The United States Food and Drug Administration (FDA) classifies
about 80% of the US food supply. The administration also has the responsibility of inspecting
packaging of the food as long as the ingredient of the food product as well. 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 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 into this category.
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 that are
classified as additives and not considered GRAS.
In the late 60’s cyclamate salts, which were employed
to artificially sweeten soft
drinks and grouped as GRAS, were brought
into question. The results prompted
then President Nixon to instruct the FDA to reevalute the components that were considered
GRAS. In 1997, the FDA claimed that they did not have adequate resources to fulfill all the demands
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 that requested classification after 1997 were given a GRAS Notice which is concluded
by individual experts outside the
government. In simpler
terms, a GRAS classification prior to 1997 was sanctioned by the FDA and following
1997 by agreement of recognized experts then quickly
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
given 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 describes 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 and the other sanctions (i.e. … adequate manufacturing practices…) are goverened
by the food processor or the gas supplier’s customer.
Likewise, 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 decision.
The important fact to take
away 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 obtained 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 are trained to search
for food grade products and like to see clean packages
with clear labels. So having predetermined
“food grade” cylinders and/or tanks is crucial to sustain 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 are available through PurityPlus. If you would like to purchase food grade gases
or other specialty gases for various industries in Cincinnati, contact
Wright Brothers at 800-637-2222 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 led teams of engineers and technicians as an R & D manager for major gas
companies. His work guided him to be the leader of the marketing
efforts of technology worldwide for industrial gas suppliers. He currently consults to
the industry on the business specializing in operations, applications and