This text “establishes good cosmetovigilance practices for companies whose cosmetic products are regulated by the National Health Surveillance Agency (Anvisa)” and covers “personal care products, cosmetics and perfumes.”

Reporting adverse events

Serious adverse events must be reported to the health authority within a maximum of 20 working days from the date of knowledge of the event.

According to the definitions given in the text:
• An adverse reaction is a reaction which is harmful to human health and which occurs as a result of the normal or reasonably foreseeable use of a cosmetic product
• An adverse event is “any undesirable or unexpected experience, detrimental to health, which occurs after use of or exposure to a cosmetic product and which is not necessarily related to cause-and-effect relationship”
• A serious adverse event is an adverse event which has one or more of the following consequences:
a) Death
b) Life-threatening risk
c) Hospitalisation
d) Permanent or significant disability or damage (substantial interruption of the person’s ability to carry out the normal functions of daily life, significant, persistent or permanent modification of body functions/structures, physical activities and/or the person’s quality of life)
e) Congenital abnormality or defect
f) Other clinically significant events …