The United States Food and Drug Administration (FDA) regulates
about 80% of the US food supply. The Food and Drug
likewise in charge of analyzing
not only the ingredients of the food product but the packaging as well. There exist
ingredients that do not alter 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 employed in the food industry for Modified
Atmosphere Packaging (MAP) and refrigeration fall under this classification.
In 1958 Congress created the Food
Additives Amendment to the Federal Food, Drug and Cosmetic Act. One item included in the
amendment was the definition of food additive:
“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 considered additives rather than GRAS.
In the late 60’s cyclamate salts, which were used
as an artificial sweetener in soft drinks and considered GRAS, began to be reconsidered. The results urged
then President Nixon to call on the FDA to reexamine all
substances classified as GRAS. In 1997, the FDA argued that they did not
have proper resources to fulfill all the insistence
that they were receiving for substances to be classified.
Since then, substances
that were previously classified as 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. To explain simply, a GRAS classification prior to 1997 was sanctioned by the FDA and later than
1997 by accord 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 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 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 gas and the other sanctions (i.e. … good manufacturing practices…) are controlled
by the food processor or the gas supplier’s customer.
Additionally, 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 insinuates
that the FDA had no questions as to the accuracy of
the outside expert’s consensus.
The crucial point to learn from this is that the any gases considered “Food Grade” have been certified in house by the manufacturer rather than 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 are trained to look
for food grade products and prefer to see clean packages
with clear labels. So having dedicated
“food grade” cylinders and/or tanks is important to service this market as is evidenced
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’re interested in
purchasing food grade gases
or other specialty gases for various industries in Minneapolis, contact
Toll Company at 612-581-9889 or contact us via email at email@example.com.
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 been a leader to teams of engineers and technicians as an R & D manager for major gas
companies. His work directed him to be in charge of the marketing
efforts of technology worldwide for industrial gas suppliers. He now consults to
the industry on the business specializing in operations, applications and