384 Chapter 15
data on the size (average and distribu-
tion), shape, surface area (average and
distribution), surface charge (zeta poten-
tial), and morphology of the particles,
as well as any other size - dependent pro-
perties (e.g., agglomeration, aggrega-
tion, dispersion) should be included, as
appropriate.
Specifi cations for identity and purity of
the petitioned food additive should be pro-
posed. If published specifi cations for the
food additive are available, for example in
the Food Chemicals Codex (FCC), 6th
edition (2008) or current edition, then these
should be cited and appropriately referenced.
The data provided in this section of a food
additive petition should represent a complete
compositional analysis of the food additive,
including:
- A description of the food additive (e.g.,
physical form, odor, color, and solubil-
ity). For food additives derived from
natural sources, the sources themselves
should be clearly identifi ed. - Identifi cation tests for the food additive,
including the method(s) used or refer-
ence(s) for a suitable method(s). - An assay of purity for the additive,
including the method used or reference
to a suitable method. - Physico - chemical characteristics of the
food additive (e.g., ash content, moisture
content, melting point, density, refrac-
tive index, pH). - Parameters related to the particle size,
shape, and surface properties of the food
additive, as appropriate, if particle size
is important for the identity and func-
tionality of the additive. - Limits for impurities and contaminants.
a. A limit for lead should be proposed.
In addition, limits for arsenic and
heavy metals, such as cadmium and
mercury, should be considered when
their presence must be controlled.
and for impurities in and degradation
products of the petitioned additive can
help OFAS further identify the chemi-
cals intended to be added to food. This
facilitates the determination of exposure
to and safety of the various chemicals
present in food as the result of the use of
the food additive. CAS registry numbers
for new compounds and assistance with
nomenclature can be obtained from CAS
Client Services, Chemical Abstracts
Service, P.O. Box 3012, Columbus, OH,
43210 - 0012.
- Empirical and structural formulas and
molecular or formula weights. - Composition of the food additive. For
mixtures, identify as many of the com-
ponents as feasible to reasonably defi ne
the composition of the mixture. In addi-
tion, information on the chemical com-
position and identity for each component
in the mixture and a material balance
should be provided. - For food additives of natural origin,
information on the source (e.g., system-
atic name, genus, species, variability
based on climate or other geographical
factors). - Further characterizing information, such
as data on chemical and physical proper-
ties of the food additive (e.g., melting
point, boiling point, specifi c gravity,
refractive index, optical rotation, pH,
solubility, and reactivity) and chromato-
graphic, spectroscopic, or spectrometric
data (e.g., spectra from nuclear magnetic
resonance, infrared, electronic absorp-
tion, or mass spectra) that can be used
as a “ fi ngerprint ” for identifi cation. If
the particle size is important for the
additive to achieve its intended techni-
cal effect, such that the additive is pro-
duced or processed using techniques or
tools that manipulate the particle size
and may contain altered particles that are
formed as manufacturing byproducts,