The United States Food and Drug Administration (FDA) controls
approximately 80% of the US food supply. The administration is also responsible for inspecting
not only the ingredients of the food product but the packaging as well. There exist
ingredients that do not affect 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 used 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. The amendment defined food
“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.”
Not included are like gas mixtures that are
classified as additives and not considered GRAS.
In the late 60’s cyclamate salts, which were utilized
as an artificial sweetener for sodas and classified
as GRAS, were brought
into question. The outcome urged
then President Nixon to call on the FDA to reevalute the components that were considered
GRAS. In 1997, the FDA argued that they did not
have proper resources to fulfill all the requests
that they were receiving for substances to be classified.
Since then, the materials that were originally 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 concluded
by individual specialists outside the
government. To explain simply, a GRAS classification earlier
than 1997 was sanctioned by the FDA and later than
1997 by consensus of recognized experts then briefly
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
granted to industrial gases employed
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 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 in charge of the purity of the product and the other sanctions (i.e. … adequate 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 means
that the FDA had no questions as to the correctness of
the outside expert’s consensus.
The main objective 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 determined 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 like to see clean packages
with clear labels. So having separate
“food grade” cylinders and/or tanks is necessary
to succeed in this market as is evidenced
by the successful 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 Winona, contact
Mississippi Welders Supply Co., Inc. at (507) 454-5231 or contact us via email at firstname.lastname@example.org.
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 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 presently consults to
the industry on the business specializing in operations, applications and