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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.
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
2
See Lehman, A.J., Food Packaging Materials, XX Q. Bull. Assn
Food and Drug OYcial of the U.S. 159, 160 (Oct. 1956).
97
98
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.
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.
99
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
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
102
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
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
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 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
107
108
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
109
110
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
112
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.
113
114
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).
115
116
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.
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
118
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
120
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
121
122