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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2013]
[CITE: 21CFR178.3295]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 178 -- INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

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 contact with food, subject to the provisions of this section:

SubstancesLimitations
Aluminum, hydroxybis[2,4,8,10-tetrakis(1,1-dimethylethyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxidato]-(CAS Reg. No. 151841-65-5)For use only as a clarifying agent at levels not to exceed 0.25 percent by weight of polypropylene and polypropylene copolymers complying with 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 176.170(c) of this chapter, under conditions of use B through H described in Table 2 of 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 176.170(c) of this chapter, under conditions of use C through G described in Table 2 of 176.170(c) of this chapter.
Bis(p-ethylbenzylidene) sorbitol (CAS Reg. No. 79072-96-1)For use only as a clarifying agent at a level not to exceed 0.35 percent by weight of olefin polymers complying with 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. 54686-97-4)For use only as a clarifying agent at a level not to exceed 0.32 percent by weight in propylene homopolymer complying with 177.1520(c) of this chapter, item 1.1, and in olefin copolymers complying with 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 176.170(c) of this chapter.
Dibenzylidene sorbitol (CAS Reg. No. 32647-67-9) formed by the condensation of two moles of benzaldehyde with one mole of sorbitol, such that the final product has a minimum content of 95 percent dibenzylidene sorbitolFor use only as a clarifying agent for olefin polymers complying with 177.1520(c) 1.1, 3.1, and 3.2 of this chapter under conditions of use C, D, E, F, and G, described in table 2 of 176.170(c) of this chapter at a level not exceeding 0.25 percent by weight of the polymer.
Dimethyldibenzylidene sorbitol (CAS Reg. No. 135861-56-2)For use only as a clarifying agent at a level not to exceed 0.4 percent by weight of olefin polymers complying with 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 176.170(c) of this chapter.
Polyvinylcyclohexane (CAS Reg. No. 25498-06-0)For use only as a clarfiying agent for polypropylene complying with 177.1520(c) of this chapter, item 1.1., and in propylene containing copolymers complying with 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 (CAS Reg. No. 10491-31-3)For use only as a clarifying agent at a level not exceeding 0.35 parts per hundred of the resin in olefin polymers complying with 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).
Sodium 2,2'-methylenebis(4,6-di-tert-butylphenyl)phosphate (CAS Reg. No. 85209-91-2)For use only:1. As a clarifying agent at a level not exceeding 0.30 percent by weight of olefin polymers complying with 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 176.170(c) of this chapter and limited to conditions of use B through H, described in table 2 of 176.170(c), or foods of all types, limited to conditions of use C through H described in table 2 of 176.170(c).2. As a clarifying agent at levels not exceeding 0.10 percent by weight of polypropylene complying with 177.1520(c) of this chapter, items 1.1(a) or 1.1(b) and of olefin polymers complying with 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 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 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 176.170(c) of this chapter, and limited to conditions of use B through H described in Table 2 of 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 176.170(c) of this chapter and limited to conditions of use C through G described in Table 2 of 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]

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