The United States Food and Drug Administration (FDA) classifies
approximately 80% of the US food supply. The administration also has the responsibility of reviewing
not only the ingredients of the food product but the packaging as well. There exist
ingredients that do not change the food product’s taste or
makeup and exist because they affect
components of the product such as
shelf preservation, color and aroma.
These added ingredients are classified Generally
Recognized As Safe (GRAS). Industrial
gases that are utilized in the food industry for Modified
Atmosphere Packaging (MAP) and refrigeration are classified into this category.
In 1958 Congress implemented the Food
Additives Amendment to the Federal Food, Drug and Cosmetic Act. One item included in the
amendment was the definition of food additive:
“Any substance the intended use for which results or may reasonably be
expected to result, directly or indirectly, in its becoming a component or
otherwise affecting the component of food.”
This did not include
substances like gas mixtures which are not considered additives and are
In the late 60’s cyclamate salts, which were utilized
as an artificial sweetener in soft drinks and classified
as GRAS, began to be reconsidered. The conclusion prompted
then President Nixon to order the FDA to reevalute the components that were considered
GRAS. In 1997, the FDA claimed that they did not have adequate resources to address all the demands
that they were receiving for substances to be classified.
Since then, substances
that were previously classified as were keeping their classification and can
be found in the Code of Federal Regulations (21 CFR). All substances that requested classification after 1997 were given a GRAS Notice which is decided
by individual specialists outside the
government. In simpler
terms, a GRAS classification earlier
than 1997 was sanctioned by the FDA and later than
1997 by consensus of recognized experts then quickly
audited by the FDA.
How does this apply
to gases used in MAP?
The most important point to be remembered is that there is no federal certification
granted to industrial gases utilized
for food processing be it freezing, formulation or packaging. The gases that are considered GRAS are carbon dioxide, helium, nitrogen, nitrous
oxide and propane. The Code of Federal
Regulations section 184.1 explains each of these gases,
with respect to suitability, with the same phrasing. This, in part, is:
ingredient must be of a purity suitable for its intended use.
accordance with 184.1--- (last three numbers identify the gas), the ingredient is used in food with no
limitations other than current good manufacturing practice. The affirmation of this ingredient as
generally recognized as safe (GRAS) as a direct human food ingredient is based
upon the following current good manufacturing conditions of use:
ingredient is used in food at levels not to exceed current good manufacturing
sanctions for this ingredient different from the uses established in this
section do not exist or have been waived.”
As stated, gas suppliers are
only responsible for the purity of the product and the other sanctions (i.e. … good manufacturing practices…) are controlled
by the food processor or the gas supplier’s customer.
In addition, hydrogen, carbon
monoxide and argon were acknowledged as ingredients
after 1997 and are not listed in 21 CFR.
They have subsequently
been given a GRAS Notice under the heading of “No Questions” which indicates
that the FDA had no questions as to the accuracy of
the outside expert’s consensus.
The main objective to take
away is that the any gases considered “Food Grade” have been certified in house by the manufacturer and
not by the FDA.
The certification is by purity determined by adequate handling and manufacturing practices until the product reaches
its final package (cylinders, micro-bulk vessels, transports and large cryogenic
vessels). Food processors have learned to search
for food grade products and like to see clean packages
with clear labels. So having dedicated
“food grade” cylinders and/or tanks is crucial to sustain this market as is demonstrated
by the dominant companies naming and trademarking their
respective lines of food grade gases.
information on food grade gases and MAP applications can be found through PurityPlus. If you would like to purchase food grade gases
or other specialty gases for various industries in St. Louis, contact
Cee Kay Supply, Inc. at 314.644.3500 or contact us via email at firstname.lastname@example.org.
Written by John Segura.
John Segura is a licensed Professional Engineer and a seasoned
executive in the industrial gas industry.
He has 30+ years of experience in areas involving sales,
marketing, and operations both domestically and internationally. He has been in charge
of teams of engineers and technicians as an R & D manager for major gas
companies. His work guided him to be the leader of the marketing
efforts of technology worldwide for industrial gas suppliers. He now consults to
the industry on the business specializing in operations, applications and