The United States Food and Drug Administration (FDA) controls
about 80% of the US food supply. The Food and Drug
Administration is also responsible for reviewing
the
packaging of the food as long as the ingredient of the food product as well. There are
ingredients that do not change the food product’s taste or
makeup and exist because they affect
components of the product such as
shelf preservation, color and aroma.
These added 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 into this category.
History
In 1958 Congress created the Food
Additives Amendment to the Federal Food, Drug and Cosmetic Act. The amendment defined food
additive as:
“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 that are considered additives rather than GRAS.
In the late 60’s cyclamate salts, which were utilized
to artificially sweeten soft
drinks and considered GRAS, began to be questioned. The conclusion incited
then President Nixon to call on the FDA to reevalute the components that were considered
GRAS. In 1997, the FDA claimed that they did not have adequate resources to carry out 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 after 1997 requesting
classification are granted a GRAS Notice which is determined
by individual authorities 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 briefly
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
assigned 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:
·
The
ingredient must be of a purity suitable for its intended use.
·
In
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:
o
The
ingredient is used in food at levels not to exceed current good manufacturing
practice.
o
Prior
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 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 recognized 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 indicates
that the FDA had no questions as to the accuracy of
the outside expert’s decision.
The main objective to take
away is that the any gases with
the label “Food Grade” have been certified in house by the manufacturer rather than by the FDA.
The certification is by purity defined by best
practice in the manufacture and handling of the product to its final package (cylinders, micro-bulk vessels, transports and large cryogenic
vessels). Food processors have learned to keep an eye out
for food grade products and wish to see clean packages
with clear labels. So having predetermined
“food grade” cylinders and/or tanks is necessary
to succeed in this market as is shown
by the dominant companies naming and trademarking their
respective lines of food grade gases.
Further
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 Columbus, contact
Delille Oxygen Company at (614) 444-1177 or contact us via email at scotta@delille.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 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
marketing.