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U.S. Food & Drug Administration Center for Food Safety & Applied Nutrition Food Ingredients and Packaging |
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 amendment 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. To access the specific Federal Register Citations listed below, select the 2000 Federal Register, type in the date of publication (EXACT) and type a keyword identifier from the subject column into the search dialogue box at the Government Printing Office web site. For information about additional food ingredient review programs in the Office of Premarket Approval, 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 Premarket Approval from January 1, 2000 until December 31, 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. For more information about the petition process visit Questions and Answers About the Petition Process on the Office of Premarket Approval's web site. Approvals for years 2000-present are also available.
| DATE | FEDERAL REGISTER CITATION | PETITION NUMBER | DOCKET 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. (Martin). |
| 1/21/2000 | 65 FR 3384 | 8B4597 | 98F-0569 | Final Rule: Ticona; Ethylene-norbornene copolymers in contact with dry food. 21 CFR 177.1520. (Smith). |
| 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. (Smith). |
| 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. (Machuga). |
| 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. (Gilliam). |
| 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. (Anand). |
| 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. (Gilliam). |
| 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. (Martin). |
| 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. (Smith). |
| 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. (Waldron). |
| 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. (Macon). |
| 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. (Gilliam). |
| 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. (Zajac). |
| 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. (Cheeseman). |
| 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. (Macon). |
| 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. (Macon). |
| 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. (Anand). |
| 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. (Macon). |
| 5/26/2000 | 65 FR 34081 | 0B4719 | 00F-0813 | Final rule: Tritex Co., Inc. Sodium xylenesulfonate in paper and paperboard. 21 CFR 176.170. (Hepp). |
| 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. (Martin). |
| 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. (Anand) |
| 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. (Gilliam). |
| 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. (Orstan). |
| 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. (Orstan). |
| 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. (Macon). |
| 7/21/2000 | 65 FR 45280 | 8M4584 | 98F-0165 | Final rule; Irradiation in the Production, Processing and Handling of Food. 21 CFR 179.26. (Trotter). |
| 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. (Waldron). |
| 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. (Orstan). |
| 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. (LaVecchia). |
| 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). (Macon). |
| 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). (Hepp). |
| 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. (Waldron). |
| 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. (Orstan) |
| 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. (Orstan) |
| 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. (Orstan) |
| 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. (LaVecchia). |
| 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. (Angeles) |
| 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. (Highbarger). |
| 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. (Zajac). |
| 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. (Martin). |
| 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. (Hepp). |
| 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. (Trotter). |
| 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. (Angeles) |