Cosmetovigilance
Cosmetovigilance is defined as the set of activities related to the detection, collection, evaluation, monitoring, understanding and prevention of unwanted effects associated with the intended use of cosmetic products.
The use of any cosmetic product can cause unwanted effects. These unexpected symptoms or signs are known as adverse cosmetic reactions (ACRs).
The objective of cosmetovigilance is to understand the safety behavior of cosmetic products over time and during widespread use. This is achieved primarily through information provided by ACR reports. The Public Health Institute analyzes reported suspected ACRs, along with safety information from other sources. When a risk is detected, the Institute proposes measures to promote the safe use of cosmetic products, preventing or mitigating health problems associated with their use and safeguarding the well-being of the population.
WHAT IS A COSMETIC PRODUCT?
A cosmetic product is a variety of mixtures of ingredients of natural or synthetic origin, for external use and topical application. These products are not ingested or injected; they are applied to the body in general, including hair, nails, lips, external genitalia, and oral mucosa. They are used to cleanse, protect, perfume, maintain, or modify the appearance of the area where they are applied. Examples of cosmetic products include shampoos, soaps, toothpaste, mouthwash, perfumes, moisturizing or nourishing creams, foot powder, deodorants, sunscreen, tanning lotions, hair dyes, and more.
WHAT IS AN ADVERSE REACTION?
Although it is authorized by the Chilean Public Health Institute (ISP), the use of any cosmetic product can cause unwanted effects. These unexpected symptoms or signs are known as adverse reactions to cosmetic products (ARPs), which can range from an allergic reaction to immediate life-threatening conditions or death. Adverse reactions may include dermatitis, eczema, discoloration, irritation, itching, peeling, infection, conjunctivitis, temporary or permanent functional impairment, disability, hospitalization, birth defects, or life-threatening conditions.
WHAT TO DO IF A ARPs IS FILED?
When you become aware of an adverse reaction, whether because an acquaintance or you yourself experience an unwanted effect, you must notify BIOTEC, which is responsible for monitoring its cosmetic products, by completing the form. It is vital that you take this action so that BIOTEC can track the product to assess whether the reaction is caused by it and take the corresponding health measures, as well as prevent a possible adverse effect from happening to other people.
STEPS TO NOTIFY:
Cosmetic Adverse Reaction Reporting Form (ACR)
To complete the form, you will need the product name, marketing authorization number (ISP Registration), and batch number. You will also need patient information, a description of the ACR, the time of onset, and other relevant details.
Send the attached form to bioteccosmetovigilancia@ispch.cl or to the email address you will be automatically redirected to after completing it.
ADVICES:
Purchase cosmetic products from established retailers.
Verify that the cosmetic product is authorized for sale.
Cosmetic products are frequently used by various people at different stages of their lives, using between 3 and 8 products daily.
Follow the manufacturer’s instructions regarding usage, warnings, precautions, and storage conditions for the cosmetic product.
If you have any doubts about a cosmetic product, consult the ISP (Chilean Public Health Institute) as you can report product quality defects, counterfeit products, products without sanitary authorization, or sales in unauthorized locations.
All cosmetic products can cause adverse reactions due to their composition, misuse, or individual user characteristics, including those labeled as hypoallergenic, natural, artisanal, or organic. Therefore, we recommend performing a skin sensitivity test by applying a small amount to an area of the body and waiting a few hours to observe the reaction.