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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2015.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2015]
[CITE: 21CFR175.125]



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 175 -- INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS

Subpart B--Substances for Use Only as Components of Adhesives

Sec. 175.125 Pressure-sensitive adhesives.

Pressure-sensitive adhesives may be safely used as the food-contact surface of labels and/or tapes applied to food, in accordance with the following prescribed conditions:

(a) Pressure-sensitive adhesives prepared from one or a mixture of two or more of the substances listed in this paragraph may be used as the food-contact surface of labels and/or tapes applied to poultry, dry food, and processed, frozen, dried, or partially dehydrated fruits or vegetables.

(1) Substances generally recognized as safe in food.

(2) Substances used in accordance with a prior sanction or approval.

(3) Color additives listed for use in or on food in parts 73 and 74 of this chapter.

(4) Substances identified in 172.615 of this chapter other than substances used in accordance with paragraph (a)(2) of this section.

(5) Polyethylene, oxidized; complying with the identity prescribed in 177.1620(a) of this chapter.

(6) 4-<4, 6-Bis(octylthio)-s -triazin-2-yl]amino]-2,6-di-tert -butylphenol (CAS Reg. No. 991-84-4) as an antioxidant/stabilizer at a level not to exceed 1.5 percent by weight of the finished pressure-sensitive adhesive.

(7) 2,2'-(2,5-Thiophenediyl)-bis(5-tert -butylbenzoxazole) (CAS Reg. No. 7128-64-5) as an optical brightener at a level not to exceed 0.05 percent by weight of the finished pressure-sensitive adhesive.

(8) 2-Hydroxy-1-[4-(2-hydroxyethoxy) phenyl]-2-methyl-1-propanone (CAS Reg. No. 106797-53-9) as a photoinitiator at a level not to exceed 5 percent by weight of the pressure-sensitive adhesive.

(9) Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium salt (also known as butanedioic acid sulfo-1, 4-diisodecyl ester, ammonium salt [CAS Reg. No. 144093-88-9]) as a surface active agent at a level not to exceed 3.0 percent by weight of the finished pressure-sensitive adhesive.

(b) Pressure-sensitive adhesives prepared from one or a mixture of two or more of the substances listed in this paragraph may be used as the food-contact surface of labels and/or tapes applied to raw fruit and raw vegetables.

(1) Substances listed in paragraphs (a)(1), (a)(2), (a)(3), (a)(5), (a)(6), (a)(7), (a)(8), and (a)(9) of this section, and those substances prescribed by paragraph (a)(4) of this section that are not identified in paragraph (b)(2) of this section.

(2) Substances identified in this subparagraph and subject to the limitations provided:

BHA.

BHT.

Butadiene-acrylonitrile copolymer.

Butadiene-acrylonitrile-styrene copolymer.

Butadiene-styrene copolymer.

Butyl rubber.

Butylated reaction product of p -cresol and dicyclopentadiene produced by reacting p -cresol and dicyclopentadiene in an approximate mole ratio of 1.5 to 1.0, respectively, followed by alkylation with isobutylene so that the butyl content of the final product is not less than 18 percent, for use at levels not to exceed 1.0 percent by weight of the adhesive formulation.

Chlorinated natural rubber.

Isobutylene-styrene copolymer.

Petrolatum.

Polybutene-1.

Polybutene, hydrogenated; complying with the identity prescribed under 178.3740(b) of this chapter.

Polyisobutylene.

cis- 1,4-Polyisoprene.

Polystyrene.

Propyl gallate.

Rapeseed oil, vulcanized.

Rosins and rosin derivatives as provided in 178.3870 of this chapter.

Rubber hydrochloride.

Rubber (natural latex solids or crepe, smoked or unsmoked).

Terpene resins ([alpha]- and [beta]-pinene), homopolymers, copolymers, and condensates with phenol, formaldehyde, coumarone, and/or indene.

Tetrasodium ethylenediaminetetraacetate.

Tri(mixed mono- and dinonylphenyl) phosphite (which may contain not more than 1 percent by weight of triisopropanolamine).

(c) Acrylonitrile copolymers identified in this section shall comply with the provisions of 180.22 of this chapter.

[42 FR 14534, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977; 48 FR 15617, Apr. 12, 1983; 63 FR 3464, Jan. 23, 1998; 63 FR 51528, Sept. 28, 1998; 64 FR 48291, Sept. 3, 1999]

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