have been included in the Handbook of Pharmaceutical Excipients, within any limits established in such lists or monographs. (6) 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. (7) 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. (8) 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. (c) Safe nonfunctional constituents (1) Definition A nonfunctional constituent in a cosmetic is any substance that— (A) has not been intentionally added as a separate substance