[Federal Register Volume 61, Number 165 (Friday, August 23, 1996)]
[Rules and Regulations]
[Pages 43451-43454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21529]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 584
[Docket No. 95G-0039]
Food Substances Affirmed As Generally Recognized As Safe In Feed
and Drinking Water of Animals; Hydrophobic Silica
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations for the listing of specific substances affirmed as
generally recognized as safe (GRAS) in the feed and drinking water of
animals and to provide that hydrophobic silica be affirmed as GRAS when
used as an anticaking/free-flowing agent in vitamin preparations for
animal feed. This action is in response to a petition filed by Degussa
Corp.
EFFECTIVE DATE: August 23, 1996.
FOR FURTHER INFORMATION CONTACT: Sharon A. Benz, Center for Veterinary
Medicine (HFV-226), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1729.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of March 21, 1995 (60
FR 14950), FDA announced that a GRAS affirmation petition for animal
use (GRASP 2419) had been filed by Degussa Corp., c/o Counsel for
Petitioner, Jerome H. Heckman, Keller and Heckman, 1001 G St. NW.,
suite 500 West, Washington, DC 20001. This petition proposes that part
584 (21 CFR part 584) be amended to provide that hydrophobic silica,
prepared by the hydrophobization of silicon dioxide with
dichlorodimethylsilane, be affirmed as GRAS as an anticaking/free-
flowing agent in vitamin preparations for animal feed. FDA gave
interested persons until June 5, 1995, to submit comments. FDA did not
receive any comments in response to that notice.
II. Standards for GRAS Affirmation
Under Sec. 570.30 (21 CFR 570.30), general recognition of safety of
food ingredients may be based only on the views of experts qualified by
scientific training and experience to evaluate the safety of food
substances. The basis of such views may be either: (1) Scientific
procedures, or (2) in the case of a substance used in food prior to
January 1, 1958, through experience based on common use in food.
General recognition of safety based upon scientific procedures requires
the same quantity and quality of scientific evidence as is required to
obtain approval of a food additive regulation for the ingredient and
ordinarily is to be based upon published studies, which may be
corroborated by unpublished studies and other data and information
(Sec. 570.30(b)). General recognition of safety through experience
based on common use of a substance in food prior to January 1, 1958,
may be determined without the quantity or quality of scientific
evidence required for approval of a food additive regulation; but
ordinarily it is to be based upon generally available data and
information concerning its pre-1958 history of use (Sec. 570.30(c)).
The subject petition relies on scientific procedures evidence to
support GRAS affirmation of hydrophobic silica in vitamin preparations
for animal feed.
III. Safety Evaluation
A. Manufacturing Process
According to the information in the petition, hydrophobic silica is
manufactured from fumed amorphous silicon dioxide or precipitated
silica by chemical reaction (methylation) of the
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surface of the silicon dioxide particle with the methylating agent,
dichlorodimethylsilane. The dichlorodimethylsilane is mixed with a
slurry of silicon dioxide and reacts with most of the silanol groups (-
Si-OH) on the surface of the particle and converts them to methylsilyl
groups (-Si-CH3). The methylation reaction occurs only at the
surface of the silicon dioxide particle leaving 97 to 99 percent of the
silicon dioxide intact. Thus, the particle of hydrophobic silica may be
viewed as being composed of silicon dioxide with a surface of
dimethylpolysiloxane ((CH3)2SiOSi(CH3)2).
After further processing, the resulting hydrophobic silica
generally contains 97 to 99 percent silicon dioxide. Fumed hydrophobic
silicas generally contain greater than 99 percent silicon dioxide and
precipitated hydrophobic silica contain greater than 97 percent silicon
dioxide.
Silicas used in the production of hydrophobic silica will be food-
grade and meet the requirements for purity as defined in the Food
Chemical Codex, 3d edition, and the U.S. Pharmacopoeia and National
Formulary XVII. The specifications for hydrophobic silica are those for
silicon dioxide in the Food Chemical Codex, with the exception of a
specification for not more than 50 parts per million (ppm) of
dichlorodimethylsilane.
B. Uses of Hydrophobic Silica
The proposed use of hydrophobic silica is as an anticaking/free-
flow agent in vitamin preparations for animal feed, as described in 21
CFR 170.3(o)(1). Anticaking agents are processing aids used to impart
noncaking, free-flowing properties to dry foods by decreasing adhesion
forces between particles of materials to which they are added.
Anticaking agents are commonly used in many foods, such as salt,
spices, cereals, and sugars, and in complete animal feeds and feed
ingredients in a manner similar to human foods.
The methylation of the surface of the silicon dioxide particle only
serves to render the particle surface of silicon dioxide hydrophobic.
The increased hydrophobicity of the particle surface allows hydrophobic
silica to act as anticaking and free-flow agents for hydrophobic
substances, such as vitamin A preparations. The individual vitamin
particles are coated with silica, which prevents caking and provides
free-flow characteristics.
Information supplied by the petitioner evidences that silicas and
silicates have been used as direct food and feed ingredients for
several decades. Silicon in the form of silicon dioxide is commonly
used as an anticaking agent in various feed ingredients and complete
feeds (21 CFR 573.940). Other silicates including silica aerogel (21
CFR 582.1711); aluminum calcium silicate (21 CFR 582.2122); calcium
silicate (21 CFR 582.2227); magnesium silicate (21 CFR 582.2437);
sodium aluminosilicate (21 CFR 582.2727); hydrated sodium calcium
aluminosilicate (21 CFR 582.2729); and tricalcium silicate (21 CFR
582.2906) are recognized as GRAS as anticaking agents and have a
history of use in the feed industry as such.
The petition proposes that hydrophobic silica should not be used at
levels greater than 5 percent in the vitamin preparation. This would
result in no more than 1.5 ppm of hydrophobic silica in the finished
feed. Other silicates are commonly used at levels 2 to 2.5 percent or
2,000 ppm in finished feeds. The proposed use of hydrophobic silica is
not expected to significantly contribute to the consumption of silicate
by animals.
C. General Recognition of Safety of Silicates
The petition provides information to support a determination that
the use of hydrophobic silica is GRAS based upon the existence of an
expert consensus that the components of hydrophobic silica have been
shown to be safe based on scientific procedures and that the safety
characteristics of the components can be extended to the product,
hydrophobic silica. Foremost in the support of safety is published
information indicating that similar silicate compounds are nontoxic at
current levels used in food and feed, and that the inherent safety of
silicon dioxide is not changed by making the surface portion
hydrophobic because the toxicological profile is essentially the same
as commonly used silicas.
Both silicon dioxide and dimethylpolysiloxane have been widely used
for years in the food, feed, pharmaceutical and dental industries.
Information in the petition shows that the food safety of silicas has
been evaluated by numerous scientific panels. These panels include the
Select Committee on GRAS Substances of the Federation of the American
Society for Experimental Biology (the Select Committee) that reviewed
the use, exposure, and safety of silicas and silicates in 1979. This
committee concluded that the absorption of ingested silicas is limited
by its solubility in the contents of the alimentary canal and the
absorbability of silicon dioxide appears to be slight. Further, the
Select Committee concluded that silicon dioxide and various silicates
occur abundantly in the earth's crust and are present in practically
all natural waters, animals, and plants; they are part of the normal
diet, and silicon compounds consumed as added food ingredients
constitute only a minor proportion of the total dietary silicon intake
(Ref. 1).
The Select Committee also reviewed the properties, uses, and safety
of methylpolysilicones for use as direct food ingredients in 1981, and
it concluded that methylpolysilicones (also called
dimethylpolysiloxane) used in food consist of high molecular weight
compounds that are not absorbed to any appreciable extent from the
gastrointestinal tract and have been demonstrated to be of low acute
and chronic toxicity to animals and man. Moreover, the Select Committee
also recognized the medical use of dimethylpolysiloxane as dimethicone
and simethicone. Simethicone is widely used in over-the-counter drugs
as an antiflatulence ingredient, and as such, is generally recognized
as safe and effective (21 CFR 332.10) (Ref. 2).
The Scientific Committee for Food of the Commission of European
Committees, which reviewed the safety of silicates and silicon dioxides
in 1991, concluded that available published data on orally administered
silica and silicates, including amorphous silicon dioxide, substantiate
the biological inertness of these compounds. It also concluded that
silicates and silicones are sufficiently safe so that a restriction on
their use is not required nor is the establishment of an acceptable
daily intake (Ref. 3).
The Food and Agriculture Organization/World Health Organization
(FAO/WHO) Joint Expert Committee on Food Additives reached the same
conclusion as the Scientific Committee for the European Communities and
also determined that an acceptable daily intake was not necessary (Ref.
4).
D. Corroborating Evidence of Safety of Hydrophobic Silica
The petitioner also submitted relevant toxicological data that
supports the safety of hydrophobic silica to man and animals. The
submitted information is an article in the published literature
entitled ``Characterization and Toxicological Behavior of Synthetic
Amorphous Hydrophobic Silica'' (Ref. 5). The results reported from
testing indicate that fumed or precipitated hydrophobic silica does not
produce inflammation of the skin or mucous membranes, and acute and
chronic oral tests yielded no adverse systemic effects. The submitted
information
[[Page 43453]]
indicates that hydrophobic silica is nontoxic and the lack of toxicity
is related to hydrophobic silica's nonabsorbability. The toxicological
profile was essentially the same as similar GRAS silicates.
IV. Conclusion
The agency has determined that the petition provides information to
support a determination that the use of hydrophobic silica is GRAS
based upon the existence of an expert consensus that the components of
hydrophobic silica have been shown to be safe based on scientific
procedures and that the safety characteristics of the components apply
to the product, hydrophobic silica. Foremost in the support of safety
is published information indicating that similar silicate compounds are
safe at current levels used in food and feed and that the inherent
safety of silicon dioxide is not changed when the particle surface is
altered by methylation. Corroborating evidence has shown that the
toxicological profile for hydrophobic silica is essentially the same as
commonly used silicas. Therefore, the agency is affirming that
hydrophobic silica when used as an anticaking/free-flowing agent in
vitamin preparations for animal feed is GRAS when used in accordance
with good manufacturing or feeding practices at levels not to exceed 5
percent of the vitamin preparation.
V. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact on small
entities. Because no current activity is prohibited by this final rule,
the compliance cost to firms is zero. Because no increase in the health
risks faced by consumers will result from this final rule, total costs
are also zero. Potential benefits include wider use of this substance
because of reduced uncertainty concerning its GRAS status, and any
resources saved by eliminating the need to prepare further petitions to
affirm the GRAS status of this substance for this use. The agency
certifies that the final rule will not have a significant economic
impact on a substantial number of small entities. Therefore, under the
Regulatory Flexibility Act, no further analysis is required.
VI. Environmental Impact
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
VII. Effective Date
As this rule recognizes an exemption from the food additive
definition in the Federal Food, Drug, and Cosmetic Act, and from the
approval requirements applicable to food additives, no delay in
effective date is required by the Administrative Procedure Act, 5
U.S.C. 553(d). The rule will therefore be effective immediately (5
U.S.C. 553(d)(1)).
VIII. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. GRASP 2419, Appendix 11, ``Evaluation of the Health Aspects
of Certain Silicates as Food Ingredients: Report of the Select
Committee on GRAS Substances.''
2. GRASP 2419, Appendix 12, ``Evaluation of the Health Aspects
of Methylpolysilicones as Food Ingredients: Report of the Select
Committee on GRAS Substances.''
3. GRASP 2419, Appendix 10, ``Report on Silicates and Silicon
Dioxide: The Scientific Committee for Food of the Commission of the
European Communities.''
4. GRASP 2419, Appendix 13, ``Evaluation Status of Silicon
Dioxide (JECFA);'' ``FAO/WHO Food Additives Data System;'' ``FAO
Food and Nutrition Paper,'' vol. 30/Rev. 1, 1985; ``Evaluations of
the Joint FAO/WHO Expert Committee on Food Additives,'' 1956-1984.
5. GRASP 2419, Appendix 6, ``Characterization and Toxicological
Behavior of Synthetic Amorphous Hydrophobic Silica.''
List of Subjects in 21 CFR Part 584
Animal feeds, Food additives.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
584 is amended as follows:
PART 584--FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
IN FEED AND DRINKING WATER OF ANIMALS
1. The authority citation for 21 CFR part 584 continues to read as
follows:
Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).
2. New Sec. 584.700 is added to subpart B to read as follows:
Sec. 584.700 Hydrophobic silicas.
(a) Product. Amorphous fumed hydrophobic silica or precipitated
hydrophobic silica (CAS Reg. No. 68611-44-9, silane, dichlorodimethyl-,
reaction products with silica).
(b) Conditions of use. An anticaking/free-flow agent in vitamin
preparations for animal feed.
(c) Limitations. Not to exceed 5 percent in the vitamin
preparation. It shall be used in accordance with good manufacturing or
feeding practices. It must be of purity suitable for intended use, and
it must comply with the following specifications:
(i) Amorphous fumed hydrophobic silica: Not less than 99.0 percent
silicon dioxide after ignition. Not more than 3 ppm arsenic. Not more
than 0.003 percent heavy metals (as lead). Not more than 10 ppm lead.
Not more than 2.5 percent loss on drying. Not more than 2 percent loss
on ignition after drying. Not more than 1 percent insoluble substances.
Not more than 50 parts per million dichlorodimethylsilane.
(ii) Precipated hydrophobic silica: Not less than 94.0 percent
silicon dioxide after ignition. Not more than 3 ppm arsenic. Not more
than 0.003 percent heavy metals (as lead). Not more than 10 ppm lead.
Not more than 7 percent loss on drying. Not more than 8.5 percent loss
on
ignition after drying. Not more than 5 percent soluble ionizable salts
(as sodium sulfate). Not more than 1 percent insoluble substances. Not
more than 50 parts per million dichlorodimethylsilane.
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Dated: August 18, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-21529 Filed 8-22-96; 8:45 am]
BILLING CODE 4160-01-F