sealing Gaskets," are not on that basis permitted for use under Section 176.170 because the former by its terms only clears the listed substances for use in closures, and paper and paperboard are not closures.
Even if a substance may be said to be cleared under Part 176, the material, like all substances used in food-contact applications, must be of a purity suitable for its intended use. This requirement flows from Section 402 of the Act, which states that a food is adulterated if it contains an added substance that may render the food injurious to health or otherwise causes the food to be unfit for consumption.
This statutory standard is implemented as a good manufacturing practice (GMP) requirement under Section 174.5 ("General provisions applicable to indirect food additives"), which states that "[a]ny substance used as a component of articles that contact food shall be of a purity suitable for its intended use." The regulation restates a well-established FDA requirement that any material that is not of suitable purity is unacceptable for use in contact with food, even if the material otherwise has a suitable regulatory status.
Suitable purity in this instance pertains to both ensuring that the product does not render food deleterious or injurious to health, or impart an off-taste or odor to food. A good example of this is a polymer emulsion that is made with a solvent. Suitable purity requires assurance that the solvent is sufficiently removed from the finished article such that it does not, for example, result in an off-taste to the food.
Thus, an explicit listing in a Part 176 regulation, the existence of a prior sanction, or determination that a compound is GRAS, does not satisfy all of the requirements under the Act. To comply fully with the Act, the substance must be of a suitable purity for its intended use.
Well, it's time to call the plant manager back at the paper mill, but this time, hopefully with more answers than questions.
2 Under the Act, statutory exemptions are provided for substances that are GRAS or are the subject of a sanction or approval issued prior to the enactment of the Food Additives Amendment of 1958. GRAS substances are those which have been found by experts in the scientific community to be safe for an intended use based on scientific studies or a long history of safe use in food. So-called prior sanctioned substances are those substances which FDA or the U.S. Department of Agriculture sanctioned for use in or with food prior to enactment of the Food Additives Amendment in 1958.