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 19 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:
Mark Hepp, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3098.
SUPPLEMENTARY INFORMATION:
In notices published in the Federal Register (FR), on the dates indicated in the table below, FDA announced the filing of 19 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notifications for review under the agency's new PMN process for food-contact substances and that their petitions be withdrawn when the corresponding notifications become effective.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 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 The corresponding food additive petitions are now withdrawn without prejudice to a future filing (21 CFR 171.7).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. | FCN No. | FR Citation and Date | Company | Section/Part | Additive | Use |
|---|---|---|---|---|---|---|
| 9B4662, 99F-1419 | 1 | 64 FR 28000, May 24, 1999 | Milliken & Co. c/o Keller & Heckman. | Proposed new section in part 178. | Silver sodium hydrogen zirconium phosphate | Antimicrobial for polymers for food packaging. |
| 8B4632, 98F-1021 | 3 | 63 FR 67075, Dec. 4,1998 | Rohm and Haas Co. c/o Keller & Heckman. | 176.170 | Styrene acrylic copolymers | Paper and paperboard coating. |
| 8B4564, 98F-0053 | 5 | 63 FR 5808, Feb. 4, 1998 | Currently, BP Amoco Chemicals, Inc. | 177.1480 | Nitrile rubber modified acrylonitrile-methyl acrylate copolymers. | Beverage containers. |
| 5B4455, 95F-0092 | 4 | 60 FR 22400, May 5, 1995 | Currently, BP Amoco Chemicals, Inc. | 177.1630 | Ethylene terephthalate-isophthalate copolymers with 83-97 weight percent ethylene terephthalate units. | Components of food-contact articles. |
| 5B4450, 95F-0130 | 8 | 60 FR 32526, June 22, 1995 | Shell Chemicals Co. | 177.1630 | Ethylene terephthalate polymers containing less than 50 weight percent of polymer units derived from ethylene 2,6-naphthalene. | Components of food-contact articles. |
| 5B4451, 95F-0129 | 9 | 60 FR 32159, June 20, 1995 | Shell Chemicals Co. | Proposed new section in part 177. | Poly(oxy-1,2-ethanediyloxycarbonyl-2,6- napthalenediylcarbonyl) polymer and the copolymer poly(oxy-1,2-ethanediyloxy carbonyl-2,6-naphthalenediylcarbonyl) with ethylene terephthalate. | Components of food-contact articles. |
| 8B4582, 98F-0058 | 10 | 63 FR 6571, Feb. 9, 1998 | Currently, Sekisui Plastics Co., Ltd. c/o Ungaretti & Harris. | 177.1630 | Pyromellitic dianhydride | Modifier in ethylene terephthalate. copolymers. |
| 7B4558, 97F-0406 | 12 | 62 FR 51873, Oct. 3, 1997 | Sveriges Starkelseproducenter c/o Kirschman Assoc. | 178.3520 | Industrial starch modified with up to 21 percent 2,3-epoxypropyltrimethyl ammonium chloride. | Component of food-contact articles. |
| 9B4685, 99F-2908 | 19 | 64 FR 47843, Sept. 1, 1999 | The Goodyear Tire & Rubber Co. c/o Keller & Heckman. | 175.300 | Piperylene/2-methyl-2-butene/ alpha-methylstyrene terpolymer. | Can end cement. |
| 9B4645, 99F-0804 | 11 | 64 FR 19182, Apr. 19, 1999 | Rohm and Haas Co. | 176.170 and 176.300. | 4,5-Dichloro-2-n-octyl 3 (2H)-isothiazolone | Preservative and slimicide for paper and paperboard. |
| 7B4554, 97F-0414 | 15 | 62 FR 52137, Oct. 6, 1997 | Stilbene Whitening Agent Task Force c/o Keller & Heckman. | 176.170 | Benzenesulfonic acid, 2,2-(1,2-ethenediyl)bis[5- [[4-[bis(2-hydroxyethyl)-amino]-6- [(4-sulfonphenyl)amino]-1,3,5-triazin-2- yl]amino]-,tetrasodium salt. | Optical brightner in paper and paperboard. |
| 8B4617, 98F-0714 | 20 | 63 FR 46226, Aug. 31, 1998 | Asahi Denka Kogyo, K.K. c/o Japan Technical Information Center, Inc. | 178.2010 | 2,2′-methylenebis(4,6-di-tert-butylphenyl)2- ethylhexyl phosphite. | Antioxidant and/or stabilizer in linear low density polyethylene. |
| 8B4599, 98F-0436 | 21 | 63 FR 34188, June 23, 1998 | Asahi Denka Kogyo, K.K. c/o Japan Technical Information Center, Inc. | 178.2010 | 2,2′-methylenebis(4,6-di-tert-butylphenyl)2 -ethylhexyl phosphite. | Antioxidant and/or stabilizer in high density polyethylene. |
| 9B4679, 99F-2552 | 22 | 64 FR 43189, Aug. 9, 1999 | Asahi Denka Kogyo, K.K. c/o Japan Technical Information Center, Inc. | 178.2010 | Phosphorous acid, cyclic neopentanetetrayl bis(2,6-di-tert-butyl-4-methylphenyl) ester. | Antioxidant and/or stabilizer in polyolefins. |
| 9B4667, 99F-2080 | 23 | 64 FR 36361, July 6, 1999 | Engelhard Corp. | 178.3297 | Solution of 1-naphthalenesulfonic acid, 12-[(2-hydroxy-6-sulfo-1- naphthalenyl)azo]-, strontium salt (1:1) and 2-naphthalenesulfonic acid, 5- [4-chloro-5-ethyl- 2-sulfophenyl)azo]-6-hydroxy-, strontium salt (1:1) (C.I. Pigment Red 277). | Colorant for polymers. |
| 7A4541, 97F-0175 | 30 | 62 FR 25633, May 9, 1997 | Currently, Betz Dearborn c/o Keller and Heckman | 173.310 | Copolymer of acrylic acid and polyethylen eglycol allyl ether. | Boiler water additive. |
| 9B4694, 99F-2998 | 29 | 64 FR 48654, Sept. 7, 1999 | Asahi Denka Kogyo, K.K. | 178.2010 | Tridecanol phosphite condensation product with butylidenebis[2-(1,1- dimethylethyl)- 5-methyl-4,1-phenylene]. | Antioxidant and/or stabilizer in styrene-isoprene-styrene copolymer to be used as a component of pressure-sensitive adhesives. |
| 9B4691, 99F-2997 | 25 | 64 FR 49496, Sept. 13, 1999 | Engelhard Corp. | 178.3297 | 1-naphthelenesulfonic acid, 2-[(4,5-dihydro-3-methyl- 5-oxo-1-(3- Sulfophenyl)-1H-pyrazol-4- yl)azo]-, strontium and calcium salt (1:1)(C.I. Pigment 209 and C.I. Pigment 209:1). | Colorant for polymers. |
| 9B4698, 99F-4373 | 26 | 64 FR 58070, Oct. 28, 1999 | Engelhard Corp. | 178.3297 | A solid solution of 2-naphthalene sulfonic acid, 15-[(5-chloro-4-methyl-2- sulfophenyl)azo]- 6-hydroxy]-, strontium salt (1:1) and 2-naphthalenesulfonic acid, 5-[(4-chloro-5-ethyl-2-sulfonphenyl)azo]-6- hydroxy]-,strontium salt (1:1)(C.I. Pigment Red 276). | Colorant for polymers. |
| Food additive petition number. | ||||||
| Food-contact notification number. |
Dated: June 28, 2000.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for food Safety and Applied Nutrition.
[FR Doc. 00-17199 Filed 7-6-00; 8:45 am]
BILLING CODE 4160-01-F