[Code of Federal Regulations] [Title 21, Volume 3] [Revised as of January 1, 2007] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR178.3295] [Page 401-403] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 178_INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND Subpart D_Certain Adjuvants and Production Aids Sec. 178.3295 Clarifying agents for polymers. Clarifying agents may be safely used in polymers that are articles or components of articles intended for use in [[Page 402]] contact with food, subject to the provisions of this section: ------------------------------------------------------------------------ Substances Limitations ------------------------------------------------------------------------ Aluminum, hydroxybis[2,4,8,10- For use only as a clarifying tetrakis(1,1-dimethylethyl)-6-hydroxy- agent at levels not to exceed 12H-dibenzo[d,g][1,3,2]dioxaphosphocin 0.25 percent by weight of 6-oxidato]-(CAS Reg. No. 151841-65-5). polypropylene and polypropylene copolymers complying with Sec. 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2. The finished polymers contact food only of types I, II, IV-B, VI- B, VII-B, and VIII as identified in Table 1 of Sec. 176.170(c) of this chapter, under conditions of use B through H described in Table 2 of Sec. 176.170(c) of this chapter or foods only of types III, IV-A, V, VI-A, VI-C, VII- A, and IX as identified in Table 1 of Sec. 176.170(c) of this chapter, under conditions of use C through G described in Table 2 of Sec. 176.170(c) of this chapter. Bis(p-ethylbenzylidene) sorbitol (CAS For use only as a clarifying Reg. No. 79072-96-1). agent at a level not to exceed 0.35 percent by weight of olefin polymers complying with Sec. 177.1520(c) of this chapter, items 1.1a, 1.1b, 3.1a, 3.2a, or 3.2b, where the copolymers complying with items 3.1a, 3.2a, or 3.2b contain not less than 85 weight percent of polymer units derived from propylene. Di(p-tolylidene) sorbitol (CAS Reg. No. For use only as a clarifying 54686-97-4). agent at a level not to exceed 0.32 percent by weight in propylene homopolymer complying with Sec. 177.1520(c) of this chapter, item 1.1, and in olefin copolymers complying with Sec. 177.1520(c) of this chapter, item 3.1 (containing at least 85 weight percent of polymer units derived from propylene), in contact with all food types under conditions of use C through G described in table 2 of Sec. 176.170(c) of this chapter. Dibenzylidene sorbitol (CAS Reg. No. For use only as a clarifying 32647-67-9) formed by the condensation agent for olefin polymers of two moles of benzaldehyde with one complying with Sec. mole of sorbitol, such that the final 177.1520(c) 1.1, 3.1, and 3.2 product has a minimum content of 95 of this chapter under percent dibenzylidene sorbitol. conditions of use C, D, E, F, and G, described in table 2 of Sec. 176.170(c) of this chapter at a level not exceeding 0.25 percent by weight of the polymer. Dimethyldibenzylidene sorbitol (CAS For use only as a clarifying Reg. No. 135861-56-2) agent at a level not to exceed 0.4 percent by weight of olefin polymers complying with Sec. 177.1520(c) of this chapter, items 1.1, 3.1, and 3.2, where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from polypropylene. The finished polymers shall be used in contact with food under conditions of use A through H described in table 2 of Sec. 176.170(c) of this chapter. Polyvinylcyclohexane (CAS Reg. No. For use only as a clarfiying 25498-06-0). agent for polypropylene complying with Sec. 177.1520(c) of this chapter, item 1.1., and in propylene containing copolymers complying with Sec. 177.1520(c) of this chapter, items 3.1 and 3.2, at a level not exceeding 0.1 percent by weight of the polyolefin. Sodium di(p-tert-butylphenyl)phosphate For use only as a clarifying (CAS Reg. No. 10491-31-3). agent at a level not exceeding 0.35 parts per hundred of the resin in olefin polymers complying with Sec. 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2 (where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from propylene). [[Page 403]] Sodium 2,2'-methylenebis(4,6-di-tert- For use only: butylphenyl)phosphate (CAS Reg. No. 1. As a clarifying agent at a 85209-91-2). level not exceeding 0.30 percent by weight of olefin polymers complying with Sec. 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2 (where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from polypropylene). The finished polymers contact foods only of types I, II, IV-B, VI-B, VII- B, and VIII as identified in table 1 of Sec. 176.170(c) of this chapter and limited to conditions of use B through H, described in table 2 of Sec. 176.170(c), or foods of all types, limited to conditions of use C through H described in table 2 of Sec. 176.170(c). 2. As a clarifying agent at levels not exceeding 0.10 percent by weight of polypropylene complying with Sec. 177.1520(c) of this chapter, items 1.1(a) or 1.1(b) and of olefin polymers complying with Sec. 177.1520(c) of this chapter, items 3.1(a), 3.1(b), 3.1(c), 3.2(a), or 3.2(b) (where the copolymers contain not less than 85 weight percent of the polymer units derived from polypropylene.) The finished polymers shall be used in contact with foods only under conditions of use A through H described in Table 2 of Sec. 176.170(c) of this chapter. 3. As a clarifying agent at a level not exceeding 0.30 percent by weight of olefin polymers complying with Sec. 177.1520(c) of this chapter, item 2.2, where the finished polymer contacts food only of types I, II, IV-B, VI-A, VI-B, and VII-B as identified in Table 1 of Sec. 176.170(c) of this chapter, and limited to conditions of use B through H described in Table 2 of Sec. 176.170(c) of this chapter, or foods of types III, IV-A, V, VI-C, and VII-A as identified in Table 1 of Sec. 176.170(c) of this chapter and limited to conditions of use C through G described in Table 2 of Sec. 176.170(c) of this chapter. ------------------------------------------------------------------------ [46 FR 59236, Dec. 4, 1981, as amended at 52 FR 30920, Aug. 18, 1987; 53 FR 30049, Aug. 10, 1988; 54 FR 12432, Mar. 27, 1989; 54 FR 14734, Apr. 12, 1989; 55 FR 52990, Dec. 26, 1990; 56 FR 1085, Jan. 11, 1991; 59 FR 13650, Mar. 23, 1994; 59 FR 25323, May 16, 1994; 61 FR 33847, July 1, 1996; 61 FR 51588, Oct. 3, 1996; 61 FR 65943, Dec. 16, 1996; 63 FR 56789, Oct. 23, 1998; 63 FR 68392, Dec. 11, 1998; 64 FR 26843, May 18, 1999; 65 FR 16316, Mar. 28, 2000]