The United States Food and Drug Administration (FDA) controls
about 80% of the US food supply. The administration is
likewise in charge of analyzing
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 added because they affect factors like
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 fall under this classification.
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.”
Excluded are like gas mixtures which are not considered additives and are
In the late 60’s cyclamate salts, which were employed
as an artificial sweetener for sodas and grouped as GRAS, began to be questioned. The outcome incited
then President Nixon to call on the FDA to reevalute the components that were considered
GRAS. In 1997, the FDA claimed that they did not have adequate resources to carry out all the demands
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 decided
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 agreement of recognized experts then concisely
reviewed 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 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 mentioned, 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.
In addition, hydrogen, carbon
monoxide and argon were acknowledged 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 indicates
that the FDA had no questions as to the correctness 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 instead of 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 learned to look
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 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 are in search of food grade gases
or other specialty gases for various industries in Pittsburgh, contact
Butler Gas Products at (412) 771-7660 or contact us via email at email@example.com.
Written by John Segura.
John Segura is a licensed Professional Engineer and a experienced
executive in the industrial gas industry.
He has spent over 30 years gaining
experience in marketing, sales, and operations for both domestic and
international affairs. 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 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