; and (B) that has annual sales receipts for cosmetic products that do not exceed $2,000,000. (8) Professional use The term professional use means the use of any cosmetic— (A) by an employee (within the scope of the employment of such employee) of; or (B) purchased by a consumer in, a hair salon, nail salon, beauty salon, spa, or other establishment that provides cosmetic treatment services for humans. (9) Reasonable certainty of no harm With respect to an ingredient or cosmetic, the term reasonable certainty of no harm means that no harm will be caused to members of the general population or any vulnerable population by aggregate exposure to the cosmetic or ingredient, taking into account possible harmful effects from— (A) low-dose exposures to the cosmetic or ingredient; (B) additive effects resulting from repeated exposure to the cosmetic or ingredient over time; or (C) cumulative exposure resulting from all sources, including both the cosmetic or ingredient and environmental sources. (10) Reproductive or developmental toxicity With respect to an ingredient or cosmetic, the term reproductive or developmental toxicity means that the ingredient or cosmetic can contribute to biologically adverse effects on the development of humans or animals, including effects on the female or male reproductive system, the endocrine system, fertility, pregnancy, pregnancy outcomes, or modifications in other functions of the body that are dependent on the integrity of the reproductive system as well normal fetal development. (11) Serious adverse event The term serious adverse event means— (A) an acute or chronic response that results in death, a life-threatening experience, short- or long-term hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, serious and persistent rashes or infections, significant hair loss, permanent or significant alteration of appearance, or impacts to maternal health, including placentia previa, gestational diabetes, and miscarriage