ingredients in NOP-listed sanitizers and hand sanitizers in food handling establishments. Any substance identified by a certified client or
applicant as a food contact substance must be accompanied by documentation that substantiates the claim.
The “Must Be On The List If It Contacts Organic Food”
In this approach, any synthetic substance in direct contact with
organic food must be on the National List, regardless if it is classified
as a food contact substance by FDA or not. This includes sanitizers
and inert ingredients in sanitizers that are used in direct contact
with food, as well as ion exchange resins.
Equipment sanitizers, non-volatile boiler chemicals, that are not
in contact with organic food, are not considered to be “in or on”
organic food and are generally allowed. However, sanitizers used
on food contact equipment must not be persistent in nature, and
are subject to an intervening event such as thorough rinsing or
purge of non-organic product before equipment is in contact with
organic food. Boiler chemicals that are not carried into steam are
permitted, as are systems that turn off injected volatile chemicals
prior to runs of organic product. Packaging materials are not
restricted, except as provided for in the regulation, with the prohibition on fumigants, preservatives and fungicides as specified in
So, What Is the Best Way to Go
About All of This?
There are no easy answers to this
complex issue. Certifiers continue to
use their best judgment and seek to
work with the NOP for further clarification. Until then, the most fail-safe
option, no matter what certifier you
are working with, is to stick with
products that are actually named on
the National List. Going outside of
the National List and using FDA food
contact substances opens up the door
for a variety of interpretations which
may complicate the certification
process and cause headaches.
If there is a material you really
need to use that is not on the list, you
may also want to consider drafting a
petition to have that material
reviewed by the NOSB. The board
then can vote to recommend (or not
recommend) to have the material
you wish to use officially added to the
Additional Key Definitions
UNDER THE NOP:
Ingredient: Any substance used in the preparation of an agricultural product that is still
present in the final commercial product as consumed.
According to the policy of December 2002, the NOP further defines “still present”
as those ingredients regulated by the FDA as food additives permitted for direct addition to food for human consumption if they fall in certain categories in 21 CFR unless
they are considered food contact substances (which are not considered still present).
Processing Aid: (1) A substance that is added to a food during the processing of such food
but is removed in some manner from the food before it is packaged in its finished
form; ( 2) A substance that is added to a food during processing, is converted into constituents normally present in the food and does not significantly increase the amount
of the constituents naturally found in the food; and ( 3) A substance that is added to a
food for its technical or functional effect in the processing but is present in the finished food at insignificant levels and does not have any technical or functional effect
in that food.
UNDER THE FDA:
Food additives: A food additive is defined as any substance, the intended use of which
results or may reasonably be expected to result, directly or indirectly, in its becoming a
component or otherwise affecting the characteristic of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing,
treating, packaging, transporting or holding food and any source of radiation intended
for any such use). This excludes substances which are not GRAS, sanctioned prior to
1958 or otherwise excluded from the definition of food additives.
Direct Food Additive: Additives that have a technical effect in food.
Indirect Food Additive: In general, these
are food additives that come into contact with food as part of packaging,
holding or processing, but are not
intended to be added directly to,
become a component of, or have a
technical effect in or on the food.
Most of the substances deemed food
contact substances would fall under
this category. Indirect food additives
mentioned in Title 21 of the U.S. Code
of Federal Regulations ( 21 CFR) used in
food-contact articles include adhesives
and components of coatings (Part 175),
paper and paperboard components
(Part 176), polymers (Part 177) and adjuvants and production aids (Part 178).
Secondary Direct Food Additive: This
term is in the title of 21 CFR 173, which
was created during recodification of
the food additive regulations in 1977. A
secondary direct food additive has a
technical effect in food during processing but not in the finished food.
Most secondary direct food additives
would be considered processing aids
while some additives also meet the
definition of a food contact substance.