Food Packaging Regulation in the United States and the European Union
The regulation of food packaging has, indeed, become a global subject as the world's commercial channels have broadened since World War II. The first comprehensive regulatory statute governing the area was the Food Additives Amendment of 1958 in the United States, a modification of the 1938 Federal Food, Drug and Cosmetic Act. Germany, Italy, the Netherlands, and Belgium began regulatory activity in the early 1960s and the European Community set in motion its own work in this direction beginning in 1976. Companies in the U.S. and Europe have been struggling with each of the laws since then.
The regulatory systems employed on the two continents are superficially similar but this is far from the truth in actual practice. Each has its own special history and set of exemptions; they vary tremendously. Each has its cadre of supporters as well but a considerable lack of understanding afflicts regulators and the regulated on both sides of the Atlantic. This three part report first discusses the history of the United States' system and its characteristics; Book II covers the history of European Union regulations and their salient features; and Book III highlights the commonalities and differences in the systems, discusses their scientific basing points, and makes some recommendations as to how they can be brought closer together in the interests of harmonization and the removal of unnecessary trade barriers.
Food Packaging Regulation in the United States
The history of formal food packaging regulation in the United States began with the passage of the Food Additives Amendment of 1958, and while selected statutes in other countries dealt with packaging generally prior to that time, it is believed that the 1958 law set in motion all of the modern thinking on the subject.
Prior to 1958, manufacturers of packaging materials and final packages were essentially regulated by their customers in that the customers often insisted on being assured of a package's safety, as well as its utility, by asking to see something from U.S. Food and Drug Administration (FDA) or the U. S. Department of Agriculture (USDA) to indicate that there was no objection to the packaging material. Government officials like Dr. Arnold Lehman at FDA and Robert Philbeck at USDA were supplied with data on packages, reviewed the same, and gave "no objection" letters to the inquirer unless there was some problem. While the submissions were customized to fit the situation, and usually included some exposure information and toxicology, the information required was not nearly as extensive as is now the case. Even so, the FDA and USDA "no objection" letters were so highly regarded that when the Food Additives Amendment was passed in 1958, these letters came to be known as "prior sanctions" which exempted the material from the need for the filing of petitions under the new ground-rules. Moreover, the "no objection" letters were so carefully drafted that none has ever been revoked.
From 1952 to 1956, prompted by persistent reports or allegations that chemicals used in foods were causing serious diseases, including cancer, Congressman James J. Delaney (D-NY) conducted a series of hearings on the subject of food additives. These hearings occasioned intensified suspicion—not necessarily justified—that food additives might be the cause of such dread diseases as cancer. At no time during the hearings was any information presented to indicate that food-contact materials were a potential source of any public health problem, nor has anything that has occurred since served to cast doubt on the safety of such materials. Nonetheless, when Congress began to hold hearings on proposed legislation to require FDA pre-clearance of food additives in 1956, all of the proposed bills included a definition of "food additive" which encompassed materials used to produce, manufacture, pack, process, prepare, treat, transport, or hold food. It soon became recognized that even though the Delaney record had brought forth no information to implicate packaging or processing materials in the adulteration of food, they were definitely slated for regulatory treatment of the same type as would be prescribed for substances directly and intentionally added to foodstuffs.
At the time, and even though the definitions being considered incorporated food marketing areas that had never required statutorily mandated regulatory action in the past, Congressional attention was focused on the direct additives, substances intentionally added to foods. What came to be called "indirect additives," principally food packaging materials, were given little attention by the legislators during the hearings, or in the course of the legislative process. Furthermore, the Congressional Subcommittee, in framing the legislation, believed that the industries most directly affected by the new law would be the food and chemical industries so that essentially all negotiations were aimed at bringing about an accommodation between FDA, the grocery trade associations and the Manufacturing Chemists Association (now the American Chemistry Council).
A number of representatives of the packaging industries participated in the hearings to protest the notion of regulating their products under a law designed to regulate direct additives. The Society of the Plastics Industry Inc. (SPI) occasioned the introduction of a separate measure, H.R. 8112, to regulate "indirect additives" in what proved to be a vain hope that Congress might deal with food-contact substances in a less onerous way than was proposed in the Administration drafts the House Subcommittee was considering. The Society's representatives and those who testified on behalf of the Adhesives Manufacturers, the American Pulp and Paper Association and the Waxed Paper Institute, all pointed out that, in all or some aspects, regulating packaging materials and substances used to make equipment under a law designed to effect pre-marketing clearance of substances to be added directly to foods was likely to prove inappropriate and unduly burdensome for both industry and the government. For example, John Kuniholm who testified as Chairman of the SPI Food and Drug Packaging Committee stated as follows:
"Inclusion of the term "chemical additive" within the meaning of the term "food" opens a Pandora's box of unimaginable consequences because it subjects packaging components to all of the food laws. Laws written in 1938 with food in mind should not be indelicately applied to packaging components...."
The members of the Subcommittee were placated where packaging was concerned by FDA assurances that the great mass of materials used to make packages or equipment would be dealt with as they had been in the past, e.g., by the informal letter response system described above and so familiar to those who dealt with Dr. Lehman and Mr. Philbeck. During discussions with packaging industry leaders and the legislators, FDA gave assurances that it would be declaring most packaging materials components "non-additives" on the basis of migration data, and, indeed, the Agency's lead spokesman on this subject, Associate Commissioner Arthur A. Checci, later emphasized the importance of this escape hatch for the first three years of the Statute's existence and administration. About the only concessions made to packaging interests as the legislative process developed was the agreement to insert the phrase "may reasonably be expected to result" in its becoming a component of food in the food additive definition, and the last minute inclusion of a colloquy during the floor debate to make it clear that Congress did not intend to have FDA regulate the components of housewares.
The first change, though by no means a completely satisfactory way to separate packaging materials regulation from direct additives regulation, did build into the statute a definition that left packaging interests in a position to properly consider themselves exempt (or to ask FDA to declare them exempt) from the onerous requirement of filing a Food Additive Petition if they were able to conduct tests that demonstrated their materials could not reasonably be expected to become a component of foods. (At the time, the best test methodology was sensitive to about one part per million and this was the level used to determine anticipation of migration or not.)
The second "change" in the form of authoritative legislative history was embodied in the following statement made by the Honorable John Bell Williams, the Chairman of the House Subcommittee on Health and Science (the Subcommittee that conducted the legislative hearings and brought the Food Additives Amendment into being), during the floor debate on the House Bill that became the Food Additives Amendment:
"I have been asked since the Committee reported the bill what is meant by a substance "holding" food, as mentioned in the bill. An example of what is meant by this would be a plastic film or paper wrapper which surrounds a package of food. This bill is not intended, for example, to give the Food and Drug Administration authority to regulate the use of components in dinnerware or ordinary eating utensils." (Emphasis supplied.)
Despite this statement of legislative intent, and the contemporaneous recognition of FDA officials, including its General Counsel, that Congress had duly indicated FDA was not to impose the Amendment's onerous pre-market clearance requirements on housewares or dispensing machine containers, from time to time to this day some Agency personnel assert that the Agency chooses not to regulate housewares as a matter of priorities, not because it has no authority to do so. Indeed, in 1974 the Agency even went so far as to propose rulemaking to cancel the housewares exemption but the proposal was vigorously opposed as running contrary to the legislative intent and was never finalized. There is little doubt but that the exemption can be effectively asserted whenever circumstances, including any court proceedings, demand.
The Food Additives Amendment of 1958--Statutory Scheme and Early Applications to Packaging Materials
The passage of the Food Additives Amendment in 1958 resulted in a new Section 201(s) of the Federal Food, Drug and Cosmetic Act of 1938 to define the term "food additive," an amendment of Section 402 of the Act to constitute the use of an uncleared food additive an act of per se food adulteration, and the inclusion of a new Section 409 of the Act to set forth the requirements and criteria for the clearance of food additives by what was then and still is a rather unique process, i.e., the filing of petitions resulting in the promulgation of regulations of general application. This Petition-Regulation concept was first used when the Miller Pesticides Amendment of 1954 was enacted but it had never been used before 1954, nor has it been advanced by FDA or anyone else as a preferred regulatory device again since passage of the Color Additives Amendment of 1960. The underlying motivation of those who advocated this approach was a belief that it would reduce the burden on the Agency if it handled all food additives, including packaging materials, as commodities, and issued rules that would let anyone manufacture or employ a cleared material for the uses that were specified in a regulation. In principle this may have sounded like an attractive idea but it was a radical departure from the way in which FDA had handled its major pre-market clearance responsibilities from 1938 to 1954; thus, the Agency had no real experience in regulating combinations of substances in the way it set out to do this with polymers, coatings, and other formulations of food-contact substances after 1958.
Soon after the 1958 law was passed, the Agency began to consult with manufacturers of both direct and indirect additives, participated in a number of public sessions to try to increase understanding about the new law, and, presumably, to seek input for the procedural regulations required. A major gathering of the time was the first Food and Drug Administration-Food Law Institute conference held on November 24 and 25, 1958. The first set of FDA proposed procedural regulations to govern the administration of the food additives law was then published on December 9, 1958, and the rules were finalized on March 28, 1959. At the time it was generally understood that FDA would consider data derived from extraction studies and would concur in "non-additive" status where such data indicated that there would be no detectable extraction with analytical methodology generally sensitive to a part or two per million.
Post 1960 FDA Policy on Food-Contact Substances—"No Giveaways" and the Beginnings of Reaction
In 1961, the FDA staffers who succeeded Arthur Checchi announced a change in administrative policy that shocked the packaging world and brought with it a morass of confusion and complication. The change was first announced at a Food and Drug Law Institute meeting in 1961 by then Associate Commissioner J. Kenneth Kirk who later summarized it in this way:
"The situation has not changed since last year's meeting. At that time, we discussed the very situation where we had been receiving reports of extraction studies which did not show any migration to the food. We wrote letters stating that we agreed that these items were not food additives. After many of these had issued, we found they were being used as sales promotion pieces, often to the detriment of other firms who had the same items, and had properly made up their minds without consulting us that the Food Additives Amendment did not involve their items. As a result, we concluded that we could no longer issue that kind of letter. Additionally, there were instances where small amounts of migratory substances were, in our opinion, properly classed as food additives. As a result of our reconsideration of the situation, we stated that we would, if requested, review data submitted to us and if this represented the right kind of work, I say right, as recommended by Mr. Ramsey's article, for example, and showed no migration, we would issue a letter which, unfortunately, would not be a letter suitable for advertising. Essentially, the letter would say: "You made your mind up. You have a perfect right to do so and even though you didn't give us any reason to say that you're wrong, we still have no facts of our own on which to agree. The other alternative is that if you want a "letter," the way to get it is to submit a petition for a Food Additive Regulation. If we can find that the product and the use involved are safe, then we can issue a regulation which will be there for all to see and will apply to everyone who has the same product for the same use."
Mr. Kirk's pronouncement amounted to a policy shift with tremendously burdensome implications for food-contact materials suppliers and their customers. The statement ignored the fact that FDA had promised to continue providing "no objection" letters on the basis of migration data during and after the legislative proceedings, that it's own procedural regulations in what was then 21 C.F.R. 121.3(d) specifically stated that the Agency would respond to inquiries by ruling on whether a substance was a food additive, and indicated that Section 121.3(d) notwithstanding, it would no longer rule on substance status unless petitions were filed. Mr. Kirk's bemoaning of the use of letters from the Agency as sales tools, and the beginning of FDA staffers' scornful reference to such letters as "give-away" letters, was especially upsetting to the regulated community since it was generally understood then, as now, that, where packaging materials are concerned, the issue is not safety, it is customer assurance.
While much of the packaging materials community was still smarting over the Kirk pronouncement, the industry's legal advisors were given an aftershock by then Deputy FDA Commissioner John L. Harvey whose remarks for the record at Rutgers University on January 18, 1962 read:
"We came to the conclusion that we had opened Pandora's box and had better find a way to close it before the situation got completely out of hand. We therefore re-evaluated our position after consultation with our legal counsel and came to the conclusion that basically, if there was enough reason to run extraction studies on packaging or equipment materials, why shouldn't it be concluded that it would be reasonable to expect that the substances involved would, in fact, become a part of the food? Since the law refers to "reasonably to be expected" we then began to advise those who asked that we were not in a position to give them a letter which would absolve their product from any responsibility under the Food Additives Amendment but instead suggested that they file petitions. That is the present status of [this] item."
The earliest public emanations of serious displeasure with the new FDA posture came at an American Chemical Society meeting in New York on September 14, 1966. At this meeting two of the papers were severely critical of the FDA's handling of "indirect additives" generally and of its policy on dealing with "no migration" cases specifically. Dr. John P. Frawley, a former FDA toxicologist, spiced his criticism with an interesting proposed remedy for the situation. His suggestion was that the Agency should exempt from regulation any substance used at less than 0.2% in an indirect additive application unless the substance was a known carcinogen, a pesticide characterized as an economic poison, or a substance proven to be toxic at a level of 40 ppm or less. At this same symposium, Jerome H. Heckman presented his paper entitled The Packaging Industries and the Food Additives Amendment of 1958—It's Time for a Change in the Law. In this paper there was a detailed critique of FDA's system for handling indirect additives and a recommendation that the 1958 law be amended to do away with the Petition-Regulation system in favor of one that would deal with food-contact substances on a case-by-case basis.
Thereafter movements got underway to seek the appointment of a Government Industry Advisory Committee under Executive Order 11,007 to consider the matter of the Agency's procedures regarding indirect food additive petitions. At about the same time, in a letter to The Society of the Plastics Industry, Inc. (February 9, 1967), then Commissioner James L. Goddard indicated that he wanted to "assure [industry] that we are most anxious to do everything possible to simplify this procedure." When there was no real action to appoint the Committee and no concrete follow up to the Goddard promise, during an August, 1967 hearing of the House Select Small Business Subcommittee on Regulatory Agencies, chaired by Congressman John D. Dingell (D-Mich), Dr. Goddard was asked a series of questions about FDA's regulation of indirect additives and its interpretation of the part of the Food Additives Amendment relating to the question of when a substance is an indirect additive and when it is a "non-additive." The Commissioner requested permission to respond to these questions in writing within thirty days.
The promised response was never made. Instead, FDA called a National Conference on Indirect Additives and used the calling of the conference as a means of assuring Congressman Dingell that he would receive a response later, presumably after the Conference was held. Prior to the holding of the National Conference, a special committee of the National Academy of Sciences reviewed the Frawley ACS paper and produced a monograph entitled Guidelines for Estimating Toxicologically Insignificant Levels of Chemicals in Food. This printed report recommended that FDA and other agencies recognize the fact that any substance which constituted less than 0.1 ppm in the diet, other than a known carcinogen, a pesticide, or a heavy metal, presents no public health problem. On February 13 and 14, 1968, after an opening address by Commissioner Goddard, the National Conference on Indirect Additives was held to discuss all issues bearing on the perceived procedural and other deficiencies in the FDA's Administration of the Law. It was soon after this meeting that Dr. Lessel L. Ramsey, Associate Director for Regulatory Programs in FDA's Office of Compliance, first advanced what came to be known as the "Ramsey Proposal" by advising that the Agency had under consideration (1) a proposal which would exempt from the requirement for the filing of a food additive petition all substances used in minor amounts in adhesives, paper packaging for dry food, and all substances used in repeated use applications, and (2) an amendment of what was 21 C.F.R. '121.500 of the food additive regulations to also exempt any substance the migration of which into the FDA prescribed food-simulating solvents would not exceed 50 parts per billion. (It is of passing interest to note here that the Ramsey proposal and "safe amount" was one-half of what the National Academy of Sciences said was safe.) In consonance with the seminal Frawley paper and the National Academy of Sciences recommendations, Dr. Ramsey duly noted that the new exemption rules, if adopted, would not apply to substances that were heavy metals, known carcinogens, or had been shown to be toxic at 40 ppm or less.
A year and a half later, at a meeting with Dr. Ramsey on June 3, 1971, representatives of a packaging group were informed that the Agency could see no way to go forward with his proposal even though it continued to believe it was scientifically sound. It was not clear then, nor has it ever been made clear, as to why the proposal could not be turned into a rule or set of rules except for some vague rumblings about political problems.
While the Ramsey Proposal fell short as far as its enshrinement into rulemaking was concerned, the principles it enunciated were considered sound by a consensus of the regulated community and most FDA staff members. As a result it became the core of what might be called the industry antidote for FDA's intransigence on the subject of concurring in non-additive status. From the early 1970s to this time, permutations of the Ramsey Proposal have formed the basis for many company decisions to escape FDA's Food Additive Petition clearance process by making the kind of self-determinations that no petition is required by the law in situations where there is no reasonable expectation of migration, i.e., when there is no detectable migration with a test method of suitable sensitivity, usually 50 parts per billion (ppb), as the Ramsey Proposal dictated. Moreover, and perhaps more important, it was the Ramsey Proposal and the later decision in Monsanto vs. Kennedy, cited infra, that has made these self-determinations generally accepted in the marketplace. While FDA was seldom asked to provide evidence of its acquiescence in this sort of self-determination, it was clearly aware of the sort of letters and the premises used to reach the conclusions in them and never took any adverse action to oppose or declaim such self-determinations. It might sensibly be inferred that FDA tacitly approved of this type of self-determination and preferred it to having to review data and provide "give away" letters of the type given quite routinely prior to 1960. It should also be noted that the same principle may continue to be employed by those who choose not to file notifications under the relatively new Food and Drug Administration Modernization and Accountability Act of 1997 (FDAMA).
The Legal Requirements for the Marketing of Food Contact Substances
Knowing how to determine food contact component status under the law, and being able to choose the correct course of action that will enable one to obtain or give satisfactory assurance that an "indirect additive" is suitable for its intended use is the daily task of many company chemists, toxicologists and lawyers. Theirs is often the job of determining what regulatory and technical principles are to be applied so that they can deal in a very practical way with the complexities of the Food Additives Amendment of 1958 in marketplace settings. In considering what follows there are two all pervasive concepts that are crucial. First, of course, is the need to understand that the rules and exemptions that can be used to avoid unnecessarily burdensome regulatory complications, and that are described here, may be applied only where there is no safety or public health question about the use of a component or formulation. If a substance actually presents a public health threat, the only principle that applies is that it should not be sold or used; if FDA is required to move in such a situation—something that has not yet occurred in the packaging world—the courts will uphold any action it takes to prevent the adulteration of food. Second, there is no way to overemphasize the fact that the actual intended conditions of use with respect to a food-contact substance will always be of critical importance to a determination of its legal status. More costly mistakes have been made by ignoring this principle than any other. For example, blindly thinking in terms of clearing a substance in a conventionally broad way, as if it will be in direct contact with all types of foods, when it will only be used in an outer layer of a package where the other layers may be functional barriers, or in limited food applications (e.g., dry food only) can result in very wasteful expenditures of time, money, and energy.
Definition of a Food Additive
Since passage of the Food Additives Amendment, Section 201(s) of the Act has defined the term food additive as embracing:
"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 characteristics of any food (including any substance intended for use in . . . packing . . . packaging . . . or holding food . . .)."
The definition specifically excludes substances that are (1) not reasonably expected to become a "component" of food; (2) generally recognized as safe (GRAS) among experts qualified by scientific training and experience to evaluate their safety; or (3) "prior sanctioned."
Thus, once more, under the Act, the term "food additive" includes not only substances directly added to food, but also substances, such as some packaging materials, that contact and are reasonably expected to migrate into food, unless those substances are GRAS or prior-sanctioned. If a substance that is reasonably expected to become a component of food is not GRAS or prior-sanctioned, the statute now provides that its use for food-contact applications must be authorized by an effective notification filed in accordance with Section 409(h)(1) and allowed to become effective, a food additive regulation issued by FDA in response to a food additive petition, or a Threshold of Regulation exemption granted under Sections 174.6 and 170.39, 21 C.F.R. 174.6 and 170.39 of the Food Additive Regulations. As will be discussed below, however, "no migration," and the GRAS and prior sanction escape clauses are not the only saviors that make filing a pre-market notification, a food additive petition, or seeking a Threshold of Regulation exemption unnecessary. This is because no regulation, threshold exemption or notification is required for housewares, substances covered by the mixture doctrine, packaging materials separated from food by a functional barrier, or processing aids used to make a duly regulated polymer.
No Migration Determinations
"No-migration" is the most significant escape clause, for it provides the most used premise for making a self-determination that a food packaging material need not be subjected to any of FDA's clearance or exemption processes. Even as things stand today, no-migration is a potent and durable regulatory principle with a long history within the FDA folklore that is as much a part of the law as the codified principles.
Based on this exclusion, manufacturers are free to market food packaging materials without prior FDA review when there is a sound basis for concluding that any food-contact substance not otherwise excluded or regulated is not a food additive because it is not reasonably expected to become a component of food under the conditions of its intended use. A solid basis for adopting a "no migration – no food additive" position exists when properly designed and conducted extraction studies show no migration to food. This same conclusion can be derived in proper cases by applying diffusion calculations, or assuming that all of a substance will migrate if the calculations show that any remotely possible migration would be so negligible as to assure that any dietary intake would be inconsequential.
A key question has been what constitutes no migration, i.e., must there literally be no migration or is an insignificant amount of migration permissible? This question received considerable attention in the case of Monsanto v. Kennedy.
The Monsanto case arose from FDA's 1977 decision to ban the use of acrylonitrile/styrene (AN/S) copolymer in the fabrication of beverage containers on the basis that the substance was an unsafe food additive. At issue was whether any unreacted AN monomer was reasonably expected to become a component of food. The evidence at the hearing clearly established that no AN monomer could be detected in test solvents designed to simulate food. The sensitivity of the analytical method was a state-of-the-art 10 parts per billion (ppb). Nonetheless, the Commissioner ruled that AN/S used in beverage containers was a food additive under Section 201(s) of the FD&C Act based on the theoretical conclusion that some unpolymerized AN monomer will always migrate from the walls of a container into the beverage. Citing a lack of data demonstrating the safety of AN/S, the Commissioner determined that the Agency would not authorize its use in the manufacture of beverage containers. Monsanto and several other manufacturers filed petitions for review of the Agency's action, noting in particular the theoretical and de minimis nature of the AN migration projected by FDA.
The U.S. Court of Appeals for the District of Columbia Circuit held that migration occurs within the meaning of the FD&C Act only if a substance's "presence in food can be predicted on the basis of a meaningful projection from reliable data." The court rejected FDA's contention that mere contact between food and its container made the container a food additive. Instead, the court stated that:
"Congress did not intend that the component requirement of a "food additive" would be satisfied by . . . a mere finding of any contact whatever with food. . . . For the component element of the definition to be satisfied, Congress must have intended the Commissioner to determine with a fair degree of confidence that a substance migrates into food in more than insignificant amounts."29
The court thus held that FDA has the discretion to determine that substances that migrate to food in very small amounts are not food additives. Since 1979 FDA has cited Monsanto as support for decisions that go so far as to permit putative carcinogenic substances to remain on the market where the substances have been found to represent insignificant risks to health.30
It is also important to note here that when it asserts that a substance is a food additive, FDA has the burden of proving there is a reasonable expectation of migration that will be more than insignificant. This was aptly explained in a 1974 statement from the Office of the General Counsel, whereby the Agency acknowledged that the legal determination that a substance is a food additive must be based on more than migration per se:
"Finally, if any court action is brought, we [FDA] have the burden of proving two things: first, that the ingredient may reasonably be expected to become a component of the food, and, second, that the amount of migration involved is not generally recognized as safe. We would need expert testimony on both issues. The fact that extreme conditions produced extraction would not... be sufficient evidence in and of itself to justify a food additive conclusion. We would be required to put on evidence of experts showing that the extraction studies are reasonably related to actual use conditions and, thus, that the results can be extrapolated to normal use. We would also be required to show that the amount that might reasonably be expected to migrate is not generally recognized as safe and, thus, is a food additive."31
Functional Barrier Doctrine
A subset of the "no-migration" exclusion is the functional barrier doctrine. If a substance is not part of the food-contact surface of a package and is separated from the food by a barrier that does not permit migration of the substance to food, the substance may not be expected to become a component of food and does not fall within the definition of a food additive subject to FDA review. This functional barrier doctrine, already a well-established, though unpublished, FDA position,32 received judicial confirmation in the 1975 case of Natick Paperboard v. Weinberger.33
Natick Paperboard dealt with the issue of whether paper and paperboard containing high levels of polychlorinated biphenyl (PCB) contaminants were impermissible food additives. In 1973, Natick Paperboard and Crown Paperboard, two manufacturers of paper food-packaging material, brought an action in district court for injunctive and declaratory relief against an FDA proposal to seize paper food-packaging materials containing more than 10 ppm of PCBs. On remand, after originally denying relief on the basis of lack of jurisdiction,34 the district court granted summary judgment for FDA, declaring that the Agency had authority under the FD&C Act to recommend seizure of such paper packaging as adulterated food.35
Although the court of appeals affirmed the district court's decision, it made an important distinction regarding the food additive status of substances separated from food by a functional barrier. In relevant part, the court stated that if "the food placed in or to be placed in the paper container is or will be insulated from PCB migration by a barrier impermeable to such migration, so that contamination cannot reasonably be expected to occur, the paperboard would not be a food additive . . . under the Act."36 In other words, substances separated from food by a functional barrier are not food additives.
Application of this concept often helps in determining the regulatory status of interior layers of laminates, outer layers of packages, and external printing inks. The only significant question for a food packager with respect to non-contact substances or layers is whether a true barrier exists. This question may be resolved by considering the package structure, the exposure conditions anticipated for the package, or, where necessary, by conducting appropriate extraction tests.
GRAS substances, as noted above, are also excluded from the regulatory impact of the food additive definition. A producer may market any substance generally recognized as safe by qualified experts without FDA approval or notification.
In light of the FD&C Act's silence on the question of procedures for determining whether a substance should be classified as GRAS, and the admitted incompleteness of FDA's official list of GRAS substances,37 it is the initial responsibility of the manufacturer to determine whether a substance it manufactures is GRAS for any specific intended use. The GRAS status of a substance often turns on how it is being used and in what quantity. It is a popular misconception that a substance must be generally regarded as safe in all possible contexts in order to be deemed GRAS. As the Monsanto court noted, a substance may be considered GRAS in concentrations below a certain threshold even though it is not GRAS in higher concentrations.38
A manufacturer may make an independent GRAS determination through reliance on qualified experts and the scientific literature. Obviously, should FDA consider a manufacturer's GRAS determination incorrect, the Agency can take appropriate regulatory action; however, the burden is then on FDA to prove that the substance is not GRAS. Until a few years ago, a manufacturer who wished to receive FDA's confirmation and have his product placed on FDA's published GRAS list could file a GRAS Affirmation Petition. FDA's formal acceptance for filing of such a Petition amounted to a prima facie finding that GRAS status was probable, and the substance could be marketed while the petition was pending. Under a more recent rulemaking proposal, now treated as policy, FDA will no longer entertain or act on GRAS Affirmation Petitions (they are not required or even provided for under the basic statute) but will, instead, accept notifications that will "become effective" ninety days after they are submitted unless FDA objects to the claimed GRAS status. Substances affirmed as GRAS as "direct additives" (i.e., substances directly added to food), and presumably any hereafter properly noticed as GRAS under the new rules, are also GRAS as "indirect additives" (i.e., additives used in packaging materials that indirectly become components of food), provided any applicable limitations on use are met and it is apparent that the indirect additive application will not lead to any significant increase in the level of dietary exposure.39
Prior Sanctioned Substances
The prior-sanctioned exclusion, like that for GRAS substances, is drawn directly from the FD&C Act. Substances sanctioned by an FDA or USDA letter or memorandum issued prior to 1958 are not food additives. A manufacturer may use any material prior-sanctioned for its intended application without further FDA clearance. As in the case of GRAS substances, there are more prior-sanctioned substances than are listed in FDA's regulations or files.
The prior-sanctioned status of a substance is a question of fact depending solely on the existence of an appropriate pre-1958 letter or other indication of acceptance. However, this does not mean FDA is powerless to control prior-sanctioned substances. The Agency has attempted to limit the scope of the exclusion by consistently construing prior sanctions as narrowly as possible. Though FDA is precluded from regulating a prior-sanctioned substance as a food additive, the Agency can prohibit or set conditions on the use of any substance which it has proof is adulterating food.40
As discussed in some detail above, the housewares exemption makes it quite clear that substances sold for use in housewares such as dinnerware or eating utensils need no FDA clearance. This exclusion flows from the legislative history of the 1958 Amendment to the FD&C Act. FDA has written many letters affirming this exclusion although the agency has also seemed to snipe at it from time to time. Nonetheless, FDA does not purport to require Food Additive Petitions for housewares applications such as empty containers, utensils or appliances sold to consumers for home use.
The mixture doctrine permits a manufacturer to physically blend two different polymers or other combinations of substances if all are cleared by FDA or are exempt in some way (GRAS, prior sanctioned, a non-migrant, or deemed exempt under the Threshold of Regulation rules) for their intended use. Such blends require no further FDA approval provided each individual substance in the mixture complies with any limitation in its respective regulation. For example, assume that polymer A is approved for use in packaging carbonated beverages. If polymer B is cleared for the same use, a blend of polymers A and B is also considered covered so long as each individual substance complies with any limitation in its respective regulation. If combining A and B results in a reaction forming a new substance "C" then C would need to be cleared, as appropriate. Where all parts of a mixture are cleared in some way but one, for example, is only cleared for a limited purpose such as packaging dry foods, this limit applies to the combination and must be observed.
Basic Polymer Doctrine
When FDA obtained authority to regulate what would become known as "indirect food additives" in 1958, regulations establishing conditions for the safe use of polymers in contact with food were among the first to be promulgated. These original polymer regulations were designed to focus on what might migrate from the polymer into food. They regulated the polymer as a whole, not the complex variations in the polymerization process, which, for a given plastic, might involve the use of an extremely small amount of any one of a variety of catalysts, reaction control agents, and other essential processing aids. At some point in the development of the polymer regulations, probably during the evaluation of the polypropylene petition which led to the first indirect additive regulation, it must have been recognized that any attempt to regulate every phase of polymer production would be a Herculean task that could never result in any kind of sensible regulation. Accordingly, FDA framed the earliest polymer regulations to put limits on what it anticipated might be significant migrants and did not in any way attempt to govern manufacturing processes, catalysts, or reaction control agents.
Such was the state of polymer regulation in 1966 when an FDA panel speaking before an industry gathering further delineated the scope and intent of FDA's polymer regulations. At a question and answer session during a meeting of The Society of the Plastics Industry's Food, Drug and Cosmetic Packaging Materials Committee, Assistant Director for Regulatory Programs Ramsey and Dr. Joseph McLaughlin of the Bureau of Science's Division of Toxicological Evaluation were asked: "What is a basic polymer?" In other words, what exactly does FDA mean when it issues a food additive regulation for a "basic polymer"? Dr. McLaughlin's response was described in a letter to the SPI Food Packaging Materials Committee that is now a part of the regulatory history as the first articulation of what has come to be known as the basic polymer doctrine.41
Commenting on a question as to what FDA means by its use of the terms "basic" or "base polymer" in various food additive regulations, Dr. McLaughlin explained that FDA considers the basic polymer to be the total polymer (without adjuvant type ingredients such as plasticizers) as it comes out of the polymerization process. He noted that if it is normally impossible or impractical to make the polymer without crosslinking agents, catalysts, anti-oxidants, or other necessary adjuvants, the basic polymer definition is intended to include such essential components employed at the polymerization stage.42
This basic polymer doctrine received further confirmation in 1968 at the FDA-sponsored National Conference on Indirect Food Additives, when, in response to a question, Dr. Ramsey made the following statement about how FDA regulates what goes into the manufacture of polymers:
"There are exceptions . . . with regard to the handling of certain substances that we really didn't regard as food additives, such as the catalysts, and the plastics industry is well aware of that. They use catalysts certainly by the dozens, if not by the hundreds. And there are no catalysts listed in the regulations unless the petitioner actually insisted that catalysts be put there."43
What Dr. Ramsey said about catalysts applies with equal force to other "basic polymer" components such as reaction control agents and surfactants. The principle is the same, namely, that where a substance is used in only a small quantity and either becomes part of the resin during polymerization or is washed from the resin at the conclusion of polymerization, its potential for significant migration is minimal. In other words, there is no reasonable expectation of migration and therefore the substance is not considered a food additive.
Beyond reliance on the lack of likelihood that the de minimis presence of components like catalyst residues will ever cause a significant adulteration problem, FDA honors the basic polymer stance because of the inherent safeguards provided by the incidental additives good manufacturing practices regulation. Under that regulation, it is a manufacturer's responsibility to make certain that any indirect food additive, or article made therefrom, will not occasion any food being in violation of the adulteration provisions of the FD&C Act. Whether it be a surfactant, a catalyst, or a reaction control agent, the manufacturer has an obligation to ensure that the raw materials and finished food-contact articles are safe and suitable for their intended use.
What this regulatory history of polymer regulation means to industry is that, as long as a polymer is listed in a regulation or is GRAS or prior-sanctioned, and is manufactured in accordance with good manufacturing practices, the polymer is covered by that regulation or exclusion even though different manufacturers may make it by different processes. It is possible, of course, that a specific polymer may be characterized, and thus separately defined from a similar polymer, by virtue of the substances or processes used to make it; if the limitations on the use of such a polymer are different from those of another polymer usually called by the same name, these limitations must be met.
Thus, catalysts, chain transfer agents, surfactants and other substances essential to polymerization used in accordance with good manufacturing practices are considered part of the basic polymer and are implicitly cleared when the basic polymer is sanctioned. The basic polymer doctrine, however, does not apply to substances not essential to the polymerization reaction. Stabilizers, antioxidants, pigments, lubricants, and other adjuvants added after polymerization require specific clearance like other food-contact substances.
The Food and Drug Administration Modernization and Accountability Act of 1997—Back to the Future Where Notifications Generally Replace Petitions
Beginning in 1994, those in the Food and Drug regulatory community began meeting to try to develop consensus industry positions on reform of the regulatory system put in place in 1958. Indirect additives aside, those with a more intense interest in direct additives wanted to try to provide incentives for more rapid handling of food additive petitions, and to try to effect other changes that would make clearance of food additives more rapid and responsive to industry's needs. Among other proposals were some that would have called for payments of perhaps $300,000 or more to FDA so that it could contract to have petitions reviewed by outside experts who could be expected to act promptly but quite efficiently on such matters. When this idea was advanced, the advocates of indirect additive interests indicated that their constituency could never support such ideas for indirect additives since most of them involved substances that could never support such payments. As a compromise on this point, the direct additive interests agreed to support, or at least not oppose, a movement towards the adoption of a notification system for indirect additives to make petitioning unnecessary in the ordinary case. In effect, what was being advocated was the old notion, advanced in 1957 and 1958, that indirect additives could be more sensibly cleared if all that was required were notifications which became effective automatically in 90 days after filing unless FDA had a sound reason to object to a notification. The objective here was to do away with the two to three years FDA was requiring for action on Petitions.
As the legislative situation developed, there was considerable difficulty with the food industry's positions on industry financing of petition processing and its other interests but there was essentially no significant opposition to the notification idea for indirect additives. Thus, in 1997 Congress finally passed The Food and Drug Administration Modernization and Accountability Act and included in it a form of the notification concept. There were a variety of compromises that became necessary during the legislative process but at the end of the day Congress passed a notification proviso that now permits new indirect additives to be used by a notifier 120 days after a notice has been filed with FDA unless serious objections are raised by the Agency to the notification. The clearance thereby obtained is proprietary but not exclusive in that others can use much of the data submitted to file similar notifications at any time.
FDA still requires and gets essentially the same data as was required in Petitions but it no longer has to produce a rule to govern the uses, so that agency circulation and drafting time is not a factor. The net result is that these notifications do become effective in 120 days in almost all cases, and this is the prevailing indirect additive regulatory process at this time. This evolution has been remarkable and quite sound so the Agency and those who helped bring it about are very proud of the advance.
Notification Data Requirements
More than 250 pages of the Code of Federal Regulations set forth the Indirect Food Additive Regulations put into play before 1997. They are and will remain effective at this time. The pre-market notification system now mandated by Congress in the Food and Drug Modernization and Accountability Act of 1997 effectively replaces the petition-regulation system put into play in 1958. Nevertheless, it is important to know what needed to be included in the Food Additive Petitions to bring about favorable FDA action since the regulations adopted under the new law require that essentially everything required to be submitted in petitions needs to be provided in an acceptable premarket notification. The FDA Form 3480 is used to prepare and submit Food Contact Notifications and FDA's Guidance Documents44 make the data requirements quite clear. In general, it does require the same data as was required for a successful Food Additive Petition but it does so in a more systematic way. A summary discussion of what was needed in a food additive petition, and what is now required in a notification follows.
Identity of the Food Additive
A food additive petition or notification requires detailed information about the identity and composition of the substance of interest and how it is made. The petition or notification must provide the structural formula of the substance or product, the Chemical Abstract Service (CAS) Registry Number, if any, and a method that can be used to identify the substance, e.g., infrared (IR), ultraviolet (UV), or nuclear magnetic resonance (NMR) spectroscopy.
In addition, the identification section of the notification asks for (1) a description of the processes by which the product is manufactured; (2) a list of all raw materials; and (3) the specifications for the raw materials in the final product. A filing should also include test methods used to verify specifications for the raw materials and the finished products. In the case of final product specifications, data from several batches of the product showing compliance with the specifications are also required. Much of this information is often of the trade secret variety and, as such, will be kept confidential by FDA but generally must be supplied so that FDA's reviewers can have a complete understanding of the substance under consideration.
Amount of Food Additive Proposed for Use
In deciding whether to clear the use of a material, FDA has a special interest in the estimated daily intake (EDI) that is expected to result from the new clearance. It will add the EDI for the new use to its estimates of what the dietary intake already is because of existing clearances for other applications. If the total EDI thus derived does not exceed FDA's acceptable daily intake (ADI),45 the notification will encounter no difficulty. The applicable safety factor and resulting ADI is dependent on the type(s) and quality of toxicological studies available for a given substance. Where only LD50 studies are available for a substance, FDA will not set an ADI of greater than 50 ppb. Again, where there are subchronic (i.e., 90-day) studies in two species, FDA will divide the No Observed Effect Level (NOEL) by 1000 to derive the ADI. As a practical matter, however, when relying on subchronic studies, FDA will not set an ADI of more than 1 ppm because it almost invariably requires chronic data to clear any substance that will be used in such a way as to result in a dietary intake of more than 1 ppm of the substance in the total daily diet. Finally, when there are two-year feeding studies, FDA sets the ADI for a substance by applying a 100-fold safety factor to the lowest NOEL, i.e., it divides the NOEL by 100. Since these studies involve long-term exposure of the test animals to a particular substance, FDA is more confident with the resulting NOEL and thus applies a much lower safety factor.
Notifiers seeking clearance of a food additive must describe the conditions under which the additive will contact food and provide data on the identity and quantity of substances likely to become components of food under the intended conditions of use of the additive. Information on the product's conditions of intended use should include identification of the type of food-contact articles (i.e., bottles, films, laminates, etc.), expected maximum wall thicknesses of these items, any information available regarding heat processing of food in the container, and anticipated types of foods the articles will contact, i.e., aqueous, alcoholic or fatty. Identifying "conditions of use" is also a prerequisite to selecting the appropriate specific protocol for determining the extent to which components of the product are likely to migrate to food in various applications.
Unless diffusion calculations can be used to derive a solid extraction estimate, or the petitioner is willing to have the Agency assume that all of the substance used in a food-contact application will migrate into the foodstuff, a notification must present the results of extraction studies conducted under the conditions that reflect the most severe intended uses. The reports on the extraction studies conducted must include the details of the test procedure, summaries of the raw data, typical chromatograms, calculations, and test validation results.
FDA has gathered data to estimate the proportions of the diet which are packaged in specific types of materials (consumption factors), and, for each of these materials, the relative amounts of different types of food packaged in the material (food-type distributions). To estimate the overall concentration of a new substance in the diet, a petitioner must first determine the amount of the material that the extraction or diffusion studies show could be present in contacted food. Actually, this determination can be made by using the results of migration data (i.e., extraction studies), diffusion studies, or by assuming 100% migration of the material into contacted food. Next, the measured or calculated migration values for the different food-simulating solvents expressed in parts per million (ppm) in the solvent (food), assuming 10 milligrams of food-contact each square inch of surface, is weighted by the respective food-type distributions to arrive at the average concentration of the additive in foods packaged in materials made from these copolymers. This number, in turn, is multiplied by the FDA-prescribed consumption factor for the polymer(s) of interest to arrive at the overall average concentration of the additive in the human diet.46
The estimated daily intake is calculated from the average concentration in the diet on the basis of a 3,000-gm daily diet for a 60-kg person to yield the total amount of the additive in the diet in terms of milligrams per kilograms body weight per day. These calculations clearly represent a conservative (worst-case) estimate of the dietary intake of an additive for two reasons. First, they are made on the assumption that the additive is used in all packaging materials of the given class. Secondly, the values for migration are those obtained under the most severe conditions of use. Thus, the EDI is calculated on the assumption that all of a given substance is used only under the most severe conditions.
If the EDI for a proposed food additive does not exceed the acceptable daily intake (ADI) for that substance, FDA generally considers the proposed food additive safe. It is important to know, however, that the EDI for existing applications of a food additive proposed for new uses must be added to the EDI for the proposed new application. As such, the aggregate EDI for a substance cannot be more than that substance's ADI as determined by FDA.
Intended Technical Effect
With regard to the product's intended technical effect, FDA generally expects that a notification will set forth an indication of the useful properties of the substance of interest. It is not necessary to show that the new additive is better than products already in use, nor is it necessary to set forth all the useful properties of the product. Legally speaking, the Agency has no power to demand data to show the efficacy of a food additive, even a direct additive. The matter of whether FDA could require proof of functional value in a Food Additive Petition was vigorously debated during the legislative process47 that led to passage of the Food Additives Amendment. In the end, the law, Public Law 85-929, omitted the language FDA sought to give it power to pass on the "functional value" of additives. FDA instead was given only the power to deny a Food Additive Petition if it can make an affirmative finding that granting the petition will clear the sale or use of an additive that will be used to deceive consumers.48
Analytical Method for Material
Notifiers are expected to provide an analytical procedure for identifying the subject material and assuring compliance with any applicable restrictions. The notification must also contain the information necessary to show that the method has been properly validated.
Safety of the Additive
Depending upon the identity and quantity of any material expected to migrate, a toxicology profile for the additive must be provided. These data can be in the form of studies undertaken by a company or existing studies in the open literature. The extent of toxicology required to clear a given substance will depend on the calculated estimated dietary intake (EDI).
In general, and although all known relevant toxicology data must be provided to FDA, if the dietary concentration of an additive is estimated to be less than 0.5 parts per billion, no data are required to establish safety. If the intake is estimated to be greater than 0.5 parts per billion, but less than 50 parts per billion (ppb), FDA will only require specified mutagenicity tests. The FDA guidance document on this question should be consulted.
If the intake of a given additive is estimated to be above 50 ppb, and below 1 ppm, two 90-day feeding studies, one performed on rats, and one on a non-rodent species (usually dogs), are the standard requirement, there being some latitude here under special circumstances that have to be discussed with the Agency on a case-by-case basis. Moreover, the Agency requires an in utero phase in the rat study which involves exposing unborn rats to the substance.
Finally, if the dietary intake of the additive is above 1 ppm, FDA will usually require a full complement of studies, including 2-year carcinogenic/toxicity studies, teratology tests, and other toxicological tests, depending upon the nature of the additive.
For functional or non-functional substances that will constitute more than 5% of a food package, and that are not just intended for use in coatings or repeated use articles,49 FDA requires an analysis of the possible environmental impact that might result from the use and disposal of the food additive substance, assuming its clearance. This analysis should include information on possible effluents (i.e., atmosphere emissions, aquatic release, solid waste) resulting from the use and disposal of the product. It should also describe the method of disposal for each released substance. While marking this information as confidential so that it will not be disclosed, the environmental assessment is expected to provide the anticipated production volume for the product and the percentage of that volume to be used in food-contact applications. (The Agency will protect the confidentiality of these data to the extent permitted by the Freedom of Information Act50 requirements.)
The history and operating characteristics of FDA's regulation of food packaging has been summarized in the foregoing paragraphs. The system has been significantly simplified by the Food Contact Notification legislation so that clearances can now be obtained in a well defined time framework. It should be noted that FDA's food-contact substance clearances are often the basis for other types of "approvals" or use acceptances. In evaluating drugs and devices, FDA generally gives proprietary approvals on the basis of applications submitted by drug and device companies. However, when it considers the entire drug or device application, it also pays attention to the packaging materials to be used in these applications. When this is done, the food additive status of a packaging materials component is usually requested and plays an important role in the drug or device reviewers' determinations.51
Food additive status also is a critical part of the evaluation and enforcement processes at the Department of Agriculture's Food Safety and Inspection Service—the part of the Department that supervises the inspection and control of meat and poultry plants and products;52 and is a sine qua non for clearance of packaging materials by the Department of the Treasury's Bureau of Alcohol, Tobacco and Firearms. Finally, the way in which food packaging materials are dealt with in the United States is of significance in the rest of the world and in world trade. As a result, most other countries consider it important to consider U. S. clearances and FDA's regulatory procedures.53
Food Packaging Regulation in the European Union54
The Origin of European Regulation and the Framework Directives
Presenting the story of the genesis and development of the European laws and regulations relating to food packaging constitutes a significant challenge. Unfortunately, it appears that no one in Europe has heretofore written to record the development of the European systems historically. Moreover, the authorities contacted for their recollections of how things came to be differed a bit in their views as to the history of European Union (EU) regulation. The story as gleaned from our contacts is essentially as follows.
After the passage of the Food Additives Amendment of 1958 in the United States, Italy was the first country to enact new legislation on plastics packaging. It did so in 1963.55 This law was based on the American example and, therefore, focused on migration issues. More specifically, it used the materials listing approach and employed the concept of "global migration" as a criterion and basic limitation. The list adopted was one of polymers (not monomers) plus a list of adjuvants for all types of polymers. The law also prohibited the use of any material where total migration would exceed 8 milligrams per square decimeter (8 mg/dm2), of package surface, roughly 48 parts per million.
At about this same time, Germany was considering the regulation of packaging materials and began to prepare its industry Recommendations based on the use of the percentage of additives permitted, specific to each of the major polymers or applications. Obviously, this approach differed greatly from the Italian approach, and from that used or being considered in France, Belgium and the Netherlands. It employed a pragmatic engineering type of regulatory concept without a clear relationship to exposure, migration or toxicology.
It became clear to those in all of the countries then working toward a common market that there was a need for harmonization so, under the influence of the interested officials of the times, work was started in the Council of Europe.56 As to why the work was started in the Council of Europe instead of the Commission of the European Union, one can only surmise that this was because the political differences made this advisable and the Council had a history of being helpful on such technical issues. In any event, a special committee of the Council was created in the early 1960s. It was composed of toxicologists and chemists and was charged to prepare a Resolution on the regulation of plastics. In the course of its deliberations, the Special Committee decided to recommend (1) establishment of an overall migration limit (OML) equal to 50 to 60 mg/kg or 8 to 10 mg/dm2, (2) development of a positive list of plastics on the basis of toxicology and not technology, and (3) development of a general list of substances authorized for use in plastics independently from the type of plastic in which the substances are used. The overall migration limit proposed was advanced in recognition of the need to avoid any interference with the law on direct additives and so that there would be some criterion for taking enforcement action where needed. It also took into account the fact that there was little toxicology to support the listing of substances so that the idea was to, in effect, set up a criterion for listing that had some basis in toxicological knowledge and lore. The Committee theorized that a man weighing 60 kilograms would eat about one kilogram of food a day packaged in plastics that migrated at the extreme possible migration of 8 mg/dm2 so that, using this limitation, intake would correspond to a tolerated daily intake (TDI) of 1 mg/kg bodyweight or 60 parts per million in food, an amount considered most conservatively protective of human health at the time.
There was a great deal of discussion on the Council's recommendations. Germany was much opposed to a binding overall migration limit and to establishing a substance list of the type the Council thought to recommend.57 After a number of years of discussion, work towards harmonization was interrupted because the differences among nations could not be resolved. However, in the later 1960s, the European Commission asked a German expert, Dr. Rudi Franck, to lead a new effort to harmonize packaging materials regulation. At the time, the members of the Community were Belgium, France, Germany, the Netherlands, Italy, and Luxembourg. Unfortunately, Dr. Franck's efforts proved fruitless so he eventually renounced harmonization, which led the various countries to develop their own laws. There thus began to appear a number of national pieces of legislation in this area. The Italians enacted a measure in 1973, and the other countries did the same in the early 1970s so that there were then separate measures in Belgium, France and the Netherlands. The Dutch regulation was the most complete in governing all of packaging, not just plastics.
In the 1970s, the six member states were obviously divided in their views but the leading experts from Belgium (Professor Thomas), Italy (Professor Sampaolo), and the Netherlands (Dr. Aldershoof) remained convinced that harmonization was essential. As a result, they organized two major conferences in Noordwijk, The Netherlands (1971) and Rome (1972) to see about continuing to work on harmonization at the Community level. Their aim was to establish a Framework Directive for all food contact materials and a specific Directive on plastics. They concluded that the specific Directive should be based on the laws of France, Italy and Belgium, and should include an overall migration limit and, in general, positive lists of monomers and additives. The Germans agreed to work with this new initiative as it was clear that no consensus could be reached on the German Recommendations based on technology. In effect then, all of the countries in the Community at the time agreed to base the regulatory scheme on their understanding of "toxicological principles," including the overall migration limit concept.
In 1972, Dr. Luigi Rossi of the Italian Superior Institute of Health was sent to Brussels to work with the European Commission and, more specifically, to develop a Framework Directive and a Directive on plastics. He was actually appointed to work half-time for the European Commission on food packaging while continuing to work for the Superior Institute of Health on occupational health avoiding any conflict of interest questions. In 1976, the first Framework Directive, prepared by the Commission in close collaboration with the nine Member States [Ed. Note: Initially, the EU consisted of just six countries: Belgium, Germany, France, Italy, Luxembourg and the Netherlands. Denmark, Ireland and the United Kingdom joined in 1973, Greece in 1981, Spain and Portugal in 1986, Austria, Finland and Sweden in 1995. In 2004, 10 new countries joined—Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, and Slovenia], was adopted.58 With regard to a plastics listing, however, new challenges appeared as the United Kingdom was now a recent member of the European Union (along with Denmark and Ireland) and opposed the adoption of any Directive listing plastics. The British position was that it would never accept any type of positive listing without an examination of the toxicological data supporting each item by the European Scientific Committee on Food (SCF). Thus the SCF began in 1980 to examine the 3000 substances already authorized or admitted by the Member States or requested by industry to be listed in a plastics directive.
In 1972, the Commission services started to prepare a draft Directive on plastics based mainly on the recommendations of the Council of Europe and the suggestions of the European plastics society known as the "BIT/MP." The premises of the draft were that (1) the system would be based on the migration approach, and (2) overall migration would be fixed as a measure of inertness and to minimize the toxicological problems, i.e. the concept of an assured 60 part per million maximum daily intake level. Later in 1973-74, at the request of Germany and the German industry (Dr. vom Bruck), which was informed about the intention of the Food and Drug Administration in the United States to begin using the concept of exposure, the Commission prepared a new draft containing an exposure formula. With the exception of Germany, all of the other Member States rejected the exposure proposal asserting that the system (1) would be too complicated, (2) would not permit compliance at national levels, (3) would increase the migration potential, and (4) would require such intense evaluation that scarce European and national resources would not permit its use and enforcement. (For political reasons, the Member States made it clear that they did not intend to increase the number of officials to be recruited or employed by the European Union to work on packaging matters.)
Finally, in 1990 the first Monomers Directive was published by the Commission, having been approved unanimously by all of the Member States.59 This approval was very important because it obliged the Union to enforce two other Council Directives on migration testing which were adopted in 1982 (82/72/EEC) and in 1985 (85/572/EEC), the application of which was postponed until a list of monomers was adopted. Along with the Framework Directives, the Monomers Directive currently forms the corpus of the European food contact regulatory system but with a possible excepting mechanism grounded in the concept of "mutual recognition," a fundamental principle of the European Union.
The Framework Directives and the Directives Adopted Thereunder
The Framework Directives
The premise for the first packaging materials Framework Directive (76/893/EEC) was that differences between the national laws relating to packaging materials and articles was impeding free movement of goods in the Community, and could create unequal conditions of competition that would affect the functioning of the Market. Packaging areas deemed to require regulation, or at least to be considered for such regulation, were Plastics, including varnishes and coatings, Regenerated Cellulose, Elastomers and rubber, Paper and board, Ceramics, Glass, Metals and alloys, Wood including cork, Textile products, and Paraffin and microcrystalline waxes. In fact, however, almost all of the operative directives since that time have dealt with plastic monomers and adjuvants for plastic products although there are also directives on regenerated cellulose, ceramics and, to a limited extent, elastomers and rubber. The directive on plastic materials is not yet complete with respect to the additives used in the production of plastics. Currently the directive is considered to be "fully harmonized" only with respect to the list of monomers that are permitted in the production of food-contact plastics. To this date there are no comprehensive directives or other regulations relating to such important areas, inter alia, as can coatings, paper and paperboard, adhesives, colorants, and glass.
On December 21, 1988, the Council of the European Communities published a new Framework Directive "to consolidate the provisions of the existing relevant texts with a view to ensuring legal clarity."60 This Council Directive noted its approval of the specific directives that had been adopted under the earlier framework and indicated the system should be retained. It also indicated the intent to have the Scientific Committee for Food continue to consult on specific directives noting most emphatically that "the principle underlying the Directive should be that any material or article intended to come into contact with or which is intentionally in contact either directly or indirectly with foodstuffs, must be sufficiently stable not to transfer substances to the foodstuffs in quantities which could endanger human health or bring about an unacceptable change in the composition of the foodstuffs or a deterioration to the organoleptic properties thereof.."
The Framework Directive in effect from 1989 to 2004 (89/109/EEC) was adopted by the Council of the European Union on December 21, 1988, to replace the 1976 Directive (76/893/EEC). However, The European Union's new Framework Regulation covering materials that are intended to come into contact with food (Regulation (EC) No 1935/2004) and repealing the former "Framework Directive" was published in the Official Journal of the European Union on November 13, 2004, and became effective December 3, 2004.
First, it should be noted that the new Regulation is a "Regulation," rather than a Directive, so that it immediately took effect in all 25 EU Member States twenty days after it is published in the Official Journal of the European Union. It also changes the European pattern so that the Commission can now adopt as specific measures not only Directives but also Regulations (generally applicable) or Decisions (applicable only to a state or a person). These last two types of measures can become effective immediately and will no longer need to go through the cumbersome state-by-state implementation process to be effective.
Generally speaking, the new Regulation carries forward all of the old provisions except that it eliminates the current section governing individual state authorization of substances on a temporary basis when they were not included in a specific EU directive or regulation, and no longer exempts food contact materials destined for export outside of the EU. The state authorization provision (Article 4 in the 1989 Directive) was eliminated because it was rarely used and the Member States wished to avoid any possibility for the adoption of conflicting national measures. The export provision is gone because of the European Parliament's fear that such provisions can result in bad products being dumped on developing countries.
More specifically then, and using the new Regulation as the basis for explanation, Article 1 notes that the purpose is to secure a high level of protection of human health and protect the interests of consumers so that the Regulation is to be applied to all materials and articles, including so-called "active and intelligent" packaging, which in their finished state are intended to contact food, or can reasonably be expected to contact food, or transfer their constituents to food under normal or foreseeable conditions of use.61 This article also confirms the old exemption for antiques, covering or coatings for foods like cheese rinds that form a part of the food and can be consumed with it, and public or private water supply equipment.
Article 2 sets forth a series of definitions beginning with definitions of active and intelligent food contact materials (discussed below), and continuing with routine prescriptions as to what constitutes a "business," "traceability," and "placing on the market."
Article 3 entitled "general requirements" sets forth the important proposition that manufacture of all materials or articles be in accordance with good manufacturing practice so that they do not transfer their constituents to food in any quantity that could endanger human health or bring about any organoleptic change or deterioration of the food. It also contains a provision proscribing any labeling that might mislead consumers.
Article 4 is devoted to a discussion of the special requirements applied to active and intelligent packaging including the requirement that neither sort of system be used to adversely affect organoleptic characteristics of foods or mask spoilage. A labeling provision, presumably to inform consumers that such packaging has been used for a specific food, is also set forth.
Article 5 is the enabling clause for the specific measures aimed at listing authorized materials and articles and providing any special conditions or limitations on their use. It authorizes the use of specific migration limits (SMLs) and overall migration limits (OMLs); and the promulgation of rules to check on compliance, sample collection, record retention, and labeling for active and intelligent packaging. Most significantly, it authorizes the Commission to maintain a register of authorized materials, and the adoption of specific procedural rules applicable to individual authorization of substances or materials. This authorization is the likely basis for indications that active and intelligent packaging materials, as well as recycled materials may be authorized by case-by-case evaluations and registrations instead of listings in general regulations.
Article 6 allows Member States to adopt national provisions if they comply with the rules of the Treaty. Article 7 notes the role of the European Safety Authority and the requirement that it be consulted prior to adoption of any safety measure. Article 8 actually prescribes the way in which an application for a listing in some suitable regulation is to be submitted noting the need for a technical dossier to comply with the guidelines published to indicate what is needed to demonstrate safety. It also describes how the authorizing authority must acknowledge receipt of an application within 14 days, and make information about the application known to the Member States of the Union.
Article 9 actually prescribes the way in which an application for a listing in some suitable regulation is to be submitted noting the need for a technical dossier to comply with the guidelines published to indicate what is needed to demonstrate safety. It also describes how the authorizing authority must acknowledge receipt of an application within 14 days, and make information about the application known to the Member States of the Union.
Article 10 sets a six month deadline requiring the authorizing authority to advise the applicant as to whether his filing complies with the safety criteria, but allows the authority to extend this time for another six months upon the giving of some suitable explanation to the applicant, the Commission and the Member States. It also includes some detailed instructions as to when the Commission can ask an applicant for more data, thereby suspending the action time. Upon approval, the authority is ordered to prepare a suitable opinion and set forth any use conditions; it must send the opinion to the Commission, the member states and the applicant, and make it public, after deletion of information identified as confidential.
Article 11 discusses authorizations that take place in the form of adoption of a specific measure, requires an explanation of any difference in the authorization that the Commission occasions as regards the recommendations of the authority, and requires that the applicant be notified if the Commission decides against a specific action. It also requires that anyone using the authorized substance immediately inform the Commission of any newly acquired scientific information which might affect the safety assessment; this can then require a reassessment of the substance by the authority. This article also announces the fact that an authorization by the Commission "shall not affect the general civil or criminal liability of any business operator in respect to the authorized substance," or its use in a consumer product.
Article 12 deals with modifications or suspensions of authorizations, and indicates the authorizing authority can reconsider any of its actions on its own, or upon request from a Member State or the Commission and then take any appropriate remedial or modification action necessary. Article 13 requires Member States to provide information on a competent national authority. Article 14 addresses administrative review.
Article 15 provides authority to require suitable labeling where needed to advance traceability or safety of use; it contains a great deal of detail about multi-language labeling and what the states can do to accomplish any local labeling purposes. Article 16 requires declarations of compliance with the Regulations, and the making of all data available to competent authorities; it allows Member States to prescribe their own provisions as to declarations of compliance. Article 17 orders that all materials and articles be labeled or otherwise identified so that traceability can be accomplished.
Article 18 permits a Member State to suspend an authorization if it determines that some new safety hazard is presented. It must then inform the other States and the Commission of its action so that the authorization can be reevaluated. The reporting Member State can then maintain its suspension until such time as the Commission either adopts changes to the authorization or declines to change the authorization on the basis of the State's assertions.
Articles 19 through 28 are housekeeping provisions dealing with the need for public access to information, confidentiality, the sharing of data, amendments to annexes, relationships with other Committees of the EU, inspection and the right to refer information to reference laboratories, sanctions for non-compliance, repeal of prior Directives, and the effective date of the Framework Regulation twenty days after its publication. Article 20 deals with the preservation of data confidentiality and the need to justify requests for such treatment by specifying what competitive position and interests justify non-disclosure.
The Monomers Directive
Simultaneously with the first Framework Directive in 1976, the Commission developed a draft of a Directive establishing the overall migration limitations as well as listing monomers on the theory that monomers are considered more dangerous than additives as their residues are very reactive and can migrate in significant quantities if the polymers made from them are not properly manufactured. Since the development of this Directive, the Commission has amended the list by changing some of the conditions of use or adding new monomers, both on the basis of new data made available to it. This practice of adding to the Directive continues to this time but the Directive is now labeled the Plastics Directive.62 The essence of the Plastics Directive is its organization of a positive list system for monomers and additives that can be used in all polymer types and by all parties based on petitions filed by any applicant.
After 1990 when the Monomers Directive was finally unanimously adopted, twenty-two "additional list[s] of monomers and additives for food contact materials" were issued by the Scientific Committee for Food (until they stopped being the designated authoritative body in 2002) and, as of October 2004, five more such lists have been issued by the successor European Food Safety Authority's "Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with food [AFC]." It is important to understand that the monomers listed constitute a true "positive list" at this time so no others can be used in Europe and the mutual recognition principle (described below) cannot be used where monomers are concerned. The list of additives in the Plastics Directive is not a "positive list" since the Directive does not purport to cover the entire spectrum of what is usable; other adjuvants can be used under the Principle of Mutual Recognition or because the laws of a member state permit. Also, the content of the lists and their operation is designed essentially to clear the items listed but with a group of conditions that can occasion special interpretation and enforcement issues.
It is important to note again that the basic list is of monomers, not polymers, so the list does not relate to a product as it appears in any marketplace. For example, the list does not really embrace such constituents of polymers as catalysts, reaction control agents, or other elements generally needed to make one or more monomers into a usable polymer. It has been indicated that lists of production aids will be forthcoming in the future.
Overall, the rule in the European Union is that migration from a package made from listed materials cannot exceed the equivalent of 60 parts per million. However, a number of monomers and adjuvants are regulated with a "Specific Migration Limit (SML)" proviso. These limits are imposed as a function of food so that, for example, Polymer X may be used, provided it does not lead to migration into any packaged food that exceeds Y parts per billion of Monomer Z, the regulated element. Practical problems can be encountered as a result of this approach unless a supplier of a material takes great care to enunciate intended uses of his products and makes certain that any limitation imposed will allow its use even with any specific migration limit imposed.
The contention has been made that some products violate an SML when a polymer is used to make films or containers for very small quantities of food.63
The problem here is not necessarily that such use would present a health hazard but that the hazard will be grossly overstated because safety determinations are usually made with some consideration for the nature of uses contemplated, anticipated consumption of the packaged food as a part of the diet, and market penetration. Using an SML approach applies a limitation to each single package so that, for example, a consumer of a slice of cheese wrapped in a film might theoretically be exposed to more of a component than the SML permits, although he will not be likely to consume so many slices of the cheese daily as to have it present a hazardous part of the diet.
The EU regulations that do not employ the SML criterion generally use what are called QMs or QMAs. What QM means is that the regulation governs a monomer by indicating the maximum quantity of the monomer that can remain as an unbound (free) substance in the finished packaging material, i.e., as a residual monomer by weight of the finished packaging material; the QMA designation limits QM by making the amount permitted related to the area of the total material or contact layer. This method of regulation seems apt for additives and perhaps some monomers.
Applications for Listings in the Plastic Directive
A form of petition or application must be submitted to include a new monomer or additive in the list of permitted substances found in the Annexes to the Plastics Directive. These petitions are evaluated by the Food-Contact Materials Working Group (FCM-WG) of the European Food Safety Authority's (EFSA's) Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC). Once the FCM-WG makes a recommendation to the AFC, it will issue its formal opinion on the safety of the use of the substance when used in contact with food and any applicable limitations that should be observed. The new Framework Regulation provides that the EFSA has six months to complete its review of a petition, but the time period can be extended provided the EFSA issues a written justification. Requests to the petitioner for additional information to support the petition also may suspend the six month review time. Once the EFSA has issued an opinion, and provided the European Commission concurs, the Commission will take the necessary steps to add the substance to the appropriate list on the Plastics Directive either through an amendment to the Directive or, in the future, by issuing a regulation.
The data and information that must be included in a request to list a new substance are set forth in the "Note for Guidance" published by the European Commission.64 The data requirements are similar to those required for a food contact notification (FCN) in the United States. The petition must generally include information on the identity of the substance of interest, its physical and chemical properties, the intended applications, authorizations for the substance in other jurisdictions, available toxicology data, and migration data demonstrating the amount of the food contact material that is expected to be present in food.
The most significant difference between the data required by FDA for an FCN and that which is required by the Commission concerns the toxicology data that must be provided in a submission. As discussed above, FDA's toxicology data requirements are tiered to correspond to the potential dietary exposure to the substance in question. In the EU, however, because consumption factors are not recognized, there is no consideration of the actual dietary exposure that may be expected; rather, the regulatory system in the EU assumes that a consumer would be potentially exposed to the entire amount of a substance that migrates to food.
In this regard, for substances that are expected to migrate to food at a level of 50 ppb or less, the EU requires a dossier to include the results of three mutagenicity tests: (1) an assay for gene mutations in bacteria, (2) an in vitro mammalian chromosome aberration test, and (3) an in vitro mammalian cell gene mutation test. For substances expected to migrate at levels greater than 50 ppb but less than 5 parts per million (ppm), additional studies, including a 90-day oral toxicity study, neurotoxicity studies, and a study showing the absence of potential for bioaccumulation (e.g., octanol/water partition coefficient determination) study, are required. For substances expected to migrate at levels greater than 5 ppm, a full battery of tests, including studies on reproduction, teratogenicity, and long-term toxicity (carcinogenicity), are required.
The Draft Super Regulation
Currently, the Commission services are working on a so-called "Superdirective" or "Super Regulation" to cover Food Contact Plastics Materials and has also released new draft regulations to govern "active and intelligent materials and articles intended to come into contact with foodstuffs," and the use of recycled materials. The Super Regulation document would pull together all of the previous directives on plastic materials and add some new conceptual ideas. If it carries through as presently proposed, the Super Regulation will be finalized in 2006 and its list of substances will become a true "positive list" by December 31, 2007, or as soon thereafter as the Commission deems appropriate. As presently drafted, the Super Regulation would contain some 4 chapters and 21 articles, 11 annexes, 5 tables, and 6 appendices. Presumably, it will (a) extend the field of application to plastic multi-material multilayers, (b) introduce the concept of "functional barriers" for materials which "can not reasonably be expected to brought into contact with foods or to transfer their constituents to the foods", (c) transform all present QMs (maximum quantity of substance in a material) or QMAs (maximum quantity of a substance in mg per 6 dm2) into SMLs, (d) establish a relationship between SMLs and QMAs and (e) introduce a new record keeping obligation. Also, it should be noted that in a new amendment of Directive 2002/72, there are to be specific requirements to regulate antimicrobial adjuvants.
Still under discussion in connection with the Super Regulation is the issue of the ratio between surface areas of materials and the volume of food in contact with them. Various proposals have been presented to give more attention to real ratios versus the conventional factors used. No decision has yet been made on this point by the Commission services which plan to continue the discussion on the content of the Super Regulation. Changes will be made on the basis of the comments of technical experts, industrial representatives, and government officials, many of whom have not yet provided their comments.
The Functional Barrier concept proposed is simply that a barrier must assure there will be no migration of non-authorized substances when a test method of 10 ppb is applied to demonstrate the barrier properties. Where this can be shown, the substances behind the barrier need not be authorized or listed in the Regulation provided the method is the best one available and any substance involved is not a carcinogen, teratogen, or mutagen.
Super Regulation—Provisions Regarding Multilayers and Antimicrobials
Article 1, Section 3 (c) of the draft Super Regulation extends its coverage to multilayers, i. e. packaging that is "composed of one or more different type[s] of materials referred to in Annex I of the [new Framework] Regulation [paper, metal, glass, textiles, wood, etc.] provided the one intended to come into direct contact with foods consists of plastics." These materials are to be referred to as "plastic multi-material layers" and the plastics so used must be covered by the listings in the Regulation as to its monomers, or, for now, be the subject of national legislation if the subject matter is an additive. Among other things, the change means that any applicable SML or OML would have to take into account any migration from the non-plastic components of a multilayer package in addition to the migration from the plastic.
Article 5b of the draft Super Regulation is to govern the listing of "surface antimicrobial substances" used to inhibit the growth of bacteria on the surface of materials or articles permitted under the general listings. As presented, the materials or articles on which they are used must be "adequately labeled to indicate they contain surface antimicrobial substances," the antimicrobial must be suitable and efficacious under real conditions of use, and their use must not mislead consumers as to the food's suitability. These antimicrobials are to be listed in Annex III of the Regulation along with all of the other authorized additives.
A number of questions have been raised with respect to this proposal by the European Member States and by industry representatives. There is some chance that the surface biocides question may be left out of the regulation and acted upon in some other context. In any case, we are advised that it is premature to deal with this subject further since the current proposal has not been discussed at the necessary European levels.
Draft Super Regulation—The Record Keeping Provisions
The new requirements for extensive record-keeping have raised some concerns in industry. There is no disagreement on the keeping of records and making them available for official examination. However, there is some trepidation that the provision is written so broadly that it will make it possible for others in industry to obtain the records and get trade secret or other confidential information that is not relevant to product safety.
Draft Regulation on Active and Intelligent Packaging
The proposed totally new "Regulation relating to active and intelligent materials and articles intended to come into contact with foodstuffs" would bring about a proprietary system of clearances based on individual company applications and publication of a register of such items, presumably designed to protect trade secrets. As presently framed, this new regulation would seem designed to promote the use of materials or substances aimed at better preserving foodstuffs or enhancing the environment in a food package. The regulation would proscribe any uses deemed to be capable of altering foods so as to make them misleading to consumers.
Draft Regulation on Recycled Plastic Materials
This new draft, released simultaneously with the active and intelligent packaging proposal, also looks towards proprietary authorizations, this time of recycling processes that lead to the use of recycled materials for food packaging. It clearly provides that only suitable (cleared by regulation) food contact materials can be recycled and requires the installation of quality assurance systems. Labeling is also to be prescribed so that there will be symbols for suitable material.
It is important to note that the draft clearly exempts from the need for further clearance materials obtained by depolymerization and recovery of inplant scrap provided, of course, that the materials so recovered are of the type covered by the Plastics Regulations.
Unlike the case in the United States, there is no basis for any exemption from regulation such as the "housewares," or "basic polymer," concepts. More obviously, there is no exemption for any sort of "prior sanctioned" or "generally recognized as safe (GRAS)" status. At present, the principle of "mutual recognition," discussed in detail in the following section can be viewed as presenting an exemption approach for plastics additives but it could become inapplicable if the additives list, like the monomers list, is ultimately designated a true positive list and the EU regulation is fully harmonized.
There are clear exemptions from the regulatory requirements for salts of aluminum, ammonium, calcium, iron, magnesium, potassium and sodium authorized acids, phenols or alcohols. There is a limited exemption for salts of zinc authorized acids, phenols or alcohols (group SML of 25 mg/kg.) Also exempt are mixtures obtained by mixing authorized substances with no chemical reaction, and natural or synthetic polymeric substances that function as the main component of finished articles provided they are made with cleared monomers and additives.
Also, of course, there are no listings of impurities in the substances used, reaction intermediates such as oligomers, or decomposition or reaction products. As indicated above, recycled materials obtained by depolymerization or from inplant scrap may be used without further authorization so long as good manufacturing practices are observed.
There is some concern in Europe about what some have called the "forest of peaks" issue, i.e., the data developed by some scientists tending to indicate that when exhaustive extractions of such items as can enamels are performed using acetonitrile, a myriad of impurities show up on the analytical screens. Those who have done this work insist that all of the peaks that show up on chromatograms indicate substances that should be subjected to toxicological study. Most scientists in Europe tend to disagree, believing there is no need to conduct expensive toxicology studies for minute amounts of impurities.
The Free Movement of Goods: The Principle of Mutual Recognition
The concept of "free movement of goods," is one of the fundamental objectives of the European Community. To further the free movement of goods, the authors of the Treaty of Rome provided for the establishment of a "Customs Union" and for the elimination of obstacles to free trade within the Member States. Customs duties and import quotas were to be eliminated, as well as "measures that can have equivalent effect," i.e. technical barriers to trade.
Articles 28 (formerly 30) and 30 (formerly 36) of the Treaty of Rome
The Treaty of Rome looks towards the elimination of technical barriers on imports with a rule (Article 28) and an exception (Article 30).65 Article 28 of the Treaty provides that "Quantitative restrictions on imports and measures having equivalent effects shall . . . be prohibited between Member States". Article 30 provides that "the provisions of Article 28 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals and plants." Article 30 also states that "such prohibitions or restrictions shall not constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States," so it is clear that the intent of the Article 30 exception is to limit its application to cases where a real detriment to human health or safety is a likelihood.
While customs duties and quantitative restrictions had been eliminated rapidly after the adoption of the Treaty of Rome in 1958, technical barriers remained largely in effect, preventing goods from freely circulating in the EU. Various ways were opened to address this issue, including the harmonization of the legislation of the Member States using Article 9566 of the Treaty and legal actions against national measures that were contrary to Article 28 of the Treaty.
Mutual Recognition: the Principle
The application of Articles 28 and 30 has evolved over the years, principally through judicial review by the European Court of Justice. Most importantly, Article 28 has been interpreted by the Court of Justice in Cassis de Dijon and subsequent cases to prohibit all national legislation that does not allow the importation of "products lawfully manufactured and marketed in another Member State."67 This is the principle of "mutual recognition."
Mutual recognition is based on the concept that, once a product has been lawfully manufactured or placed on the market in any Member State, it is to be presumed that the Member State's laws guarantee an adequate level of protection of health, against consumer fraud, for the environment, and so forth so that all other member states must accept the placement of the product in their markets.
The Commission has also been active in developing a policy towards achieving the free movement of goods in the EU through both harmonization and the principle of mutual recognition. In particular, in its 1989 communication on foodstuffs, the Commission provided that the "single market for foodstuffs" shall be characterized by (1) the application of Community legislation to matters requiring harmonization and (2) the application of mutual recognition to matters requiring harmonization and not requiring harmonization until such time as these matters are harmonized.
Essentially, two conditions are required to allow a product that does not comply with the legislation of all the Member States to circulate throughout the EU on the basis on mutual recognition:
- The material must not be fully regulated by harmonized Community provisions. Mutual recognition will therefore apply to products which are covered by member state legislation that is not harmonized or to substances or aspects of a product which are covered by non-harmonized legislation. Today, in the food sector, mutual recognition will accordingly apply to legislation as diverse as the use of plants in food supplements, the use of processing aids in food products, or in the sector of food contact materials, to the use of additives and other substances which are not yet listed in any harmonization measure, including colorants and solvents. By contrast, mutual recognition will not apply to monomers used in plastic materials as they have been fully harmonized under the Plastics Directive.68
- The material must meet the test elaborated by the Court in Cassis de Dijon, i.e., it must have been "lawfully manufactured and/or marketed in another Member State." Since the Court of Justice did not issue general rules specifying when a product is to be considered "lawfully manufactured and/or marketed in another Member State," this concept raises several issues that can only be dealt with on a case-by-case basis. However, it is clear that it is not necessary for materials to be manufactured and marketed in the same Member State and that the principle of mutual recognition applies not only to finished materials but also at all stages of the production of materials and articles. Moreover, the lawful manufacturing in a Member State covers not only products that fulfill the technical rules laid down in that country, but also products that merely do not infringe any other rules, and even products that are manufactured in the absence of specific national technical rules or any other rule. Finally, application of the principle would also be triggered by the fact that a product is only marketed in a Member State. Hence, a product manufactured in a third country and lawfully marketed in a Member State may benefit from mutual recognition within the whole internal market.
Mutual Recognition: the Exceptions
The Court has had many occasions to refine the concept of mutual recognition and in particular to set up the conditions under which Member States may invoke Article 30. Worth mentioning among its most recent decisions are rulings against Denmark and France69 where the Court clarified the conditions under which a Member State may question the presumption that, because the product has been lawfully manufactured or placed on the market of a Member State, it guarantees an adequate degree of safety. Under the recent case law, this presumption can be rebutted by another Member State only under very strict conditions. The following rules are applicable:
1. Member States are only entitled to restrict the importation and marketing of products eligible for mutual recognition where the restrictive measures are necessary to satisfy a legitimate objective listed in article 30, such as the protection of public health, or mandatory requirements, such as the fairness of commercial transactions, and defending the consumer against fraud.
2. The burden of proof is with the state that seeks to be excepted from the general mutual recognition principle. It must conduct a case-by-case risk assessment; precisely identify the alleged risk; assess the probability of its occurrence; and assess the severity of the consequences. Only then:
a. in case of certainty, the member state may impose a restrictive measure that is proportionate to the legitimate objective pursued, meaning that it must be suitable to achieve it and that no alternative measure would achieve it while being less restrictive on intra-community trade.
b. in case of uncertainty, i.e., if the risk assessment reveals scientific uncertainty as to the existence or extent of real risk to human health, it may invoke the precautionary principle and impose a restriction that has to be proportionate, but that should also be temporary, pending resolution of the scientific uncertainty.
3. From a procedural standpoint, the Court has recognized that to the extent that uncertainties continue to exist in the current state of scientific research, it is for the member states to decide on their intended level of protection of human health and on whether to verify the degree of safety achieved by the imported product. Accordingly, under certain strict conditions and provided it is justified as a legitimate objective, the member state of destination may be entitled to verify, through a prior authorization procedure, the degree of safety achieved by the product.
To be proportionate to the objective pursued, however, such an authorization procedure must (a) be easily accessible to traders (traders must be adequately informed on the procedure); (b) be completed within a reasonable time (the Commission added: within 90 days); (c) be subject to challenge before national courts; and, (d) lead to a measure of general application, i.e., that is applicable to similar materials (the measure needs to be published).
Mutual Recognition: General Application and Support
In general, it seems clear that one may market products, including packaging materials, in a member state when the product is made and sold in another member state, and may do so without complying with the national packaging regulations of the country of import, provided there is compliance with the EU Framework Directive, and the product presents no cause for public health or safety concern. While some member states might disagree with this conclusion, it is consistent with the legal principles and court decisions now extant.
Additional support for the use of the principle of mutual recognition for food-contact materials can be found in the European Council resolution on mutual recognition of 28 October 1999.70 In this resolution, the Council encourages economic operators and citizens to make full use of the mutual recognition principle and invites the Commission to take measures to improve its application through information campaigns, guidebooks, and brochures.
Commonalities, Differences, Conclusions and Harmonization
A Comparison of Data Requirements in the U.S. and Europe and the Use Thereof
At first blush it might seem to many that the data requirements for food contact materials clearances in the United States and in Europe are essentially the same, there being only minor differences in the toxicological and analytical data submitted at various times in the process of obtaining clearances. The fact is that the difference in the way data is sought and used by the regulators is vastly dissimilar, and this distinction is critical to an understanding of the two systems.
In the United States, under the older Petition/Regulation process, as well as now under the Premarket Notification program, extraction data, or calculations that validly indicate migration levels, are essential for clearing any substance or material, and are the basis for making a risk assessment en route to clearance. The extraction data required are, generally speaking, the results of tests conducted by exposing the material to be cleared to 10% alcohol, and 50 or 95% ethanol using a test sample that sets up an exposure equivalent to 10 grams per square inch of surface, i.e., a ten to one ratio of solvent to surface area is required. The results of this testing are then extrapolated into a dietary intake by applying the anticipated use to the amount of extraction. For example, let us suppose that the extraction testing indicates that 1 ppm will extract into food simulating solvents, and that the petitioner or notifier duly estimates that the material will come into contact with a maximum of 10% of the food on the market, this being a high estimate to assure conservatism. Then it can be said that no more than 100 ppb of the material will become a part of the diet. Armed with this estimate, the petitioner or notifier will then know what toxicity data will be required of him.
Many materials are cleared on the basis of two genotoxicity studies when the estimated dietary intake is quite low; others will require the conducting of 90-day feeding studies; and, rarely, a two-year study will be needed. The process, however, can be easily summarized by saying you start with extraction data extrapolated into dietary intake, add the indicated toxicity data based on the extraction work, and bring about a clearance that permits the use of the material in contact with all of the foods for which it is intended. Under the Petition system, the Regulation issued would then indicate the specifications for the material and its intended use. Under the Notification system, the specifications are in the Notice, as is the intended use. In both cases, once the regulatory process has been completed, there are no imponderables for an end user (e.g. a food packager) to try to determine. All a food packager need do is make certain to purchase materials that comply with the regulatory specifications and compliance is assured.
In Europe to obtain approval of an application for an assessment leading to the addition of a substance to the Plastics Directive, the basic ingredient required is the submission of three genotoxicity tests, along with all other pertinent toxicity data, that can be evaluated leading to the setting of a permitted exposure level. Extraction data obtained by exposing samples of the product to be cleared to water, 3% acetic acid, and olive oil (in some cases 95% ethanol, or some other fat can be used if it can be shown that olive oil will not work) must also be submitted. Up to now, the extraction work has been provided by testing done with the 10-to-one ratio of solvent to surface area. However, the extraction data is not used to develop a dietary intake amount but is used only to show compliance with the permitted exposure level set on the basis of the toxicology. Frequently, the clearance then given includes a Specific Migration Limit (SML) which, if all that is submitted is the three genotoxic studies, will be 50 ppb. If more toxicology has been supplied and is satisfactory, the limit can be higher or lower but in no case can extraction be higher than the overall European limit of 60 ppm from a package, and no SML can exceed that dictated by the toxicology data. The main point is that the extraction information is used only to provide some assurance of compliance with the safety limit set on the basis of the toxicity data; dietary intake is not considered, nor is any market penetration factor.
The two systems obviously differ dramatically in their conception. The United States system permits the user of a material to have reasonable certainty about its regulatory acceptability if a material or substance is the subject of a Food Additive Regulation or a Pre-Market Notification. The European system clearly provides the end user with much less certainty for the reasons discussed below.
When a plastic monomer or adjuvant is regulated in Europe, a purchaser has no way of knowing that what he purchases will comply with the regulatory clearance or not, unless he buys it from the party that sought the clearance, and they can assure him they have extraction data to show that his use of their product will be in compliance. If he buys from another company, he must ask them if they have done extraction work to show they comply with the regulatory provision, or he must do the work himself to be assured that his use is legal. Rarely is a food processor set up to do the sort of testing necessary, nor are they generally willing to do so. Indeed, many would say that the average purchaser of food packaging materials has no knowledge of the EU or national regulations governing the use of such materials, much less the know-how needed to conduct extraction studies and do the extrapolations to see if what he is using complies with an SML.
The nature of the system brings into play several other conditions that make it difficult to apply. Where the clearance includes an SML, and the new Super Regulation currently under development indicates that many more substances will have SMLs when the plastics directive is turned into a positive list in 2008, the food packager will need to do extraction work, or have such work done by someone, to assure that his particular use will not result in migration that exceeds the SML.
The European approach is designed to assure safety by requiring testing that is as close as possible to analyzing food itself for the presence of migrants. As logical as this might seem, it glorifies the specter of perpetuating a system that is wholly impractical when the same public health goals can be better achieved by a system like the Premarket Notification plan in the United States which allows for tailored clearances that take into account dietary intake, intended use, and toxicological requirements, without putting a burden on food processors, or other intermediates, to conduct testing that is expensive and beyond their normal capabilities.
Toxicological Insignificance—an Important Criterion
From the earliest expressions of interest in packaging materials components regulation, there has been an understanding that the likelihood of their impacting on public health is remote. Thus, for example, the legendary and illustrious chief toxicologist of the United States' FDA, Dr. Arnold Lehman, noted shortly after enactment of the Food Additives Amendment of 1958 that those who must approve packaging materials should attend carefully to analytical chemistry because solid extraction data and dietary intake estimation can, more often than not, make expensive toxicological testing unnecessary. In a simple and direct way, he said that "the dose still makes the poison," and any "dose" from packaging almost always will be so minimal that the need for toxicological concern is apt to be non-existent.
As previously noted, Dr. John P. Frawley, a former FDA toxicologist, and Lehman protégé, indicated at a Sept. 14, 1966 meeting of the American Chemical Society held in New York, that any substance used at less than 0.2% in an indirect additive application should be exempt from regulation unless the substance is a known carcinogen, a pesticide characterized as an economic poison, or a substance proven to be toxic at a level of 40 ppm or less.71 He based his recommendation on a survey of 220 chemicals which had been the subject of two year chronic toxicity studies. He concluded that adopting his exemption provision would mean that exposures would not exceed 0.1 ppm of any food packaging substance into the diet, and that this exposure, characterized as extremely conservative, would leave zero risk. In his 1966 paper, Dr. Frawley bemoaned the then relatively new regulatory system in the United States saying, in pertinent part:
"It has always seemed axiomatic to me that in all matters of environmental health, the degree of hazard should define the degree of control. The amount of attention devoted to each problem should be in relation to the hazard. To distribute our limited efforts on any other basis is a form of gambling with public health.
Unfortunately, in this decade of doubt, the scientific community has little control over the area of its explorations. For the most part, the decision is made by national governments as to which area of environmental health should receive concerted attention and at least in the United States, these decisions are not always made on the basis of relative hazard to health. This certainly has been the case for food-packaging materials and it appears that many countries are prepared to follow in our footsteps."
Later, the Food Protection Committee of the National Academy of Sciences reviewed the Frawley ACS and BIBRA presentations and produced its monograph entitled " Guidelines for Estimating Toxicologically Insignificant Levels of Chemicals in Foods."72 This monograph strongly recommended that FDA and other agencies recognize the fact that any substance that constitutes less than 0.1 ppm in the diet (100 ppb), other than a known carcinogen, a pesticide, or a heavy metal, presents no public health concern.
In 1990, a workshop formed by the Canadian Centre for Toxicology and led by Dr. Ian C. Munro of the Centre reported on its deliberations and evaluations of data reviewed on the safety assessment of food packaging materials.73 The Centre cited the prior work done by Alan Rulis in 1986 and Gary Flamm in 1987, which indicated that the conservative and prudent way to establish a threshold of regulation would be to anticipate all potential toxicity endpoints, including carcinogenesis,for untested chemicals. The Centre concluded that "a threshold of regulation of up to 1 ppb in the diet, based on the Rulis methodology, may be contemplated for indirect additives for which no toxicological data have been developed" but went on to note that, where there is information about structure/activity relationships and in vitro short-term genotoxicity, a higher threshold could be set based on classical toxicological principles. The likelihood that this level could often be as high as 15 ppb was later indicated in the Cheeseman paper discussed below.
After the work of Munro and his associates was published in 1990, in 1992, Dr. Alan Rulis of FDA, noted in another paper that he and his staff had reviewed more than 1800 short term toxicological studies and found that acute effects were seen only where exposure exceeded 1000 ppb.74 This paper also noted that the results of 2-year chronic oral feeding studies on 220 compounds showed that only 5 of the 220 chemicals exhibited toxic effects below 1,000 ppb, and that all 5 of these chemicals were pesticides. The paper was a major premise for FDA's promulgation of a rule to govern exemptions based on a threshold of regulation concept.75 This new regulation, including an exhaustive discussion of all the comments urging that a higher threshold level be set, was published in 1995 and set the very conservative threshold level of 0.5 ppb in the diet for substances where there is no toxicological data available. The preamble to the regulation concedes that the level set is ultra-conservative but notes that this level of conservatism is necessary for such a broad rule-making proposal and because of the Delaney Clause in the United States.
Then, in 1999, Mitch Cheeseman, Ed Machuga and Alan Bailey of FDA published their article entitled "A Tiered Approach to Threshold of Regulation,"76 In this paper, the effect of taking into account structure/activity, genotoxicity, and short term (LD50) data was discussed and the Threshold of Regulation was posited as belonging between 5 and 15 ppb in the diet when acceptable data of this type is at hand. Finally, in 2003, Dr. R. Kroes of Utrecht University in Holland, Dr. A.G. Renwick of the University of Southampton in England, Dr. Cheeseman, Dr. J. Kleiner of the Fraunhofer Institute in Germany, Dr. I. Mangelsdorf of the National Institute of Health in Holland, and four other European toxicologists, published another paper entitled "Structure-based Thresholds of Toxicological Concern (TTC): Guidance for Application to Substances Present at Low Levels in the Diet."77 This paper advocates the adoption of the concept of thresholds of concern based on a decision tree and notes that its adoption would make toxicity testing and safety evaluations for many chemicals unnecessary. Application of the tree in most cases would result in much higher acceptable estimated daily intakes, as indicated in the cited Cheeseman, Machuga, Bailey paper.
The point here is that the authorities world over are in agreement that packaging materials present a minimal, if any, risk to public health. Indeed, practical experience makes this even clearer inasmuch as one cannot cite any indication that a plastic material has given rise to a food safety problem since before 1958 and for all the years since the Food Additives Amendment was passed. As Dr. Frawley so aptly put it in his 1967 paper, "Experience has taught us that most uses of food-packaging materials are safe beyond any reasonable doubt." This being the case, it would certainly appear that food packaging regulation, while perhaps necessary, should be kept in bounds consistent with the risk presented. In short, it should be kept as simple as possible, and clearances should be given very promptly. It is submitted that the Congress of the United States and FDA recognized the evolution that had taken place, and the fact of toxicological insignificance when the Food and Drug Modernization and Accountability Act of 1997 was passed, and put the Premarket Notification system into place in the United States.
Comparative Analysis and Conclusion
The European and United States regulatory concepts differ not only in detail but in fundamental approach so harmonization will require much more than the polishing of some fine points. The European approach is one that is based on the theory that all materials should be explicitly cleared and publicized in regulations, and that all clearances must be based on a toxicological evaluation of the listed substances. In the United States, substances that may not reasonably be expected to become components of food, or that are not likely to give rise to any public health problem, are cleared (or deemed not to require regulation) on the basis of analytical chemistry data and extrapolations that show such components present no cause for toxicological concern because of minimal dietary exposure. In short, the U. S. approach gives considerable credibility to the Paracelsian idea that "the dose makes the poison" so that toxicological justification is not needed, or is greatly minimized by exposure assessments, while the European approach starts from the principle that there must be toxicological data on all substances regardless of the level of anticipated exposure.
Unless Europeans and Americans can somehow come to an agreement in principle on the matter of whether dietary exposure is a valid scientific premise and may be used in making risk assessments, harmonization is unlikely. Taking into account the fact that so many authorities in both the United States and Europe have concluded that food contact materials and substances do not present a significant public health problem, and that there has never been a case where the contrary has been demonstrated, it would seem that something could be done to resolve these differences. At least in theory, this could make the European system of general regulations somewhat less severe because it might permit regulatory clearances based on dietary exposure and less toxicology than is presently the case. Even so, the problem of the small containers, and other similar issues could complicate the process and continue to make regulatory generalization an arcane process.
Perhaps the only way the two systems could be harmonized without undue prejudice to any legitimate interest is if clearances for food contact surfaces were given by the use of a system akin to the filing of premarket notifications of the type used in the United States since 2000. This system allows for specific judgments on every material without having to develop a regulation of broad application that requires foreseeing how everyone in the marketplace will sell their goods, what conditions of use have to be covered or dealt with in some special way, and how migration can be limited without involving the food processor customer in the situation. With the notifications, or some similar case-by-case treatment, evaluations can proceed on the basis of the facts presented to the regulator in a very specific way for a clearly defined material and set of use circumstances. The notifier can be required to indicate what his product is used for, what migration can be expected for the intended uses, and how he will market the product to assure there will be no public health problems.
Under this system, a regulator can look at the data presented and find that no toxicology data are needed where the use will involve a functional barrier because the proposed use will involve virtually no dietary exposure. He could reach this same conclusion if the substance is intended to be used in such small amounts, or in some way that will otherwise limit exposure so that no public safety question will arise. He could also decide to let a notification or registration become effective if the substance of interest has a long history of unremarkable use (i.e., is generally recognized as safe). Likewise, if use of a substance to make small packages is contemplated he can evaluate based on the data presented as to how much of the substance under consideration will get into the food using the recommended larger surface to volume ratios when it is packaged in small packages; on the other hand, if small packages are not a likelihood, it would not be necessary to enlarge the surface to volume ratios as some in Europe have suggested be done to bring about compliance with established SMLs. Any number of other nagging problems can be resolved in this way and the Canadian and American experience has already demonstrated that the case-by-case evaluation system does not require much additional personnel or expense. A European counterpart seems to be a sensible way to go at this juncture. If such a notification or registration system is to be used for "active and intelligent" packaging, and the use of some of the recycled material, it is hard to see why it cannot be used generally. It is respectfully submitted that the European regulatory evolution is now reaching a point where the complications in the system are outweighing its usefulness and susceptibility to practical application so that some change is obviously needed.
On the matter of harmonization in an even broader sense, if Europe were to move to a notification or registration system, or make some changes to make its regulatory policies compatible with those of the United States, consideration might also be given to the use of "mutual recognition" to permit substances cleared in one part of the world to be used in all of the others. It would certainly seem that packaging regulation has evolved and become sophisticated enough to permit the various jurisdictions in Europe and the United States to agree that a material or substance which passes muster in one area can be accepted in the other, i.e., to agree that the safety evaluations are potent enough to assure safety whatever the locale of use. Adoption of a "mutual recognition" policy could also delimit the resource requirements in all of the jurisdictions and perhaps influence governments in Asia, Africa and South America to conclude that they do not need to develop additional divergent systems.
1. Food Additives Amendment of 1958, Pub.L. No. 85-929, 72 Stat. 1784, 21 USC 301-395.
2. See A. J. Lehman, Food Packaging Materials, XX Q. Bull. Ass'n Food and Drug Official of the U.S. 159, 160 (Oct. 1956).
3. See FD&C Act § 201(s), 21 U.S. C. § 321(s); see also Lehman, supra note 2 at 160; Letter from E. H. Hageman, Head, Facilities Section, Inspection Branch, Poultry Division, USDA, to Jerome H. Heckman, Keller & Heckman (Jan. 17, 1963)(on file with author) (confirming subsequent prior sanctioned status of "Lehman List"); Letter from R. H. Philbeck, Chief Staff Officer for Chemical Evaluation and Control, Meat Inspection Division, Agricultural Research Search, USDA to Jerome H. Heckman, Keller & Heckman (Dec. 11, 1962) (on file with the author (same); Letter from Asst. Commissioner J. K. Kirk, FDA, to Jerome H. Heckman, Keller & Heckman, (July 22, 1960) (on file with author)(same).
4. Food Additives: Hearings on Bills to Amend the Federal Food, Drug, and Cosmetic Act with Respect to Chemical Additives in Food Before a Subcomm. of the House Comm. on Interstate & Foreign Commerce, 85th Cong. 44 (1958) [hereinafter Food Additives Amendment Hearings].
5. See Food Additives Amendment Hearings, supra note 4, at 494-96 (testimony of John G. Kuniholm & Jerome H. Heckman, Society of the Plastics Indus.); 410 (testimony of George P. Lamb, Waxed Paper Inst.); 444-46 (testimony of Frederick S. Leinbach & Robert E. O'Connor, American Pulp & Paper Assn); 482-85 (testimony of Kenyon Loomis, Adhesive Mfrs. Assn.).
6. See H.R. 8112, 84th Cong.; see also Food Additive Amendment Hearings, supra note 4, at 43-50. This citation notes the introduction of HR 8112 in the 84th Congress and includes it in a chart which compared all of the measures under consideration in the hearings.
7. See Food Additive Amendment Hearings, supra note 4, at 149, 151. While then FDA Commissioner George Larrick took pointed issue with Mr. Kuniholm's characterization of the inclusion of packaging materials as "indelicate," and insisted that an additive, direct or indirect, could and should be regulated under the same law; it is now clear that he did not begin to appreciate the complexities involved in regulating the combinations of chemicals that make up food-contact substances in the same way that discrete chemicals were to be regulated for addition to foods.
8. 104 Cong. Rec. 417, 418 (1958) (Statement of Hon. John Bell Williams, Chair, House Subcommittee on Health & Science).
9. FDA has, on occasion, cited the so-called Cathy Rose case as indicating that the housewares exemption has been bypassed by the Courts and, hence, is no longer valid. See United States v. Articles of Food...consisting of 668 cases...of pottery, 370 F. Supp. 371 (E.D. Mich. 1974). The fact is that the existence of the exemption was not asserted in the case, the point was never argued, and in all subsequent cases where seizures of such items as lead containing ceramic housewares have occurred, the courts have not cited the Food Additives Amendment as authority for upholding FDA seizures or condemnations of such products but have instead relied on the general authority given FDA under Section 402 of the Act to seize any product which adulterates or will lead directly to the adulteration of foods because of its intended use. See FD&C Act § 402, 21 U.S.C. § 342.
10. See 39 Fed. Reg. 13,285 (1974). Despite the fact that this rulemaking proposal was abandoned as ill-advised, some Agency staffers continue to write letters which are bound to mislead inquirers. One such letter, written in 1994, stated:
Items that are manufactured for contact with food, whether for home or commercial use, fall under the jurisdiction of the Food, Drug and Cosmetic Act. Components of these food-contact articles would be considered food additives (as defined in Section 201 (s) of the FC&C Act) if they migrate, or are reasonably expected to migrate, into food. The proposed rule of April 12, 1974, that you mention was specifically aimed at clarifying the regulatory status of the use food-contact articles [sic] in the home, food-service establishments, and food-dispensing equipment. However, because of limited agency resources, the proposed rule was never finalized.
Letter from FDA (Sept. 20, 1994) (on file with author) (emphasis added).The sharp contrast between this kind of misleading advice and the fully supported statements made in public speeches by higher level staffers such as Dr. Patricia Schwarz in a European speech is hard to explain and often confuses the regulated industries and the public.
11. The most significant change the Food and Drug Modernization and Accountability Act of 1997 (FDAMA) had was the making virtually obsolete the generic clearance-by-published-regulation scheme FDA used for food contact substances from 1958 to 1997. Now, the preferred approach for those seeking clearances is for them to file notifications that describe their specific products of interest in detail. Unless a safety or some other substantive question arises after filing, such notifications become effective in 120 days and are proprietary, i.e., no Federal Register publication is made and the clearance by notification is applicable only to the notifier. The effective date of notifications is published on an internet Web Page (http://vm.cfsan.fda.gov/~dms/opa-fcn.html).
12. See 23 Fed. Reg. 9511, 9512 (1958).
13. Panel Discussion of Questions Submitted to the 1961 FDA-FDLI Conference, 17 Food Drug Cosm. L.J. 79 (Jan. 1962) (quoting J. Kenneth Kirk, Assoc. Commr, FDA).
14. See Lehman, supra note 2, at 159.
15. See Scheuplein, One or Two mg/day, More or Less, Paper Delivered at Semi-Annual Meeting of the Food, Drug and Cosmetics Packaging Materials Committee of The Society of the Plastics Industry, Inc. (June 1995). Said Dr. Scheuplein, at the time the chief toxicologist in the Center for Food Safety and Nutrition at FDA: "The issue, at least the troublesome issue [with food-contact materials], is not safety, but safety assurance. And this makes all the difference."
16. John L. Harvey, Remarks at Rutgers University (Jan. 18, 1962), in Food Additives and Regulation, 17 Food Drug Cosm. L.J. 275 (1962) (emphasis added).
17. See Frawley, J. P. Scientific Evidence and Common Sense as a Basis for Food-Packaging Regulations, Food Cosmet. Toxicology, 5 Pages 293-308 (published in 1967). This citation is to a paper Dr. Frawley gave at a British Industrial Biological Research Association (BIBRA) meeting in London on January 25, 1967, but the substance of the paper made the same points as Dr. Frawley first made at the cited ACS meeting in 1966, a fact noted in the BIBRA paper.
18. Jerome H. Heckman, The Packaging Industries and the Food Additives Amendment of 1958--It's Time for a Change in the Law, 21 Food Drug Cosm. L.J.. 647 (1966).
19. Food Protection Committee-Food and Nutrition Board, National Academy of Sciences-National Research Council, USDA National Agricultural Library, Beltsville, Maryland, Bookplate AD-33 (1969).
20. Lessel L. Ramsey, The Food Additive Problem of Plastics Used in Food Packaging, Paper Presented at meeting of The Society of Plastics Engineers (Nov. 1969) [hereinafter The Food Additive Problem].
21. Evidence of FDA's complete understanding of the procedures used by industry in making its "no migration" determinations, and the Agency's tacit approval of them is to be found in the Preamble of the Threshold of Regulation rulemaking proposal published in 1993. See 58 Fed. Reg. 2720 (1993).
22. FD&C Act § 201(s), 21 U.S.C.§ 321(s).
23. See id. A "prior-sanctioned" substance is one permitted or approved by FDA or USDA prior to 1958, usually in response to an informal inquiry. These informal approvals attained official status with the enactment of the Food Additives Amendment of 1958.
24. The system for dealing with Food-Contact Notifications is provided in the Agency's guidance documents (Cf, http://www.cfsan.fda.gov._____): (1) Guidance for Industry: Preparation of Premarket Notifications for Food Contact Substances: Chemistry Recommendations; (2) Guidance for Industry: Preparation of Premarket Notifications for Food Contact Substances: Toxicology Recommendations; and (3) Draft Guidance for Industry: Preparation of Premarket Notifications for Food Contact Substances: Administrative. Notifications are prepared on FDA Form 3480.
25. FD&C Act. § 409(a), 21 U.S.C. § 348(a).
26. For more information on diffusion theory and methodology, see A. Baner, J. Brandisch, R. Franz, and O.G. Piringer, "The applications of a predictive migration model for evaluating the compliance of plastic materials with European food regulations," Food Additives and Contaminants, 13(5), 587-601 (1996); W. Limm and H.C. Hollifield, "Modeling of additive diffusion in polyolefins," Food Additives and Contaminants, 13(8), 949-967 (1996); T.D. Lickly, C.V. Breder, and M.L. Rainey, "A Model for Estimating the Daily Dietary Intake of a Substance from Food-Contact Articles: Styrene from Polystyrene Food-Contact Polymers," Regulatory Toxicology and Pharmacology, 21, 406-417, (1995).
27. 613 F.2d 947, 955 (D.C. Cir. 1979).
28. Id. at 955.
29. Id. at 948.
30. Scott v. Food and Drug Administration, 728 F. 2d 322 (6th Cir. 1984).
31. Memorandum from Peter Barton Hutt, General Counsel, FDA, to Sam D. Fine (Oct. 31, 1974) (on file with author) [hereinafter Hutt Memorandum].
32. See e.g., Letter from Frederick A. Cassidy, FDA, to Jerome H. Heckman (June 9, 1965) (on file with author). Perhaps the first mention of the concept is to be found in the Lehman article of 1956, wherein the FDA Chief Toxicologist observed with respect to a rust inhibitor used in making a closure for jars: "Since the inhibitor is on the outside surface of the jar and the food does not have contact with this surface, no contamination could occur..." Lehman, supra note 3, at 167.
33. 525 F.2d 1103 (1st Cir. 1975).
34. See Natick Paperboard v. Weinberger, 498 F.2d 125, 125 (1st Cir. 1974).
35. See Natick Paperboard v. Weinberger, 389 F. Supp. 794, 798 (D. Mass. 1975).
37. See 21 C.F.R. Parts 182, 184, 186 (1997) (setting forth FDA's list of GRAS substances). The Agency acknowledges that this list is by no means exhaustive:
The food ingredients listed as GRAS in Part 182 of this chapter or affirmed as GRAS in Part 184 or § 186.1 of this chapter do not include all substances that are generally recognized as safe for their intended use in food. Because of the large number of substances. . . . it is impractical to list all such substances that are GRAS.
38. See Monsanto v. Kennedy, 613 F.2d 947, 956 (D.C.Cir. 1979). Were it not for the recognition given to this principle by Monsanto, and in other quarters, it would have been impossible for FDA to promulgate its widely hailed Threshold of Regulation rules in 1995. See 60 Fed. Reg. 36,582 (1995) (describing the Threshold of Regulation). In a sense at least, the argument can be made that an FDA Threshold of Regulation exemption is tantamount to a finding that a given specified use of the substance deemed exempt amounts to a finding that it can be considered generally recognized as safe for the prescribed use.
39. See note 37. § 184.1(a).
40. See 21 C.F.R. Part 181.
41. See Letter from Jerome H. Heckman, Keller & Heckman, to SPI Food Packaging Materials Committee (Dec. 28, 1966) (on file with author). Dr. McLaughlin confirmed his statement regarding the definition of a "basic polymer" after the meeting, and, prior to its mailing, the letter from Mr. Heckman was reviewed by Messrs. Ramsey and McLaughlin.
42. See id.
43. See Indirect Food Additives Conference, supra note 39, 202-03. Dr. Ramsey's final observation about catalysts being listed based on a petitioner's insistence simply shows how inconsistency in this regulatory area helps to confuse the issues. Petitioners have occasionally tried to steal a march on the competition by getting FDA to include their particular catalyst or manufacturing process in the regulation for a new polymer.
44. See note 24, supra.
45. The acceptable daily intake is the maximum daily intake of a substance (e.g., a food additive), in milligrams per kilogram of body weight per day, that FDA considers safe on a per person basis. It derives its ADIs by examining the toxicological characteristics of the particular substance, taking into account the long standing safety factors it has used depending on the type of toxicology studies available for the substance. More specifically, what FDA does is to take the no-observable effect levels (NOEL) demonstrated in either 90-day (subchronic) or 2-year (chronic) animal studies and divides the NOEL by an applicable safety factor, generally 1000 for 90 day studies and 100 for chronic data. This is how FDA arrives at an ADI for the substance as far as humans are concerned.
47. See Food Additives: Hearings Before a Subcommittee of the Committee on Interstate and Foreign Commerce, House of Representatives, 85th Congress, July 15, 16, 17, 18, 19, 22, 23, 24, August 6, 7, 1957 and April 15, 1958 and H.R. 6747 (1957).
48. See Food Additives Amendment of 1958, Senate Report No. 2422, August 18, 1958, U.S. Code, Congressional and Administrative News, Vol. 3 at 5306. Memorandum Does FDA Have the Power to Demand Efficacy Data to Clear Food Additives? (1999) (on file with author).
49. See 21 CFR § 25.32 (i) - (j); 62 Fed. Reg. 40,595 (1997).
50. Freedom of Information Act (Codified as amended at 5 U.S.C. §552 (1996)).
51. See (Guidance for Industry: Submission of Documentation in Drug Applications for Container Closure Systems Used for the Packaging of Human Drugs and Biologics (Draft)), 62 Fed. Reg. 37,925 (July 15, 1997) (pointing out in Part II.B.1.c., Part II.F.1 and Table Seven that FDA's Center for Drug Research and Evaluation relies heavily on evidence of cleared food additive status in determining the acceptability of materials used in drug packages).
52. See Charles R. Edwards, Chief, Product Safety Branch, Food Ingredient Assessment Division, Science, Food Safety and Inspection Service, USDA, USDA Role in the Evaluation of Plastics, Address to The Society of the Plastics Industry, Inc,. Food, Drug and Cosmetic Packaging Materials Committee (May 31, 1983).
53. See Jerome H. Heckman, Is It Time to Look for a New Approach to Harmonization?, Paper Presented at the ICI/PIRA International Symposium, Washington, D.C., (June 21-22, 1995); Jerome H. Heckman, De Minimis and Harmonization of International Regulations, Paper Presented at ICI/PIRA International Symposium, Geneva, Switzerland, (Mar. 2, 1994); Jerome H. Heckman, Food-Contact Substances Regulation--United States Reform and World Harmonization, Paper Presented at ICI/PIRA International Conference, London, England, (Dec. 16, 1977). See generally Jean-Philippe Montfort, "The Article 30 Solution": An Alternative to Market Food-Contact Materials in the European Union, 51 Food Drug Cosm. L.J. 161 (1996).
54. Cf. Baughan and Montfort, Food Contact Materials: The View from the European Union, Packaginglaw.com. Very useful Web Pages for finding the European Directives and Regulations, including some proposals are: http://europa.eu.int/comm/food/food/ chemicalsafety/foodcontact/documents_en.htm
55.The author is deeply indebted to a number of European contacts who advised as to their best recollection of how the regulation of food packaging came about in Europe. Chief among those who consulted with us on this matter was Dr. Luigi Rossi of the European Commission. Also, however, we were helped in very material ways by Dr. Robert Ashby of ICI (Imperial Chemical Industries) in England, and Dr. Rinus Rijk of TNO in the Netherlands.
56. The Council of Europe is a supranational political body with representation from over 43 countries. The aim of the organization is to integrate legal and regulatory reforms in Central and Eastern Europe. In the case of food-contact materials, the CoE addresses these issues through a committee of experts on food contact materials established under the Partial Agreement in the Social and Public Health Field. Within this group, the CoE has now established a Committee of Experts for materials coming into contact with food and nine ad hoc committees dealing with specific types of food-contact materials. While the resolutions and guidances passed by the CoE do not have the force of law in its member countries, they are intended to be the basis of future Community-wide legislation and, in some cases, may be incorporated directly into the food-contact materials laws in place in the Member States.
57. See Council of Europe publication entitled "Substances Utilisees Dans les Matieres Plastiques Destinees a Entrer en Contact avec Des Denrees Alimentaires. (1982)
58. Dr. Rossi is now a full time employee of the Commission. His official affiliation is with the Directorate General Health and Consumer Protection, European Commission. Under the Framework Directive 89/109/EC he is obliged to consult with the relatively new European Food Safety Authority's Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (EFSA-AFC) on all matters related to health risk assessments.
59. Directive 90/128/EEC of 23 February 1990 concerning plastic materials and articles intended to come into contact with foodstuffs (OJ), as amended by Directive 92/39/EEC of 14 May 1992, Directive 93/9/EEC of 15 March 1993, Directive 95/3/EC of 14 February 1995, Directive 96/11/EC of 5 March 1996, Directive 1999/91/EC of 23 November 1999, Directive 2001/62/EC of 9 August 2001, and Directive 2002/17/EC of 21 February 2002.
60. Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs.
61. The new language "can reasonably be expected to contact food" is not comparable to the similar language in the law of the United States in that it was added to make it clear that even such items as paper wrappings for tea bags are subject to the law. It does not introduce the United States' "no migration" concept in Europe.
62. Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs.
63. Cf." Limits for Migration from Food Packaging Materials; 1. Food Should Prevail Simulants; 2. More Realistic Conversion from Concentrations to Limits per Surface. PVC Cling Films in Contact with Cheese as Example." Grob, Pfenninger, Pohl, Laso, Imhof, and Rieger.
64. See "Note for guidance of petitioner when presenting an application for safety assessment of a substance to be used in food contact materials prior to its authorization," European Commission (January 6, 2004).
65. These Articles were, until 1997 designated Articles 30 and 36. In 1997 the numerical designations in the European Union Treaty were changed to conform to those in the Treaty of Amsterdam so they are now Articles 28 and 30. In the remainder of this paper, the new designations are used although the court decisions referred to used the old designations.
66. Formerly Article 100.
67. European Court Reports 1979, page 00649. In its decision the European Court ruled that, under Article 30, the Germans had to admit for sale the French Liqueur, Cassis de Dijon, even though its alcoholic content was less than the 25% called for by a German law relating to the sale of liqueurs. The German contention that its minimum alcoholic content measure protected the public health by preventing the induction of tolerances allegedly produced by lower alcoholic content of beverages was rejected by the Court. Likewise, a German argument that the lower content of beverages like Cassis de Dijon would promote unfair competitive practices vis a vis higher alcohol content beverages was rejected. (1979)
68. Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs.
69. Judgments of the Court of September 23, 2003, Case C-192/01, "Commission v. Denmark" and of February 5, 2004, Case C-24/00, "Commission v. France", not yet published.
70. Council Resolution of 28 October 1999 on mutual recognition (2000/C 141/02), OJ C 141/5 of 19 May 2000.
71. Frawley, J. P. Scientific Evidence and Common Sense as a Basis for Food-Packaging Regulations, Food Cosmet. Toxicology, 5 Pages 293-308 (published in 1967). This citation is to a paper Dr. Frawley gave at a British Industrial Biological Research Association (BIBRA) meeting in London on January 25, 1967, but the substance of the paper made the same points as Dr. Frawley first made at the cited ACS meeting in 1966, a fact noted in the BIBRA paper.
72. Food Protection Committee-Food and Nutrition Board, National Academy of Sciences-National Research Council, USDA National Agricultural Library, Beltsville, Maryland, Bookplate AD-33 (1969).
73. 12 Regulatory Toxicology and Pharmacology, No. 1, Pages 2 through 52 (1990).
74. Rulis, A., "Threshold of Regulation: Options for Handling Minimal Risk Situations," in Food Safety Assessment, edited by Finley, J. W., S. F. Robinson, and D. J. Armstrong, American Chemical Society Symposium Series 484, pp. 132-139, 1992.
75. 60 Fed. Reg. 136 (pages 36581-36596).
76. Food and Chemical Toxicology 37 (1999).
77. Food and Chemical Toxicology 42 (2004).