§174.5. General provisions applicable to indirect food additives. — Inbound Citations

(b) The manufacturer shall maintain all records that pertain to food-packaging materials subject to § 174.5 of this chapter and that bear on whether such materials would cause an infant formula to be adulterated within the meaning of section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(2)(C)).

(b) The basic polymer identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic polymer. These optional adjuvant substances may include substances used in accordance with § 174.5 of this chapter.

(c) Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer, identified in paragraph (a) of this section, may contain optional adjuvant substances required in their production. The optional adjuvants may include substances used in accordance with § 174.5 of this chapter.

(3) Optional adjuvant substances used in accordance with § 174.5 of this chapter.

(b) The basic polyaryletherketone resins identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic resins. These adjuvants may include substances used in accordance with § 174.5 of this chapter and the following:

(2) [Reserved]

(1) Substances used in accordance with § 174.5 of this chapter.

(1) Optional adjuvant substances authorized for this use in accordance with § 174.5 of this chapter.

(ii) Volatile substances employed in the manufacture of high-temperature laminates must be removed to the greatest extent possible in keeping with good manufacturing practice prescribed in § 174.5(a) of this chapter.

(c) Optional adjuvant substances employed in the production of the coatings or added thereto to impart desired properties may include sodium dodecylbenzenesulfonate in addition to substances described in § 174.5(d) of this chapter.

(b) The basic polysulfone resins identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic resins. The optional adjuvant substances required in the production of the basic polysulfone resins may include substances described in § 174.5(d) of this chapter and the following:

(b) The basic resins identified in paragraph (a) may contain optional adjuvant substances used in their production. These adjuvants may include substances described in § 174.5(d) of this chapter and the following:

(b) The basic resins identified in paragraphs (a)(1) and (a)(2) of this section may contain optional adjuvant substances described in § 174.5(d) of this chapter and the following: