The United States Food and Drug Administration (FDA) controls
approximately 80% of the US food supply. The Food and Drug
likewise in charge of reviewing
food product’s packaging along with its ingredients. There are
ingredients that do not affect the food product’s taste or
makeup and are present for reasons such as
shelf preservation, color and aroma.
These 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 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 which are not considered additives and are
In the late 60’s cyclamate salts, which were utilized
to artificially sweeten soft
drinks and grouped as GRAS, began to be questioned. The conclusion incited
then President Nixon to order the FDA to reevalute the components that were considered
GRAS. In 1997, the FDA declared that they did not
have enough resources to address 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 after 1997 requesting
classification are granted a GRAS Notice which is concluded
by individual experts outside the
government. Simply put, a GRAS classification before 1997 was sanctioned by the FDA and after
1997 by consensus of recognized experts then quickly
reviewed by the FDA.
How does this apply
to gases used in MAP?
The most important point to be remembered is that there is no federal certification
given to industrial gases used
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 declared above, gas suppliers are
only responsible for the purity of the gas
product and the other sanctions (i.e. … good manufacturing practices…) are controlled
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 subsequently
been given a GRAS Notice under the heading of “No Questions” which indicates
that the FDA had no questions as to the validity of
the outside expert’s consensus.
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 and
not by the FDA.
The certification is by purity defined by adequate handling and manufacturing practices until the product reaches
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 are available through PurityPlus. If you’re interested in
purchasing food grade gases
or other specialty gases for various industries in Portland, contact
Cryo-Source at 503-235-0168 or contact us via email at firstname.lastname@example.org.
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 been in charge
of 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 presently consults to
the industry on the business specializing in operations, applications and