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
not only the ingredients of the food product but the packaging as well. Several
ingredients that do not alter the food product’s taste or
makeup and are present for reasons such as
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.”
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
as an artificial sweetener for sodas and classified
as GRAS, began to be reconsidered. The conclusion incited
then President Nixon to instruct the FDA to reexamine all
substances classified as GRAS. In 1997, the FDA argued that they did not
have proper resources to carry out all the insistence
that they were receiving for substances to be classified.
Since then, previous substances that were considered GRAS were maintaining 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 determined
by individual authorities outside the
government. In simpler
terms, a GRAS classification earlier
than 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 main objective to keep in mind 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 stated, gas suppliers are
only in charge of the purity of the gas
product and the other sanctions (i.e. … good 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.
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 validity of
the outside expert’s classification.
The main objective 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 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 search
for food grade products and want to see clean packages
with clear labels. So having dedicated
“food grade” cylinders and/or tanks is important to service this market as is proven
by the major 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 El Paso, contact
SYOXSA, Inc. at 915-771-7674 or contact us via email at Esteban.Trejo@syoxsa.com.
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 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