21 CFR §74.2340

1. (a)Identity and specifications.
   1. (1)The color additive FD&C Red No. 40 shall conform in identity and specifications to the requirements of § 74.340(a)(1) and (b) of this chapter.
   2. (2)The listing of this color additive includes lakes prepared as described in §§ 82.51 and 82.1051 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by § 82.51 or § 82.1051 of this chapter.
2. (b)Uses and restrictions. FD&C Red No. 40 may be safely used in coloring cosmetics generally, except that only FD&C Red No. 40 and FD&C Red No. 40 Aluminum Lake may be safely used in coloring cosmetics intended for use in the area of the eye. These uses are subject to the following restrictions:
   1. (1)The color additive may be used in amounts consistent with current good manufacturing practice.
   2. (2)The color additive shall not be exposed to oxidizing or reducing agents that may affect the integrity of the color additives or any other condition that may affect their integrity.
3. (c)Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.
4. (d)Certification. All batches of FD&C Red No. 40 shall be certified in accordance with regulations in part 80 of this chapter.