; and (iv) experience with the ingredient or non-functional constituent in products that are distributed in the United States or in other countries, if such experience is well-documented and has resulted in substantial human exposure to the ingredient or non-functional constituent over time. . 609. Safety of finished cosmetic products (a) Determination (1) In general Each responsible person for a finished cosmetic product, before first introducing or delivering for introduction into interstate commerce, or, in the case of such a product in interstate commerce on the date of enactment of the Personal Care Products Safety Act , not later than the date on which registration is first required under subsection 605(b), shall make a written determination that the product is safe under the conditions of use recommended in the labeling of the product. Such determination shall be based on adequate evidence that each ingredient in the finished product is safe for the use recommended or suggested in the labeling of the product and that the finished product is safe. (2) New information If new information relevant to the determination becomes available, the responsible person shall promptly update the determination to address that information. (3) Safety with respect to ranges of possible amounts In the case of a cosmetic product for which there is a range of possible amounts of cosmetic ingredients included in the cosmetic ingredient statement, as described in section 606(c)(2)(E), the safety determination under paragraph (1) shall include substantiation of the safety of the full range in the finished product. (4) Small businesses A small business registrant (as defined in section 605(e)(2)(B)(ii)) may satisfy the requirements of this section by using the ingredients in concentrations recommended by available medical or scientific guidelines, or cosmetic manufacturing reference, and following any other specific instructions for use recommended by the ingredient manufacturer. (b) Presumption of adequate evidence (1) In general