This document discusses the increasing regulatory requirements and risks around flexible food packaging. It notes that brand owners are demanding more testing and transparency from suppliers to ensure packaging safety. Material suppliers must understand how their products will be used and potential hazards to determine if they are suitable. The document also summarizes key regulations for food packaging in the US and EU and discusses approaches for determining if a product is suitable for a given use in the absence of specific regulations, including understanding the product formulation, end use conditions, potential migration, and risk assessment.

1. The Current Regulatory and Risk
Landscape for
Flexible Food Packaging
White Paper
Ashland Specialty Ingredients, Adhesives
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2. Overview
Requirements for food packaging safety are becoming
increasingly stringent. Brand owners and material suppliers
are being pressured to guarantee the safety of their packaging
by non-governmental organizations, grassroots consumer
advocates, and even the media. Brand owners are, in turn,
pressuring the supply chain to conform to negative lists –
chemicals that brand owners have declined to use – despite
those products holding government approvals. Companies
are also asking supply chain vendors to demonstrate safety
through testing and migration studies, as well as by providing
highly detailed formulation disclosures. Some brand owners
and converters have requirements that hold packaging
and ingredient suppliers to the same standards as food
manufacturers, mandating Good Manufacturing Practices
(GMP) or Hazard Analysis Critical Control Point (HACCP)
procedures even though these efforts may not be required by
regulation. Today, simply obtaining a packaging compliance
letter from a raw material supplier, or assuming that the
package construction will prevent chemical migration, is not
enough.
Material suppliers must be cognizant of the potential hazards
their products may bring to the food packaging supply chain.
Suppliers must understand the risk profile of their products
for their customers’ end uses. This can only be done by
knowing the components of the raw material supply chain,
their conditions of use, the types of food to be packaged,
and the migration potential of the packaging components. If
a packaging supplier understands these elements, they can
understand the risk profile of their product and can make a
determination as to whether their product is fit for its intended
use.
Flexible Packaging and its Relationship to Food
Packaging Regulation and Risk
Flexible packaging currently has the highest global growth
rate of all packaging options. Unlike rigid packaging, flexible
packaging typically requires fewer materials that weigh less,
so it can be cost-effectively manufactured and shipped.
Material innovations are yielding more sustainable solutions,
including down-gauging, which leads to lower cost and
greater downstream packaging equipment efficiencies. Energy
costs are significantly lower at each stage of the supply chain
compared to other packaging options.
This rapid growth and innovation in flexible packaging has
given rise to new challenges and potential safety risks born
out of new chemistries and material combinations outpacing
hazard data development and regulation. This is readily
observed with newer technologies that rely on technologies
such as ultraviolet (UV), electron beam (EB), and, more recently,
UV light-emitting diode (LED) radiation-curable materials.
Efforts to decrease weight and cost through film down-
gauging has resulted in thinner barriers to prevent migration.
Brand owners are also trying to meet consumer demands
for added convenience with packaging that is microwavable,
ovenable, or otherwise subject to extreme conditions. These
demands can also increase chemical migration.
With these trends and regulations, and hazard data unable to
keep pace, the burden to provide effective, safe, and compliant
packaging will continue to fall on the shoulders of the flexible
packaging supply chain.
Regulations for Flexible Food Packaging
In the United States, the Food and Drug Administration
(FDA) regulates food packaging, and all materials must have
premarket clearance before they can be used. Premarket
clearance typically means the materials are listed in Title 21 of
the Code of Federal Regulations (e.g., 21 CFR 175.105, 175.300,
177.1630). In addition to using 21 CFR to determine pre-market
clearance, the FDA allows the use of materials which are 1)
Generally Recognized as Safe (GRAS) as demonstrated by
published toxicological data, 2) materials for which the FDA has
granted prior sanction (pre-1958), and 3) materials which are
not expected to become a component of the diet as described
in 21 CFR 170.39 (Threshold of Regulation).
Additionally, a company may ask the FDA to review new
packaging materials under the Food Contact Notification (FCN)
Program. The FCN program provides an excellent opportunity
for flexible packaging suppliers to demonstrate safety via FDA
review of the product and its intended use. Unfortunately,
many new technologies, such UV, EB, and LED, do not have
premarket clearance. FCN submissions for these types of
technologies remain sparse. If the packaging components do
not meet the premarket requirement(s) listed above and later
migrate into the food, the food is automatically considered
adulterated by FDA.
In the European Union, the Framework Regulation (1935/2004)
regulates materials and articles that come into contact with
food. Article 3 of the Framework Regulation requires that
materials and articles must be manufactured in accordance
with GMP and must not transfer constituents to food that can
endanger human health, change the composition of the food,
or deteriorate the organoleptic (taste/smell) properties of the
food. The European Food Safety Authority (EFSA) reviews new
materials for use in food packaging and issues opinions and
restrictions for food contact materials. Beyond the Framework

3. Regulation, the EU has developed harmonized measures to
address specific food contact materials. The most notable
is the Plastics Implementing Measure (PIM, 10/2011), which
regulates plastics such as the polymeric films used in flexible
packaging. However, the EU has not issued harmonized
measures for materials such as inks, coatings, and adhesives,
making it difficult for flexible packaging suppliers to determine
compliance and safety. Flexible packaging suppliers must rely
on Article 3 of the Framework Regulation. They must ensure
the packaging materials are safe for intended use and do not
affect the odor, taste or composition of the food.
Determining Fitness for Use in the Absence of
Specific Regulations
How can suppliers, brand owners and converters determine if a
product is fit for use without FDA premarket clearance or listing
under an EU-harmonized regulation?
Many technologies used in flexible food packaging are
separated from the food by a polymeric film. In general,
the flexible packaging industry has assumed that for lower-
temperature applications (anything <49 °C), any barrier will
prevent chemical migration into food. This is commonly
referred to in the industry as “indirect contact.” This idea
assumes that the polymeric film is a functional barrier.
Polyethylene terephthalate (PET) film >1 mm would meet
this criterion. However, most other polymeric films do not.
Films have very different barrier properties depending on
their thickness, the environmental conditions (particularly
temperature), and the food contained within.
Probably the most frequently used barrier film is LLDPE, but
it is a poor barrier depending on the conditions. The barrier
properties of some common polymeric films are listed below,
from lowest to highest.
Linear low-density polyethylene (LLDPE)
High-density polyethylene (HDPE)
Polypropylene (PP)
Polyethylene terephthalate (PET)
Some materials have been well studied for migration and have
low toxicity profiles, making them of little concern. There are,
however, a multitude of chemicals used in flexible packaging
that have no migration data or are known to have high
toxicity profiles. For these chemicals, a general assumption
that any polymeric film is automatically a functional barrier
under all conditions could lead to unintended contamination
– potentially resulting in product recalls, unwanted media
scrutiny, and/or government intervention.
Companies could reduce the risk of exposure to such
consequences if they reviewed their products using a fit for
use approach, particularly for materials that lack premarket
clearance or regulatory listing.
Frequently, flexible packaging manufacturers and suppliers
rely on raw material compliance letters as guarantees of
safety. However, certain components may not appear on
the Certificate of Analysis. Further, by-products caused by
incidental exposure or chemical reactions, such as oxidation,
are also not accounted for on CA documents. Efforts should
be made to know the materials used in manufacturing, either
through extensive communication with the raw material
supplier or analysis of the raw material.
Determinaton of Fitness for Use
A fit for use determination requires a complete understanding
of: 1) the formulation of raw materials, including base
chemistries, contaminants, and by-products; 2) the end-use
profile of the packaged product; 3) the migration profile of the
product based on its end use; and 4) a risk assessment of the
migrants.
To design and execute appropriate migration studies or
diffusion calculations, suppliers must understand the end use
of their products, including:
• packaging structures (films, primers, inks, coatings,
adhesives, etc.)
• range of temperatures to which the product materials will
be exposed
• types of food that will go into that package
• anticipated shelf life of the packaged food
Perhaps most critical is a complete understanding of the
film that will be in contact with the food. The density,
gauge, molecular weight distribution, comonomer type,
long chain branching level and distribution, and blown-film
process represent the key variables that affect the crystalline
morphology. This morphology is what constitutes the barrier
qualities of any given package.
In addition, how the material is stored can affect migration. For
example, during manufacture, package material coming off
a laminator is stored in rolls. This puts the non-food-contact
side (outside) of the packaging in direct contact with the
food-contact side (inside) of the packaging. This may create
a condition to allow incidental chemical migration (off-set) to
occur during storage.
As temperature and time increase, so does migration. FDA and

4. EFSA have provided guidance for temperature and time condition migration testing. These guidelines also address extended shelf
life, so materials don’t need to be tested for the full shelf life period.
For example, FDA recommends testing at 40 °C for 10 days to mimic 6-12 months shelf life for food stored at room temperature.
FDA and EFSA time and temperature guidance are listed in Tables 1 and 2a/2b, respectively. Please note that this is not the
complete guidance. Consult FDA1 and PIM2 (10/2011) for additional details.
Table 1. FDA Time and Temperature Guidance[1]
FDA Condition of Use
A. High temperature, heat sterilized or retorted 2 hours at 121 °C followed by 10 days at 40 °C
B. Boiling water sterilized 2 hours at 100 °C followed by 10 days at 40 °C
C. Hot filled or pasteurized above 66 °C 2 hours at 66 °C followed by 10 days at 40 °C
D. Hot filled or pasteurized below 66 °C 30 minutes at 66 °C followed by 10 days at 40 °C
E. Room temperature filled and stored 10 days at 40 °C
F. Refrigerated storage 10 days at 20 °C
G. Frozen storage 5 days at 20 °C
H. Frozen or refrigerated storage; ready-prepared foods intended to be
reheated in container at time of use
2 hours at 100 °C followed by time temperature of storage
I. Irradiation (ionizing radiation) Consult with FDA
J. Cooking at temperatures exceeding 121 °C Consult with FDA
Table 2a. European Union Time and Temperature Guidance from Plastics Implementing Measure (10/2011) [2]
Contact time in worst foreseeable use Test Time
t ≤ 5 min 5 min
5 min < t ≤ 0,5 hour 0,5 hour
0,5 hours < t ≤ 1 hour 1 hour
1 hour < t ≤ 2 hours 2 hours
2 hours < t ≤ 6 hours 6 hours
6 hours < t ≤ 24 hours 24 hours
1 day < t ≤ 3 days 3 days
3 days < t ≤ 30 days 10 days
Above 30 days See specific conditions
Table 2b. European Union Time and Temperature Guidance from Plastics Implementing Measure (10/2011) [2]
Conditions of contact in worst foreseeable use Test conditions
Contact temperature Test temperature
T ≤ 5 °C 5 °C
5 °C < T ≤ 20 °C 20 °C
20 °C < T ≤ 40 °C 40 °C
40 °C < T ≤ 70 °C 70 °C
70 °C < T ≤ 100 °C 100 °C or reflux temperature
100 °C < T ≤ 121 °C 121 °C
121 °C < T ≤ 130 °C 130 °C
130 °C < T ≤ 150 °C 150 °C
150 °C < T ≤ 175 °C 175 °C
T > 175 °C Adjust the temperature to the real temperature at
the interface with the food (*)
* This temperature should be used only for food
stimulants D2 and E. For applications heated under
pressure, migration testing under pressure at the
relevant temperature may be performed. For food
stimulants A, B, C or D1, the test may be replaced
by a test at 100 °C or at reflux temperature for
duration of four times the time selected according
to the conditions in Table 2A.

5. The type of food inside the package also affects the migration
of chemical substances based on the chemistry of the food
and migrants. Fatty foods and aqueous foods tend to pull
lipophilic chemicals and hydrophilic chemicals from the
package, respectively. Migration testing in specific foods is not
required as FDA and EFSA have provided lists of solvents that
act as food simulants. It is absolutely necessary to test products
in the proper simulant representing the food that is intended
to be packaged. The recommended food simulants for FDA
and PIM (10/2011) are listed in Tables 3 and 4. The FDA also
recognizes 95% ethanol as an effective fatty food simulant
in its Chemistry Guidance, and 3% acetic acid can be used in
lieu of 10% ethanol when food acidity is expected to lead to
significantly higher levels of migration or there is a chemical
interaction between the chemical migrant and ethanol.[1]
In
addition, an example of food types is provided in Table 5.
Table 3. FDA Food Simulants[1]
Food Type Recommended Simulant
Aqueous & Acidic Foods 10% Ethanol
Low- and High-Alcoholic Foods 10 or 50% Ethanol
Fatty Foods Food oil (e.g., corn oil), HB307,
Miglyol 812, or others
Table 4. Plastic Implementing Measure (10/2011)
Simulants[2]
Food Simulant Abbreviation
Ethanol 10% (v/v) Food simulant A
Acetic acid 3% (v/v) Food simulant B
Ethanol 20% (v/v) Food simulant C
Ethanol 50% (v/v) Food simulant D1
Vegetable oil Food simulant D2
Poly(2,6-diphenyl-p-phenylene
oxide), particle size 60-80 mesh,
pore size 200 nm
Food simulant E
Table 5. Food Type Examples [3]
Food Type Example
Aqueous Fruits, vegetables, juices, mustard,
ketchup, salad, milk, bread
Alcoholic Beer, ale, wine, distilled spirits
Fatty Cheese, butter, meats, seafood, ice
cream, doughnuts, cookies, potato
chips, nuts
Dry Uncooked pasta, cereals, rice cakes,
coffee
Effects of Food Simulant, Temperature, and
Time On Material Migration
The following tables demonstrate the effect of food simulant,
time, and temperature on aromatic isocyanate migration from
a laminating adhesive through LLDPE. Aromatic isocyanates
were investigated because of their common use in adhesives
and their ability to quickly form aromatic amines in the
presence of water. Aromatic amines are carcinogens and their
potential to migrate need to be carefully monitored. The data
presented is a typical aromatic isocyanate-based laminated
adhesive currently in the market.
Table 6. Effect of Food Simulant on Migration
Adhesive
Cure Time
3% Acetic Acid
Simulant Migration
(ppb)*
95% Ethanol
Simulant Migration
(ppb)**
2 days 6.1 174.7
3 days 2.9 73.0
7 days 3.7 3.9
Sealant film – 1.0 mil LLDPE; Test condition – 2 hours @ 70 °C
* Measurement of aromatic amine (UV/Vis)
** Measurement of the diethylurethane of methylene diphenyl diisocyanate (HPLC/UV)
As Table 6 exhibits, migration into a fatty food simulant (95%
ethanol) is greatly enhanced when compared to an aqueous
food simulant (3% acetic acid).
Table 7. Effect of Time and Temperature on Migration
Adhesive Cure
Time
Room Temp.
Migration (a)
(ppb)*
FDA Condition
of Use H
Migration (b)
(ppb)*
Hot Fill w/
Extended
Shelf Life
Migration (c)
(ppb)*
2 days 7.7 95 345
4 days 0.9 9.3 24.7
7 days 0.7 1.5 2.7
Sealant film – 3.0 mil LLDPE; simulant – 95% ethanol
*Measurement of diethylurethane of 4, 4’-methylene diphenyl diisocyanate (HPLC/UV)
Test conditions: (a) 10 days @ 40 °C, (b) 2 hrs. @ 100 °C, (c) 2 hrs. @ 100 °C + 96 hrs. @ 40 °C
Table 7 shows the effect of temperature on aromatic
isocyanate migration – as temperature increases so does
migration. The table also demonstrates that as shelf life
increases, migration is significantly enhanced (i.e., 2 hours at
100 °C followed by 4 days at 40 °C compared to just 2 hours at
100 °C).
Tables 6 and 7 clearly demonstrate the effect that food
simulant, temperature, and time can have on chemical
migration. When testing migration for food packaging, flexible

6. packaging manufacturers and suppliers must perform the
migration study that matches the customer’s end use. If
migration testing does not mimic customer end use, then
there is potential that exposure and consumer risk will be
underestimated.
Risk Assessment of the Food Package
The flexible packaging manufacturer and supplier must
determine which chemicals are likely to migrate, determine
the hazards of the migrants, and then establish an appropriate
detection limit based on the hazards and potential exposure.
In Europe, there are detection limits in the PIM for some
chemical migrants. These are known as Specific Migration
Limits (SML). FDA does not publish SML, so flexible packaging
manufacturers must rely on risk-based approaches to
determine a suitable detection limit (i.e., hazard of the material
is evaluated, a safe dietary level is determined, and from the
dietary level, the detection limit can be established).
After the migration studies or diffusion calculations have
been performed, the product needs to be risk assessed for its
intended use. In essence, this is simply evaluating the migration
values against the detection limits. If the migration results are
below the detection limit for the appropriate conditions of use,
then a conclusion can be made that the packaging product is
safe for use.
Summary
A determination of fitness for use requires an understanding
of the raw material supply, the conditions of use, the types of
food to be packaged, and the hazards of the chemicals that
are likely to migrate, as well as migration testing or calculations
using SML or risk-based detection limits to determine if the
level of migration is below levels that could be of concern. A
step-by-step approach may look something like this:
1. Review product formulation for compliance with
applicable regulation and any toxicological issues.
• This allows the supplier to know if a material will need to
be registered in a particular geography or if a particular
migrant will be problematic, i.e., banned for food
applications.
2. Understand the package structure, the food types to be
packaged, and the conditions the package is designed to
encounter.
• This will determine the appropriate conditions for
migration testing.
3. Determine all migrants (including oligomers) and
acceptable detection limits based on validated and
conservative toxicological data and exposure potential or
suitable SML.
4. Perform migration testing, migration calculations, or
diffusion calculations and compare values to detection
limit or applicable SML.
If flexible packaging manufacturers and suppliers follow these
steps, then they should be able to determine if their product is
safe and fit for use.
References
[1] Guidance for Industry: Preparation of Premarket
Submissions for Food Contact Substances: Chemistry
Recommendations document prepared by the United
States Food and Drug Administration. Retrieved from
http://www.fda.gov/Food/GuidanceRegulation/
GuidanceDocumentsRegulatoryInformation/
IngredientsAdditivesGRASPackaging/ucm081818.htm.
[2] Commission Regulation (EU) No 10/2011 of 14 January
2011 on plastic materials and articles intended to come
into contact with food (Text with EEA relevance). Retrieved
from http://eur-lex.europa.eu/LexUriServ/LexUriServ.
do?uri=OJ:L:2011:012:0001:0089:EN:PDF
[3] Technical Advisor’s Report to the Food, Drug, and
Cosmetic Packaging Materials Committee “FDA and EU
Food Types.” Prepared by Dr. Lester Borodinsky, Keller and
Heckman LLP, for the June 20-23, 2005 meeting of The
Society of the Plastics Industry, Inc.’s (SPI) Food, Drug, and
Cosmetic Packaging Materials Committee, Pentagon City,
Virginia, Ritz-Carlton. http://www.plasticsindustry.org/files/
about/fdcpmc/techpdfs/FDA%20and%20EU%20Food%20
Types,%20June%202005.pdf

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