2000 Food and Color Additive Final Rules

One of the charges of the Center for Food Safety and Applied Nutrition is to assure that the use of food ingredients and color additives is safe. The authority for this mission is derived from the 1958 food additive and 1960 color additive amendments to the Federal Food, Drug and Cosmetic Act. Towards this end, CFSAN evaluates new petitions to determine if substances are considered safe for addition to the food supply. When a petition for a food ingredient or color additive is approved, a regulation identifying the conditions of use is published in the Federal Register. For information about additional food ingredient review programs in the Office of Food Additive Safety, consult the Inventory of Effective Premarket Notifications for Food Contact Substances and the Summary of all GRAS Notices.

The following listing documents the Final rules issued by the Office of Food Additive Safety during calendar year 2000. The exact date of the Publication and the Federal Register citation is listed along with other identifying information that can be found in the published Federal Register document. A link to the Government Printing Office Web site below the listing provides access to Federal Register documents.

For more information about the petition process, see Questions and Answers About the Petition Process. Final rules for years 2000-present are also available.

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DATE	FEDERAL REGISTER CITATION	PETITION NUMBER		SUBJECT
1/12/2000	65 FR 1776	9A4692	99F-2907	Final rule: Alcide Corp. Acidified sodium chlorite antimicrobial on red meat parts and organs. 21 CFR 173.325.
1/21/2000	65 FR 3384	8B4597	98F-0569	Final Rule: Ticona; Ethylene-norbornene copolymers in contact with dry food. 21 CFR 177.1520.
2/11/2000	65 FR 6889	3B4346	92F-0443	Final Rule; Dow Corning Corp. 1,2-dibromo-2,4- dicyanobutane (DBDCB) and a mixture of 5-chloro-2- methyl-4- isothiazolin-3-one (CMI) and 2-methyl-4- isothiazoline-3-one (MI). Optional magnesium nitrate as antimicrobial agents in emulsion-based silicone coating formulations. 21 CFR 175.500 and 175.320.
2/18/2000	65 FR 8272	9B4131, 9B4132, 9B4133	92F-0111	Final Rule; The Lubrizol Corp. 2-acrylamido-2-methyl- propanesulfonic acid, homopolymer, sodium salt in food contact adhesives and as component of paper and paperboard. 21 CFR 175.105 and 176.170.
3/14/00	65 FR 13675	5B4452	95F-0065	Final Rule: BASF Corp. Polyamidoamine- ethyleneimine- epichlorohydrin resin retention aid in manufacture of paper and paperboard in contact with aqueous and fatty food. 21 CFR 176.170.
3/21/2000	65 FR 15057	9B4644	99F-0461	Final rule: Ticona; Polyphenylene sulfone resins as articles intended for repeated use. 21 CFR 177.2500.
3/23/2000	65 FR 15545	4B4430	94F-0334	Final rule: Morton International, Inc. Methyltin-2- mercaptoethyloleate sulfide alone or in combination with optional substances as heat stabilizer in rigid polyvinyl chloride and rigid vinyl chloride copolymers for pipes and fittings in food processing plants. 21 CFR 178.2010.
3/28/2000	65 FR 16312	0A4705	99F-5523	Final rule: Alcide Corp. Acidified Sodium chlorite solutions as antimicrobial agent on poultry carcass parts. 21 CFR 173.325.
3/28/2000	65 FR 16313	8B4601	98F-0567	Final rule: The Dow Chemical Co. Expanded safe use of ethylene- octene-1 copolymers, containing not less than 50 weight percent of polymer units derived from ethylene. 21 CFR 177.1520.
3/28/2000	65 FR 16314	9B4639	99F-0126	Final rule: Ciba Specialty Chemicals Corp. N,N"-1,2- ethanediylbis (N-(3-((4,6-bis (butyl(1,2,2,6,6-pentamethyl-4- piperidinyl) amino) -1,3,5-triazin-2- yl)amino)propyl) -N',N"- dibutyl-N'," -bis (1,2,2,6,6-pentamethyl-4- piperidinyl)-1,3,5- triamine) as light/thermal stabilizer in olefin polymers. 21 CFR 178.2010.
3/28/2000	65 FR 16315	9B4638	99F0298	Final rule: Asahi Denka Kogyo K.K. Aluminum hydroxybis (2,4,8,10- tetrakis (1,1-dimethylethyl)-6- hydroxy-12H- dibenzo (d,g) (1,3,2)dioxaphosphocin 6-oxidato)- as clarifying agent for polypropylene and polypropylene copolymers. 21 CFR 178.3295.
3/29/2000	65 FR 16518	3B4367	93F-0132	Final rule: Lonza, Inc. Mixture of hydroxymethyl-5,5- dimethylhydantoin and 1,3-bis(hydroxymethyl)-5,5- dimethylhydantoin as preservative in clay type fillers for paper and paperboard in contact with aqueous and fatty food. 21 CFR 176.170.
3/30/2000	65 FR 16816	7B4537	97F-0157	Final Rule: Japan Vilene Co., Ltd. 2-propenoic acid, polymer with 2-ethyl-2-(((1-oxo-2- propenyl)oxy)methyl)-1,3- propanediyl di-2-propenoate as fluid absorbant material. 21 CFR 177.1211.
3/31/2000	65 FR 17134	4B4421	94F-0246	Final Rule: Kuraray Co., Ltd. Ethylene- vinyl acetate - vinyl alcohol copolymers with revised specifications. 21 CFR 177.1360.
4/18/2000	65 FR 20727	9B4641	99F-0925	Final rule: The Dow Chemical Co. 2,2-dibromo-3- nitrilopropionamide preservative for adhesives and coatings in paper and paperboard. 21 CFR 175.105 and 176.170.
4/21/2000	65 FR 21311	8B4606	98F-0675	Final rule: The Dow Chemical Co. Polyphenylamines as cross-linking agents for epoxy resins in coatings. 21 CFR 175.300.
5/5/2000	65 FR 26129	0B4703	99F-5111	Final Rule: Goodyear Tire & Rubber Co. Acid catalyzed condensation reaction products of branched 4-nonylphenol, formaldehyde, and 1-dodecanethiol as antioxidant in adhesives, pressure-sensitive adhesives, and repeated- use rubber articles. 21 CFR 178.2010.
5/9/2000	65 FR 26746	9B4675	99F-1910	Final rule; Cytec Industries, Inc. 2-(4,6-bis(2,4-dimethylphenyl) -1,3,5-triazin-2- yl)-5- (octyloxyphenol) stabilizer for olefin polymers. 21 CFR 178.2010. (Anand).
5/9/2000	65 FR 26744	8B4631	98F-1019	Final rule; BF Goodrich Specialty Chemicals, Polyurethane resins from diphenylmethane diisocyanate, 1,4-butanediol, and adipic acid component of cap liners in bottles. 21 CFR 177.1210.
5/26/2000	65 FR 34081	0B4719	00F-0813	Final rule: Tritex Co., Inc. Sodium xylenesulfonate in paper and paperboard. 21 CFR 176.170.
5/31/2000	65 FR 34587	0A4716	00F-0786	Final rule: Eka Chemicals, Inc. Chlorine dioxide made from aqueous sodium chlorite with hydrogen peroxide in presence of sulfuric acid. 21 CFR 173.300.
6/12/2000	65 FR 36786	9B4669	99F-1581	Final rule: imidazolium compounds, 2-(C17 and C17-unsaturated alkyl)-1-(2- C18 and C18-unsaturated amido)ethyl)-4,5-dihydro-1-methyl, methyl sulfates debonding agent in the manufacture of paper and paperboard in contact with aqueous and fatty food and in contact with dry food. 21 CFR 176.170.
6/30/2000	65 FR 40496	4B4418	94F-0185 95F-0111	Final Rule; Great Lakes Chemical Corp. and Lonza, Inc. 1,3-dihalo-5,5- dimethylhydantoin (where the dihalo (halogen) may be bromine and/or chlorine) that may contain no more than 20 weight percent 1,3-dihalo-5- ethyl-5-methylhydantoin (where the dihalo (halogen) may be bromine and/or chlorine), as a slimicide in the manufacture of paper and paperboard. 21 CFR 176.300.
7/6/2000	65 FR 41581	8C0256	98C-0212	Final Rule; Cyanotech Corp. Haematococcus Algae Meal as a color additive in feed of salmonids to enhance color. 21 CFR 73.185.
7/6/2000	65 FR 41584	8C0252	97C-0466	Final Rule: Archer Daniels Midland Co., Phaffia yeast as color additive in feed of salmonids to enhance color. 21 CFR 73.385.
7/7/2000	65 FR 41874	9B4656	99F-1456	Final rule; Ciba Specialty Chemicals, Inc. 1,6-hexanediamine, N,N'-bis (2,2,6,6- tetramethyl-4- piperidinyl)-, polymer with 2,4,6-trichloro- 1,3,5-triazine, reaction products with N-butyl-1- butanamine and N-butyl- 2,2,6,6- tetramethyl-4- piperidinamine stabilizer in olefin polymers. 21 CFR 178.2010.
7/21/2000 4/13/2011	65 FR 45280 76 FR 20509	8M4584	98F-0165	Final rule; Irradiation in the Production, Processing and Handling of Food. 21 CFR 179.26. Final rule; denial of requests for a hearing and response to objections.
7/28/2000	65 FR 46342	9C0266	99C-1455	Final rule; Genzyme Surgical Products Corp. D&C Violet No. 2 as a color additive in absorbable sutures prepared from homopolymers of glycolide for general surgery. 21 CFR 74.3602.
8/8/2000	65 FR 48375	7C0251	97C-0415	Final rule: Zauder Bros., Inc. Luminescent zinc sulfide in certain externally applied cosmetics (nail polish and facial). 21 CFR 73.2995.
8/8/2000	65 FR 48377	0A4709	00F-0119	Final rule; National Food Processors Association; alcium disodium EDTA (ethylenediaminetetraacetate) or disodium EDTA to promote color retention for all edible types of cooked, canned legumes. 21CFR 172.120 and 172.135.
8/31/2000	65 FR 52907	8B4593	98F-0484	Final rule; Eastman Chemical Co. di-2-ethylhexyl terephthalate as a component of closures with sealing gaskets for food containers 21 CFR 177.1210).
8/31/2000	65 FR 52908	9B4635	99F-0127	Final rule; GEO Specialty Chemicals. trimethylolethane as a dispersant for pigments used as components of food-contact articles. 21 CFR 178.3725
9/28/2000	65 FR 58221	9C0266	99C-1455	Final Rule; Confirmation of Effective Date; for D&C Violet No. 2 as a color additive in absorbable sutures prepared from homopolymers of glycolide for general surgery. 21 CFR 74.3602.
10/6/2000	65 FR 59717	7C0251	97C-0415	Final rule; Confirmation of Effective Date (CED) Zauder Brothers; Luminescent zinc sulfide for use in certain externally applied cosmetics. 21 CFR 73.2995. Effective 9/8/2000.
10/6/2000	65 FR 59717	8C0252	97C-0466	Final rule; Confirmation of Effective Date CED; Archer Daniels Midland; Phaffia Yeast as a color additive in salmonid fish feed. 21 CFR 73.255. Effective 8/8/2000.
10/6/2000	65 FR 59717	8C0256	98C-0212	Final rule; Confirmation of Effective Date CED; Cyanotech Corp. Haematococcus algae meal as a color additive in salmonid fish feed. 21 CFR 73.185. Effective 8/8/00.
10/13/2000	65 FR 60858	9A4684	99F-3087	Final Rule; American Ingredients Co. Sodium stearoyl lactylate as emulsifier, stabilizer, and texturizer in cream liqueur drinks. 21 CFR 172.846.
10/30/2000	65 FR 64604	2A4332	92F-0305	Final Rule; Pfizer, Inc. Polydextrose as a bulking agent, texturizer, or both in tablespreads 21 CFR 172.841.
10/30/2000	65 FR 64605	9M4673	99F-2673	Final rule; Caudill Seed Co., Inc. Ionizing radiation to control microbial pathogens in seeds for sprouting; 21 CFR 179.26.
11/15/2000	65 FR 68888	3B4377	93F-03190	Final rule: Zeon Chemicals, Inc. Hydrogenated butadiene/ acrylonitrile copolymers in repeated use applications. 21 CFR 177.2600.
11/27/2000	65 FR 70660	0A4720	00F-1332	Final rule; Ecolab, Inc. Peroxyacetic acid, octanoic acid, acetic acid, hydrogen peroxide, peroxyoctanoic acid, and 1-hydroxyethylidene-1,1- diphosphonic acid as an antimicrobial agent on red meat carcasses. 21 CFR 173.370.
11/28/2000	65 FR 70789	9B4668	99F-1719	Final Rule: 4-(diiodomethyl sulfonyl) toluene slimicide in food contact paper and paperboard. 21 CFR 176.300.
11/29/2000	65 FR 71056	9M4676	99F-1912	Final rule; California Day-Fresh Foods, Inc., ultraviolet (UV) irradiation to reduce human pathogens and other microorganisms in juice product; 21 CFR 179.39.
12/20/2000	65 FR 79718	5A4478	95F-0305	Final Rule;  Pfizer, Inc.  Polydextrose as a bulking agent, texturizer, or both in fruit and water ices.  21 CFR 172.841.