The United States Food and Drug Administration (FDA) controls
approximately 80% of the US food supply. The Food and Drug
Administration also has the responsibility of reviewing
not only the ingredients of the food product but the packaging 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 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. 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.”
This did not include
substances like gas mixtures that are
classified as additives and not considered GRAS.
In the late 60’s cyclamate salts, which were utilized
to artificially sweeten soft
drinks and classified
as GRAS, began to be reconsidered. The outcome incited
then President Nixon to instruct the FDA to reevalute the components that were considered
GRAS. In 1997, the FDA claimed that they did not have adequate resources to fulfill all the requests
that they were receiving for substances to be classified.
Since then, the materials that were originally considered
GRAS 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 determined
by individual experts outside the
government. In simpler
terms, a GRAS classification earlier
than 1997 was sanctioned by the FDA and following
1997 by consensus 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 employed
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 describes 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 product and the other sanctions (i.e. … proper manufacturing practices…) are regulated
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 means
that the FDA had no questions as to the validity of
the outside expert’s classification.
The important fact to learn from this is that the any gases considered “Food Grade” have been certified in house by the manufacturer instead of by the FDA.
The certification is by purity obtained 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 have been
conditioned to keep an eye out
for food grade products and want to see clean packages
with clear labels. So having separate
“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 are available through PurityPlus. If you would like to purchase food grade gases
or other specialty gases for various industries in Mexico, contact
AOC Mexico S.A. de C.V. at 818-647-7427 or contact us via email at firstname.lastname@example.org.
Written by John Segura.
John Segura is a licensed Professional Engineer and a well-rounded
executive in the industrial gas industry.
He has over 30 years of experience covering sales, marketing and
operations both domestic and international. He has been a leader to 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 currently consults to
the industry on the business specializing in operations, applications and