The United States Food and Drug Administration (FDA) classifies
about 80% of the US food supply. The administration also has the responsibility of reviewing
food product’s packaging along with its ingredients. There exist
ingredients that do not alter the food product’s taste or
makeup and exist because they affect
components of the product such as
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. 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
to artificially sweeten soft
drinks and grouped as GRAS, were brought
into question. The outcome 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 address 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 that requested classification after 1997 were given a GRAS Notice which is decided
by individual authorities outside the
government. Simply put, a GRAS classification before 1997 was sanctioned by the FDA and later than
1997 by consensus of recognized experts then concisely
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 classified as 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 accountable for the purity of the gas
product and the other sanctions (i.e. … adequate manufacturing practices…) are regulated
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 means
that the FDA had no questions as to the accuracy of
the outside expert’s consensus.
The crucial point 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 obtained by proper
handling and manufacturing of the final product until it reaches its final
package (cylinders, micro-bulk vessels, transports and large cryogenic
vessels). Food processors have learned to search
for food grade products and wish to see clean packages
with clear labels. So having separate
“food grade” cylinders and/or tanks is important to service 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 would like to purchase food grade gases
or other specialty gases for various industries in Auburn, contact
Spec Air Specialty Gases at 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 over 30 years of experience covering sales, marketing and
operations both domestic and international. He has led teams of engineers and technicians as an R & D manager for major gas
companies. His work guided him to be in charge 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