The United States Food and Drug Administration (FDA) controls
about 80% of the US food supply. The Food and Drug
likewise in charge of reviewing
packaging of the food as long as the ingredient of the food product as well. Several
ingredients that do not change the food product’s taste or
makeup and are added because they affect factors like
shelf preservation, color and aroma.
These added ingredients are classified Generally
Recognized As Safe (GRAS). Industrial
gases that are employed in the food industry for Modified
Atmosphere Packaging (MAP) and refrigeration are
classified as such.
In 1958 Congress implemented 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.”
Not included are like gas mixtures that are
classified as additives and not considered GRAS.
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 order the FDA to reconsider all substances that fit the GRAS classification. In 1997, the FDA claimed that they did not have adequate resources to carry out all the insistence
that they were receiving for substances to be classified.
Since then, substances
that were previously classified as were upholding their classification and can
be found in the Code of Federal Regulations (21 CFR). All substances requesting
classification after 1997 were given a GRAS Notice which is concluded
by individual experts outside the
government. Simply put, a GRAS classification earlier
than 1997 was sanctioned by the FDA and later than
1997 by agreement of recognized experts then concisely
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 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 mentioned, gas suppliers are
only accountable for the purity of the gas and the other sanctions (i.e. … adequate 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 since that time
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 classification.
The important fact to take from this article is that the any gases labeled “Food Grade” have been certified in house by the manufacturer and
not by the FDA.
The certification is by purity obtained by best
practice in the manufacture and handling of the product to its final package (cylinders, micro-bulk vessels, transports and large cryogenic
vessels). Food processors have been
conditioned to look
for food grade products and like to see clean packages
with clear labels. So having dedicated
“food grade” cylinders and/or tanks is necessary
to succeed in 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
obtained through PurityPlus. If you’re interested in
purchasing food grade gases
or other specialty gases for various industries in Springfield, contact
ILMO Products Company at (217) 245-2183 or contact us via email at email@example.com.
Written by John Segura.
John Segura is a licensed Professional Engineer and a well-rounded
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 guided him to lead the marketing
efforts of technology worldwide for industrial gas suppliers. He currently consults to
the industry on the business specializing in operations, applications and