The United States Food and Drug Administration (FDA) regulates
about 80% of the US food supply. The Food and Drug
Administration also has the responsibility of analyzing
not only the ingredients of the food product but the packaging as well. There are
ingredients that do not affect the food product’s taste or
makeup and exist because they affect
components of the product such as
shelf preservation, color and aroma.
These additives are classified Generally
Recognized As Safe (GRAS). Industrial
gases that are used in the food industry for Modified
Atmosphere Packaging (MAP) and refrigeration are
classified as such.
In 1958 Congress created the Food
Additives Amendment to the Federal Food, Drug and Cosmetic Act. One of the items that the amendment covered
was the definition of a Food Additive which was:
“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
to artificially sweeten soft
drinks and grouped as GRAS, began to be reconsidered. The conclusion incited
then President Nixon to order the FDA to reexamine all
substances classified as 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, the materials that were originally considered
GRAS were upholding 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 authorities outside the
government. Simply put, a GRAS classification prior to 1997 was sanctioned by the FDA and later than
1997 by accord of recognized experts then quickly
audited by the FDA.
How does this apply
to gases used in MAP?
The essential point
to take away is that there is no federal certification
given 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 details 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 mentioned, gas suppliers are
only responsible for the purity of the gas
product and the other sanctions (i.e. … good manufacturing practices…) are goverened
by the food processor or the gas supplier’s customer.
In addition, hydrogen, carbon
monoxide and argon were recognized as ingredients
after 1997 and are not listed in 21 CFR.
Since then, they
been given a GRAS Notice under the heading of “No Questions” which insinuates
that the FDA had no questions as to the accuracy of
the outside expert’s decision.
The main objective to take
away is that the any gases labeled “Food Grade” have been certified in house by the manufacturer rather than by the FDA.
The certification is by purity determined by proper
handling and manufacturing of the final product until it reaches its final
package (cylinders, micro-bulk vessels, transports and large cryogenic
vessels). Food processors are trained to keep an eye out
for food grade products and like to see clean packages
with clear labels. So having dedicated
“food grade” cylinders and/or tanks is important to service this market as is demonstrated
by the successful 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 are in search of food grade gases
or other specialty gases for various industries in Atlanta, GA, contact
Sidney Lee Medical & Scientific Gases at 770-946-4287 or contact us via email at Grace.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 led teams of engineers and technicians as an R & D manager for major gas
companies. His work directed him to be in charge 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