{"data":{"id":"us/21-cfr-73.3110","jurisdiction":"us","citation":"21 CFR 73.3110","heading":"Chlorophyllin-copper complex, oil soluble.","body":"(a) Identity. The color additve is chlorophyllin-copper complex, oil soluble. The chlorophyllin is obtained by extraction from a mixture of fescue and rye grasses. The chlorophyll is acid-treated to remove chelated magnesium which is replaced with hydrogen, which is turn is replaced with copper. This mixture is diluted to a 5 percent concentration with a mixture of palm oil, peanut oil, and hydrogenated peanut oil.\n(b) Specifications. The color additive chlorophyllin-copper complex, oil soluble (5 percent in palm oil, peanut oil, and hydrogenated peanut oil), shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice:\nMoisture, not more than 0.5 percent.\nNitrogen, not less than 0.2 percent and not more than 0.3 percent.\nTotal copper, not less than 0.2 percent and not more than 0.4 percent.\nFree copper, not more than 200 parts per million.\nLead, not more than 20 parts per million.\nArsenic, not more than 5 parts per million.\nSulfated ash, not more than 2.5 percent.\nTotal color, not less than 4.5 percent and not more than 5.5 percent.\n(c) Uses and restrictions. (1) The color additive chlorophyllin-copper complex, oil soluble (5 percent in palm oil, peanut oil, and hydrogenated peanut oil), may be safely used to color polymethylmethacrylate bone cement. Chlorophyllin-copper complex may be used at levels that do not exceed 0.003 percent by weight of the bone cement.\n(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the polymethylmethacrylate bone cement in which chlorophyllin-copper complex, oil soluble, is used.\n(d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.\n(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL","PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION","Subpart D—Medical Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"4f7fcf846847d690c60b89f50327f1c8cc567286680a018beaebb43978b1da9f","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-73.3107","next":"us/21-cfr-73.3110a"},"notice":"GroundRules: Original legal text. Not legal advice."}