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Regulatory Toxicology and Pharmacology 42 (2005) 96122

www.elsevier.com/locate/yrtph

Food packaging regulation in the United States


and the European Union
Jerome H. Heckman
Keller and Heckman, Washington Center, 1001 G Street, N.W. Washington, DC 20001, USA
Received 4 February 2005
Available online 10 March 2005

Abstract
The regulation of food packaging has, indeed, become a global subject as the worlds commercial channels have broadened since
World War II. The Wrst comprehensive regulatory statute governing the area was the Food Additives Amendment of 1958 in the
United States, a modiWcation 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 United States and the Europe have been struggling with each of the laws since then. The regulatory systems
employed on the two continents are superWcially 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
aZicts regulators and the regulated on both sides of the Atlantic. This three part report Wrst 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 diVerences in the systems, discusses their scientiWc 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.
2005 Elsevier Inc. All rights reserved.

1. Book I: 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 1958,1 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 Wnal packages were essentially regulated by their
customers in that the customers often insisted on being
assured of a packages safety, as well as its utility, by
asking to see something from the Food and Drug

Administration (FDA) or the Department of Agriculture (USDA) to indicate that there was no objection to
the packaging material. Government oYcials 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.2 While the submissions were
customized to Wt the situation, and usually included
some exposure information and toxicology, the data
required were 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 Wling of petitions under the new

Fax: +1 202 434 4646.


E-mail address: heckman@khlaw.com.
1
Food Additives Amendment of 1958, Pub.L. No. 85-929, 72 Stat.
1784, 21 U.S.C. 301395.
0273-2300/$ - see front matter 2005 Elsevier Inc. All rights reserved.
doi:10.1016/j.yrtph.2005.02.002

2
See Lehman, A.J., Food Packaging Materials, XX Q. Bull. Assn
Food and Drug OYcial of the U.S. 159, 160 (Oct. 1956).

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

ground-rules.3 Moreover, the no objection letters were


so carefully drafted that none have 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 of New York conducted a series of hearings on the
subject of food additives. These hearings occasioned
intensiWed suspicionnot necessarily justiWedthat food
additives might be the cause of such dread diseases as cancer. At no time during the hearings was there 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 1956,4 all
of the proposed bills included a deWnition 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 deWnitely slated for regulatory
treatment of the same type as would be prescribed for
substances directly and intentionally added to foodstuVs.
At the time, and even though the deWnitions 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
aVected 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
3
See FD&C Act 201(s), 21 US C. 321(s); see also Lehman, supra note
2 at 160; Letter from Hageman, E.H, Head, Facilities Section, Inspection
Branch, Poultry Division, USDA, to Jerome H. Heckman, Keller, and
Heckman (Jan. 17, 1963) (on Wle with author) (conWrming subsequent prior sanctioned status of Lehman List); Letter from Philbeck, R.H., Chief
StaV OYcer for Chemical Evaluation and Control, Meat Inspection Division, Agricultural Research Search, USDA to Jerome H. Heckman, Keller, and Heckman (Dec. 11, 1962) (on Wle with the author (same); Letter
from Asst. Commissioner Kirk, J.K., FDA, to Jerome H. Heckman, Keller, and Heckman, (July 22, 1960) (on Wle 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 and Foreign
Commerce, 85th Cong. 44 (1958) [hereinafter Food Additives Amendment Hearings].

97

regulating their products under a law designed to regulate


direct additives.5 The Society of the Plastics Industry Inc.
(SPI) occasioned the introduction of a separate measure,
H.R. 8112,6 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 Societys representatives and those who
testiWed 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 eVect 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 testiWed 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 Pandoras 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 .7
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 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 nonadditives on the basis of migration data, and, indeed, the
Agencys lead spokesman on this subject, Associate
Commissioner Arthur A. Checci, later emphasized the
importance of this escape hatch for the Wrst three years of
the Statutes existence and administration. About the only
5
See Food Additives Amendment Hearings, supra note 4, at 49496
(testimony of John G. Kuniholm and Jerome H. Heckman, Society of
the Plastics Indus.); 410 (testimony of George P. Lamb, Waxed Paper
Inst.); 44446 (testimony of Frederick Leinbach, S. and Robert E.
OConnor, American Pulp & Paper Assn); 48285 (testimony of Kenyon Loomis, Adhesive Mfrs. Assn).
6
See H.R. 8112, 84th Cong.; see also Food Additive Amendment
Hearings, supra note 4, at 4350. This citation notes the introduction
of H.R. 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. Kuniholms 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.

98

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

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 deWnition, and the
last minute inclusion of a colloquy during the Xoor debate
to make it clear that Congress did not intend to have FDA
regulate the components of housewares.
The Wrst change, though by no means a completely
satisfactory way to separate packaging materials regulation from direct additives regulation, did build into the
Statute a deWnition 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 Wling 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 a 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 Xoor 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 Wlm 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.8 (Emphasis supplied.)
Despite this statement of legislative intent, and the
contemporaneous recognition of FDA oYcials, including its General Counsel, that Congress had duly indicated FDA was not to impose the Amendments onerous
pre-market clearance requirements on housewares or
dispensing machine containers,9 from time to time to this
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. Suppl. 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.

day some Agency personnel on occasion 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 exemption10
but the proposal was vigorously opposed as running
contrary to the legislative intent and was never Wnalized.
There is little doubt but that the exemption can be eVectively asserted whenever circumstances, including any
court proceedings, demand.
1.1. The food additives amendment of 1958statutory
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 deWne 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
Wling of petitions resulting in the promulgation of regulations of general application. This Petition-Regulation
concept was Wrst 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 speciWed in a regulation.
In principle this may have sounded like an attractive
idea but it was a radical departure from the way in which
10
See 39 Fed. Reg. 13,285 (1974). Despite the fact that this rulemaking proposal was abandoned as ill-advised, some Agency staVers 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 deWned 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 speciWcally
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 Wnalized.
Letter from FDA (Sept. 20, 1994) (on Wle 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
staVers such as Dr. Patricia Schwarz in a European speech is hard to
explain and often confuses the regulated industries and the public.

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

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 1958.11
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
Wrst Food and Drug Administration-Food Law Institute
conference held on November 24 and 25, 1958. The Wrst
set of FDA proposed procedural regulations to govern
the administration of the food additives law was then
published on December 9, 1958,12 and the rules were
Wnalized 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.
1.2. Post 1960 FDA policy on food-contact substances
no giveaways and the beginnings of reaction
In 1961, the FDA staVers 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
Wrst 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 years 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 Wrms who had the same items, and
had properly made up their minds without consulting us
11
The most signiWcant change the Food and Drug Modernization
and Accountability Act of 1997 (FDAMA) made has led to the virtual
obsoleting of 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 Wle notiWcations that describe their speciWc products of interest in detail. Unless a safety or some other substantive question arises after Wling, such
notiWcations become eVective in 120 days and are proprietary, i.e., no
Federal Register publication is made and the clearance by notiWcation
is applicable only to the notiWer. The eVective date of notiWcations is
published on an internet Web Page (http://vm.cfsan.fda.gov/~dms/
opa-fcn.html).
12
See 23 Fed. Reg. 9511, 9512 (1958).

99

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. Ramseys 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 didnt give us any reason to say
that youre 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 Wnd 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.13
Mr. Kirks pronouncement amounted to a policy shift
with tremendously burdensome implications for foodcontact 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,14 that its own procedural regulations in what was
then 21 C.F.R. 121.3(d) speciWcally stated that the
Agency would respond to inquiries by ruling on whether
or not 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
Wled. Mr. Kirks bemoaning of the use of letters from the
Agency as sales tools, and the beginning of FDA staVers
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.15
While much of the packaging materials community
was still smarting over the Kirk pronouncement, the
industrys legal advisors were given an aftershock by
then Deputy FDA Commissioner John L. Harvey whose

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, 1 or 2 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 diVerence.

100

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

remarks for the record at Rutgers University on January


18, 1962 read:
We came to the conclusion that we had opened Pandoras box and had better Wnd 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 shouldnt 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 Wle petitions. That is the present status of [this]
item.16
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 Food and Drug Administrations handling of
indirect additives generally and of its policy on dealing
with no migration cases speciWcally. 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.17 At this same symposium, Jerome H. Heckman presented his paper entitled The Packaging Industries and the Food Additives Amendment of
1958Its Time for a Change in the Law.18 In this paper
there was a detailed critique of FDAs 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 Com16
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. ScientiWc Evidence and Common Sense as a Basis
for Food-Packaging Regulations, Food Cosmet. Toxicology, 5, pp.
293308 (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 Wrst 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 1958Its Time for a Change in the Law, 21
Food Drug Cosm. L.J. 647 (1966).

mittee under Executive Order 11,007 to consider the


matter of the Agencys procedures regarding indirect
food additive petitions. At about the same time, in a letter to The Society of the Plastics Industry (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, Dr.
Goddard was asked a series of questions about FDAs
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 30 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
InsigniWcant Levels of Chemicals in Food.19 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
deWciencies in the FDAs Administration of the Law. It
was soon after this meeting that Dr. Lessel L. Ramsey,
Associate Director for Regulatory Programs in FDAs
OYce of Compliance, Wrst 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 Wling 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 foodsimulating solvents would not exceed 50 parts per
billion. (It is of passing interest to note here that the
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).

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

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.20
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 scientiWcally 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 staV members; as a result it became the core of what might be
called the industry antidote for FDAs 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 FDAs 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 selfdetermination and preferred it to having to review data
and provide give away letters of the type given quite
routinely prior to 1960.21 It should also be noted that the
same principle may continue to be employed by those
who choose not to Wle notiWcations under the relatively

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 FDAs complete understanding of the procedures used
by industry in making its no migration determinations, and the
Agencys 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).

101

new Food and Drug Administration Modernization and


Accountability Act of 1997 (FDAMA).
1.3. The legal requirements for the marketing of foodcontact 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 situationsomething that has not yet occurred in the packaging worldthe 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.
1.3.1. DeWnition of a food additive
Since passage of the Food Additives Amendment,
Section 201(s) of the Act has deWned 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 aVecting the characteristics of any food (including any substance intended
for use in packing packaging or holding food ).22
The deWnition speciWcally excludes substances that
are (1) not reasonably expected to become a compo22

FD&C Act 201(s), 21 U.S.C.321(s).

102

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

nent of food; (2) generally recognized as safe (GRAS)


among experts qualiWed by scientiWc training and experience to evaluate their safety; or (3) prior sanctioned.23
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
eVective notiWcation Wled in accordance with Section
409(h)(1) and allowed to become eVective,24 a food additive regulation issued by FDA in response to a food
additive petition,25 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 Wling a pre-market notiWcation, a
food additive petition, or seeking a Threshold of Regulation exemption unnecessary. This is because no regulation, threshold exemption or notiWcation 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.
1.3.2. No migration determinations
No-migration is the most signiWcant escape clause,
for it provides the most used premise for making a selfdetermination that a food packaging material need not
be subjected to any of FDAs 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 codiWed 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 reason23
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 oYcial status with
the enactment of the Food Additives Amendment of 1958.
24
The system for dealing with Food-Contact NotiWcations is provided in the Agencys guidance documents (cf, http://www.cfsan.
fda.gov.____): (1) Guidance for Industry: Preparation of Premarket
NotiWcations for Food Contact Substances: Chemistry Recommendations; (2) Guidance for Industry: Preparation of Premarket NotiWcations for Food Contact Substances: Toxicology Recommendations;
and (3) Draft Guidance for Industry: Preparation of Premarket NotiWcations for Food Contact Substances: Administrative. NotiWcations
are prepared on FDA Form 3480.
25
FD&C Act. 409(a), 21 U.S.C. 348(a).

ably expected to become a component of food under the


conditions of its intended use. A solid basis for adopting
a no migrationno 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 diVusion 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.26
A key question has been what constitutes no migration, i.e., must there literally be no migration or is an
insigniWcant amount of migration permissible? This
question received considerable attention in the case of
Monsanto v. Kennedy. 27 Monsanto arose from FDAs
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 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 Wled
petitions for review of the Agencys 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 substances presence in
food can be predicted on the basis of a meaningful projection from reliable data.28 The court rejected FDAs
contention that mere contact between food and its container made the container a food additive. Instead, the
court stated that:
26
For more information on diVusion theory and methodology, see
Baner, A., Brandisch, J., Franz, R., and Piringer, O.G., The applications of a predictive migration model for evaluating the compliance of
plastic materials with European food regulations, Food Additives
and Contaminants, 13(5), 587601 (1996); Limm, W. and HolliWeld,
H.C., Modeling of additive diVusion in polyoleWns, Food Additives
and Contaminants, 13(8), 949967 (1996); Lickly, T.D., Breder, C.V.,
and Rainey, M.L. 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, 406417 (1995).
27
613 F.2d 947, 955 (D.C. Cir. 1979).
28
Id. at 955.

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

Congress did not intend that the component requirement of a food additive would be satisWed by a
mere Wnding of any contact whatever with food . For
the component element of the deWnition to be satisWed,
Congress must have intended the Commissioner to
determine with a fair degree of conWdence that a substance migrates into food in more than insigniWcant
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 insigniWcant 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 insigniWcant. This was aptly
explained in a 1974 statement from the OYce 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: Wrst, 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
suYcient 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
1.3.3. 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 deWnition of a food additive subject to
FDA review. This functional barrier doctrine, already a
29

Id. at 948.
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 Wle with author) [hereinafter Hutt
Memorandum].
30

103

well-established, though unpublished, FDA position,32


received judicial conWrmation 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 foodpackaging 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 aYrmed the district
courts 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 signiWcant 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.
1.3.4. GRAS substances
GRAS substances, as noted above, are also excluded
from the regulatory impact of the food additive deWnition. A producer may market any substance generally

32
See, e.g., Letter from Frederick A. Cassidy, FDA, to Jerome H.
Heckman (June 9, 1965) (on Wle with author). Perhaps the Wrst 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. Suppl. 794, 798 (D.
Mass. 1975).
36
Id.

104

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

recognized as safe by qualiWed experts without FDA


approval or notiWcation.
In light of the FD&C Acts silence on the question of
procedures for determining whether a substance should
be classiWed as GRAS, and the admitted incompleteness
of FDAs oYcial list of GRAS substances,37 it is the initial responsibility of the manufacturer to determine
whether a substance he manufactures is GRAS for any
speciWc 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 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 qualiWed experts and
the scientiWc literature. Obviously, should FDA consider
a manufacturers 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 FDAs conWrmation and have his product placed on FDAs published
GRAS list could Wle a GRAS AYrmation Petition.
FDAs formal acceptance for Wling of such a Petition
amounted to a prima facie Wnding 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 AYrmation Petitions (they
are not required or even provided for under the basic
statute) but will, instead, accept notiWcations that will
become eVective 90 days after they are submitted
unless FDA objects to the claimed GRAS status. Substances aYrmed 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
37
See 21 C.F.R. Parts 182, 184, 186 (1997) (setting forth FDAs 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


aYrmed 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 Wnding that a given speciWed use of
the substance deemed exempt amounts to a Wnding that it can be considered generally recognized as safe for the prescribed use.

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 signiWcant increase in the
level of dietary exposure.39
1.3.5. 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 FDAs
regulations or Wles.
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
1.3.6. Housewares exemption
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 Xows from the
legislative history of the 1958 Amendment to the FD&C
Act. FDA has written many letters aYrming this exclusion albeit it has also seemed to snipe at it from time to
time. Nonetheless, the Agency does not purport to
require Food Additive Petitions for housewares applications such as empty containers, utensils or appliances
sold to consumers for home use.
1.3.7. Mixture doctrine
The mixture doctrine permits a manufacturer to physically blend two diVerent polymers or other combinations of substances if all are cleared by FDA or are
exempt in some way (GRAS, prior sanctioned, a nonmigrant, 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
39
40

See note 37. 184.1(a).


See 21 C.F.R. Part 181.

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

polymers A and B are 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.
1.3.8. 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 Wrst 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 Wrst 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 signiWcant 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 FDAs
polymer regulations. At a question and answer session
during a meeting of The Society of the Plastics Industrys Food, Drug, and Cosmetic Packaging Materials
Committee, Assistant Director for Regulatory Programs
Ramsey and Dr. Joseph McLaughlin of the Bureau of
Sciences 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. McLaughlins
response was described in a letter to the SPI Food Packaging Materials Committee that is now a part of the regulatory history as the Wrst 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 deWnition is intended to include
such essential components employed at the polymerization stage.42
This basic polymer doctrine received further conWrmation 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 didnt 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 signiWcant 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 signiWcant 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 manufacturers 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
42

See id.
See Indirect Food Additives Conference, supra note 39, 20203. Dr.
Ramseys Wnal observation about catalysts being listed based on a petitioners 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.
43

41
See Letter from Jerome H. Heckman, Keller, and Heckman, to SPI
Food Packaging Materials Committee (Dec. 28, 1966) (on Wle with author). Dr. McLaughlin conWrmed his statement regarding the deWnition of a basic polymer after the meeting, and, prior to its mailing,
the letter from Mr. Heckman was reviewed by Messrs. Ramsey and
McLaughlin.

105

106

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

materials and Wnished 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 diVerent manufacturers may
make it by diVerent processes. It is possible, of course,
that a speciWc polymer may be characterized, and thus
separately deWned 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 diVerent 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 speciWc clearance
like other food-contact substances.
1.4. The Food and Drug Administration Modernization
and Accountability Act of 1997Back to the future where
notiWcations 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 eVect other
changes that would make clearance of food additives
more rapid and responsive to industrys 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
eYciently 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 notiWcation system
for indirect additives to make petitioning unnecessary in
the ordinary case. In eVect, 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 notiWcations which became eVective

automatically in 90 days after Wling unless FDA had a


sound reason to object to a notiWcation. The objective
here was to do away with the 23 years FDA was requiring for action on Petitions.
As the legislative situation developed, there was considerable diYculty with the food industrys positions on
industry Wnancing of petition processing and its other
interests but there was essentially no signiWcant opposition to the notiWcation idea for indirect additives. Thus,
in 1997 Congress Wnally passed The Food and Drug
Administration Modernization and Accountability Act
and included in it a form of the notiWcation concept.
There were a variety of compromises that became necessary during the legislative process but at the end of the
day Congress passed a notiWcation proviso that now permits new indirect additives to be used by a notiWer 120
days after a notice has been Wled with FDA unless serious objections are raised by the Agency to the notiWcation. The clearance thereby obtained is proprietary but
not exclusive in that others can use much of the data
submitted to Wle similar notiWcations 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 notiWcations do become eVective 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.
1.4.1. NotiWcation 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 eVective at this time. The Pre-Market NotiWcation system
now mandated by Congress in the Food and Drug Modernization and Accountability Act of 1997 eVectively
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 Pre-Market NotiWcation.
The FDA Form 3480 is used to prepare and submit
Food Contact NotiWcations and FDAs 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
needed to be in a food additive petition, and what is now
required in a notiWcation follows.
44

See note 24, supra.

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

1.4.2. Identity of the food additive


A food additive petition or notiWcation requires
detailed information about the identity and composition
of the substance of interest and how it is made. The petition or notiWcation 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 identiWcation section of the notiWcation asks for (1) a description of the processes by which
the product is manufactured; (2) a list of all raw materials; and (3) the speciWcations for the raw materials in the
Wnal product. A Wling should also include test methods
used to verify speciWcations for the raw materials and
the Wnished products. In the case of Wnal product speciWcations, data from several batches of the product showing compliance with the speciWcations are also required.
Much of this information is often of the trade secret
variety and, as such, will be kept conWdential by the
Food and Drug Administration but generally must be
supplied so that FDAs reviewers can have a complete
understanding of the substance under consideration.
1.4.3. 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 FDAs acceptable daily intake
(ADI),45 the notiWcation will encounter no diYculty. 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
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
45
The acceptable daily intake is the maximum daily intake of a substance (e.g., a food additive), in mg/kg of body weight/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 speciWcally, what FDA does is to take the no-observable eVect 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.

107

intake of more than 1 ppm of the substance in the total


daily diet. Finally, when there are 2-year feeding studies,
FDA sets the ADI for a substance by applying a 100fold 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 conWdent with the resulting NOEL and
thus applies a much lower safety factor.
NotiWers 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 products conditions of intended use
should include identiWcation of the type of food-contact
articles (i.e., bottles, Wlms, 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 speciWc protocol for determining the extent
to which components of the product are likely to migrate
to food in various applications.
Unless diVusion 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
foodstuV, a notiWcation must present the results of
extraction studies conducted under the conditions that
reXect 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 speciWc types of materials (consumption factors), and, for each of these materials, the relative amounts of diVerent 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 Wrst determine the amount of
the material that the extraction or diVusion 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), diVusion studies, or by
assuming 100% migration of the material into contacted
food. Next, the measured or calculated migration values
for the diVerent food-simulating solvents expressed in
parts per million (ppm) in the solvent (food), assuming
10 mg 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 FDAprescribed consumption factor for the polymer(s) of

108

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

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 3000gm 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/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. Second, 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 substances
ADI as determined by FDA.
1.4.4. Intended technical eVect
With regard to the products intended technical eVect,
FDA generally expects that a notiWcation 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 it is necessary
to set forth all the useful properties of the product.
Legally speaking, the Agency has no power to demand
data to show the eYcacy 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 aYrmative Wnding that granting the petition
will clear the sale or use of an additive that will be used
to deceive consumers.48

46

Id.
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, and 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,
Autust 18, 1958, U.S. Code, Congressional and Administrative News,
Vol. 3 at 5306. Memorandum Does FDA Have the Power to Demand
EYcacy Data to Clear Food Additives? (1999) (on Wle with author).
47

1.4.5. Analytical method for material


NotiWers are expected to provide an analytical procedure for identifying the subject material and assuring
compliance with any applicable restrictions. The notiWcation must also contain the information necessary to
show that the method has been properly validated.
1.4.6. Safety of the additive
Depending upon the identity and quantity of any
material expected to migrate, a toxicology proWle 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 ppb, no data are required to establish safety. If the
intake is estimated to be greater than 0.5 ppb, but less
than 50 ppb, FDA will only require speciWed 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.
1.4.7. Environmental assessment
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 eZuents (i.e., atmosphere emissions, aquatic
release, and 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 conWdential 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
49

See 21 CFR 25.32 (i)(j); 62 Fed. Reg. 40,595 (1997).

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

food-contact applications. (The Agency will protect the


conWdentiality of these data to the extent permitted by
the Freedom of Information Act50 requirements.)
The history and operating characteristics of the Food
Administrations regulation of food packaging has been
summarized in the foregoing paragraphs. The system has
been signiWcantly simpliWed by the Food Contact NotiWcation legislation so that clearances can now be obtained
in a well deWned time framework. It should be noted here
that FDAs 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
Agricultures Food Safety and Inspection Servicethe
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 Treasurys Bureau of Alcohol, Tobacco, and Firearms. Finally, the way in which
food packaging materials are dealt with in the United
States is of signiWcance in the rest of the world and in
world trade. As a result, most other countries consider it
important to consider US clearances so the FDA regulatory procedures are a subject of interest and signiWcance
in the global marketplace of today.53
50
Freedom of Information Act [CodiWed 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 7 that
FDAs 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, DC (June 2122, 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
RegulationUnited 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).

109

2. Book II: Food Packaging Regulation in the European


Union54
2.1. 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 signiWcant 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 diVered 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 Wrst
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 speciWcally, 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 eight 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, speciWc to each of
the major polymers or applications. Obviously, this
approach diVered 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 inXuence of the
interested oYcials of the times, work was started in the
54
Cf. Baughan and Montfort, Food Contact Materials: The View
from the European Union, Packaginglaw.com. Very useful Web Pages
for Wnding the European Directives and Regulations, including some
proposals are: http://europa.eu.int/comm/food/food/chemicalsafety/
foodcontact/documents_en.htm, http://europa.eu.int/comm/food/food/
chemicalsafety/foodcontact/legisl_list_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.

110

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

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 diVerences 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 60s; 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 5060 mg/kg or 810 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 eVect, set up a criterion for listing that had some basis in toxicological
knowledge and lore. The Committee theorized that a
man weighing 60 kg would eat about 1 kg 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 Councils
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
diVerences among nations could not be resolved. However, in the later 1960s, the European Commission asked
56
The Council of Europe is a supranational political body with representation from over 43 countries. The aim of the organization was 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 speciWc 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 Destineees a Entrer en Contact avec Des
Denrees Alimentaires. (1982).

a German expert, Dr. Rudi Franck, to lead a new eVort


to harmonize packaging materials regulation. At the
time, the members of the Community were Belgium,
France, Germany, The Netherlands, Italy, and Luxembourg. Unfortunately, Dr. Francks eVorts 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 Nordwijk
(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 speciWc Directive on plastics. They
concluded that the speciWc 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 eVect 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 speciWcally, 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 conXict of interest questions.
In 1976, the Wrst Framework Directive, prepared by the
Commission in close collaboration with the nine Member States, 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
58
Dr. Rossi is now a full time employee of the Commission. His oYcial aYliation 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 Authoritys ScientiWc Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (EFSAAFC) on all matters related to health risk assessments.

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

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 ScientiWc
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 Wxed as a measure of
inertness and to minimize the toxicological problems,
i.e., the concept of an assured 60 parts per million maximum daily intake level. Later in 197374, 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 oYcials to be
recruited or employed by the European Union to work
on packaging matters.)
Finally, in 1990 the Wrst 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.

59
Directive 90/128/EEC of 23 February 1990 concerning plastic materials and articles intended to come into contact with foodstuVs (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.

111

2.2. The framework directives and the directives adopted


thereunder
2.2.1. The framework directives
The premise for the Wrst packaging materials Framework Directive (76/893/EEC) was that diVerences
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 aVect 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 ParaYn and microcrystalline
waxes. In point of 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 speciWc directives that
had been adopted under the earlier framework and indicated the system should be retained. It also indicated the
intent to have the ScientiWc Committee for Food continue to consult on speciWc 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 foodstuVs, must be suYciently stable not to transfer substances to the foodstuVs
in quantities which could endanger human health or
bring about an unacceptable change in the composition
of the foodstuVs or a deterioration to the organoleptic
properties thereof .
The Framework Directive now in eVect (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 Parliament and Council have
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 foodstuVs.

112

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

now agreed on a new Framework Regulation (Interinstitutional File 2003/0272) (7781/04 UnoYcial) that will be
published in October of 2004, and will replace the 1989
Directive. First, it should be noted that the new Regulation is being promulgated as a Regulation, rather than
as a Directive, so that it will be immediately in force in
all 25 EU Member States 20 days after it is published in
the OYcial Journal of the European Union. It also
changes the European pattern so that the Commission
can now adopt as speciWc 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 eVective immediately and
will no longer need to go through the cumbersome stateby-state implementation process to be eVective.
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 speciWc EU directive or regulation, and
no longer exempts food contact materials destined for
export outside of the EU from the regulations. 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 conXicting national measures. The export
provision is gone because of the European Parliaments
fear that such provisions can result in bad products
being dumped on developing countries.
More speciWcally 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 Wnished 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 conWrms 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 deWnitions beginning
with deWnitions 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 mate61
The new language can reasonably be expected to contact food is
not equatable 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.

rials 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 aVect organoleptic characteristics of
foods nor mask spoilage. A labeling provision, presumably to inform consumers that such packaging has been
used for a speciWc food, is also set forth.
Article 5 is the enabling clause for the speciWc measures aimed at listing authorized materials and articles
and providing any special conditions or limitations on
their use. It authorizes the use of speciWc migration limits
(SMLs) and overall limits (OMLs); and the promulgation of rules to check on compliance, sample collection,
record retention, and labeling for active and intelligent
packaging. Most signiWcantly, it authorizes the Commission to maintain a register of authorized materials, and
the adoption of speciWc 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
recycle may be authorized by case-by-case evaluations
and registrations instead of listings in general
regulations.
Article 6 notes the role of the European Safety
Authority and the requirement that it be consulted prior
to adoption of any safety measure. Article 7 sets forth
the fact that anyone can seek an authorization for a substance but before listing there must be proof of safety.
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 sets a six month deadline requiring the
authorizing authority to advise the applicant as to
whether his Wling 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 identiWed as
conWdential.

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

Article 10 discusses authorizations that take place in


the form of adoption of a speciWc measure, requires an
explanation of any diVerence in the authorization that
the Commission occasions as regards the recommendations of the authority, and requires that the applicant be
notiWed if the Commission decides against a speciWc
action. It also requires that anyone using the authorized
substance immediately inform the Commission of any
newly acquired scientiWc information which might aVect
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 aVect the general civil or criminal liability of any business operator in respect to the
authorized substance, or its use in a consumer product.
Article 11 deals with modiWcations 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 modiWcation
action necessary. Article 12 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 13
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
14 was omitted by transfer to another article.) Article 15
orders that all materials and articles be labeled or otherwise identiWed so that traceability can be accomplished.
Article 16 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
States assertions.
Articles 1726 are housekeeping provisions dealing
with the need for public access to information, conWdentiality, 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 eVective date of the Framework Regulation
20 days after its publication. Article 18 deals with the
preservation of data conWdentiality and the need to justify requests for such treatment by specifying what competitive position and interests justify non-disclosure.
2.2.2. The monomers directive
Simultaneously with the Wrst Framework Directive in
1976, the Commission developed a draft of a Directive

113

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 signiWcant 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 Wled by any applicant.
After 1990 when the Monomers Directive was Wnally
unanimously adopted, twenty-two additional list(s) of
monomers and additives for food contact materials
were issued by the ScientiWc Committee for Food (until
they stopped being the designated authoritative body in
2002) and, as of October 2004, Wve more such lists have
been issued by the successor European Food Safety
Authoritys ScientiWc 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
SpeciWc Migration Limit (SML) proviso. These limits
are imposed as a function of food so that, for example,
Polymer X may be used but only provided it does not
lead to migration into any packaged food that exceeds Y
62
Directive 2002/72/EC of 6 August 2002 relating to plastic materials
and articles intended to come into contact with foodstuVs.

114

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

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 speciWc migration limit imposed.
The contention has been made that some products
violate an SML when a polymer is used to make Wlms 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 Wlm 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 Wnished packaging material, i.e., as a residual monomer by weight of the Wnished 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.
2.2.3. 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 FoodContact Materials Working Group (FCM-WG) of the
European Food Safety Authoritys (EFSAs) ScientiWc
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 that the EFSA issues a
written justiWcation. Requests to the petitioner for additional information to support the petition also may sus63
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.

pend 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 notiWcation (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 signiWcant diVerence 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,
FDAs 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 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 coeYcient 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.
2.2.4. 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
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).

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

intelligent materials and articles intended to come into


contact with foodstuVs,and the use of recycled materials. The Super Regulation document, anticipated to be
Wnalized sometime in 2006, 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 Wnalized 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 Weld of application to
plastic multi-material multilayers, (b) introduce the concept of functional barriers for materials which cannot 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/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 new speciWc 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 oYcials, 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.
2.2.5. Super regulationprovisions 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 diVerent 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

115

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 eYcacious under real conditions of
use, and their use must not mislead consumers as to the
foods 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.
2.2.6. Draft super regulationthe record keeping
provisions
The new requirements for extensive record-keeping
has raised some concerns in industry. There is no disagreement on the keeping of records and making them
available for oYcial 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 conWdential information that is not relevant to product safety.
2.2.7. 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 foodstuVs 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 foodstuVs 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.
2.2.8. Draft regulation on recycled plastic materials
This new draft, released simultaneously with the
active and intelligent packaging proposal, also looks

116

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

towards proprietary authorizations, this time of recycling processes that lead to the use of recycle 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.

2.3. The free movement of goods: The principle of


mutual recognition

2.2.9. Regulatory exemptions


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
Wnished 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, recycle 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 there 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.

2.3.1. 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 eVects 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
justiWed 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 sit 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 eVect, 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.

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 eVect, i.e., technical
barriers to trade.

2.3.2. 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
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.

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

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 States 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
market.
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 foodstuVs, the Commission provided that the
single market for foodstuVs 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:
1. 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

67
European Court Reports 1979, p. 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 foodstuVs.

117

2. 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 Wnished 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 fulWll 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 speciWc 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 beneWt from mutual recognition
within the whole internal market.
2.3.3. Mutual recognition: The exceptions
The Court has had many occasions to reWne 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 clariWed 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
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.

118

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

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 scientiWc 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 scientiWc uncertainty.
(3) From a procedural standpoint, the Court has recognized that to the extent that uncertainties continue
to exist in the current state of scientiWc 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 justiWed 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).
2.3.4. 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
70
Council Resolution of 28 October 1999 on mutual recognition
(2000/C 141/02), OJ C 141/5 of 19 May 2000.

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.

3. Book III: Commonalities, diVerences, conclusions,


and harmonization
3.1. A comparison of data requirements in the United
States and Europe and the use thereof
At Wrst blush it might seem to many that the data
requirements for food contact materials clearances in the
United States and in the Europe are essentially the same,
there being only minor diVerences in the toxicological
and analytical data submitted at various times in the
process of obtaining clearances. The fact is that the
diVerence 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 PetitionRegulation process, as well as now under the Pre-Market
NotiWcation program, extraction data, or calculations
that validly indicate migration levels, are a sine qua
nonfor 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 g/in.2 of surface, i.e., a 101 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 notiWer 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 notiWer 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 2-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,

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

the Regulation issued would then indicate the speciWcations for the material and its intended use. Under the
NotiWcation system, the speciWcations 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 he need do is make certain he is purchasing
materials that comply with the regulatory speciWcations
and his 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 101 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 SpeciWc 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 to be noted here 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 diVer 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 NotiWcation. 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 neces-

119

sary, 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 diYcult 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 gloriWes 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
Pre-Market NotiWcation 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.
3.2. Toxicological insigniWcancean 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
Food and Drug Administration, 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, in 1966, Dr. John P. Frawley, a
former FDA toxicologist, and Lehman protg, indicated at a meeting of the American Chemical Society
held in New York on September 14, 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

120

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

level of 40 ppm or less.71 He based his recommendation


on a survey of 220 chemicals which had been the subject
of 2-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
deWne the degree of control. The amount of attention
devoted to each problem should be in relation to the
hazard. To distribute our limited eVorts on any other
basis is a form of gambling with public health.
Unfortunately, in this decade of doubt, the scientiWc
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 InsigniWcant 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
71
Frawley, J.P. ScientiWc Evidence and Common Sense as a Basis for
Food-Packaging Regulations, Food Cosmet. Toxicology, 5, pp. 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 Wrst 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, pp. 252
(1990).

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 the Food and
Drug Administration, noted in another paper that he
and his staV had reviewed more than 1800 short-term
toxicological studies and found that acute eVects 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 eVects below 1000 ppb,
and that all Wve of these chemicals were pesticides. The
paper was a major premise for FDAs 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 rulemaking proposal and because of the Delaney Clause in the
United States.
Then, in 1999, Mitch Cheeseman, Ed Machuga and
Alan Bailey of the Food and Drug Administration published their article entitled A Tiered Approach to
Threshold of Regulation.76 In this paper, the eVect of
taking into account structure/activity, genotoxicity, and
short term (LD50) data were 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. Renwick, A.G., 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
74
Rulis, A., Threshold of Regulation: Options for Handling Minimal Risk Situations, in Food Safety Assessment, edited by Finley,
J.W., Robinson, S.F., and Armstrong, D.J., American Chemical Society
Symposium Series 484, pp. 132139, 1992.
75
60 Fed. Reg. 136 (pp. 3658136596)
76
Food and Chemical Toxicology 37 (1999).

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

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 the Food and
Drug Administration recognized the evolution that had
taken place, and the fact of toxicological insigniWcance
when the the Food and Drug Modernization and
Accountability Act of 1997 was passed, and put the PreMarket NotiWcation system into place in the United
States.
3.3. Comparative analysis and conclusion
The European and United States regulatory concepts
diVer not only in detail but in fundamental approach so
harmonization will require much more than the polishing of some Wne 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, US approach gives
considerable credibility to the Paracellsian idea that the
dose makes the poison so that toxicological justiWcation is not needed, or is greatly minimized by exposure
assessments, while the European approach starts from
77

Food and Chemical Toxicology 42 (2004).

121

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 scientiWc 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 signiWcant 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 diVerences. 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 Wling of premarket notiWcations of the type used in the United
States since 2000. This system allows for speciWc 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 notiWcations, or some
similar case-by-case treatment, evaluations can proceed
on the basis of the facts presented to the regulator in a
very speciWc way for a clearly deWned material and set
of use circumstances. The notiWer 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 Wnd 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
notiWcation or registration become eVective 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

122

J.H. Heckman / Regulatory Toxicology and Pharmacology 42 (2005) 96122

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 notiWcation or registration system is to
be used for active and intelligent packaging, and the
use of some of the recycle, 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 notiWcation or registration system, or make some changes to compatibilize
its regulatory policies 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 inXuence
governments in Asia, Africa, and South America to
conclude that they do not need to develop additional
divergent systems.