The United States Food and Drug Administration (FDA) regulates
about 80% of the US food supply. The Food and Drug
Administration is also responsible for analyzing
food product’s packaging along with its ingredients. There are
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 utilized in the food industry for Modified
Atmosphere Packaging (MAP) and refrigeration are classified into this category.
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.”
Not included are like gas mixtures that are considered additives rather than GRAS.
In the late 60’s cyclamate salts, which were utilized
as an artificial sweetener for sodas and grouped as GRAS, began to be reconsidered. The results prompted
then President Nixon to call on the FDA to reevalute the components that were considered
GRAS. In 1997, the FDA declared that they did not
have enough resources to address all the demands
that they were receiving for substances to be classified.
Since then, previous substances that were considered GRAS were keeping 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 determined
by individual experts outside the
government. In simpler
terms, a GRAS classification before 1997 was sanctioned by the FDA and later than
1997 by accord of recognized experts then quickly
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 mentioned, gas suppliers are
only responsible for the purity of the product and the other sanctions (i.e. … good manufacturing practices…) are controlled
by the food processor or the gas supplier’s customer.
In addition, 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 indicates
that the FDA had no questions as to the correctness of
the outside expert’s consensus.
The important fact to take
away 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 adequate handling and manufacturing practices until the product 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 separate
“food grade” cylinders and/or tanks is crucial to sustain this market as is proven
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 are in search of food grade gases
or other specialty gases for various industries in Northern Illinois, contact
Weldstar at 855-998-4875 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 spent over 30 years gaining
experience in marketing, sales, and operations for both domestic and
international affairs. 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 presently consults to
the industry on the business specializing in operations, applications and