; and (ii) explaining why the available data and information are not adequate to assess the safety of the ingredient or non-functional constituent. (B) Adequate data and information If the Food and Drug Administration determines, after considering any additional data and information submitted under paragraph (1)(B), that the available data and information are adequate to make a determination regarding safety under subsection (d)(4), the Food and Drug Administration shall, within 180 days of the close of the comment period, issue a proposed order, followed by a final order, on such cosmetic ingredient or non-functional constituent, in accordance with such subsection. (h) Safety assessment (1) In general In assessing the safety of an ingredient or non-functional constituent, the Food and Drug Administration shall consider whether there is adequate evidence to support a reasonable certainty among competent scientists that the ingredient is not harmful under the recommended or suggested conditions of use or customary or usual use, or that a non-functional constituent is not harmful under the recommended or suggested tolerance levels or the level at which it is customarily or usually present. The Food and Drug Administration may not consider an ingredient or non-functional constituent harmful solely because it can cause minor adverse health reactions, such as minor transient allergic reactions or minor transient skin irritations, in some users. (2) Factors In assessing the safety of an ingredient or non-functional constituent, the Food and Drug Administration shall consider, among other relevant factors, the following: (A) The probable human exposure to the ingredient or non-functional constituent from expected use in cosmetics. (B) The probable cumulative and aggregate effect in humans of relevant exposure to the ingredient or non-functional constituent or to any chemically or pharmacologically related substances from use in cosmetics or other products with similar routes of exposure under recommended or suggested