AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of 18 food additive petitions proposing that the food additive regulations be amended to provide for the safe use of certain new food additives. The petitioners subsequently requested that their petitions be converted to food-contact notifications for review under the agency’s new premarket notification (PMN) program for food-contact substances. The requested uses are now the subjects of effective notifications.
FOR FURTHER INFORMATION CONTACT:
Sylvia D. Dodson, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3087.
SUPPLEMENTARY INFORMATION:
In notices published in the Federal Register on the dates indicated in the table below, FDA announced the filing of 18 food additive petitions. These petitions proposed to amend the food additive regulations in the sections listed in the table to provide for the safe use of the listed substances intended for use in food-contact articles. Since publication of these filing notices, the petitioners have requested that their respective petitions be converted to food-contact notifications for review under the agency’s new PMN process for food-contact substances and that their petitions be withdrawn when the corresponding notifications become effective. These petitions were converted to notifications and subsequently reviewed under the PMN process. The requested uses are now the subjects of effective notifications. The corresponding food additive petitions are now withdrawn without prejudice to a future filing (21 CFR 171.7).
Table 1.
| FAP No. and Docket No. | FNC No. | FR Citation and Date | Company | Section/Part | Additive | Use |
|---|---|---|---|---|---|---|
| 3B4354, 93F-0199 | 28 | 59 FR 59410, Nov. 17, 1994 | Asahi Chemical Industry Co., Ltd., c/o Regulatory Assistance Corp. | 175.105 and 177.1810 | Maleic anhydride modified hydrogenated styrene butadiene block polymer. | Not Specified. |
| 7A4539, 98F-0226 | 31 | 63 FR 18921, Apr. 16, 1998 | Nalco Chemical Co. | 173.310 | Disodium or dipotassium fluorescein. | In boilers where steam may contact food. |
| 8B4569, 98F-0289 | 34 | 63 FR 25864, May 11, 1998 | UBE Industries, Ltd., c/o Center for Regulatory Services. | 177.1500 | Nylon 6/12 copolymer resins manufactured using at least 80 weight percent epsilon-caprolactam and no more than 20 weight percent omega-aminododecanoic acid. | In contact with food. |
| 0B4204, 90F-0188 | 44 | 55 FR 26264, June 27, 1990 | Toyobo Co., Ltd. | 177.1630 | Hexanedioic acid polymer with 1,3-benzenedimethanamine. | Modifier for polyethylene phthalate (PET) polymers. |
| 9A4659, 99F-1074 | 45 | 64 FR 23337, Apr. 30, 1999 | Life Technologies, Inc. | 173.25 | Quaternary amine cellulose ion exchange resins. | Isolation and purification of protein concentrates and isolates from aqueous process streams for food processing. |
| 6B4488, 96F-0032 | 47 | 61 FR 5001, Feb. 2, 1996 | Shinagawa Fuel Co., Ltd., c/o Keller and Heckman. | Proposed new section in part 178. | Silver-zinc zeolite. | Agent to control the growth of microorganisms in plastic resins used in food-contact applications. |
| 0B4702, 00F-0089 | 51 | 65 FR 1908, Jan. 12, 2000 | Ciba Specialty Chemicals Corp. | 178.2010 | Phosphorous acid, bis[2,4-bis(1,1-dimethyl)-6-methylphenyl]ethyl ester. | Stabilizer in olefin polymers intended to contact food. |
| 0B4700, 99F-5012 | 53 | 64 FR 66480, Nov. 26, 1999 | Ciba Specialty Chemicals Corp. | 178.2010 | Oxidized bis (hydrogenated tallow alkyl) amines. | Process stabilizer for certain olefin polymers intended for use in contact with food. |
| 6B4506, 96F-0223 | 54 | 61 FR 35770, July 8, 1996 | Henkel Corp. | Proposed new section in part 176. | α-Sulfo--(dodecyloxy)poly(oxyethylene), sodium salt. | An emulsifier in the production of acrylic and vinyl acetate polymers coatings for paper and paperboard. |
| 9A4677, 99F-2244 | 55 | 64 FR 37984, July 14, 1999 | Bayer Corp., c/o ENVIRON International Corp. | 173.25 | Terpolymer of styrene, divinyl benzene, and ethylvinyl benzene, aminomethylated, then quarternized with methyl chloride. | As an ion exchange resin for use in treating aqueous solutions of sugar and hydrolyzed starch. |
| 5B4448, 95F-0011 | 63 | 60 FR 7060, Feb. 6, 1995 | Kuraray International Co. | 177.1810 | Styrene block copolymer with 2-methyl-1,3-butadiene and 1,3-butadiene, hydrogenated. | As a component of articles that contact food. |
| 3B3677, 82F-0349 | 64 | 47 FR 56556, Dec. 17, 1982 | Calgon Corp. | 176.170 | Diallyldimethylammonium chloride and acrylamide. | As a retention and/or drainage aid employed in the manufacture of paper and paperboard intended to contact food. |
| 9B4646, 99F-0460 | 67 | 64 FR 13430, Mar. 18, 1999 | Akzo Nobel Chemicals, Inc., c/o Keller and Heckman. | 177.1520 and 177.2600 | 3,6,9-Triethyl-3,6,9-trimethyl-1,4,7-triperoxynonane. | As a modifier in the production of olefin polymers used as components of food-contact articles. |
| 8B4590, 98F-0288 | 68 | 63 FR 25213, May 7, 1998 | Mitsui Chemicals, Inc., c/o Keller and Heckman | 177.1520 | Propylene/butene-1 copolymers containing greater than 15 but no more than 35 weight percent of polymer units derived from butene-1. | In contact with food. |
| 1B4256, 91F-0169 | 69 | 56 FR 32435, July 16, 1991 | W. R. Grace, Ltd. | 175.300 | Styrene-butadiene-methacrylic acid terpolymer, 1,2-benzisothiazolin-3-one, and sulfosuccinic acid 4-ester with polyethylene glycol dodecyl ether, disodium salt. | Components in can end cements in contact with food. |
| 3B4373, 93F-0157 | 70 | 58 FR 29231, May 19, 1993 | Shell Oil Co. | Proposed new section. | Two carbon monoxide-olefin polymers, carbon monoxide-ethylene, and carbon monoxide-ethylene-propylene. | As articles or components of articles intended for use in contact with food. |
| 9A4640, 99F-0052 | 74 | 64 FR 3703, Jan. 25, 1999 | Bayer Corp., c/o ENVIRON Corp. | 173.25 | Completely hydrolyzed tetrapolymer of divinyl benzene, ethyl vinyl benzene, acrylonitrile, and 1, 7-octadiene. | In treating aqueous sugar solutions and beverage water. |
| 9B4672, 99F-2245 | 83 | 64 FR 37984, July 14, 1999 | BP Amoco Chemicals, Inc. | Proposed new section in part 177. | Poly(oxy[1,1′-biphenyl]-4,4′-diyloxy-1,4-phenylenesulfonyl-1,4-phenylene) prepared by reaction of biphenol and 4,4′-dichlorodiphenylsulfone. | As articles or components of articles intended for contact with food. |
| Food additive petition number. | ||||||
| Food contact notification number. |
October 25, 2000.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for Food Safety and Applied Nutrition.
[FR Doc. 00-30326 Filed 11-27-00; 8:45 am]
BILLING CODE: 3510-22-S