The United States Food and Drug Administration (FDA) controls
about 80% of the US food supply. The FDA is also responsible for inspecting
food product’s packaging along with its ingredients. Several
ingredients that do not change 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. 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.”
This did not include
substances like gas mixtures that are considered additives rather than GRAS.
In the late 60’s cyclamate salts, which were utilized
as an artificial sweetener in soft drinks and grouped as GRAS, were brought
into question. The outcome incited
then President Nixon to instruct the FDA to reexamine all
substances classified as GRAS. In 1997, the FDA declared that they did not
have enough resources to fulfill all the insistence
that they were receiving for substances to be classified.
Since then, substances
that were previously classified as were maintaining their classification and can
be found in the Code of Federal Regulations (21 CFR). All substances after 1997 requesting
classification are granted a GRAS Notice which is determined
by individual experts outside the
government. Simply put, a GRAS classification earlier
than 1997 was sanctioned by the FDA and following
1997 by consensus of recognized experts then concisely
reviewed by the FDA.
How does this apply
to gases used in MAP?
The main objective to keep in mind 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 given
the classification of 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 stated, gas suppliers are
only accountable for 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.
Likewise, hydrogen, carbon
monoxide and argon were recognized as ingredients
after 1997 and are not listed in 21 CFR.
Since then, they
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 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 obtained 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 like to see clean packages
with clear labels. So having predetermined
“food grade” cylinders and/or tanks is important to service 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 are available through PurityPlus. If you would like to purchase food grade gases
or other specialty gases for various industries in Richmond, Virginia, contact
Arc3 Gases at (804) 644-4521 or contact us via email at firstname.lastname@example.org.
Written by John Segura.
John Segura is a licensed Professional Engineer and a seasoned
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 in charge
of 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 currently consults to
the industry on the business specializing in operations, applications and