QUESTIONS FOR DISCUSSION BY THE
FOOD AND DRUG ADMINISTRATION PANEL
Prepared For
Special Meeting of The Society of
the Plastics Industry's Food
Packaging Materials Committee
Shoreham Hotel, Washington, D.C.
December 14, 1966

The following questions were prepared on the basis of
suggestions made by the members of the Food Packaging
Materials Committee of The Society of the Plastics industry.
It is anticipated that this list of questions, which is
being supplied to the Food and Drug Administration in advance,
will provide the basis for all discussions at the Special
Meeting of the Food Packaging Materials Committee to be held
on December 14, 1966.
All members of the Committee who plan to be in atten­
dance at the December 14 sessions should familiarize them­
selves with the questions posed so that, if subsidiary
extemporaneous questions are posed at the meeting, they will
be- raised in connection with discussion of the most appropriate
question set forth below.
it is to be understood that the
Chairman of the Food Packaging Materials Committee may have
to limit the asking of additional extemporaneous questions
in light of time considerations.
Question No. 1
As the Food and Drug Administration is well aware, one
of the most vexing problems faced by almost every packaging
material supplier or producer relates to the so-called
"no migration" or "no extraction" concept.
Under the law,
it is recognized that substances which "may not reasonably
be expected to become components of food" are not really
"food additives".
However, there are many situations which,
from a practical point of view, demand obtaining Food and
Drug Administration confirmation of "non-additive" status
to satisfy the packaging industries' customers.

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At one time, this need could be met rather simply by
corresponding with the Food and Drug Administration,
supplying such extraction or other data as might appear
appropriate, and then eliciting an FDA opinion as. to
whether a substance, in a given intended use, would or
would not be considered a food additive under the "may
not reasonably be expected to become a component of food"
criterion.

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Since about 1961, generally speaking; wa understand that
the policy of the Food and Drug Administration has been to
refuse to give so-called "no migration", "non-additive"
letters which might be used to assure customers of satis­
factory status.
This has, in a number of cases, led to
petitions and regulations governing what would really
appear to be "non-additives" within the meaning of the law.
With this background in mind:
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a.
in what situations may so-called "no migration",
"non-additive" letters still be obtained upon the
filing of a proper request and any necessary associa­
ted data?
b.
is the Food and Drug Administration giving any
new. thought to this over-all problem and, if so,
'have there been any changes in the so-called
"no migration" policy, or are any to be anticipated
in the near future? How may we best keep abreast
of shifts in FDA thinking along these or related
lines?
Question No. 2
In the past we have been advised that the Food and
Drug Administration does not consider components of printing
inks food additives in the absence of any indication that
the inks are likely to leach from the outer surface of a
wrapping material to foods.
Under what conditions may it
be assumed now that the Food and Drug Administration position
remains the same as to printing inks and components thereof?

F.C

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Questiqn No. 3
At the recent American Chemical Society Symposium
on Safety Evaluation of Coatings and Plastics for Pood
Packaging, Dr. Frawley concluded that "any coating material
at a level not exceeding 0.2% by weight is generally recog­
nized as safe, provided it is not a heavy metal or pesticide."
What is FDA * s thinking on this matter? Does FDA plan to
pursue this approach at all in dealing with minor indirect
additives, or are other approaches under consideration to
alleviate the problems and confusion with respect to these
minor food packaging components?
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Question No. 4
On many occasions it seems likely that scientific
personnel in the Food and Drug Administration's Divisions
of Food Standards and Additives and Toxicological Evaluation
might well have questions* or desire minor clarification,
as regards data submitted in a food additive petition.
When
this occurs, are the scientific personnel in these Divisions
free to communicate directly with petitioners concerning any
such questions? May the petitioner feel free to communicate

with personnel in the Divisions to determine whether or not
such questions exist, and to obtain definitive and authori­
tative first-hand reactions to the data submitted in a
petition?
Question No. 5
The following questions relate to the status of a food
packaging material component when there is in existence some
form of approval for use of the substance as a direct food
additive.
It is recognized that a variety of situations can
be presented when this set of basic circumstances is involved.
a.
Is it safe to assume that, if a substance is listed
. as "GRAS" in Section 121.101 of the Food Additive
Regulations, applicable to intentional food additives,
it may be used as a packaging or processing material
component without the necessity for any additional regu­
lations? In answering this question, assume that the
use as a possible indirect additive will not result in
any addition of the substance to foods greater than would
be permitted in direct additive use.
EC 31,21

b.
If a material is covered by a conventional direct
food additive regulation (without narrow limitations),
may it be assumed that it can be used as a packaging
material component without the necessity for additional
regulations.
c.
Suppose a direct additive regulation exists (again
without narrow limitations), based upon a petition by
one company.
Suppose another company subsequently
submits a petition for an indirect additive regulation
for the same chemical, complete except, for the omission
of toxicological data, but incorporating by reference,
sight unseen, the toxicological data on which the direct
additive regulation is based.
Will PDA grant the petition and promulgate the proposed
indirect additive regulation?
Questibn No. 6
The following questions are asked with reference to
the possibility of eliminating extraction studies in certain
special "indirect additive" situations:
. a.
Suppose a company submits a petition for an indirect
additive regulation proposing use of a component for
specific packaging applications and, in so doing, reason­
ably estimates the portion of the diet that may be
packaged in material employing the component.
Suppose
further that the data in the petition or otherwise
available shows that, under the intended conditions of
use, even if all of the additive were to migrate, the
level of addition of the regulated substance to food
■ would be safe.
Is there any need to undertake migration
studies or file extraction data in such circumstances?
Assume that a company wishes to have a substance
b.
added to an existing regulation such as the one govern­
ing can enamels.
In filing the petition, the company
submits toxicological data showing that as much as
50 ppm of the substance would be safe should this amount
migrate to food from a can enamel formulation.
Is it
necessary for the petitioner to submit extraction data

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in addition to the toxicological studies if he is willing
to have his substance regulated under the 50 ppm maximum
extraction criterion already established in the can
enamel regulation for all other components?

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Question No. 7

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Prior to the early days of the Pood Additive Amendment,
in designing extraction studies and evaluating the results
thereof, the volume-to-surface ratio most often employed
was 2 to 1, or 2 ml. solvent per sq. in. of area,
in
promulgating Section 121.2514 of the Regulations — the
so-called "can enamel" regulation — the Food and Drug
Administration moved to the somewhat more realistic approach
of using a 10 to 1 volume-to-surface ratio and clearer
specifications as to varying intended conditions of use.
Recently, there appears to have arisen some confusion as to
which of the ratios, or what other ratios, should be applied.
For example, there appears to be some FDA thinking in the
direction of a return to the 2 to 1 ratio.
a.
What are the reasons for the changes in FDA
thinking in this area if, indeed, the thinking has
changed?
b. Where the nature of the intended use of a given
indirect additive can be fairly accurately defined
by a petitioner, will the Food and Drug Administration
consider evaluation of the 'petition by reference to
actual volume-to-surface ratios anticipated, ’ disregard­
ing the 2 to 1 or 10 to 1 "rules of thumb"?
*
Question No. 8
A company is manufacturing a paperboard container for
use in contact with aqueous and fatty foods. All the
ingredients are cleared under Section 121.2526, with all
but one minor ingredient included in paragraph (a) where no
extraction test is required.
However, with the one ingredient
listed in paragraph (b), the extraction test must be run.
It is,, and net corrected extractives of 0.6 mg./ sq. in.
(i.e. 0.1 mg./sq. in. over the regulatory limit) are found.
.What does the company do?

EC

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Question No. 9

Several regulations in Subpart F refer to “basic
polymers" or "base polymer".
What is meant by these terms?
>
Question No. 10
In many of the food additive regulations it is provided
that a regulated substance may be used with, or made with
other adjuvant substances including "substances permitted
for such use by applicable regulations".
In trying to
determine when a collateral regulation is "applicable" so
that the substances cleared under it may be used with other
materials without requiring further regulations, what is
FDA's position on the following situations:
a.
Suppose one wishes to use one of the adjuvants
listed in the acrylics regulation. Section 121.2591,
in a polyolefin formulation.
Under what circumstances
would this be appropriate without recourse to the
filing of a new petition?
b.
Suppose a polymer is "prior sanctioned" or "GRAS",
or is regulated under a provision such as that for
nylon resins (Section 121.2502), where no adjuvants are
listed.
Is it permissible to use with such a resin
selected adjuvants listed under such regulations as
the one for "resinous and polymeric coatings for poly­
olefin film" (Section 121.2569)? in other words, may
it be assumed that the listings of resinous and poly­
meric coatings for polyolefin film is, in a practical
sense, "applicable" so that the materials listed in
that regulation can be employed in conjunction with
other resins?
c.
If the response to these questions is that, in both
cases, the use of an "adjuvant" listed as satisfactory
for use with one polymer may not be used with others
under the "applicable regulation" doctrine, what is
the rationale for not permitting such cross-referencing,
and how may petitioners be guided in deciding whether
or not a regulation is truly "applicable" or not?

Question No.

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What prevents FDA from developing more of the functional
type regulations (e.g., 121.2541 - Emulsifiers and/or
surface active agents) with broader applications, whereby
approval of a substance for a functional use covers packag­
ing materials generally?
Question No. 12
Subpart F of the food additive regulations has become a
large catalog of food packaging and equipment components
used in broad and specific applications.
Does FDA have any
plans to revise Subpart F by simplifying, consolidating,
clarifying, deleting, or making the regulations more uniform?
If so, how and when will this be accomplished ?
Question No.

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Experiences have varied as to arranging for discussion
and review by FDA of analytical and toxicological results
prior to the filing of a petition.
What does FDA .now
recommend to the potential petitioner to make such meetings
most meaningful? How can such preliminary work be under­
taken effectively to obviate the possibility of a later
demand by FDA that a petition be "withdrawn without prejudice"
due to a need for additional studies or data never previously
requested?
Question No. 14
In a paper delivered at a recent American Chemical
Society Symposium, an FDA spokesman stated that a petitioner,
for a food additive regulation must provide "proof that the
additive has a bona fide function in relation to'the Amend­
ment", and that there: must be "adequate proof that the
additive is safe and effective under a given set of conditions.
What is the legal basis-for the Food and Drug Administration's
apparent requirement for*proof of efficacy of an incidental
food additive? Please explain what interest the Food and
Drug Administration might have as to whether or not a component
of a food packaging material performs its intended function
in a package, assuming, of course, that the additive is not
intended to migrate to foods.

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Question No. 15

Are FD&C certified colors permitted as components of
food contact articles provided they do not color the food
with which they are in contact in any way that is "visible
to the naked eye"?
Question No. 16
Generally speaking, it has been the custom in the
plastics and other industries to use inorganic pigments
on a "no migration" basis. More specifically, industry
has generally taken the position that unless an inorganic
pigment used in a plastic has measurable extraction in
amounts greater than 10 ppb, it may be considered a "non­
additive" requiring no formal regulatory coverage.
Is
this a sound position for industry to take where inorganic
pigments are concerned?
• Does FDA presently have in mind, or have under active
study, any criteria for the use of pigments or dyes in
packaging materials? Any other comments on the general
question of pigments and dyes in packaging applications
would be welcomed.

EC