The United States Food and Drug Administration (FDA) regulates
approximately 80% of the US food supply. The administration is also responsible for analyzing
packaging of the food as long as the ingredient of the food product as well. There exist
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 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 as such.
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
classified as additives and not considered GRAS.
In the late 60’s cyclamate salts, which were employed
as an artificial sweetener in soft drinks and considered GRAS, were brought
into question. The conclusion urged
then President Nixon to order the FDA to reevalute the components that were considered
GRAS. In 1997, the FDA argued that they did not
have proper resources to carry out all the insistence
that they were receiving for substances to be classified.
Since then, substances
that were previously classified as 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 concluded
by individual experts outside the
government. To explain simply, a GRAS classification before 1997 was sanctioned by the FDA and later than
1997 by accord of recognized experts then briefly
audited 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 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 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 accountable for the purity of the gas
product and the other sanctions (i.e. … adequate manufacturing practices…) are regulated
by the food processor or the gas supplier’s customer.
Likewise, hydrogen, carbon
monoxide and argon were acknowledged 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 correctness of
the outside expert’s consensus.
The crucial point to take
away is that the any gases labeled “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 search
for food grade products and wish to see clean packages
with clear labels. So having predetermined
“food grade” cylinders and/or tanks is important to service this market as is proven
by the successful companies naming and trademarking their
respective lines of food grade gases.
information on food grade gases and MAP applications can be
obtained through PurityPlus. If you would like to purchase food grade gases
or other specialty gases for various industries in Pittsburgh, contact
Greco Gas at (724) 226-3800 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 30+ years of experience in areas involving sales,
marketing, and operations both domestically and internationally. He has been a leader to 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 currently consults to
the industry on the business specializing in operations, applications and