The United States Food and Drug Administration (FDA) classifies
approximately 80% of the US food supply. The administration also has the responsibility of analyzing
packaging of the food as long as the ingredient of the food product as well. There exist
ingredients that do not alter the food product’s taste or
makeup and are added because they affect factors like
shelf preservation, color and aroma.
These ingredients 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 into this category.
In 1958 Congress created the Food
Additives Amendment to the Federal Food, Drug and Cosmetic Act. The amendment defined food
“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.”
Excluded are like gas mixtures which are not considered additives and are
In the late 60’s cyclamate salts, which were used
as an artificial sweetener in soft drinks and considered GRAS, began to be reconsidered. The conclusion urged
then President Nixon to call on 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 insistence
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 experts outside the
government. To explain simply, a GRAS classification before 1997 was sanctioned by the FDA and following
1997 by agreement of recognized experts then concisely
approved 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
assigned to industrial gases utilized
for food processing be it freezing, formulation or packaging. The gases that are given
the classification of 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 declared above, gas suppliers are
only in charge of the purity of the gas and the other sanctions (i.e. … adequate manufacturing practices…) are regulated
by the food processor or the gas supplier’s customer.
In addition, hydrogen, carbon
monoxide and argon were identified 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 means
that the FDA had no questions as to the correctness of
the outside expert’s consensus.
The crucial point to learn from this is that the any gases with
the label “Food Grade” have been certified in house by the manufacturer instead of by the FDA.
The certification is by purity defined 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 search
for food grade products and prefer to see clean packages
with clear labels. So having separate
“food grade” cylinders and/or tanks is important to service this market as is evidenced
by the dominant companies naming and trademarking their
respective lines of food grade gases.
information on food grade gases and MAP applications can be
obtained through PurityPlus. If you would like to purchase food grade gases
or other specialty gases for various industries in Riverside, contact
Elite Air at (951) 686-7822 or contact us via email at email@example.com.
Written by John Segura.
John Segura is a licensed Professional Engineer and a experienced
executive in the industrial gas industry.
He has spent over 30 years gaining
experience in marketing, sales, and operations for both domestic and
international affairs. He has been a leader to teams of engineers and technicians as an R & D manager for major gas
companies. His work eventually
led him to be the leader of the marketing
efforts of technology worldwide for industrial gas suppliers. He presently consults to
the industry on the business specializing in operations, applications and