Dairy-based Ingredients: Regulatory Aspects 381among qualifi ed experts that those data and
information establish that the substance is
safe under the conditions of its intended use.New Ingredient Approval Process
Any food additive intended to have a techni-
cal effect in food and any color additive for
use in foods, drugs, cosmetics, or medical
devices that are in contact with the body for
a signifi cant period of time is deemed unsafe
unless it conforms to the terms of a regulation
prescribing its use or to an exemption for
investigational use. A petition for a food
additive or color additive is submitted to
request issuance of a regulation allowing new
uses of the additive, and must contain the
necessary supporting data and information.
Prior to submitting a petition, it may be
useful to verify that the candidate ingredient
is not already regulated for the intended use
by consulting the FDA ’ s regulations in Title
21 of the CFR, parts 170 to 199 for food
additives, and parts 73 and 74 for color addi-
tives. In addition, the FDA has a nice resource
titled Everything Added to Food in the United
States (EAFUS). If a food additive is regu-
lated for use in food, it is listed in EAFUS
with a “ regnum ” (a regulation in 21 CFR).
To be acceptable for a particular application,
an additive must meet the identity, specifi ca-
tions, and use limitation provisions in the
applicable regulation.
The following administrative steps are
involved in a new food additive approval
cycle (Figure 15.1 ):- Data are submitted by the petitioner
- There is communication between the
FDA and the petitioner - The FDA reviews the data as clari-
fi ed by the communication and prepares
memoranda - The FDA publishes a fi nal regulation,
which authorizes a specifi c use of the
additive, must withstand legal challenge,
and bears FDA ’ s credibility.
tion (62 FR 18938; April 17, 1997). Under
21 CFR 170.30(b), general recognition of
safety through scientifi c procedures requires
the same quantity and quality of scientifi c
evidence as is required to obtain approval of
the substance as a food additive and ordinar-
ily is based upon published studies, which
may be corroborated by unpublished studies
and other data and information.
Typically, industry submits the GRAS
notice under the GRAS notifi cation proce-
dure. The FDA evaluates whether each sub-
mitted notice provides a suffi cient basis for a
GRAS determination and whether informa-
tion in the notice or otherwise available to
FDA raises issues that lead the agency to
question whether use of the substance is
GRAS. The FDA responds to the notifi er by
letter (FDA, 2009 ). Among the ingredients
approved by the GRAS mechanism are
canola oil, enzyme preparations, whey, cocoa
butter substitute, and phytosterols.
While preparing the GRAS notifi cation, it
is important to remember the following points.
Regardless of whether the use of a substance
is a food additive or GRAS, there must be
evidence that the substance is safe under the
conditions of its intended use. FDA has
defi ned safe (21 CFR 170.3(i)) as a reason-
able certainty in the minds of competent sci-
entists that the substance is not harmful under
its intended conditions of use. The specifi c
data and information that demonstrate safety
depend on the characteristics of the sub-
stance, the estimated dietary intake, and the
population that will consume the substance.
For a food additive, privately held data
and information about the use of the sub-
stance are sent by the sponsor to the FDA,
which evaluates those data and information
to determine whether the substance is safe
under the conditions of its intended use (21
CFR 171.1). For a GRAS substance, gener-
ally available data and information about the
use of the substance are widely known and
accepted by qualifi ed experts, and there is a
basis to conclude that there is consensus