[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