The United States Food and Drug Administration (FDA)
regulates about 80% of the US food supply.
The administration is also responsible for reviewing not only the
ingredients of the food product but the packaging as well. There are ingredients that do not affect the
food product’s taste or makeup and are present for reasons such as shelf
preservation, color and aroma. These
additives are classified Generally Recognized As Safe (GRAS). Industrial gases that are used in the food
industry for Modified Atmosphere Packaging (MAP) and refrigeration fall under
In 1958 Congress enacted the Food Additives Amendment to the
Federal Food, Drug and Cosmetic Act. One
of the items that the amendment covered was the definition of a 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.”
Excluded are substances like gas mixtures which are not
considered additives and are considered GRAS.
In the late 60’s cyclamate salts, which were used as an
artificial sweetener in soft drinks and considered GRAS, were brought into
question. The results prompted then
President Nixon to order the FDA to reexamine all substances classified as
GRAS. In 1997, the FDA declared that
they did not have enough resources to address all the requests 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
after 1997 requesting classification are granted a GRAS Notice which is
determined by individual experts outside the government. Simply put, a GRAS classification before 1997
was sanctioned by the FDA and after 1997 by consensus 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 granted to industrial gases used 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 describes 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 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.
Additionally, 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 means that the FDA had no
questions as to the validity 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 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 been
conditioned to look for food grade products and like 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 major companies naming and trademarking their respective lines
of food grade gases.
More information on
food grade gases and MAP applications are available through PurityPlus. Whether you’re looking for specialty gases to be used in food and beverage applications, or any other industry that utilizes specialty gases, PurityPlus has a plethora of specialty gas products to meet your need. We have a large selection of specialty gases and specialty gas equipment, along with the resources and experts on hand to answer your questions and assist your needs. For more information, browse our online catalog or contact us via our website or at 877-81P-PLUS (877-817-7587).
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 led teams of engineers and technicians
as an R & D manager for major gas companies. His work directed him to lead the marketing
efforts of technology worldwide for industrial gas suppliers. He now consults to the industry on the
business specializing in operations, applications and marketing.