The United States Food and Drug Administration (FDA) regulates
about 80% of the US food supply. The Food and Drug
Administration is also responsible for reviewing
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 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 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. 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 that are
classified as additives and not considered GRAS.
In the late 60’s cyclamate salts, which were utilized
as an artificial sweetener in soft drinks and considered GRAS, were brought
into question. The conclusion prompted
then President Nixon to call on the FDA to reconsider all substances that fit the GRAS classification. In 1997, the FDA argued that they did not
have proper resources to fulfill all the insistence
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 after 1997 requesting
classification are granted a GRAS Notice which is determined
by individual experts outside the
government. To explain simply, a GRAS classification before 1997 was sanctioned by the FDA and following
1997 by accord 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
granted to industrial gases used
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 explains 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 responsible for the purity of the gas 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 identified 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 insinuates
that the FDA had no questions as to the correctness of
the outside expert’s classification.
The main objective to take from this article 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 defined 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 keep an eye out
for food grade products and prefer to see clean packages
with clear labels. So having predetermined
“food grade” cylinders and/or tanks is necessary
to succeed in this market as is evidenced
by the major 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 Fresno, contact
Fresno Oxygen & Welding Supplies/Barnes Welding Supply at 559-341-4456 or contact us via email at firstname.lastname@example.org.
Written by John Segura.
John Segura is a licensed Professional Engineer and a experienced
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 been a leader to teams of engineers and technicians as an R & D manager for major gas
companies. His work eventually
led him to lead the marketing
efforts of technology worldwide for industrial gas suppliers. He presently consults to
the industry on the business specializing in operations, applications and