[Federal Register Volume 60, Number 51 (Thursday, March 16, 1995)]
[Notices]
[Pages 14287-14289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6529]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0136]
New Monographs and Revisions of Certain Food Chemicals Codex
Monographs; Opportunity for Public Comment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on pending changes to certain Food
Chemicals Codex specifications monographs from the third edition and
its four supplements. New monographs and additions, revisions, and
corrections to current monographs are being prepared for certain
substances used as food ingredients, by the National Academy of
Sciences/Institute of Medicine (NAS/IOM) Committee on Food Chemicals
Codex (the committee). This material will be published in the fourth
edition of the Food Chemicals Codex, which is scheduled for release in
March 1996. When the committee completes its review of the comments,
the agency will announce the availability of copies of the new and
revised monographs in a future issue of the Federal Register.
DATES: Written comments by April 17, 1995. The committee advises that
comments received after this date cannot be considered for the fourth
edition but will be considered for later supplements.
ADDRESSES: Submit written comments and supporting data and
documentation to the NAS/IOM Committee on Food Chemicals Codex,
National Academy of Sciences, 2101 Constitution Ave. NW., Washington,
DC 20418. Submit written request for copies of the proposed new
monographs and/or revisions to current monographs to NAS (address
above) or the Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Fatima N. Johnson, Committee on Food Chemicals Codex, Food and
Nutrition Board, National Academy of Sciences, 2101 Constitution Ave.
NW., Washington, DC 20418, 202-334-2580; or
Paul M. Kuznesof, Center for Food Safety and Applied Nutrition
(HFS-247), Food and Drug Administration, 200 C St. SW., Washington, DC
20204, 202-418-3009.
SUPPLEMENTARY INFORMATION: FDA provides contracts to NAS/IOM to support
the preparation of the Food Chemicals Codex, which is a compendium of
specifications for substances used as food ingredients. Before any
specifications are included in a Food Chemicals Codex publication,
public announcement is made in the Federal Register.
FDA has previously announced that the committee was considering new
monographs and monograph revisions for inclusion in the fourth edition
of the Food Chemicals Codex, which is now being prepared. In addition,
notice and opportunity for public comment have been given on policies
adopted by the committee for the fourth edition on lead and heavy
metals specifications (58 FR 38129, July 15, 1993), and on arsenic
specifications (59 FR 11789, March 14, 1994).
The committee will continue to provide the opportunity for public
comment on intended changes in monographs by means of Federal Register
notices before their inclusion in the fourth edition. If notice of
changes is not provided, the monographs will be carried into the fourth
edition unchanged from the third edition or subsequent supplements,
except for minor editorial changes. Therefore, interested parties are
invited to review all monographs in the third edition of the Food
Chemicals Codex and its four supplements in preparation for their
inclusion in the fourth edition. Interested parties should submit all
suggestions with supporting documentation to the National Academy of
Sciences at the above address.
FDA now gives notice that the committee is soliciting comments and
information on certain proposed new monographs and revisions to certain
additional current monographs. These new monographs and revisions will
be published in the fourth edition of the Food Chemicals Codex. The
proposed new monographs and revisions to current monographs may be seen
in the Dockets Management Branch (address above) between 9 a.m. and 4
p.m., Monday through Friday. Copies of the new monographs and proposed
revisions to current monographs may be obtained from NAS or the Dockets
Management Branch. Requests for copies should be identified with the
docket number found in brackets in the heading of this document, and it
should specify the monographs desired.
FDA emphasizes, however, that it will not consider adopting and
incorporating any of the committee's new monographs or monograph
revisions into FDA regulations without ample opportunity for public
comment. If FDA decides to propose the adoption of new monographs and
changes that have received final approval of the committee, such
opportunity for public comment will be announced in a future issue of
the Federal Register.
The committee invites comments and suggestions on specifications by
all interested parties on the proposed new monographs and revisions of
current monographs, that follow: [[Page 14288]]
I. Proposed New Monographs
Calcium acid pyrophosphate
Carbon dioxide
Dammar gum
Dried yeast
Ferrous lactate
Furcelleran
Gelatin
Glycerol ester of gum rosin
Glycerol ester of partially hydrogenated gum rosin
Magnesium gluconate
Maltitol syrup
Partially hydrolyzed proteins
Sodium potassium tripolyphosphate
Whey
II. Current Monographs to Which the Committee Proposes to Make
Revisions
Acacia gum (description, heavy metals, lead)
N-Acetyl-L-methionine (specific rotation)
Acid hydrolysates of proteins ([formerly Acid hydrolyzed proteins]
description, requirements, assay, tests)
Agar (lead)
L-Alanine (specific rotation)
Alginic acid (heavy metals, lead)
Ammonium alginate (heavy metals, lead)
Annatto extracts (identification, heavy metals, residual solvent,
packaging and storage)
L-Arginine (specific rotation, loss on drying)
L-Arginine monohydrochloride (assay, specific rotation)
Ascorbic acid (functional use in foods, identification, tests)
L-Asparagine (loss on drying)
Benzoyl peroxide (heavy metals)
Butadiene-styrene 50/50 rubber (description, heavy metals, lithium,
residual hexane)
Butadiene-styrene 75/25 rubber (description, heavy metals)
Calcium alginate (ash, heavy metals, lead)
Calcium glycerophosphate (heavy metals)
Calcium lactobionate (numerous changes)
Calcium pantothenate (heavy metals, tests)
Calcium silicate (heavy metals, lead)
Calcium peroxide (heavy metals)
Calcium pantothenate, racemic (heavy metals)
Calcium phosphate, dibasic (formula weight, functional use in foods,
assay, fluoride, heavy metals, lead)
Calcium phosphate, monobasic (formula weight, fluoride, heavy
metals, lead, labeling)
Calcium phosphate, tribasic (synonym, functional use in foods,
fluoride, heavy metals, lead)
Canola oil (linolenic acid)
Carmine (description, assay)
-Carotene (description, identification, loss on drying,
melting range, solution in chloroform)
Cholic acid (assay, heavy metals, specific rotation)
Choline chloride (heavy metals, lead)
Choline bitartrate (heavy metals, lead)
Copper gluconate (identification)
Corn oil (Unhydrogenated) (identification)
L-Cysteine Monohydrochloride (specific rotation)
L-Cystine (loss on drying)
Desoxycholic acid (assay, heavy metals)
Dexpanthenol (identification)
Dextrose (chloride)
Dimethylpolysiloxane (identification)
Enzyme preparations (numerous changes)
FD & C Blue No. 1 (description, identification, mercury, subsidiary
colors)
FD & C Blue No. 2 (description, identification, subsidiary and
isomeric colors)
FD & C Green No. 3 (description, identification, subsidiary colors)
FD & C Red No. 3 (description, mercury, uncombined intermediates and
products of side reactions)
FD & C Red No. 40 (mercury)
FD & C Yellow No. 5 (description, ether extracts, subsidiary colors,
uncombined intermediates and products of side reactions)
FD & C Yellow No. 6 (description, subsidiary colors, total color,
uncombined intermediates and products of side reactions)
Ferric phosphate (lead)
Ferric pyrophosphate (lead)
Ferrous gluconate (identification, assay, lead)
Ferrous fumarate (lead)
Gellan gum (ash, heavy metals)
L-Glutamic acid (residue on ignition, loss on drying, specific
rotation)
L-Glutamic acid hydrochloride (assay)
L-Glutamine (identification, assay, loss on drying)
Glycerin (identification; assay; acrolein, glucose, and ammonium
compounds)
Glycerol ester of wood rosin (heavy metals, lead)
Glycerol ester of polymerized rosin (heavy metals, lead)
Glycerol ester of partially dimerized rosin (heavy metals, lead)
Glycerol ester of tall oil rosin (heavy metals, lead)
Glycerol ester of partially hydrogenated wood rosin (heavy metals,
lead)
Glyceryl-lacto esters of fatty acids (name change)
Glycine (assay, loss on drying)
Grape skin extract (assay, arsenic, sulfur dioxide, packaging and
storage)
Guar gum (acid-insoluble matter, galactomannans, lead, loss on
drying, protein)
Gum Ghatti (heavy metals, lead)
High-fructose corn syrup (assay, lead, total solids, labeling)
L-Histidine (specific rotation)
L-Histidine monohydrochloride (assay, loss on drying)
Hydroxylated lecithin (heavy metals)
Invert sugar (total solids)
L-Isoleucine (specific rotation)
Karaya gum (heavy metals, insoluble matter, lead, loss on drying)
Kelp (heavy metals)
Lanolin, anhydrous (heavy metals)
Lecithin (heavy metals)
L-Leucine (loss on drying)
Limestone, ground (heavy metals, mercury)
Locust (carob) bean gum (lead)
L-Lysine monohydrochloride (specific rotation, assay)
Magnesium stearate (assay, heavy metals)
Magnesium silicate (description, heavy metals)
Manganese gluconate (numerous changes)
Manganese sulfate (heavy metals)
Manganese glycerophosphate (identification, assay, heavy metals)
Manganese hypophosphite (heavy metals)
Mannitol (identification, assay, heavy metals, melting range,
specific rotation)
Masticatory substances, natural (heavy metals)
DL-Methionine (assay, loss on drying)
L-Methionine (assay, heavy metals specific rotation)
Methyl ester of rosin, partially hydrogenated (heavy metals)
Methyl formate (delete monograph from the Food Chemicals Codex)
Mineral oil, white (sulfur compounds)
Monoglyceride citrate (description)
Monopotassium L-Glutamate (loss on drying)
Niacinamide (identification, heavy metals)
Paraffin, synthetic (heavy metals)
Pectins (umerous changes)
Pentaerythritol ester of partially hydrogenated wood rosin (heavy
metals)
Pentaerythritol ester of wood rosin (heavy metals)
Petroleum wax (synonym, description, identification, functional use
in foods, heavy metals, lead, ultraviolet absorbance, packaging and
storage)
Petroleum wax, synthetic (synonym, description, heavy metals, lead,
ultraviolet absorbance)
DL-Phenylalanine (loss on drying)
L-Phenylalanine (loss on drying, specific rotation)
Polyisobutylene (heavy metals)
Polypropylene glycol (residue on ignition)
Potassium alginate (ash, heavy metals, lead, loss on drying)
Potassium chloride (description, assay)
Potassium gluconate (identification, loss on drying)
Potassium glycerophosphate (identification)
L-Proline (description, specific rotation)
Propylene glycol (identification, acidity, heavy metals)
Pyridoxine hydrochloride (assay, heavy metals)
Riboflavin 5'-phosphate sodium (assay, free riboflavin, riboflavin
diphosphate)
Riboflavin (description, specific rotation)
L-Serine (specific rotation)
Sodium acid pyrophosphate (assay, heavy metals, lead)
Sodium alginate (ash, heavy metals, lead, loss on drying)
Sodium aluminosilicate (lead)
Sodium aluminum phosphate, acidic (assay, heavy metals, lead)
Sodium chloride (heavy metals)
Sodium erythorbate (heavy metals, lead)
Sodium gluconate (identification, assay)
Sodium magnesium aluminosilicate (lead)
Sodium phosphate, tribasic (description)
Sodium polyphosphates, glassy (description)
Sorbitan monostearate (identification, assay)
Sorbitol (identification, chloride, heavy metals, lead, sulfate)
Sorbitol solution (identification, chloride, heavy metals, lead,
reducing sugars, sulfate)
Soybean oil (unhydrogenated) (identification)
Spice oleoresins (heavy metals; oleoresin paprika: additional
requirements)
Sucrose (calculation formula for invert sugar) [[Page 14289]]
Sunflower oil (unhydrogenated) (identification)
Talc (description, identification, extractable fluoride)
Tannic acid (definition, heavy metals, loss on drying)
Terpene resin, natural (heavy metals)
Terpene resin, synthetic (heavy metals)
Thiamine mononitrate (assay)
Thiamine hydrochloride (assay)
L-Threonine (specific rotation)
DL--Tocopherol (lead, heavy metals)
d--Tocopherol concentrate (description, heavy metals, lead)
Tocopherols concentrate, mixed (description, heavy metals, lead)
DL--Tocopheryl acetate (lead, heavy metals)
d--Tocopheryl acetate (heavy metals, lead)
d--Tocopheryl acetate concentrate (description, heavy
metals, lead)
d--Tocopheryl acid succinate (heavy metals, lead)
Tragacanth (heavy metals, lead)
L-Tryptophan (description, specific rotation)
L-Tyrosine (specific rotation)
L-Valine (specific rotation)
Vitamin B12 (identification, assay)
Vitamin D2 (identification)
Vitamin D3 (identification)
Xanthan gum (ash, heavy metals)
Xylitol (lead)
Yeast extract ([formerly Autolyzed yeast extract] description,
requirements, assay, other tests)
Zinc gluconate (numerous changes)
Interested persons may, on or before April 17, 1995, submit to NAS
(address above) written comments regarding the monographs listed in
this notice. Those wishing to make comments are encouraged to submit
supporting data and documentation with their comments. Two copies of
any comments are to be submitted. Comments and supporting data or
documentation are to be identified with the docket number found in
brackets in the heading of this document and should include a statement
that it is in response to this Federal Register notice. NAS will
forward a copy of each comment to the Dockets Management Branch
(address above). Received comments may be seen in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: March 3, 1995.
L. Robert Lake,
Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-6529 Filed 3-15-95; 8:45 am]
BILLING CODE 4160-01-F