The United States Food and Drug Administration (FDA) regulates
approximately 80% of the US food supply. The Food and Drug
Administration is also responsible for reviewing
food product’s packaging along with its ingredients. There are
ingredients that do not change 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 utilized in the food industry for Modified
Atmosphere Packaging (MAP) and refrigeration are
classified as such.
In 1958 Congress enacted the Food
Additives Amendment to the Federal Food, Drug and Cosmetic Act. One item included in the
amendment was the definition of food additive:
“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 for sodas and classified
as GRAS, were brought
into question. The results urged
then President Nixon to call on the FDA to reexamine all
substances classified as 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, previous substances that were considered GRAS 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 decided
by individual specialists outside the
government. In simpler
terms, a GRAS classification prior to 1997 was sanctioned by the FDA and following
1997 by consensus of recognized experts then quickly
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 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 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 stated, gas suppliers are
only responsible for the purity of the gas
product and the other sanctions (i.e. … adequate manufacturing practices…) are goverened
by the food processor or the gas supplier’s customer.
Additionally, hydrogen, carbon
monoxide and argon were acknowledged 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 indicates
that the FDA had no questions as to the accuracy of
the outside expert’s consensus.
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 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 want 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 proven
by the dominant 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 Beaumont, contact
Coastal Welding Supply at 800-852-4177 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 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 now consults to
the industry on the business specializing in operations, applications and