Sec. 8. Safety substantiation for cosmetic ingredients and nonfunctional constituents
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Chapter VI ( 21 U.S.C. 361 et seq.), as amended by sections 3, 4, 5, 6, and 7, is further amended by adding at the end the following: A manufacturer or distributor of a cosmetic may rely on this section to substantiate the safety of such cosmetic. Unless and until prohibited or limited by the Secretary by regulation, the following ingredients are deemed to be adequately substantiated for safe use in cosmetics subject to the requirements of good manufacturing practice: Color additives approved by the Secretary for use in cosmetics, within any limits established in such approval.
Food additives approved by the Secretary for direct addition to food for human consumption, within any limits established in such approval. Food ingredients that have been determined by the Secretary to be generally recognized as safe for direct addition to food for human consumption, within any limits established in such determination. Food ingredients for which monographs have been included in the Food Chemicals Codex for direct addition to food for human consumption, within any limits established in such monographs.
Pharmaceutical excipients and inactive ingredients approved or permitted by the Secretary, listed on a Food and Drug Administration website for use in drugs for human consumption or for which monographs have been included in the Handbook of Pharmaceutical Excipients, within any limits established in such lists or monographs. Cosmetic ingredients that have been reviewed for safety by a qualified nongovernmental or governmental expert scientific body, including the Cosmetic Ingredient Review Expert Panel, and that are the subject of a monograph published in a peer-reviewed scientific journal, within any limits established in such monographs.
Fragrance ingredients that have been reviewed for safety by a qualified nongovernmental or governmental expert scientific body, including the Research Institute of Fragrance Materials Expert Panel, and that are the subject of a monograph published in a peer-reviewed scientific journal, within any limits established in such monographs. Cosmetic ingredients approved or permitted for use in cosmetics by any of the countries listed in section 802(b)(1)(A) as having an adequate regulatory authority, within any limits established by such regulatory authority.
A nonfunctional constituent in a cosmetic is any substance that— has not been intentionally added as a separate substance; and serves no technical or cosmetic function in the cosmetic. The following nonfunctional constituents are deemed to be adequately substantiated for safe use in cosmetics, subject to the requirements of good manufacturing practice and any limits or bans established by the Secretary by regulation: The levels approved or permitted for nonfunctional constituents by the Secretary for color additives for cosmetic use and for food additives and generally recognized as safe food ingredients for direct human consumption.
The levels approved or permitted for nonfunctional constituents by the Secretary for cosmetics and for food and food ingredients for direct human consumption in compliance policy guides, guidance, and website statements. The levels approved or permitted for nonfunctional constituents by the Secretary or the United States Pharmacopeia for oral nonprescription drugs. The levels approved or permitted for nonfunctional constituents by the Environmental Protection Agency for direct human consumption in drinking water.
The levels for nonfunctional constituents approved or permitted in cosmetics and human food and food ingredients by any of the countries listed in section 802(b)(1)(A) as having an adequate regulatory authority. The Secretary shall establish a program within the center of the Food and Drug Administration with primary responsibility for regulating cosmetics to evaluate and make determinations, by regulation, on the safe use of cosmetics and ingredients and nonfunctional constituents thereof.
A safety determination accepted or made by the Secretary or established under this section shall apply in every State. No State may establish or enforce a safety determination for a cosmetic or an ingredient or nonfunctional constituent of a cosmetic. Any regulation or guidance by the Secretary pursuant to this section concerning the safety of a cosmetic or an ingredient or nonfunctional constituent of a cosmetic shall apply beginning no earlier than the date that is 2 years after the date on which such regulation or guidance is issued as final, unless the Secretary determines, after public notice and an opportunity for public comment, that an earlier date of applicability is required to prevent serious adverse health consequences or death to humans. .
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Sec. 8
Safety substantiation for cosmetic ingredients and nonfunctional constituents
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