FOOD FOR THOUGHT

Topical Insights from our Subject Matter Experts

FOOD PACKAGING AND FOOD SAFETY

MODERNIZATION ACT:
STEPS TO TAKE NOW

The NFL White Paper Series

Volume 13, February 2014
Background

As implementation of the Food Safety Modernization Act (FSMA)1, which President Barack Obama
signed into law on January 4, 2011, rapidly approaches, many suppliers and end users of food
packaging materials are trying to determine how FSMA will affect their business. While the initial
implementation of FSMA does not address food packaging materials, the FDA has expressed they
are considering adding it to future guidelines. Risk analysis, material testing, documentation and
recall plans are key components of FSMA at this time and are likely to be incorporated when food
packaging is included in the near future. An understanding of these components and proper
implementation will allow companies to effectively follow the FSMA guidelines to improve their
companys compliance, safety and credibility in the competitive world of packaging materials.

Food contact materials are often perceived by the public as a source of dangerous chemical
contamination. In 2007 there was a public outcry due to toxic chemicals in clear plastic baby
bottles. More recently, the media has been filled with stories concerning BPA in water bottles, lead
in candy wrappers and phthalates in food packaging films, to name just a few. To help prevent
possible contamination events like these, converters and end users of food packaging materials are
requiring not only documentation of proof of safety, but actual testing data from their suppliers.
Within the last year there has been an increase in the demand for proof of safety and test results as
they pertain to the specific lot of packaging materials being purchased and used for a companys
products.

3 Important Steps Manufacturers Can Take

As food manufactures work on their food safety plans to meet FSMA regulations by doing risk
analyses, improving their testing and documentation and writing detailed recall plans, they will likely
be asking food packaging suppliers for similar efforts. This will prompt several potential questions
and important considerations, some of which are listed below:

What hazard analysis of the packaging material has been conducted?

What is the compliance status of each material, including individual lots, and the final
product?
How has the material been verified as safe?
Have the local regulations where the product is being sold been met?
Is there complete traceability?
o What material lots are in each final product?
o What production line was used?
o What was the system of transport?
o What was the system of storage and location?
Were there any changes to the above that could affect the product?

Companies too frequently assume their packaging material is safe and complies with regulatory and
client standards because of past precedent (i.e., once upon a time it was determined to be true).
Recently, a food packaging companys newly hired regulatory specialist audited the companys quality
system and determined that the compliance documentation on record consisted of an old, yellowed

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letter from a material supplier dated 1993. This letter stated All our materials comply with all
applicable regulations. The companys previous regulatory specialist accepted this thinking that as
long as something was on file, the company was covered. This proof of compliance may have
been acceptable at one time, but with the current global supply chain, as well as pending future
impacts of FSMA, much better testing and documentation are required to minimize any risk
potential and related liabilities.

Step 1: An Effective Risk Analysis

The first step in developing a good system of safety and material documentation is an effective risk
analysis to determine the level of the risk, what factors control the risk and what can be done to
mitigate the risk. The risk analysis needs to be a flexible process with the ability to be easily
updated. New material technologies are in constant development. Many companies are working
toward greener materials and processes to replace or supplement older materials. With the
growing use of these new materials, new safety potentials arise. For example, some of the materials
being investigated are plant fibers. With plant fibers, there is the potential for environmental
contaminants including, but not limited to, pesticides and heavy metals. Plant fibers may also contain
allergens which could be dangerous for some consumers. Another technology that is being
expanded is irradiation. Irradiation may be used to sterilize packaging material or to impart a
beneficial characteristic to the material such as vapor barrier or oxygen barrier properties. With
new materials, green or otherwise, it is important to do an effective risk analysis.

Even companies that have been using the same materials and processes for years need to constantly
test their product for compliance. In this industry, nothing is constant. Any one of the following
changes could affect the end product and its compliance: new material supplier, new production
line, new warehouse, material coming from a new location, new transport company or procedure,
or if a regular supplier changes any of these things in its supply chain. An effective risk analysis can
evaluate what steps or materials need regular testing to prevent product safety issues.

Step 2: Verification of Preventive Controls and Compliance to Guidelines

Once a risk analysis has been completed, verification of the preventive controls needs to be
determined. For food packaging, material testing is a critical component. The appropriate tests,
frequency and volume must be determined. As suggested, materials made from plant fibers could
require pesticide or heavy metals testing. Many of the paperboard, coating and polymer materials
currently in use today have very specific testing requirements spelled out in the food packaging
regulations.

The European Union (EU) has very detailed testing guidelines including global migration into foods
and specific compound migration into foods based on the packaging material and its end use2. The
United States Food and Drug Administration (FDA) has a document entitled Guidance for Industry:
Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations3
that helps companies with new materials or processes through the challenges of getting FDA
approval.

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A key regulatory document used by the FDA is the Code of Federal Regulation (CFR), specifically
21 CFR parts 170 to 199.4 Materials that have been used for years for food contact use are
described in detail in this CFR as well as use levels and testing requirements. An important idea
when determining appropriate testing is the type of food and the time and temperature the food will
be in contact with the packaging material. Many of the 21 CFR test sections refer back to Tables 1
and 2 of 21 CFR 176.170.

Table 1 of 21 CFR 176.170 (below) details the food type categories as defined by the FDA for many
21 CFR compliance tests.

Table 1: Types of Raw and Processed Foods

I. Nonacid, aqueous products; may contain salt or sugar or both (pH above 5.0).
II. Acid, aqueous products: may contain salt or sugar or both, and including oil-in-water
emulsions of low- or high-fat content.
III. Aqueous, acid or nonacid products containing free oil or fat: may contain salt, and including
water-in-oil emulsions of low- or high-fat content.
IV. Dairy products and modifications:
A. Water-in-oil emulsions, high- or low-fat.
B. Oil-in-water emulsions, high- or low-fat.
V. Low-moisture fats and oil.
VI. Beverages:
A. Containing up to 8 percent of alcohol.
B. Nonalcoholic.
C. Containing more than 8 percent alcohol.
VII. Bakery products other than those included under Types VIII or IX of this table:
A. Moist bakery products with surface containing free fat or oil.
B. Moist bakery products with surface containing no free fat or oil.
VIII. Dry solids with the surface containing no free fat or oil (no end test required).
IX. Dry solids with the surface containing free fat or oil.

The FDA understands that testing using every possible food is impractical and may even be
impossible; thus, food simulants are used. A food simulant, as the name suggests, simulates the food
type of interest so that one test can be conducted using the food simulant, and results of that test
apply to all other foods that match that food type. For example, both diced apples and diced
tomatoes are food type II. If testing using food type II demonstrates compliance, that packaging
material can be used for both diced apples and diced tomatoes and any other food type II.

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Once the food type category is determined from Table 1, the condition of use that best matches the
time and temperature the food will contact the packaging is decided using Table 2 (below).

Table 2: Test Procedures with Time Temperature Conditions for Determining

Amount of Extractives from the Food-Contact Surface of Uncoated or Coated Paper
and Paperboard, Using Solvents Simulating Types of Foods and Beverages

Food-simulating solvents
Types of 8 percent 50 percent
Water Heptane1
Condition of use food alcohol alcohol
(see table 1) Time and Time and Time and Time and
temperature temperature temperature temperature
A. High temperature
heat-sterilized (e.g., I, IV-B, VII-B 250 F, 2 hr
over 212 F)
III, IV-A, VII-A ......do 150 F, 2 hr
B. Boiling water
II, VII-B 212 F, 30 min
sterilized
III, VII-A ......do 120 F, 30 min
C. Hot filled or
Fill boiling, cool
pasteurized above II, IV-B, VII-B
to 100 F
150 F
III, IV-A, VII-A ......do 120 F, 15 min
V, IX ......do
D. Hot filled or
pasteurized below II, IV-B, VI-B,
150 F
VII-B 150 F, 2 hr
III, IV-A, VII-A ......do 100 F, 30 min
V, IX ......do
VI-A 150 F, 2 hr
VI-C 150 F, 2 hr
E. Room temperature
filled and stored
I, II, IV-B, VI-
(no thermal 120F, 24 hr
B, VII-B
treatment in the
container)
III, IV-A, VII-A ......do 70F, 30 min
V, IX ......do
VI-A 120F, 24 hr
VI-C 120F, 24 hr
F. Refrigerated
storage (no
III, IV-A, VII-A 70F, 48 hr 70F, 30 min
thermal treatment
in the container)
I, II, IV-B, VI-
......do
B, VII-B
VI-A 70 F, 48 hr
VI-C 70 F, 48 hr

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Table 2 continued:

Food-simulating solvents
Types of
8 percent 50 percent
food Water Heptane1
Condition of use alcohol alcohol
(see table
1) Time and Time and Time and Time and
temperature temperature temperature temperature
G. Frozen storage (no
I, II, IV-B, VII-
thermal treatment 70 F, 24 hr
B
in the container)
III, VII-A ......do 70 F, 30 min
H. Frozen or
refrigerated
storage: Ready-
prepared foods
intended to be
reheated in
container at time
of use:
1. Aqueous or oil-
in-water I, II, IV-B, VII-
212 F, 30 min
emulsion of B
high- or low-fat
2. Aqueous, high-
III, IV-A, VII-
or low-free oil ......do 120 F, 30 min
A, IX
or fat

1
Heptane extractability results must be divided by a factor of five in arriving at the extractability for
a food product having water-in-oil emulsion or free oil or fat. Heptane food-simulating solvent is
not required in the case of wax-polymer blend coatings for corrugated paperboard containers
intended for use in bulk packaging of iced meat, iced fish, and iced poultry.

There are two important things to note in understanding Table 2.

1) Do is an abbreviation for ditto. This means that in a box that says do, use the time and
temperature specified in the box above it in the table.

2) If a sample material complies with the testing requirements when testing using a certain
condition of use and food simulant, then it also complies with all other conditions of use with
lower test temperatures when using that food simulant.

Example A: If a material complies when tested using condition of use A with water, that material
also complies for all conditions of use with lower temperatures than condition of A,
which in this case is all conditions of use with all food types that have water as a
food simulant.

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 Example B: If a material complies when tested using condition of use D with water, that material
also complies for conditions of use E, F and G with all food types that have water as
a food simulant. Testing using condition of use D does not demonstrate compliance
with conditions of use A, B, C and H since higher temperatures would be required
to prove compliance.

Step 3: Documentation

Once all material compliance testing has been completed, either by the supplier, converter or end
user, it is important to keep detailed documentation. A batch or lot of finished material should be
easily traced back to all materials used in its production including the results of appropriate
compliance or contaminant testing. Internal and external audits provide important feedback to the
entire process allowing a company to fine tune testing and documentation.

The next step which is closely tied to documentation is an effective recall plan. If it is determined
that a companys product is a safety risk, that company needs to be able to quickly trace all products
that may be affected and have a written system to inform and recall those materials and products.
Complete and organized documentation of lot numbers, production dates, locations, buyers and
suppliers is important for the recall plan.

How The NFL Can Help

Food packaging companies that follow the FSMA food handling guidelines by doing risk analysis,
testing materials, providing detailed documentation and having a written recall plan will be far ahead
of the game when food packaging material also becomes regulated by FSMA. The above suggestions
will help prevent and mitigate food safety issues. Packaging companies that practice this philosophy
will also be in a much better position to work with food companies that are working really hard to
comply with FSMA in their own plants.

The NFL has been doing packaging migration testing for over 20 years. We have worked closely
with many packaging material suppliers and converters to help them develop material compliance
testing programs that fit their company and material needs. We have also developed a very effective
risk analysis system that we have used to work closely with many companies, large and small, to
help focus their testing resources on important steps in their process to get the most value for their
testing dollar while still protecting their brand. Even companies that have fairly effective risk analysis
systems have benefited from having The NFL evaluate their system with a fresh and objective point
of view.

About The NFL

The National Food Laboratory is a food and beverage consulting and testing firm providing creative,
practical and science-based solutions for the following areas: Food Safety and Quality; Product and
Process Development; and Sensory and Consumer Research. We create value for our clients by
enabling them to develop commercially safe, high quality and great tasting foods and beverages. For
more information about The National Food Laboratory, please visit us at www.TheNFL.com.

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Footnotes:
1) http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm
2) http://ec.europa.eu/food/food/chemicalsafety/foodcontact/eu_legisl_en.htm
3) http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGR
ASPackaging/ucm081818.htm
4) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

For more information about The NFLs Analytical Packaging services, please contact:
Dan McCoy at McCoyD@TheNFL.com, 925.551.4215

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